TY - JOUR AU - Arrington-Sanders, Renata AU - Hailey-Fair, Kimberly AU - Wirtz, Andrea AU - Cos, Travis AU - Galai, Noya AU - Brooks, Durryle AU - Castillo, Marne AU - Dowshen, Nadia AU - Trexler, Constance AU - D?Angelo, J. Lawrence AU - Kwait, Jennafer AU - Beyrer, Chris AU - Morgan, Anthony AU - Celentano, David AU - PY - 2020/9/16 TI - Providing Unique Support for Health Study Among Young Black and Latinx Men Who Have Sex With Men and Young Black and Latinx Transgender Women Living in 3 Urban Cities in the United States: Protocol for a Coach-Based Mobile-Enhanced Randomized Control Trial JO - JMIR Res Protoc SP - e17269 VL - 9 IS - 9 KW - African-American KW - Latinx KW - men and transgender KW - HIV KW - youth KW - mobile phone N2 - Background: The US National HIV/AIDS Strategy 2020 calls for increasing access to care, improving outcomes of people living with HIV, and targeting biomedical prevention efforts, including access to pre-exposure prophylaxis (PrEP) in communities where HIV is most heavily concentrated. The cities of Baltimore, Maryland (MD); Washington, DC; and Philadelphia, Pennsylvania (PA) are disproportionately burdened by high rates of new cases of HIV infection, with high prevalence among young Black and Latinx men who have sex with men (YBLMSM) and young Black and Latinx transgender women (YBLTW) aged 15-24 years. Objective: This study aims (1) to identify and recruit YBLMSM and YBLTW who are at risk or living with HIV in Baltimore, MD; Philadelphia, PA; and Washington, DC, using respondent-driven sampling (RDS) with targeted seed selection, and (2) to assess the efficacy of a coach-based mobile-enhanced intervention (MEI) compared with standard of care (SOC) to increase successful engagement and retention into HIV, PrEP, and substance use treatment care across the HIV care and prevention continua in 3 Mid-Atlantic cities. This paper describes the protocol and progress as of October 20, 2019. Methods: This study uses a multiphase mixed methods design. The first phase is a formative, qualitative research with focus group discussions and key informant interviews. The second phase consists of evaluating the ability of RDS with targeted seed selection. The third phase includes 2 embedded randomized controlled trials (RCTs), where participants complete a baseline sociobehavioral survey, rapid HIV testing, and eligible youth enroll in parallel status-dependent RCTs that randomize the participant to 1 of 2 study arms: MEI with coach or SOC. Participants are asked to complete a web-based survey and provide biologic specimens?HIV-1 RNA (viral load) or HIV-1 antibody test and urine drug screen?at baseline and at 3, 6, and 12 months, and an exit interview at 18 months. Results: A formative qualitative research was conducted in February 2017 and May 2018, and this led to further refinement of recruitment and study methods. Aim 1 recruitment began in September 2017 with subsequent enrollment into the RCTs. Recruitment is ongoing with 520 participants screened and 402 (77.3%) enrolled in aim 1 by October 2020. Of these, 159 are enrolled in the 2 randomized trials: 36 (22.6%) HIV-positive not virally suppressed (aim 2) and 123 (77.4%) high-risk HIV-negative (aim 3). Conclusions: This study has the potential to significantly impact the medical and substance use services provided to YBLMSM and YBLTW in the United States by providing rigorous scientific evidence outlining approaches and strategies that improve the uptake and engagement of YBLMSM and YBLTW in the HIV treatment and prevention continuum. Trial Registration: ClinicalTrials.gov NCT03194477; https://clinicaltrials.gov/ct2/show/NCT03194477 International Registered Report Identifier (IRRID): DERR1-10.2196/17269 UR - https://www.researchprotocols.org/2020/9/e17269 UR - http://dx.doi.org/10.2196/17269 UR - http://www.ncbi.nlm.nih.gov/pubmed/32935662 ID - info:doi/10.2196/17269 ER - TY - JOUR AU - Chen, Jinsong AU - Ho, Elsie AU - Jiang, Yannan AU - Whittaker, Robyn AU - Yang, Tingzhong AU - Bullen, Christopher PY - 2020/9/18 TI - A Mobile Social Network?Based Smoking Cessation Intervention for Chinese Male Smokers: Protocol for a Pilot Randomized Controlled Trial JO - JMIR Res Protoc SP - e18071 VL - 9 IS - 9 KW - mHealth KW - mobile phone KW - smoking cessation KW - public health N2 - Background: Approximately 2 million Chinese people die annually from tobacco-related diseases, mostly men; yet, fewer than 8% of Chinese smokers ever receive any smoking cessation advice or support. A social network?based gamified smoking cessation intervention (SCAMPI: Smoking Cessation App for Chinese Male: Pilot Intervention) is designed to help Chinese male smokers to quit smoking. Objective: This paper aims to present the protocol of a study examining the preliminary effectiveness of SCAMPI by comparing the prolonged abstinence rate of a group of users with a comparator group during a 6-week follow-up period. Methods: A two-arm pilot randomized controlled trial was conducted to assess the preliminary effectiveness and acceptability of the SCAMPI program as a smoking cessation intervention. After initial web-based screening, the first 80 eligible individuals who had gone through the required registration process were registered as participants of the trial. Participants were randomly allocated to the intervention group (n=40) and the control group (n=40). Participants in the intervention group used the full version of the SCAMPI program, which is a Chinese smoking cessation program developed based on the Behavior Change Wheel framework and relevant smoking cessation and design guidelines with involvement of target users. The program delivers a range of smoking cessation approaches, including helping users to make quitting plans, calculator to record quitting benefits, calendar to record progress, gamification to facilitate quitting, providing information about smoking harms, motivational messages to help users overcome urges, providing standardized tests to users for assessing their levels of nicotine dependence and lung health, and providing a platform to encourage social support between users. Participants in the control group used the restricted version of the SCAMPI program (placebo app). Results: Recruitment for this project commenced in January 2019 and proceeded until March 2019. Follow-up data collection was commenced and completed by June 2019. The primary outcome measure of the study was the 30-day bio-verified smoking abstinence at the 6-week follow-up (self-reported data verified by the Nicotine Cotinine Saliva Test). The secondary outcome measures of the study included participants? cigarette consumption reduction (compared baseline daily cigarette consumption with end-of-trial daily cigarette consumption), participants? 7-day smoking abstinence at 4-week and 6-week follow-up (self-reported), participants? 30-day smoking abstinence at 6-week follow-up (self-reported data only), and participants? acceptability and satisfaction levels of using the SCAMPI program (measured by the Mobile App Rating Scale questionnaire). Conclusions: If the SCAMPI program is shown to be preliminary effective, the study will be rolled out to be a future trial with a larger sample size and longer follow-up (6 months) to identify if it is an effective social network?based tool to support Chinese male smokers to quit smoking. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12618001089224; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375381 International Registered Report Identifier (IRRID): RR1-10.2196/18071 UR - http://www.researchprotocols.org/2020/9/e18071/ UR - http://dx.doi.org/10.2196/18071 UR - http://www.ncbi.nlm.nih.gov/pubmed/32945261 ID - info:doi/10.2196/18071 ER - TY - JOUR AU - Bernal, Marie Caroline Maite AU - Lhuisset, Lena AU - Fabre, Nicolas AU - Bois, Julien PY - 2020/9/23 TI - School-Based Multicomponent Intervention to Promote Physical Activity and Reduce Sedentary Time of Disadvantaged Children Aged 6-10 Years: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e17815 VL - 9 IS - 9 KW - children KW - school KW - intervention KW - promotion KW - physical activity KW - sedentary time KW - attention KW - academic achievement N2 - Background: In our modern society, physical activity (PA) is decreasing and sedentary time (ST) is increasing, especially for children from disadvantaged neighborhoods. School-based interventions to promote PA and decrease ST are therefore required among this population in order to change children?s lifestyle habits. Moreover, attentional capacities and academic achievement can be enhanced by chronic PA during childhood. The relationships between these variables have been poorly studied with this population. Objective: The objective of this study is to present the rationale and methods for a randomized controlled trial among 6-10-year-old children with low socioeconomic status that will (1) evaluate the effectiveness of a school-based intervention designed to promote PA and reduce ST and (2) study the relationships between PA, ST, motor skills, attentional capacities, and academic achievement. Methods: A randomized controlled trial was conducted in 2 eligible primary schools. During academic year 2016-2017, 1 school was randomly assigned as the experiment one and the other was assigned as the control one. Five assessments times were used: baseline (T1 [November 2016] to T2 [June 2017]), follow-up (T3 [November 2017] to T4 [June 2018]), and final assessment (T5 [June 2019]). The school-based intervention included various components on different levels of the socioecological model: (1) curriculum-based program for children; (2) sensitization workshops and newsletters for parents; (3) training workshops for teachers; (4) environmental adaptation of playgrounds and reorganization of recess time; (5) time adaptation of lunch breaks; and (6) collaboration with political groups. PA, ST, motor skills, and attentional capacities were evaluated and academic achievement was recorded. Results: The presented intervention and its different assessments have been successfully implemented. In order to achieve the 2 objectives of this randomized controlled trial, data analyses are about to be completed. Conclusions: The implementation of this randomized controlled trial can help to determine effective strategies to promote PA in the context of increasing prevalence of physical inactivity among children with sedentary lifestyle which will be useful for researchers, stakeholders, and public policy makers. Trial Registration: ClinicalTrials.gov NCT03983447; https://clinicaltrials.gov/ct2/show/NCT03983447 International Registered Report Identifier (IRRID): RR1-10.2196/17815 UR - http://www.researchprotocols.org/2020/9/e17815/ UR - http://dx.doi.org/10.2196/17815 UR - http://www.ncbi.nlm.nih.gov/pubmed/32965238 ID - info:doi/10.2196/17815 ER - TY - JOUR AU - Maier, Rebecca AU - Bawamia, Bilal AU - Bennaceur, Karim AU - Dunn, Sarah AU - Marsay, Leanne AU - Amoah, Roland AU - Kasim, Adetayo AU - Filby, Andrew AU - Austin, David AU - Hancock, Helen AU - Spyridopoulos, Ioakim PY - 2020/9/23 TI - Telomerase Activation to Reverse Immunosenescence in Elderly Patients With Acute Coronary Syndrome: Protocol for a Randomized Pilot Trial JO - JMIR Res Protoc SP - e19456 VL - 9 IS - 9 KW - coronary heart disease KW - acute coronary syndrome KW - immunosenescence KW - telomerase activator N2 - Background: Inflammation plays a key role in the pathophysiology of coronary heart disease (CHD) and its acute manifestation, acute coronary syndrome (ACS). Aging is associated with a decline of the immune system, a process known as immunosenescence. This is characterized by an increase in highly proinflammatory T cells that are involved in CHD progression, plaque destabilization, and myocardial ischemia?reperfusion injury. Telomere dysfunction has been implicated in immunosenescence of T lymphocytes. Telomerase is the enzyme responsible for maintaining telomeres during cell divisions. It has a protective effect on cells under oxidative stress and helps regulate flow-mediated dilation in microvasculature. Objective: The TACTIC (Telomerase ACTivator to reverse Immunosenescence in Acute Coronary Syndrome) trial will investigate whether a telomerase activator, TA-65MD, can reduce the proportion of senescent T cells in patients with ACS with confirmed CHD. It will also assess the effect of TA-65MD on decreasing telomere shortening, reducing oxidative stress, and improving endothelial function. Methods: The study was designed as a single-center, randomized, double-blind, parallel-group, placebo-controlled phase II trial. Recruitment started in January 2019. A total of 90 patients, aged 65 years or older, with treated ACS who have had CHD confirmed by angiography will be enrolled. They will be randomized to one of two groups: TA-65MD oral therapy (8 mg twice daily) or placebo taken for 12 months. The primary outcome is the effect on immunosenescence determined by a decrease in the proportion of CD8+ TEMRA (T effector memory cells re-expressing CD45RA [CD45 expressing exon A]) cells at 12 months. Secondary outcomes include leukocyte telomere length, endothelial function, cardiac function as measured by echocardiography and NT-proBNP (N-terminal fragment of the prohormone brain-type natriuretic peptide), systemic inflammation, oxidative stress, and telomerase activity. Results: The study received National Health Service (NHS) ethics approval on August 9, 2018; Medicines and Healthcare products Regulatory Agency approval on October 19, 2018; and NHS Health Research Authority approval on October 22, 2018. The trial began recruiting participants in January 2019 and completed recruitment in March 2020; the trial is due to report results in 2021. Conclusions: This pilot trial in older patients with CHD will explore outcomes not previously investigated outside in vitro or preclinical models. The robust design ensures that bias has been minimized. Should the results indicate reduced frequency of immunosenescent CD8+ T cells as well as improvements in telomere length and endothelial function, we will plan a larger, multicenter trial in patients to determine if TA-65MD is beneficial in the treatment of CHD in elderly patients. Trial Registration: ISRCTN Registry ISRCTN16613292; http://www.isrctn.com/ISRCTN16613292 and European Union Drug Regulating Authorities Clinical Trials Database (EudraCT), European Union Clinical Trials Register 2017-002876-26; https://tinyurl.com/y4m2so8g International Registered Report Identifier (IRRID): DERR1-10.2196/19456 UR - http://www.researchprotocols.org/2020/9/e19456/ UR - http://dx.doi.org/10.2196/19456 UR - http://www.ncbi.nlm.nih.gov/pubmed/32965237 ID - info:doi/10.2196/19456 ER - TY - JOUR AU - Holt, M. Jeana AU - Cusatis, Rachel AU - Winn, Aaron AU - Asan, Onur AU - Spanbauer, Charles AU - Williams, S. Joni AU - Flynn, E. Kathryn AU - Somai, Melek AU - Laud, Purushottam AU - Crotty, H. Bradley PY - 2020/9/23 TI - The Impact of Previsit Contextual Data Collection on Patient-Provider Communication and Patient Activation: Study Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e20309 VL - 9 IS - 9 KW - physician-patient relations KW - consumer health informatics KW - patient participation KW - vulnerable populations KW - randomized controlled trial KW - patient-centered care KW - mobile phone N2 - Background: Patient-centered care is respectful of and responsive to individual patient preferences, needs, and values. To provide patient-centered care, clinicians need to know and incorporate patients? context into their communication and care with patients. Patient contextual data (PCD) encompass social determinants of health and patients? needs, values, goals, and preferences relevant to their care. PCD can be challenging to collect as a routine component of the time-limited primary care visit. Objective: This study aims to determine if patient-provider communication and patient activation are different for patient users and patient nonusers of an electronic health record (EHR)?integrated PCD tool and assess if the impact of using PCD on patient-provider communication and patient activation differs for Black and White patients. Methods: We describe a randomized controlled trial of a prospective cohort of non-Hispanic White and Black patients who receive primary care services at a midwestern academic health care system in the United States. We will evaluate whether providing PCD through a consumer informatics tool enhances patient-provider communication, as measured by the Communication Assessment Tool, and we will evaluate patient activation, as measured by the Patient Activation Measure for PCD tool users and nonusers. Furthermore, owing to racial disparities in care and communication, we seek to determine if the adoption and use of the tool might narrow the differences between patient groups. Results: The trial was funded in November 2017 and received local ethics review approval in February 2019. The study began recruitment in April 2019 and enrollment concluded in October 2019 with 301 participants. The analysis was completed in May 2020, and trial results are expected to be published in winter 2020. Conclusions: Recently, there has been increased attention to the role of health information technology tools to enable patients to collaborate with providers through the sharing of PCD. The adoption of such tools may overcome the barriers of current EHRs by directly engaging patients to submit their contextual data. Effectively, these tools would support the EHR in providing a more holistic understanding of the patient. Research further supports that individuals who have robust digital engagement using consumer informatics tools have higher participation in treatment follow-up and self-care across populations. Therefore, it is critical to investigate interventions that elicit and share patients? social risks and care preferences with the health care team as a mechanism to improve individualized care and reduce the gap in health outcomes. Trial Registration: ClinicalTrials.gov NCT03766841; https://clinicaltrials.gov/ct2/show/NCT03766841 International Registered Report Identifier (IRRID): RR1-10.2196/20309 UR - http://www.researchprotocols.org/2020/9/e20309/ UR - http://dx.doi.org/10.2196/20309 UR - http://www.ncbi.nlm.nih.gov/pubmed/32965223 ID - info:doi/10.2196/20309 ER - TY - JOUR AU - Wang, Xiaoxia AU - Zhou, Xiaoyan AU - Yang, Hui PY - 2020/9/24 TI - Guided Self-Help Behavioral Activation Intervention for Geriatric Depression: Protocol for Pilot Randomized Controlled Trial JO - JMIR Res Protoc SP - e18259 VL - 9 IS - 9 KW - psychiatry KW - clinical KW - psychology KW - geriatric depression KW - guided self-help KW - behavior activation KW - behavior inhibition KW - behavior treatment N2 - Background: Aging is a social concern. The increased incidence of depression in older populations in China poses a challenge to the health care system. Older adults who are depressed often suffer from a lack of motivation. Behavioral activation treatment, an evidence-based guided self-help treatment, is effective in reducing anhedonia and amotivation in depression; however, the efficacy of guided self-help behavioral activation in older adults with depression is not yet known. Objective: The aim of this study is to pilot a self-help guided intervention for the treatment of depression in older adults. Methods: This study has been designed as a pilot randomized controlled trial with inpatients (n=60; to be randomly allocated 1:1) between the ages of 60 and 70 and who have major depressive disorder. Patients attending clinical psychological clinics at the Mental Health Center of Chongqing will be randomized to either receive guided self-help behavioral activation (intervention) or to be on a 6-week waiting list (control). Participants in the treatment group will receive 6 sessions of guided self-help behavioral activation delivered over the telephone. The waiting list control group will receive the intervention after a period of 6 weeks. Exclusion criteria will be individuals who are at significant risk of harming themselves or others, who have a primary mental health disorder other than depression, or who have an intellectual disability that would hamper their ability to participate in the intervention. Effects of the treatment will be observed using outcomes in 3 domains: (1) clinical outcomes (symptom severity, recovery rate), (2) process variables (patient satisfaction, attendance, dropout), and (3) economic outcomes (cost and resource use). We will also examine mediators of outcomes in terms of patient variables (behavioral activation or inhibition motivation). We hypothesize that guided self-help behavioral activation will have a beneficial effect. Results: The study was approved by the research ethics committee of the Mental Health Center of Chongqing in November 2019. As of July 2020, recruitment had not yet begun. Data collection is expected to be completed by December 2020. Data analysis is expected to be completed by June 2021. Results will then be disseminated to patients, to the public, to clinicians, and to researchers through publications in journals and presentations at conferences. Conclusions: This will be the first study in China to investigate guided self-help interventions for patients who are older adults and who are depressed, a group which is currently underrepresented in mental health research. The intervention is modular and adapted from an empirically supported behavioral activation treatment for depression. The generalizability and broad inclusion criteria are strengths. Trial Registration: Chinese Clinical Trial Register ChiCTR1900026066; http://www.chictr.org.cn/showprojen.aspx?proj=43548 International Registered Report Identifier (IRRID): PRR1-10.2196/18259 UR - https://www.researchprotocols.org/2020/9/e18259 UR - http://dx.doi.org/10.2196/18259 UR - http://www.ncbi.nlm.nih.gov/pubmed/32518060 ID - info:doi/10.2196/18259 ER - TY - JOUR AU - Minian, Nadia AU - Lingam, Mathangee AU - Moineddin, Rahim AU - Thorpe, E. Kevin AU - Veldhuizen, Scott AU - Dragonetti, Rosa AU - Zawertailo, Laurie AU - Taylor, H. Valerie AU - Hahn, Margaret AU - deRuiter, K. Wayne AU - Melamed, Osnat AU - Selby, Peter PY - 2020/9/29 TI - Impact of a Web-Based Clinical Decision Support System to Assist Practitioners in Addressing Physical Activity and/or Healthy Eating for Smoking Cessation Treatment: Protocol for a Hybrid Type I Randomized Controlled Trial JO - JMIR Res Protoc SP - e19157 VL - 9 IS - 9 KW - smoking cessation KW - physical activity KW - healthy eating KW - clinical decision support system KW - hybrid type 1 N2 - Background: Modifiable risk factors such as tobacco use, physical inactivity, and poor diet account for a significant proportion of the preventable deaths in Canada. These factors are also known to cluster together, thereby compounding the risks of morbidity and mortality. Given this association, smoking cessation programs appear to be well-suited for integration of health promotion activities for other modifiable risk factors. The Smoking Treatment for Ontario Patients (STOP) program is a province-wide smoking cessation program that currently encourages practitioners to deliver Screening, Brief Intervention, and Referral to treatment for patients who are experiencing depressive symptoms or consume excessive amounts of alcohol via a web-enabled clinical decision support system. However, there is no available clinical decision support system for physical inactivity and poor diet, which are among the leading modifiable risk factors for chronic diseases. Objective: The aim of this study is to assess whether adding a computerized/web-enabled clinical decision support system for physical activity and diet to a smoking cessation program affects smoking cessation outcomes. Methods: This study is designed as a hybrid type 1 effectiveness/implementation randomized controlled trial to evaluate a web-enabled clinical decision support system for supporting practitioners in addressing patients? physical activity and diet as part of smoking cessation treatment in a primary care setting. This design was chosen as it allows for simultaneous testing of the intervention, its delivery in target settings, and the potential for implementation in real-world situations. Intervention effectiveness will be measured using a two-arm randomized controlled trial. Health care practitioners will be unblinded to their patients? treatment allocation; however, patients will be blinded to whether their practitioner receives the clinical decision support system for physical activity and/or fruit/vegetable consumption. The evaluation of implementation will be guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Results: Recruitment for the primary outcome of this study is ongoing and will be completed in November 2020. Results will be reported in March 2021. Conclusions: The findings of the study will provide much needed insight into whether adding a computerized/web-enabled clinical decision support system for physical activity and diet to a smoking cessation program affects smoking cessation outcome. Furthermore, the implementation evaluation would provide insight into the feasibility of online-based interventions for physical activity and diet in a smoking cessation program. Addressing these risk factors simultaneously could have significant positive effects on chronic disease and cancer prevention. Trial Registration: ClinicalTrials.gov NCT04223336; https://clinicaltrials.gov/ct2/show/NCT04223336 International Registered Report Identifier (IRRID): DERR1-10.2196/19157 UR - http://www.researchprotocols.org/2020/9/e19157/ UR - http://dx.doi.org/10.2196/19157 UR - http://www.ncbi.nlm.nih.gov/pubmed/32990250 ID - info:doi/10.2196/19157 ER - TY - JOUR AU - Nelson, Suchitra AU - Albert, M. Jeffrey AU - Milgrom, Peter PY - 2020/9/8 TI - Comparative Effectiveness of Two Nonsurgical Treatments to Reduce Oral Health Disparities From Untreated Tooth Decay in Older Adults: Protocol for a Cluster Randomized Trial JO - JMIR Res Protoc SP - e17840 VL - 9 IS - 9 KW - dental caries KW - older adults KW - atraumatic restorative treatment KW - silver diamine fluoride KW - fluoride varnish N2 - Background: The majority of dental caries lesions in older adults are at the gumline, at the edges of failed fillings and crowns, and in the surfaces of roots after gum recession. These lesions are difficult to restore with conventional surgical treatments using a dental drill and restorations often fail. Clinical guidelines are general and apply treatments that were designed for younger individuals in the dental care of older adults. Objective: This study will compare the effectiveness of 2 evidence-based nonsurgical strategies to manage dental caries lesions in adults aged 62 or older: (1) biannual topical application of silver diamine fluoride versus (2) atraumatic restorative treatment + biannual fluoride varnish. Methods: A cluster randomized clinical trial is being conducted in 22 publicly subsidized and other low-income housing facilities/sites (Arm 1: 11 sites, 275 participants; Arm 2: 11 sites, 275 participants). At baseline, participants will be screened for caries lesions. Those with nonurgent lesions will be treated according to the treatment arm to which the housing site was randomly assigned. The primary outcomes are caries lesion arrest, tooth sensitivity, and tooth pain at 52 weeks after treatment. Analytic methods for the primary aim include a generalized estimating equation approach to determine noninferiority of silver diamine fluoride relative to atraumatic restorative treatment + fluoride varnish treatment. Results: The trial was funded in April 2019. Enrollment began in September 2019 and results are expected in June 2023. Conclusions: This study will inform the standard of care for treating caries lesions in older adults. If effective, either of these interventions has broad applicability in clinical and community-based settings. Trial Registration: ClinicalTrials.gov NCT03916926; https://clinicaltrials.gov/ct2/show/NCT03916926 International Registered Report Identifier (IRRID): DERR1-10.2196/17840 UR - http://www.researchprotocols.org/2020/9/e17840/ UR - http://dx.doi.org/10.2196/17840 UR - http://www.ncbi.nlm.nih.gov/pubmed/32897236 ID - info:doi/10.2196/17840 ER - TY - JOUR AU - Dibley, John Michael AU - Alam, Ashraful AU - Fahmida, Umi AU - Ariawan, Iwan AU - Titaley, Rialine Christiana AU - Htet, Kyaw Min AU - Damayanti, Rita AU - Li, Mu AU - Sutrisna, Aang AU - Ferguson, Elaine PY - 2020/9/8 TI - Evaluation of a Package of Behaviour Change Interventions (Baduta Program) to Improve Maternal and Child Nutrition in East Java, Indonesia: Protocol for an Impact Study JO - JMIR Res Protoc SP - e18521 VL - 9 IS - 9 KW - infant KW - feeding behavior KW - diet, food, and nutrition KW - growth disorders KW - undernutrition KW - nutrition during pregnancy KW - water treatment N2 - Background: Over the past decade, the prevalence of stunting has been close to 37% in children aged <5 years in Indonesia. The Baduta program, a multicomponent package of interventions developed by the Global Alliance for Improved Nutrition, aims to improve maternal and infant nutrition in Indonesia. Objective: This study aims to assess the impact of the Baduta program, a package of health system strengthening and behavior change interventions, compared with the standard village health services on maternal and child nutrition. Methods: The impact evaluation uses a cluster randomized controlled trial design with 2 outcome assessments. The first uses cross-sectional surveys of mothers of children aged 0-23 months and pregnant women before and after the interventions. The second is a cohort study of pregnant women followed until their child is 18 months from a subset of clusters. We will also conduct a process evaluation guided by the program impact pathway to assess coverage, fidelity, and acceptance. The study will be conducted in the Malang and Sidoarjo districts of East Java, Indonesia. The unit of randomization is the subdistricts. As random allocation of interventions to only 6 subdistricts is feasible, we will use constrained randomization to ensure balance of baseline covariates. The first intervention will be health system strengthening, including the Baby-Friendly Hospital Initiative, and training on counseling for appropriate infant and young child feeding (IYCF). The second intervention will be nutrition behavior change that includes Emo-Demos; a national television (TV) advertising campaign; local screening TV spots; a free, text message service; and promotion of low-cost water filters and hygiene practices. The primary study outcome is child stunting (low length-for-age), and secondary outcomes include length-for-age Z scores, wasting (low weight-for-length), anemia, child morbidity, IYCF indicators, and maternal and child nutrient intakes. The sample size for each cross-sectional survey is 1400 mothers and their children aged <2 years and 200 pregnant women in each treatment group. The cohort evaluation requires a sample size of 340 mother-infant pairs in each treatment group. We will seek Gatekeeper consent and written informed consent from the participants. The intention-to-treat principle will guide our data analysis, and we will apply Consolidated Standards of Reporting Trials guidelines for clustered randomized trials in the analysis. Results: In February 2015, we conducted a baseline cross-sectional survey on 2435 women with children aged <2 years and 409 pregnant women. In February 2017, we conducted an end-line survey on 2740 mothers with children aged <2 years and 642 pregnant women. The cohort evaluation began in February 2015, with 729 pregnant women, and was completed in December 2016. Conclusions: The results of the program evaluation will help guide policies to support effective packages of behavior change interventions to prevent child stunting in Indonesia. International Registered Report Identifier (IRRID): RR1-10.2196/18521 UR - https://www.researchprotocols.org/2020/9/e18521 UR - http://dx.doi.org/10.2196/18521 UR - http://www.ncbi.nlm.nih.gov/pubmed/32897234 ID - info:doi/10.2196/18521 ER - TY - JOUR AU - Nsagha, Shey Dickson AU - Siysi, Verla Vincent AU - Ekobo, Same AU - Egbe, Obinchemti Thomas AU - Kibu, Dzemo Odette PY - 2020/9/30 TI - One-Way and Two-Way Mobile Phone Text Messages for Treatment Adherence Among Patients With HIV: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e16127 VL - 9 IS - 9 KW - HIV KW - antiretroviral therapy KW - short message service KW - adherence N2 - Background: Incomplete adherence to antiretroviral therapy (ART) is one of the factors that contribute to HIV drug resistance, and it is a major problem for the public health system in controlling the HIV pandemic. There is emerging evidence that SMS can play an important role in health care delivery among patients with HIV on ART, especially in resource-limited settings. Objective: This paper aims to assess the impact of two-way and one-way SMS text messaging on adherence to HIV treatment. We hypothesized that sending weekly text messages through the one-way and two-way SMS text messaging approach will improve adherence to ART among patients with HIV and improve associated clinical outcomes (quality of life). Methods: A randomized controlled trial is being carried out among participants with HIV who have been on ART for at least one month from an accredited treatment center, namely the Buea Regional Hospital and Kumba District Hospital of South West Region, Cameroon. Participants with HIV, both male and female, aged 21 years and older make up a sample size of 207. The interventions involved the use of mobile phone text messages. Before commencing the intervention, a focus group discussion was carried out among the participants to understand their perception about the use of SMS-based interventions to improve adherence. A total of 246 participants were randomized to receive either a one-way text message (SMS sent to a recipient without recipient sending a reply) or two-way text message (SMS sent to a recipient and recipient sends a reply) or the control (no SMS, only standard care). Data on adherence and quality of life were collected at baseline and after 6 months and will be analyzed using SPSS version 21, while qualitative data will be analyzed using Atlas.ti 7.5. Results: Data collection began in September 2019 with focus group discussions and baseline data collection. After 1 month of baseline data collection, the intervention began in October 2019, and postintervention data were collected after 6 months (March 2020). At the end of the study, we will be able to understand the perception of patients toward SMS text messaging?based interventions and also assess the impact of one-way and two-way SMS text messages on treatment adherence among patients with HIV and on associated clinical outcomes (quality of life). Conclusions: The impact of SMS text messaging varies across different settings. The results from this study will determine the perception of patients toward an SMS text messaging?based intervention and its impact on adherence to ART. International Registered Report Identifier (IRRID): DERR1-10.2196/16127 UR - http://www.researchprotocols.org/2020/9/e16127/ UR - http://dx.doi.org/10.2196/16127 UR - http://www.ncbi.nlm.nih.gov/pubmed/32996886 ID - info:doi/10.2196/16127 ER - TY - JOUR AU - Whiteley, Laura AU - Olsen, Elizabeth AU - Mena, Leandro AU - Haubrick, Kayla AU - Craker, Lacey AU - Hershkowitz, Dylan AU - Brown, K. Larry PY - 2020/9/14 TI - A Mobile Gaming Intervention for Persons on Pre-Exposure Prophylaxis: Protocol for Intervention Development and Randomized Controlled Trial JO - JMIR Res Protoc SP - e18640 VL - 9 IS - 9 KW - pre-exposure prophylaxis (PrEP) KW - adherence KW - mobile gaming intervention KW - HIV prevention KW - men who have sex with men (MSM) N2 - Background: In the United States, young minority men who have sex with men (MSM) are the most likely to become infected with HIV. Pre-exposure prophylaxis (PrEP) is an efficacious and promising prevention strategy. However, PrEP?s safety and effectiveness can be greatly compromised by suboptimal adherence to treatment. To maximize the positive impact of PrEP, it is necessary to combine its prescription with cost-effective behavioral interventions that promote adherence and decrease HIV risk behaviors. In this project, we developed a theoretically informed app/gaming intervention to engage young MSM in learning information, practicing behaviors, and improving motivation for HIV preventative behaviors and PrEP adherence. Objective: The goal of this project was to develop and test a cutting-edge, engaging, and entertaining app/gaming intervention for improving adherence to PrEP and building HIV prevention knowledge, skills, and behavior. Methods: This study was conducted in two phases. In the developmental phase, we conducted qualitative interviews with young MSM (n=20) to guide the development of the gaming intervention. In the randomized controlled trial, we tested the preliminary efficacy of the gaming intervention compared to a comparison condition among young MSM. Subjects were recruited from the University of Mississippi Medical Center HIV/STI testing clinics (n=60). Results: Institutional review board approval was received in February 2015. Research activities began in June 2015 and are still ongoing. Conclusions: This app/gaming intervention aimed to improve PrEP adherence and HIV preventative behaviors in young MSM. Engaging young MSM in learning information, practicing behaviors, and improving motivation for increased adherence to PrEP has the potential to decrease HIV seroconversion. It is important to develop interventions that are enjoyable, engaging, and easily incorporated into clinical settings. Trial Registration: ClinicalTrials.gov RCT02611362; https://tinyurl.com/y65gkuwr International Registered Report Identifier (IRRID): DERR1-10.2196/18640 UR - http://www.researchprotocols.org/2020/9/e18640/ UR - http://dx.doi.org/10.2196/18640 UR - http://www.ncbi.nlm.nih.gov/pubmed/32924954 ID - info:doi/10.2196/18640 ER - TY - JOUR AU - Rozwadowski, Michelle AU - Dittakavi, Manasa AU - Mazzoli, Amanda AU - Hassett, L. Afton AU - Braun, Thomas AU - Barton, L. Debra AU - Carlozzi, Noelle AU - Sen, Srijan AU - Tewari, Muneesh AU - Hanauer, A. David AU - Choi, Won Sung PY - 2020/9/18 TI - Promoting Health and Well-Being Through Mobile Health Technology (Roadmap 2.0) in Family Caregivers and Patients Undergoing Hematopoietic Stem Cell Transplantation: Protocol for the Development of a Mobile Randomized Controlled Trial JO - JMIR Res Protoc SP - e19288 VL - 9 IS - 9 KW - family caregivers KW - mobile health app KW - mHealth KW - randomized controlled trial KW - wearable wrist sensor KW - hematopoietic stem cell transplantation KW - HSCT N2 - Background: Cancer patients who undergo allogeneic hematopoietic stem cell transplantation are among the most medically fragile patient populations with extreme demands for caregivers. Indeed, with earlier hospital discharges, the demands placed on caregivers continue to intensify. Moreover, an increased number of allogeneic hematopoietic stem cell transplantations are being performed worldwide, and this expensive procedure has significant economic consequences. Thus, the health and well-being of family caregivers have attracted widespread attention. Mobile health technology has been shown to deliver flexible, and time- and cost-sparing interventions to support family caregivers across the care trajectory. Objective: This protocol aims to leverage technology to deliver a novel caregiver-facing mobile health intervention named Roadmap 2.0. We will evaluate the effectiveness of Roadmap 2.0 in family caregivers of patients undergoing hematopoietic stem cell transplantation. Methods: The Roadmap 2.0 intervention will consist of a mobile randomized trial comparing a positive psychology intervention arm with a control arm in family caregiver-patient dyads. The primary outcome will be caregiver health-related quality of life, as assessed by the PROMIS Global Health scale at day 120 post-transplant. Secondary outcomes will include other PROMIS caregiver- and patient-reported outcomes, including companionship, self-efficacy for managing symptoms, self-efficacy for managing daily activities, positive affect and well-being, sleep disturbance, depression, and anxiety. Semistructured qualitative interviews will be conducted among participants at the completion of the study. We will also measure objective physiological markers (eg, sleep, activity, heart rate) through wearable wrist sensors and health care utilization data through electronic health records. Results: We plan to enroll 166 family caregiver-patient dyads for the full data analysis. The study has received Institutional Review Board approval as well as Code Review and Information Assurance approval from our health information technology services. Owing to the COVID-19 pandemic, the study has been briefly put on hold. However, recruitment began in August 2020. We have converted all recruitment, enrollment, and onboarding processes to be conducted remotely through video telehealth. Consent will be obtained electronically through the Roadmap 2.0 app. Conclusions: This mobile randomized trial will determine if positive psychology-based activities delivered through mobile health technology can improve caregiver health-related quality of life over a 16-week study period. This study will provide additional data on the effects of wearable wrist sensors on caregiver and patient self-report outcomes. Trial Registration: ClinicalTrials.gov NCT04094844; https://www.clinicaltrials.gov/ct2/show/NCT04094844 International Registered Report Identifier (IRRID): PRR1-10.2196/19288 UR - https://www.researchprotocols.org/2020/9/e19288 UR - http://dx.doi.org/10.2196/19288 UR - http://www.ncbi.nlm.nih.gov/pubmed/32945777 ID - info:doi/10.2196/19288 ER - TY - JOUR AU - Edwards, G. Gabriel AU - Reback, J. Cathy AU - Cunningham, E. William AU - Hilliard, L. Charles AU - McWells, Charles AU - Mukherjee, Sukrit AU - Weiss, E. Robert AU - Harawa, T. Nina PY - 2020/9/22 TI - Mobile-Enhanced Prevention Support Study for Men Who Have Sex With Men and Transgender Women Leaving Jail: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e18106 VL - 9 IS - 9 KW - HIV KW - MSM KW - transgender women KW - peer navigation KW - jail KW - substance use disorder KW - eHealth KW - PrEP KW - sexually transmitted infections KW - hepatitis C KW - mobile phone KW - smartphone N2 - Background: Men who have sex with men (MSM) and transgender women, particularly those who have experienced criminal justice involvement, have particularly high HIV burdens, and a majority of those in jail have substance use disorders (SUDs). MSM and transgender women also experience elevated rates of incarceration. Once community re-entry occurs, individuals are in a critical period for addressing potential risks of HIV and sexually transmitted infection (STI) acquisition and negative sequelae of substance use. Further, the impact experienced by one?s social and sexual networks experienced at the time of detention and release have important health implications for MSM and transgender women. Objective: The purpose of this study is to test a new intervention?Mobile-Enhanced Prevention Support (MEPS)?that involves a GPS-based mobile app called GeoPassport (referred to as GeoPass in practice), incentives, and peer support for promoting HIV prevention, substance use treatment, and use of related services. Methods: A two-arm, unblinded, randomized controlled trial will seek to enroll 300 HIV-negative MSM and transgender women, aged 18-49 years, with SUDs, who are either in jail or have recently left jail. Participants will be enrolled by study staff and randomized to the MEPS intervention group or usual care group. The intervention group will receive customized wellness goals in addition to GeoPass, cash incentives, and the support of a trained peer mentor for 6 months. Data collection will consist of a baseline survey and three follow-up surveys at 3, 6, and 9 months postenrollment, either in person or by phone or videoconference when necessary. The primary outcomes include establishing a primary care provider; being prescribed and adhering to pre-exposure prophylaxis (PrEP) for HIV; screening for HIV, STIs, and hepatitis C virus; and engagement in recommended treatment for SUDs. Secondary outcomes include obtaining treatment for any identified infections and avoiding recidivism. Results: Enrollment began in November 2019 and study completion is expected in 2023. Conclusions: This study will advance our knowledge base on patient navigation and peer mentor interventions. Peer navigation services have been studied for the treatment of HIV, but less often in the context of HIV and STI prevention among sexual and gender minority populations at the time of re-entry into the community from jail. The MEPS study will examine the acceptability and feasibility of combining peer mentor services with a mobile app to facilitate service utilization and participant?peer mentor communication. MEPS will assess patterns of PrEP uptake and utilization in MSM and transgender women leaving jail. The study will provide heretofore unavailable data from persons leaving jail regarding HIV PrEP, STI screening, substance abuse treatment, and service utilization patterns and experiences, including geocoded data for those in the intervention arm. Trial Registration: ClinicalTrials.gov (NCT04036396); https://www.clinicaltrials.gov/ct2/show/NCT04036396 International Registered Report Identifier (IRRID): PRR1-10.2196/18106 UR - http://www.researchprotocols.org/2020/9/e18106/ UR - http://dx.doi.org/10.2196/18106 UR - http://www.ncbi.nlm.nih.gov/pubmed/32959786 ID - info:doi/10.2196/18106 ER - TY - JOUR AU - Kroska, B. Emily AU - Hoel, Sydney AU - Victory, Amanda AU - Murphy, A. Susan AU - McInnis, G. Melvin AU - Stowe, N. Zachary AU - Cochran, Amy PY - 2020/9/23 TI - Optimizing an Acceptance and Commitment Therapy Microintervention Via a Mobile App With Two Cohorts: Protocol for Micro-Randomized Trials JO - JMIR Res Protoc SP - e17086 VL - 9 IS - 9 KW - acceptance and commitment therapy KW - clinical trial KW - mobile apps KW - bipolar disorder KW - students KW - mobile phone N2 - Background: Given gaps in the treatment of mental health, brief adaptive interventions have become a public health imperative. Transdiagnostic interventions may be particularly appropriate given high rates of medical comorbidity and the broader reach of transdiagnostic therapies. One such approach utilized herein is acceptance and commitment therapy (ACT), which is focused on increasing engagement with values, awareness, and openness to internal experiences. ACT theory posits that experiential avoidance is at the center of human suffering, regardless of diagnosis, and, as such, seeks to reduce unworkable experiential avoidance. Objective: Our objective is to provide the rationale and protocol for examining the safety, feasibility, and effectiveness of optimizing an ACT-based intervention via a mobile app among two disparate samples, which differ in sociodemographic characteristics and symptom profiles. Methods: Twice each day, participants are prompted via a mobile app to complete assessments of mood and activity and are then randomly assigned to an ACT-based intervention or not. These interventions are questions regarding engagement with values, awareness, and openness to internal experiences. Participant responses are recorded. Analyses will examine completion of assessments, change in symptoms from baseline assessment, and proximal change in mood and activity. A primary outcome of interest is proximal change in activity (eg, form and function of behavior and energy consumed by avoidance and values-based behavior) following interventions as a function of time, symptoms, and behavior, where we hypothesize that participants will focus more energy on values-based behaviors. Analyses will be conducted using a weighted and centered least squares approach. Two samples will run concurrently to assess the capacity of optimizing mobile ACT in populations that differ widely in their clinical presentation and sociodemographic characteristics: individuals with bipolar disorder (n=30) and distressed first-generation college students (n=50). Results: Recruitment began on September 10, 2019, for the bipolar sample and on October 5, 2019, for the college sample. Participation in the study began on October 18, 2019. Conclusions: This study examines an ACT-based intervention among two disparate samples. Should ACT demonstrate feasibility and preliminary effectiveness in each sample, a large randomized controlled trial applying ACT across diagnoses and demographics would be indicated. The public health implications of such an approach may be far-reaching. Trial Registration: ClinicalTrials.gov NCT04098497; https://clinicaltrials.gov/ct2/show/NCT04098497; ClinicalTrials.gov NCT04081662; https://clinicaltrials.gov/ct2/show/NCT04081662 International Registered Report Identifier (IRRID): DERR1-10.2196/17086 UR - http://www.researchprotocols.org/2020/9/e17086/ UR - http://dx.doi.org/10.2196/17086 UR - http://www.ncbi.nlm.nih.gov/pubmed/32965227 ID - info:doi/10.2196/17086 ER - TY - JOUR AU - Schuurmans, T. Angela A. AU - Nijhof, S. Karin AU - Scholte, Ron AU - Popma, Arne AU - Otten, Roy PY - 2020/9/23 TI - Game-Based Meditation Therapy to Improve Posttraumatic Stress and Neurobiological Stress Systems in Traumatized Adolescents: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e19881 VL - 9 IS - 9 KW - Adolescents KW - Autonomic nervous system KW - Cortisol KW - Meditation KW - Neurofeedback KW - Posttraumatic stress KW - Randomized controlled trial KW - Trauma N2 - Background: Many adolescents in residential care have been exposed to prolonged traumatic experiences such as violence, neglect, or abuse. Consequently, they suffer from posttraumatic stress. This not only negatively affects psychological and behavioral outcomes (eg, increased anxiety, depression, and aggression) but also has adverse effects on physiological outcomes, in particular on their neurobiological stress systems. Although current evidence-based treatment options are effective, they have their limitations. An alternative to traditional trauma treatment is meditation-based treatment that focuses on stress regulation and relaxation. Muse is a game-based meditation intervention that makes use of adolescents? intrinsic motivation. The neurofeedback element reinforces relaxation abilities. Objective: This paper describes the protocol for a randomized controlled trial in which the goal is to examine the effectiveness of Muse (InteraXon Inc) in reducing posttraumatic stress and normalizing neurobiological stress systems in a sample of traumatized adolescents in residential care. Methods: This will be a multicenter, multi-informant, and multimethod randomized controlled trial. Participants will be adolescents (N=80), aged 10 to 18 years, with clinical levels of posttraumatic symptoms, who are randomized to receive either the Muse therapy sessions and treatment as usual (intervention) or treatment as usual alone (control). Data will be collected at 3 measurement instances: pretest (T1), posttest (T2), and at 2-month follow-up. Primary outcomes will be posttraumatic symptoms (self-report and mentor report) and stress (self-report) at posttest. Secondary outcomes will be neurobiological stress parameters under both resting and acute stress conditions, and anxiety, depression, and aggression at posttest. Secondary outcomes also include all measures at 2-month follow-up: posttraumatic symptoms, stress, anxiety, depression aggression, and neurobiological resting parameters. Results: The medical-ethical committee Arnhem-Nijmegen (NL58674.091.16) approved the trial on November 15, 2017. The study was registered on December 2, 2017. Participant enrollment started in January 2018, and the results of the study are expected to be published in spring or summer 2021. Conclusions: Study results will demonstrate whether game-based meditation therapy improves posttraumatic stress and neurobiological stress systems, and whether it is more effective than treatment as usual alone for traumatized adolescents. Trial Registration: Netherlands Trial Register NL6689 (NTR6859); https://www.trialregister.nl/trial/6689 International Registered Report Identifier (IRRID): DERR1-10.2196/19881 UR - http://www.researchprotocols.org/2020/9/e19881/ UR - http://dx.doi.org/10.2196/19881 UR - http://www.ncbi.nlm.nih.gov/pubmed/32965226 ID - info:doi/10.2196/19881 ER - TY - JOUR AU - Meisel, F. Zachary AU - Goldberg, B. Erica AU - Dolan, R. Abby AU - Bansal, Esha AU - Rhodes, V. Karin AU - Hess, P. Erik AU - Cannuscio, C. Carolyn AU - Schapira, M. Marilyn AU - Perrone, Jeanmarie AU - Rodgers, A. Melissa AU - Zyla, M. Michael AU - Bell, J. Jeffrey AU - McCollum, Sharon AU - Shofer, S. Frances PY - 2020/9/24 TI - Stories to Communicate Individual Risk for Opioid Prescriptions for Back and Kidney Stone Pain: Protocol for the Life STORRIED Multicenter Randomized Clinical Trial JO - JMIR Res Protoc SP - e19496 VL - 9 IS - 9 KW - prescription opioids KW - opioid misuse KW - acute pain: opioid risk KW - probabilistic risk tool KW - renal colic KW - musculoskeletal back pain KW - narratives KW - randomized controlled trial N2 - Background: Prescription opioid misuse in the United States is a devastating public health crisis; many chronic opioid users were originally prescribed this class of medication for acute pain. Video narrative?enhanced risk communication may improve patient outcomes, such as knowledge of opioid risk and opioid use behaviors after an episode of acute pain. Objective: Our objective is to assess the effect of probabilistic and narrative-enhanced opioid risk communication on patient-reported outcomes, including knowledge, opioid use, and patient preferences, for patients who present to emergency departments with back pain and kidney stone pain. Methods: This is a multisite randomized controlled trial. Patients presenting to the acute care facilities of four geographically and ethnically diverse US hospital centers with acute renal colic pain or musculoskeletal back and/or neck pain are eligible for this randomized controlled trial. A control group of patients receiving general risk information is compared to two intervention groups: one receiving the risk information sheet plus an individualized, visual probabilistic Opioid Risk Tool (ORT) and another receiving the risk information sheet plus a video narrative?enhanced probabilistic ORT. We will study the effect of probabilistic and narrative-enhanced opioid risk communication on the following: risk awareness and recall at 14 days postenrollment, reduced use or preferences for opioids after the emergency department episode, and alignment with patient preference and provider prescription. To assess these outcomes, we administer baseline patient surveys during acute care admission and follow-up surveys at predetermined times during the 3 months after discharge. Results: A total of 1302 patients were enrolled over 24 months. The mean age of the participants was 40 years (SD 14), 692 out of 1302 (53.15%) were female, 556 out of 1302 (42.70%) were White, 498 out of 1302 (38.25%) were Black, 1002 out of 1302 (76.96%) had back pain, and 334 out of 1302 (25.65%) were at medium or high risk. Demographics and ORT scores were equally distributed across arms. Conclusions: This study seeks to assess the potential clinical role of narrative-enhanced, risk-informed communication for acute pain management in acute care settings. This paper outlines the protocol used to implement the study and highlights crucial methodological, statistical, and stakeholder involvement as well as dissemination considerations. Trial Registration: ClinicalTrials.gov NCT03134092; https://clinicaltrials.gov/ct2/show/NCT03134092 International Registered Report Identifier (IRRID): DERR1-10.2196/19496 UR - http://www.researchprotocols.org/2020/9/e19496/ UR - http://dx.doi.org/10.2196/19496 UR - http://www.ncbi.nlm.nih.gov/pubmed/32969832 ID - info:doi/10.2196/19496 ER - TY - JOUR AU - Meyers, Milena AU - Margraf, Jürgen AU - Velten, Julia PY - 2020/9/29 TI - Psychological Treatment of Low Sexual Desire in Women: Protocol for a Randomized, Waitlist-Controlled Trial of Internet-Based Cognitive Behavioral and Mindfulness-Based Treatments JO - JMIR Res Protoc SP - e20326 VL - 9 IS - 9 KW - sexual desire KW - sexual dysfunction KW - women?s sexual health KW - cognitive behavioral therapy N2 - Background: Psychological therapies are effective treatments for hypoactive sexual desire dysfunction (HSDD; formerly hypoactive sexual desire disorder), a common sexual dysfunction among women. Access to evidence-based treatments, however, remains difficult. Internet-based interventions are effective for a variety of psychological disorders and may be a promising means to close the treatment gap for HSDD. Objective: This article describes the treatment protocol and study design of a randomized controlled trial, aiming to study the efficacy of cognitive behavioral and mindfulness-based interventions delivered via the internet for women with HSDD to a waitlist control group. Outcomes are sexual desire (primary) and sexual distress (secondary). Additional variables (eg, depression, mindfulness, rumination) will be assessed as potential moderators or mediators of treatment success. Methods: A cognitive behavioral and a mindfulness-based self-help intervention for HSDD will be provided online. Overall, 266 women with HSDD will be recruited and assigned either to one of the intervention groups, or to a waitlist control group (2:2:1). Outcome data will be assessed at baseline, at 12 weeks, and at 6 and 12 months after randomization. Intention-to-treat and completer analyses will be conducted. Results: We expect improvements in sexual desire and sexuality-related distress in both intervention groups compared to the waitlist control. Recruitment has begun in January 2019 and is expected to be completed in August 2021. Results will be published in 2022. Conclusions: This study aims to contribute to the improvement and dissemination of psychological treatments for women with HSDD and to clarify whether cognitive behavioral and/or mindfulness-based treatments for HSDD are feasible and effective when delivered via the internet. Trial Registration: ClinicalTrials.gov NCT03780751; https://clinicaltrials.gov/ct2/show/NCT03780751 International Registered Report Identifier (IRRID): DERR1-10.2196/20326 UR - http://www.researchprotocols.org/2020/9/e20326/ UR - http://dx.doi.org/10.2196/20326 UR - http://www.ncbi.nlm.nih.gov/pubmed/32990248 ID - info:doi/10.2196/20326 ER - TY - JOUR AU - Mesguich, Charles AU - Hulin, Cyrille AU - Latrabe, Valerie AU - Asselineau, Julien AU - Bordenave, Laurence AU - Perez, Paul AU - Hindie, Elif AU - Marit, Gerald PY - 2020/9/10 TI - Prospective Comparison of 18F-Choline Positron Emission Tomography/Computed Tomography (PET/CT) and 18F-Fluorodeoxyglucose (FDG) PET/CT in the Initial Workup of Multiple Myeloma: Study Protocol of a Prospective Imaging Trial JO - JMIR Res Protoc SP - e17850 VL - 9 IS - 9 KW - multiple myeloma KW - PET/CT KW - MRI KW - 18-FDG KW - 18F-choline KW - cancer KW - medical imaging KW - skeletal system N2 - Background: The International Myeloma Working Group recommends the use of 18-fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) for treatment response evaluation, as it is superior to magnetic resonance imaging (MRI). However, at initial staging, the sensitivity of FDG-PET remains inferior to that of MRI. Therefore, there is a need for an imaging technique that could have a sensitivity equal to that of MRI at diagnosis and could serve to evaluate therapy. 18F-choline has shown increased sensitivity when compared with 18-FDG, with about 75% more lesions detected in patients with relapsed or progressive multiple myeloma (MM). Objective: Our primary objective is to prospectively compare the detection rate of bone lesions by 18F-choline PET/CT (FCH-PET) and FDG-PET in newly diagnosed MM. Our secondary objectives are to assess the accuracy of both PET modalities for the detection of bone lesions and the diagnosis of diffuse disease, to assess the detection rate of extramedullary lesions. Methods: We will prospectively include 30 patients in a paired comparative accuracy study. Patients with de novo MM will undergo FCH-PET, FDG-PET, and whole-body MRI (WB-MRI) within a 3-week period. WB-MRI will be composed of conventional sequences on the spine and pelvis and of whole-body diffusion axial sequences. The following 6 skeletal areas will be defined: skull, sternum/costal grid, spine, pelvis, superior limbs, and inferior limbs. The number of focal lesions, their respective localization, and intensity of uptake will be retrieved for each skeletal area. Readings will be performed blinded from other imaging techniques. The reference standard will be WB-MRI. Focal lesions present on PET/CT but not on WB-MRI will require a decision made with a consensus of experts based on clinical and imaging data. The number of bone lesions and number of extramedullary lesions will be compared using the Wilcoxon test. The accuracy of FCH-PET and FDG-PET will be compared using the McNemar test. Results: The study started in September 2019, and enrollment is ongoing. As of June 2020, 8 participants have been included. Data collection is expected to be completed in June 2021, and the results are expected to be available in December 2021. Conclusions: This study will assess if FCH-PET is superior to FDG-PET for the evaluation of MM tumor burden. This will pave the way for future prospective evaluations of the prognostic value of 18-FCH for treatment response evaluation in MM patients. Additionally, this work may provide new perspectives for better assessment of the risk of smoldering MM progressing to MM. Trial Registration: ClinicalTrials.gov NCT03891914; https://clinicaltrials.gov/ct2/show/NCT03891914 International Registered Report Identifier (IRRID): DERR1-10.2196/17850 UR - http://www.researchprotocols.org/2020/9/e17850/ UR - http://dx.doi.org/10.2196/17850 UR - http://www.ncbi.nlm.nih.gov/pubmed/32909953 ID - info:doi/10.2196/17850 ER - TY - JOUR AU - Smith, Yvonne AU - Garcia-Torres, Rosalia AU - Coughlin, S. Steven AU - Ling, Jiying AU - Marin, Terri AU - Su, Shaoyong AU - Young, Lufei PY - 2020/9/2 TI - Effectiveness of Social Cognitive Theory?Based Interventions for Glycemic Control in Adults With Type 2 Diabetes Mellitus: Protocol for a Systematic Review and Meta-Analysis JO - JMIR Res Protoc SP - e17148 VL - 9 IS - 9 KW - social cognitive theory KW - type 2 diabetes mellitus KW - glycemic control KW - self-efficacy KW - self-management KW - HbA1c KW - glycosylated hemoglobin N2 - Background: For those living with type 2 diabetes mellitus (T2DM), failing to engage in self-management behaviors leads to poor glycemic control. Social cognitive theory (SCT) has been shown to improve health behaviors by altering cognitive processes and increasing an individual?s belief in their ability to accomplish a task. Objective: We aim to present a protocol for a systematic review and meta-analysis to systematically identify, evaluate, and analyze the effect of SCT-based interventions to improve glycemic control in adults with T2DM. Methods: This protocol follows the 2009 Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines. Data sources will include PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsychINFO, Cochrane Library, and Web of Science, and data will be reviewed with the use of customized text mining software. Studies examining SCT-based behavioral interventions for adults diagnosed with T2DM in randomized controlled trials located in the outpatient setting will be included. Intervention effectiveness will be compared with routine care. Screening and data collection will be performed in multiple stages with three reviewers as follows: (1) an independent review of titles/abstracts, (2) a full review, and (3) data collection with alternating teams of two reviewers for disputes to be resolved by a third reviewer. Study quality and risk of bias will be assessed by three reviewers using the Cochrane risk of bias tool. Standardized mean differences will be used to describe the intervention effect sizes with regard to self-efficacy and diabetes knowledge. The raw mean difference of HbA1c will be provided in a random effects model and presented in a forest plot. The expected limitations of this study are incomplete data, the need to contact authors, and analysis of various types of glycemic control measures accurately within the same data set. Results: This protocol was granted institutional review board exemption on October 7, 2019. PROSPERO registration (ID: CRD42020147105) was received on April 28, 2020. The review began on April 29, 2020. The results of the review will be disseminated through conference presentations, peer-reviewed journals, and meetings. Conclusions: This systematic review will appraise the effectiveness of SCT-based interventions for adults diagnosed with T2DM and provide the most effective interventions for improving health behaviors in these patients. Trial Registration: PROSPERO CRD42020147105; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=147105 International Registered Report Identifier (IRRID): PRR1-10.2196/17148 UR - https://www.researchprotocols.org/2020/9/e17148 UR - http://dx.doi.org/10.2196/17148 UR - http://www.ncbi.nlm.nih.gov/pubmed/32673210 ID - info:doi/10.2196/17148 ER - TY - JOUR AU - van Velsen, Lex AU - Cabrita, Miriam AU - op den Akker, Harm AU - Brandl, Lena AU - Isaac, Joana AU - Suárez, María AU - Gouveia, Afonso AU - Dinis de Sousa, Rute AU - Rodrigues, Maria Ana AU - Canhão, Helena AU - Evans, Nathaniel AU - AU - Blok, Marije AU - Alcobia, Carlos AU - Brodbeck, Jeannette PY - 2020/9/8 TI - LEAVES (optimizing the mentaL health and resiliencE of older Adults that haVe lost thEir spouSe via blended, online therapy): Proposal for an Online Service Development and Evaluation JO - JMIR Res Protoc SP - e19344 VL - 9 IS - 9 KW - eHealth KW - grief KW - bereavement KW - widowhood KW - aged KW - resilience KW - telemedicine KW - mental health N2 - Background: Loss of a spouse is a frequent occurrence in later life. While most older adults successfully process this loss and will return to a normal life, about 10% of the individuals are unable to cope, and progress to prolonged grief (PG). PG, in turn, can result in mental and physical problems including poor sleep, cardiovascular problems, depression, and suicidal tendencies. Objective: LEAVES (optimizing the mentaL health and resiliencE of older Adults that haVe lost thEir spouSe via blended, online therapy) is an online bereavement program that will support the prevention and treatment of PG, so that elderly mourners can continue to lead an active, meaningful, and dignified life. LEAVES will cater to secondary end users (eg, family, informal caregivers) by reducing stress. Methods: LEAVES will help older adults to process the loss of a spouse in an online environment, which consists of (1) an existing online grief self-help program LIVIA, (2) the Before You Leave program that allows for storing personal memories, (3) a virtual agent platform, and (4) an accessible front-end design. LEAVES can detect persons at risk for complications, reveal negative trends in their emotional life, and act to counter such trends. The service relies on online support whenever possible but is blended with telephone or face-to-face counseling when necessary. Results: The project will take place between February 2020 and January 2023 and includes a real-life evaluation in which 315 end users will use the service across 3 countries (the Netherlands, Portugal, and Switzerland). The evaluation of LEAVES will focus on clinical effect, its business case, and technology acceptance. The results will pave the way for smooth integration into existing care paths and reimbursement schemes. Conclusions: The LEAVES service aims to soften the mourning process, prevents depression or social isolation, strengthens widow(er)s resilience and well-being, and quickens one?s return to societal participation. International Registered Report Identifier (IRRID): DERR1-10.2196/19344 UR - https://www.researchprotocols.org/2020/9/e19344 UR - http://dx.doi.org/10.2196/19344 UR - http://www.ncbi.nlm.nih.gov/pubmed/32897238 ID - info:doi/10.2196/19344 ER - TY - JOUR AU - Felder, M. Tisha AU - Heiney, P. Sue AU - Hebert, R. James AU - Friedman, B. Daniela AU - Elk, Ronit AU - Franco, Regina AU - Gansauer, Lucy AU - Christensen, Barbara AU - Ford, E. Marvella PY - 2020/9/3 TI - Improving Adherence to Adjuvant Hormonal Therapy Among Disadvantaged Women Diagnosed with Breast Cancer in South Carolina: Proposal for a Multimethod Study JO - JMIR Res Protoc SP - e17742 VL - 9 IS - 9 KW - breast neoplasms KW - medicaid KW - medication adherence KW - vulnerable populations KW - hormonal therapy KW - endocrine therapy KW - qualitative methods N2 - Background: Current clinical guidelines recommend that hormone receptor?positive breast cancer survivors take adjuvant hormonal therapy (AHT) for 5 to 10 years, following the end of definitive treatment. However, fewer than half of patients adhere to the guidelines, and suboptimal adherence to AHT is associated with an increased risk of breast cancer mortality. Research has extensively documented sociodemographic and disease-specific factors associated with adherence to AHT, but very little evidence exists on behavioral factors (eg, knowledge, patient-provider communication) that can be modified and targeted by interventions. Objective: The goal of this study is to develop and test a theory-based, multilevel intervention to improve adherence to AHT among breast cancer survivors from racially and socioeconomically disadvantaged backgrounds (eg, Medicaid-insured). The specific aims are to (1) explore multilevel (eg, patient, health care system) factors that influence adherence to AHT; (2) develop a theory-based, multilevel intervention to improve adherence to AHT; and (3) pilot test and evaluate the intervention developed in Aim 2. Methods: For Aim 1, we will recruit breast cancer survivors and health care professionals to participate in semistructured interviews to gain their perspectives about barriers and facilitators to AHT use. We will conduct a directed content analysis of the Aim 1 qualitative interview data. For Aim 2, we will integrate Aim 1 findings and current literature into the design of a multilevel intervention using an Intervention Mapping approach. For Aim 3, we will recruit Medicaid-insured breast cancer survivors to assess the feasibility of the pilot intervention. Results: From May 2016 to July 2018, we completed interviews with 19 breast cancer survivors and 23 health care professionals in South Carolina. We will conduct a directed content analysis of the qualitative interview data. Results from this analysis will be used, in combination with current literature, to design (Aim 2) and pilot test a theory-based multilevel intervention (Aim 3) in Summer 2021. Results of the pilot are expected for Fall 2021. Conclusions: This study will provide a deeper understanding of how to improve adherence to AHT, using a novel and multilevel approach, among socioeconomically disadvantaged breast cancer survivors who often experience disproportionate breast cancer mortality. International Registered Report Identifier (IRRID): DERR1-10.2196/17742 UR - https://www.researchprotocols.org/2020/9/e17742 UR - http://dx.doi.org/10.2196/17742 UR - http://www.ncbi.nlm.nih.gov/pubmed/32880374 ID - info:doi/10.2196/17742 ER - TY - JOUR AU - Lin, Yilu AU - Bailey, E. James AU - Surbhi, Satya AU - Shuvo, A. Sohul AU - Jackson, D. Christopher AU - Chen, Ming AU - Price-Haywood, G. Eboni AU - Mann, Joshua AU - Fort, Daniel AU - Burton, Jeffrey AU - Sandlin, Ramona AU - Castillo, Alexandra AU - Mei, Hao AU - Smith, Patti AU - Leak, Cardella AU - Le, Phi AU - Monnette, M. Alisha AU - Shi, Lizheng PY - 2020/9/9 TI - Continuity of Care for Patients with Obesity-Associated Chronic Conditions: Protocol for a Multisite Retrospective Cohort Study JO - JMIR Res Protoc SP - e20788 VL - 9 IS - 9 KW - continuity of care KW - obesity-associated chronic conditions KW - disparity KW - obesity KW - diabetes N2 - Background: Obesity affects nearly half of adults in the United States and is contributing substantially to a pandemic of obesity-associated chronic conditions such as type 2 diabetes, hypertension, and arthritis. The obesity-associated chronic condition pandemic is particularly severe in low-income, medically underserved, predominantly African-American areas in the southern United States. Little is known regarding the impact of geographic, income, and racial disparities in continuity of care on major health outcomes for patients with obesity-associated chronic conditions. Objective: The aim of this study is to assess, among patients with obesity-associated chronic conditions, and within this group, patients with type 2 diabetes, (1) whether continuity of care is associated with lower overall and potentially preventable emergency department and hospital utilization, (2) the effect of geographic, income, and racial disparities on continuity of care and on health care utilization, (3) whether continuity of care particularly protects individuals at risk for disparities from adverse health outcomes, and (4) whether characteristics of health systems are associated with higher continuity of care and better outcomes. Methods: Using 2015-2018 data from 4 practice-based research networks participating in the Southern Obesity and Diabetes Coalition, we will conduct a retrospective cohort analysis and distributed meta-analysis. Patients with obesity-associated chronic conditions and with type 2 diabetes will be assessed within each health system, following a standardized study protocol. The primary study outcomes are overall and preventable emergency department visits and hospitalizations. Continuity of care will be calculated at the facility level using a modified version of the Bice-Boxerman continuity of care index. Race will be assessed using electronic medical record data. Residence in a low-income area or a health professional shortage area respectively will be assessed by linking patient residence ZIP codes to the Centers for Medicare & Medicaid Services database. Results: In 4 regional health systems across Tennessee, Mississippi, Louisiana, and Arkansas, a total of 53 adult hospitals were included in the study. A total of 147,889 patients with obesity-associated chronic conditions who met study criteria were identified in these health systems, of which 45,453 patients met the type 2 diabetes criteria for inclusion. Results are expected by the end of 2020. Conclusions: This study should reveal whether health system efforts to increase continuity of care for patients with obesity and diabetes have potential to improve outcomes and reduce costs. Analyzing disparities in continuity of care and their effect on major health outcomes can help demonstrate how to improve care and use of health care resources for vulnerable patients with obesity-associated chronic conditions, and within this group, patients with type 2 diabetes. Better understanding of the association between continuity and health care utilization for these vulnerable populations will contribute to the development of higher-value health systems in the southern United States. International Registered Report Identifier (IRRID): DERR1-10.2196/20788 UR - https://www.researchprotocols.org/2020/9/e20788 UR - http://dx.doi.org/10.2196/20788 UR - http://www.ncbi.nlm.nih.gov/pubmed/32902394 ID - info:doi/10.2196/20788 ER - TY - JOUR AU - Amadou, Amina AU - Coudon, Thomas AU - Praud, Delphine AU - Salizzoni, Pietro AU - Leffondre, Karen AU - Lévêque, Emilie AU - Boutron-Ruault, Marie-Christine AU - Danjou, N. Aurélie M. AU - Morelli, Xavier AU - Le Cornet, Charlotte AU - Perrier, Lionel AU - Couvidat, Florian AU - Bessagnet, Bertrand AU - Caudeville, Julien AU - Faure, Elodie AU - Mancini, Romana Francesca AU - Gulliver, John AU - Severi, Gianluca AU - Fervers, Béatrice PY - 2020/9/15 TI - Chronic Low-Dose Exposure to Xenoestrogen Ambient Air Pollutants and Breast Cancer Risk: XENAIR Protocol for a Case-Control Study Nested Within the French E3N Cohort JO - JMIR Res Protoc SP - e15167 VL - 9 IS - 9 KW - breast cancer KW - hormone receptor status KW - air pollution KW - endocrine disruptors KW - multipollutant KW - geographic information system KW - land use regression KW - chemistry-transport model KW - epigenetic KW - gene-environment interaction KW - prospective study N2 - Background: Breast cancer is the most frequent cancer in women in industrialized countries. Lifestyle and environmental factors, particularly endocrine-disrupting pollutants, have been suggested to play a role in breast cancer risk. Current epidemiological studies, although not fully consistent, suggest a positive association of breast cancer risk with exposure to several International Agency for Research on Cancer Group 1 air-pollutant carcinogens, such as particulate matter, polychlorinated biphenyls (PCB), dioxins, Benzo[a]pyrene (BaP), and cadmium. However, epidemiological studies remain scarce and inconsistent. It has been proposed that the menopausal status could modify the relationship between pollutants and breast cancer and that the association varies with hormone receptor status. Objective: The XENAIR project will investigate the association of breast cancer risk (overall and by hormone receptor status) with chronic exposure to selected air pollutants, including particulate matter, nitrogen dioxide (NO2), ozone (O3), BaP, dioxins, PCB-153, and cadmium. Methods: Our research is based on a case-control study nested within the French national E3N cohort of 5222 invasive breast cancer cases identified during follow-up from 1990 to 2011, and 5222 matched controls. A questionnaire was sent to all participants to collect their lifetime residential addresses and information on indoor pollution. We will assess these exposures using complementary models of land-use regression, atmospheric dispersion, and regional chemistry-transport (CHIMERE) models, via a Geographic Information System. Associations with breast cancer risk will be modeled using conditional logistic regression models. We will also study the impact of exposure on DNA methylation and interactions with genetic polymorphisms. Appropriate statistical methods, including Bayesian modeling, principal component analysis, and cluster analysis, will be used to assess the impact of multipollutant exposure. The fraction of breast cancer cases attributable to air pollution will be estimated. Results: The XENAIR project will contribute to current knowledge on the health effects of air pollution and identify and understand environmental modifiable risk factors related to breast cancer risk. Conclusions: The results will provide relevant evidence to governments and policy-makers to improve effective public health prevention strategies on air pollution. The XENAIR dataset can be used in future efforts to study the effects of exposure to air pollution associated with other chronic conditions. International Registered Report Identifier (IRRID): DERR1-10.2196/15167 UR - http://www.researchprotocols.org/2020/9/e15167/ UR - http://dx.doi.org/10.2196/15167 UR - http://www.ncbi.nlm.nih.gov/pubmed/32930673 ID - info:doi/10.2196/15167 ER - TY - JOUR AU - Löffler, Christin AU - Krüger, Antje AU - Daubmann, Anne AU - Iwen, Julia AU - Biedermann, Marc AU - Schulz, Maike AU - Wegscheider, Karl AU - Altiner, Attila AU - Feldmeier, Gregor AU - Wollny, Anja PY - 2020/9/30 TI - Optimizing Antibiotic Prescribing for Acute Respiratory Tract Infection in German Primary Care: Study Protocol for Evaluation of the RESIST Program JO - JMIR Res Protoc SP - e18648 VL - 9 IS - 9 KW - antibacterial agents KW - respiratory tract infection KW - upper respiratory tract infection KW - lower respiratory tract infection KW - primary care KW - primary health care KW - physician-patient relation KW - shared decision making KW - antibiotic resistance N2 - Background: The emergence and increased spread of microbial resistance is a major challenge to all health care systems worldwide. In primary care, acute respiratory tract infection (ARTI) is the health condition most strongly related to antibiotic overuse. Objective: The RESIST program aims at optimizing antibiotic prescribing for ARTI in German primary care. By completing a problem-orientated online training course, physicians are motivated and empowered to utilize patient-centered doctor-patient communication strategies, including shared decision making, in the treatment of patients with ARTI. Methods: RESIST will be evaluated in the form of a nonrandomized controlled trial. Approximately 3000 physicians of 8 (out of 16) German federal states can participate in the program. Patient and physician data are retrieved from routine health care data. Physicians not participating in the program serve as controls, either among the 8 participating regional Associations of Statutory Health Insurance Physicians (control group 1) or among the remaining associations not participating in RESIST (control group 2). Antibiotic prescription rates before the intervention (T0: 2016, 1st and 2nd quarters of 2017) and after the intervention (T1: 3rd quarter of 2017 until 1st quarter of 2019) will be compared. The primary outcome measure is the overall antibiotic prescription rate for all patients insured with German statutory health insurance before and after provision of the online course. The secondary outcome is the antibiotic prescription rate for coded ARTI before and after the intervention. Results: RESIST is publicly funded by the Innovations funds of the Federal Joint Committee in Germany and was approved in December 2016. Recruitment of physicians is now completed, and a total of 2460 physicians participated in the intervention. Data analysis started in February 2020. Conclusions: With approximately 3000 physicians participating in the program, RESIST is among the largest real-world interventions aiming at reducing inadequate antibiotic prescribing for ARTI in primary care. Long-term follow up of up to 21 months will allow for investigating the sustainability of the intervention. Trial Registration: ISRCTN Registry ISRCTN13934505; http://www.isrctn.com/ISRCTN13934505 International Registered Report Identifier (IRRID): RR1-10.2196/18648 UR - http://www.researchprotocols.org/2020/9/e18648/ UR - http://dx.doi.org/10.2196/18648 UR - http://www.ncbi.nlm.nih.gov/pubmed/32996888 ID - info:doi/10.2196/18648 ER - TY - JOUR AU - Blair, K. Cindy AU - Harding, Elizabeth AU - Herman, Carla AU - Boyce, Tawny AU - Demark-Wahnefried, Wendy AU - Davis, Sally AU - Kinney, Y. Anita AU - Pankratz, S. Vernon PY - 2020/9/1 TI - Remote Assessment of Functional Mobility and Strength in Older Cancer Survivors: Protocol for a Validity and Reliability Study JO - JMIR Res Protoc SP - e20834 VL - 9 IS - 9 KW - physical function KW - physical performance KW - older adults KW - remote assessment KW - videoconferencing KW - cancer survivors KW - cancer KW - elderly KW - physical activity KW - telehealth N2 - Background: Older cancer survivors, faced with both age- and treatment-related morbidity, are at increased and premature risk for physical function limitations. Physical performance is an important predictor of disability, quality of life, and premature mortality, and thus is considered an important target of interventions designed to prevent, delay, or attenuate the physical functional decline. Currently, low-cost, valid, and reliable methods to remotely assess physical performance tests that are self-administered by older adults in the home-setting do not exist, thus limiting the reach, scalability, and dissemination of interventions. Objective: This paper will describe the rationale and design for a study to evaluate the accuracy, reliability, safety, and acceptability of videoconferencing and self-administered tests of functional mobility and strength by older cancer survivors in their own homes. Methods: To enable remote assessment, participants receive a toolkit and instructions for setting up their test course and communicating with the investigator. Two standard gerontologic performance tests are being evaluated: the Timed Up and Go test and the 30-second chair stand test. Phase 1 of the study evaluates proof-of-concept that older cancer survivors (age ?60 years) can follow the testing protocol and use a tablet PC to communicate with the study investigator. Phase 2 evaluates the criterion validity of videoconference compared to direct observation of the two physical performance tests. Phase 3 evaluates reliability by enrolling 5-10 participants who agree to repeat the remote assessment (without direct observation). Phase 4 enrolls 5-10 new study participants to complete the remote assessment test protocol. Feedback from participants in each phase is used to refine the test protocol and instructions. Results: Enrollment began in December 2019. Ten participants completed the Phase 1 proof-of-concept. The study was paused in mid-March 2020 due to the COVID-19 pandemic. The study is expected to be completed by the end of 2020. Conclusions: This validity and reliability study will provide important information on the acceptability and safety of using videoconferencing to remotely assess two tests of functional mobility and strength, self-administered by older adults in their homes. Videoconferencing has the potential to expand the reach, scalability, and dissemination of interventions to older cancer survivors, and potentially other older adults, especially in rural areas. Trial Registration: ClinicalTrials.gov NCT04339959; https://clinicaltrials.gov/ct2/show/NCT04339959 International Registered Report Identifier (IRRID): DERR1-10.2196/20834 UR - https://www.researchprotocols.org/2020/9/e20834 UR - http://dx.doi.org/10.2196/20834 UR - http://www.ncbi.nlm.nih.gov/pubmed/32769075 ID - info:doi/10.2196/20834 ER - TY - JOUR AU - Lawless, Thomas Michael AU - Archibald, Mandy AU - Pinero de Plaza, Alejandra Maria AU - Drioli-Phillips, Phoebe AU - Kitson, Alison PY - 2020/9/14 TI - Peer-to-Peer Health Communication in Older Adults? Online Communities: Protocol for a Qualitative Netnographic Study and Co-Design Approach JO - JMIR Res Protoc SP - e19834 VL - 9 IS - 9 KW - aged KW - chronic illness and disease KW - long-term conditions KW - self-management KW - peer support KW - social media KW - online community KW - netnography KW - co-design KW - COVID-19 N2 - Background: Online communities provide an environment in which people with similar health concerns can interact and access content that can support the self-management of long-term conditions (LTCs). Recently, the importance of online social networks as sources of health information and social support has been brought into focus with the emergence and widespread societal impacts of COVID-19. Although online communities exist for older adults, little is known about the specific health and self-care topics that older people discuss in such environments and how these relate to users? support needs and outcomes. A better understanding of users? needs and peer-to-peer communication in these communities is necessary to inform the design of information and communication technology (ICT) interventions that are relevant to older people and their peer supporters. Objective: This study aims to use a two-phase, web-based ethnographic (netnography) and co-design approach to explore specific health care and self-care topics that older adults discuss in a UK-based online community and how peer supporters respond to these queries with informational and/or social support and engage with stakeholders to define the needs and requirements for new ICT-based interventions capable of reducing social isolation and facilitating LTC self-management support. Methods: The first phase of the research will involve a qualitative netnographic analysis of posts in discussion forums in a publicly accessible online community. The second phase will involve co-design workshops with health care consumers (ie, older adults and carers) and service providers to determine the needs and requirements for new ICT-based interventions and digital innovations. Constructivist grounded theory will be used in the first phase; in the second phase, the co-design workshops will be audiorecorded and analyzed thematically. Results: This research project is in progress. Permission was obtained from the website administrator to use materials from the social media forum; data collection for the first phase began in April 2020. The second phase of the study is expected to begin in late 2020. This study is due to be completed by the end of 2021. Conclusions: This study is the first, to the best of our knowledge, to combine qualitative netnography with an iterative co-design framework to specify the needs and requirements for new ICT-based interventions. The findings from this study will inform the next phase of the multiphase knowledge translation project and will provide insights into the potential of online peer health communities to reduce social isolation and facilitate chronic illness self-management support and self-care. International Registered Report Identifier (IRRID): PRR1-10.2196/19834 UR - http://www.researchprotocols.org/2020/9/e19834/ UR - http://dx.doi.org/10.2196/19834 UR - http://www.ncbi.nlm.nih.gov/pubmed/32924960 ID - info:doi/10.2196/19834 ER - TY - JOUR AU - Kittisakmontri, Kulnipa AU - Lanigan, Julie AU - Wells, K. Jonathan C. AU - Fewtrell, Mary PY - 2020/9/17 TI - The Impact of Dietary Protein in Complementary Foods on Infant Growth and Body Composition in a Population Facing the Double Burden of Malnutrition: Protocol for a Multicenter, Prospective Cohort Study JO - JMIR Res Protoc SP - e18112 VL - 9 IS - 9 KW - complementary feeding KW - protein intake KW - double burden of malnutrition KW - infant growth KW - body composition N2 - Background: Protein is an essential macronutrient with an important role during complementary feeding. Low protein intake contributes to undernutrition while high intake, especially from animal sources, may increase obesity risk. However, the influences of different protein sources (dairy, meat, and plants) on growth, and underlying mechanisms for these effects, are poorly understood. Animal-sourced foods provide both high-quality protein and iron and are recommended to improve iron status. However, it is unclear whether current dietary recommendations are adequate to support healthy growth and optimize iron status. These issues are of particular concern in countries facing the double burden of malnutrition, the coexistence of all forms of malnutrition. More evidence is needed to develop appropriate recommendations for these countries. Objective: This study will investigate associations between protein intake during complementary feeding and growth, body composition, and iron status of infants in Thailand, a country facing the double burden of malnutrition. The study will also explore how different protein sources influence growth via the growth hormone?insulin-like growth factor I (IGF-1) axis and plasma amino acids. Methods: A multicenter cohort study will be conducted in Chiang Mai, Thailand, in 150 healthy term infants aged 4-6 months with birth weight ?2500 g. Demographic data, dietary intake, and anthropometry will be collected at 6, 9, and 12 months. Dietary intake will be assessed using 24-hour dietary recalls, 3-day food records, and food frequency questionnaires. Blood samples for iron status, growth hormone, IGF-1, insulin-like growth factor-binding protein III (IGFBP-3), and plasma amino acids and urine samples for body composition analysis using stable isotope dilution will be obtained at 12 months. Results: The recruitment of study participants and data collection was undertaken from June 2018 to May 2019. Data and laboratory analyses are ongoing and are expected to be completed by December 2020. A total of 150 participants were enrolled, and 146 completed the study. We hypothesized that protein intake from animal-sourced foods in recommended quantities could support normal weight and length gain and lower the risk of undernutrition associated with similar amounts of plant-based protein. However, higher protein intake, especially from milk protein, may be linked to increased body fat via plasma amino acids and the growth hormone-IGF axis. Conclusions: The results of this study will provide data on current complementary feeding practices, focusing on protein and iron intake in Thai infants. This information, combined with data on associations with infant growth and iron status, will help inform complementary feeding recommendations for this population and may be found relevant to other settings experiencing the double burden of malnutrition. International Registered Report Identifier (IRRID): DERR1-10.2196/18112 UR - http://www.researchprotocols.org/2020/9/e18112/ UR - http://dx.doi.org/10.2196/18112 UR - http://www.ncbi.nlm.nih.gov/pubmed/32940616 ID - info:doi/10.2196/18112 ER - TY - JOUR AU - Dove, Erica AU - Wang, Rosalie AU - Zabjek, Karl AU - Astell, Arlene PY - 2020/9/18 TI - Impacts of Motion-Based Technology on Balance, Movement Confidence, and Cognitive Function Among People With Dementia or Mild Cognitive Impairment: Protocol for a Quasi-Experimental Pre- and Posttest Study JO - JMIR Res Protoc SP - e18209 VL - 9 IS - 9 KW - motion-based technology KW - dementia KW - mild cognitive impairment KW - cognitive dysfunction KW - postural balance KW - movement confidence KW - cognition KW - exercise movement techniques N2 - Background: While exercise can benefit the health and well-being of people with dementia or mild cognitive impairment, many exercise programs offered to this population are passive, unengaging, and inaccessible, resulting in poor adherence. Motion-based technologies are increasingly being explored to encourage exercise participation among people with dementia or mild cognitive impairment. However, the impacts of using motion-based technologies with people with dementia or mild cognitive impairment on variables including balance, movement confidence, and cognitive function have yet to be determined. Objective: The purpose of this study is to examine the impacts of a group motion-based technology intervention on balance, movement confidence, and cognitive function among people with dementia or mild cognitive impairment. Methods: In this quasi-experimental pre- and posttest design, we will recruit 24 people with dementia or mild cognitive impairment from 4 adult day programs and invite them to play Xbox Kinect bowling in a group setting, twice weekly for 10 weeks. We will require participants to speak and understand English, be without visual impairment, and be able to stand and walk. At pretest, participants will complete the Mini-Balance Evaluation Systems Test (Mini-BESTest) and the Montreal Cognitive Assessment (MoCA). We will video record participants during weeks 1, 5, and 10 of the intervention to capture behavioral indicators of movement confidence (eg, fluency of motion) through coding. At posttest, the Mini-BESTest and MoCA will be repeated. We will analyze quantitative data collected through the Mini-BESTest and the MoCA using an intent-to-treat analysis, with study site and number of intervention sessions attended as covariates. To analyze the videos, we will extract count and percentage data from the coded recordings. Results: This study will address the question of whether a group motion-based technology intervention, delivered in an adult day program context, has the potential to impact balance, movement confidence, and cognitive function among people with dementia or mild cognitive impairment. The project was funded in 2019 and enrollment was completed on February 28, 2020. Data analysis is underway and the first results are expected to be submitted for publication in 2021. Conclusions: This study will assess the feasibility and potential benefits of using motion-based technology to deliver exercise interventions to people with dementia or mild cognitive impairment. This work can also be used as the basis for developing specific software and future exercise programs using motion-based technology for people with dementia or mild cognitive impairment, as well as understanding some of the conditions in which these programs can be delivered. International Registered Report Identifier (IRRID): DERR1-10.2196/18209 UR - http://www.researchprotocols.org/2020/9/e18209/ UR - http://dx.doi.org/10.2196/18209 UR - http://www.ncbi.nlm.nih.gov/pubmed/32945780 ID - info:doi/10.2196/18209 ER - TY - JOUR AU - Nguyen, T. Tuan AU - Weissman, Amy AU - Cashin, Jennifer AU - Ha, T. Tran AU - Zambrano, Paul AU - Mathisen, Roger PY - 2020/9/21 TI - Assessing the Effectiveness of Policies Relating to Breastfeeding Promotion, Protection, and Support in Southeast Asia: Protocol for a Mixed Methods Study JO - JMIR Res Protoc SP - e21286 VL - 9 IS - 9 KW - breastfeeding KW - breast milk substitute KW - Code of Marketing of Breast-milk Substitutes (The Code) KW - maternity protection KW - maternal, infant, and young child nutrition KW - mixed methods study KW - Southeast Asia N2 - Background: Despite its well-known benefits, breastfeeding practices remain suboptimal worldwide, including in Southeast Asia. Many countries in the region have thus enacted policies, such as maternity protection and the World Health Assembly International Code of Marketing of Breast-milk Substitutes (the Code), that protect, promote, and support breastfeeding. Yet the impact of such national legislation on breastfeeding practices is not well understood. Objective: This study aims to review the content, implementation, and potential impact of policies relating to maternity protection and the Code in Myanmar, the Philippines, Thailand, and Vietnam. Methods: This mixed methods study includes a desk review, trend and secondary data analyses, and quantitative and qualitative data collection. Desk reviews will examine and compare the contents, implementation strategies, coverage, monitoring, and enforcement of national policies focusing on maternity protection and the Code in each country with global standards. Trend and secondary data analyses will examine the potential impact of these policies on relevant variables such as breast milk substitute (BMS) sales and women?s workforce participation. Quantitative data collection and analysis will be conducted to examine relevant stakeholders? and beneficiaries? perceptions about these policies. In each country, we will conduct up to 24 in-depth interviews (IDI) with stakeholders at national and provincial levels and 12 employers or 12 health workers. Per country, we will survey approximately 930 women who are pregnant or have a child aged 0-11 months, of whom approximately 36 will be invited for an IDI; 12 partners of the interviewed mothers or fathers of children from 0-11 months will also be interviewed. Results: This study, funded in June 2018, was approved by the Institutional Review Boards of the relevant organizations (FHI 360: April 16, 2019 and May 18, 2020; and Hanoi University of Public Health: December 6, 2019). The dates of data collection are as follows: Vietnam: November and December 2019, May and June 2020; the Philippines: projected August 2020; Myanmar and Thailand: pending based on permissions and funding. Results are expected to be published in January 2021. As of July 2020, we had enrolled 1150 participants. We will present a comparison of key contents of the policies across countries and against international standards and recommendations and a comparison of implementation strategies, coverage, monitoring, and enforcement across countries. We will also present findings from secondary data and trend data analyses to propose the potential impact of a new or amended policy. For the surveys with women, we will present associations between exposure to maternity protection or BMS promotion on infant and young child feeding practices and their determinants. Findings from IDIs will highlight relevant stakeholders? and beneficiaries? perceptions. Conclusions: This study will increase the understanding of the effectiveness of policy interventions to improve breastfeeding, which will be used to advocate for stronger policy adoption and enforcement in study countries and beyond. International Registered Report Identifier (IRRID): DERR1-10.2196/21286 UR - http://www.researchprotocols.org/2020/9/e21286/ UR - http://dx.doi.org/10.2196/21286 UR - http://www.ncbi.nlm.nih.gov/pubmed/32955449 ID - info:doi/10.2196/21286 ER - TY - JOUR AU - Weber, Shannon AU - Lazar, Laura AU - McCord, Alan AU - Romero, Charlie AU - Tan, Judy PY - 2020/9/22 TI - Online Navigation for Pre-Exposure Prophylaxis via PleasePrEPMe Chat for HIV Prevention: Protocol for a Development and Use Study JO - JMIR Res Protoc SP - e20187 VL - 9 IS - 9 KW - pre-exposure prophylaxis: PrEP KW - online chat KW - health systems navigation KW - HIV prevention KW - online navigation N2 - Background: Pre-exposure prophylaxis is an HIV medication taken by an individual who is HIV-negative to prevent infection before exposure to the virus. Numerous clinical studies in various communities have shown high rates of effectiveness when pre-exposure prophylaxis is taken as prescribed. Since FDA (US Food and Drug Administration) approval of the first product for pre-exposure prophylaxis in 2012, uptake has been lower than the estimated 1.1 million US adults who could benefit from its use, with an estimated 70,394 individuals on pre-exposure prophylaxis in 2017. Of these, only 11% were Black and 13% were Hispanic despite Black and Hispanic individuals comprising two-thirds of individuals who could benefit, highlighting racial and ethnic disparities in pre-exposure prophylaxis uptake. Patient navigators have been shown to be effective in improving the linkage and retention in care outcomes of people living with HIV across the HIV treatment cascade and can be used throughout the pre-exposure prophylaxis care continuum to assist decision making and connect potential users to pre-exposure prophylaxis services. Objective: PleasePrEPMe Chat was designed as a novel online strategy aimed at improving engagement in pre-exposure prophylaxis care services with pre-exposure prophylaxis?eligible populations in California via free HIV-prevention information and health care navigation services. Methods: Visitors connected with navigators via online bilingual (English, Spanish) chat. During the chat, navigators helped locate pre-exposure prophylaxis services through the PleasePrEPMe provider directory, provided links to HIV-prevention resources, and supported uninsured, insured, and undocumented visitors with benefits navigation. Data such as date, time, type of encounter, visitor type, key demographics, discussion topics, insurance, and other relevant information were collected via a chat log and through the HealthEngage chat platform. Results: From April 2017 to December 2019, PleasePrEPMe completed 2191 online chats. Mean interaction time was 16 minutes, with 68% of chats covering more than one topic. Conversation topics included health care navigation (1104/2191, 50.39%), provider identification (954/2191, 43.54%), pre-exposure prophylaxis information (773/2191, 35.28%), post-exposure prophylaxis information (318/2191, 14.91%), and the California Pre-Exposure Prophylaxis Assistance Program (232/2191, 10.59%). Referrals to pre-exposure prophylaxis? or non pre-exposure prophylaxis?related resources included directory updates, HIV testing and treatment, undetectable=untransmittable, reproductive health, sexually transmitted infections, and other prevention methods. A total of 368 chat visitors completed a voluntary satisfaction scale rating the quality and helpfulness of the service provided, producing a mean rating of 4.7 out of 5. Conclusions: Online chat is a method for reaching people not already engaged in HIV-prevention services, supporting HIV-prevention decision making, and linking people seeking information online with in-person services. Additional research to evaluate online sexual health information services and understand how social determinants of health influence online engagement is needed to better understand how to reach priority populations not well served by current HIV-prevention services. International Registered Report Identifier (IRRID): RR1-10.2196/20187 UR - http://www.researchprotocols.org/2020/9/e20187/ UR - http://dx.doi.org/10.2196/20187 UR - http://www.ncbi.nlm.nih.gov/pubmed/32960183 ID - info:doi/10.2196/20187 ER - TY - JOUR AU - Milne-Ives, Madison AU - Lam, Ching AU - van Velthoven, Michelle AU - Meinert, Edward PY - 2020/9/24 TI - Mobile Fitness and Weight Management Apps: Protocol for a Quality Evaluation JO - JMIR Res Protoc SP - e17685 VL - 9 IS - 9 KW - mobile apps KW - telemedicine KW - smartphone KW - exercise KW - weight loss KW - obesity KW - physical fitness KW - fitness trackers N2 - Background: Obesity is a contributing factor for many noncommunicable diseases and a growing problem worldwide. Many mobile apps have been developed to help users improve their fitness and weight management behaviors. However, the speed at which apps are created and updated means that it is important to periodically assess their quality. Objective: The purpose of this study is to evaluate the quality of fitness and weight management mobile health apps using the Mobile Application Rating Scale (MARS). It will also describe the features of the included apps and compare the results to a previous evaluation conducted in 2015. Methods: Searches for ?fitness,? ?weight,? ?exercise,? ?physical activity,? ?diet,? ?eat*,? and ?food? will be conducted in the Apple App Store and Google Play. Apps that have been updated over the past 5 years will be included. Two reviewers will rate the apps? quality using the MARS objective and subjective quality subscales. Interrater reliability will also be assessed. Features included in high-quality apps will be assessed, and changes in quality, features, and behavior change techniques made during the past 5 years will be described. Results: The results will be included in the evaluation paper, which we aim to publish in 2020. Conclusions: This evaluation will assess the quality of currently available fitness and weight management apps. International Registered Report Identifier (IRRID): PRR1-10.2196/17685 UR - http://www.researchprotocols.org/2020/9/e17685/ UR - http://dx.doi.org/10.2196/17685 UR - http://www.ncbi.nlm.nih.gov/pubmed/32969830 ID - info:doi/10.2196/17685 ER - TY - JOUR AU - Bass, Alec AU - Aubertin-Leheudre, Mylène AU - Vincent, Claude AU - Karelis, D. Antony AU - Morin, N. Suzanne AU - McKerral, Michelle AU - Duclos, Cyril AU - Gagnon, H. Dany PY - 2020/9/24 TI - Effects of an Overground Walking Program With a Robotic Exoskeleton on Long-Term Manual Wheelchair Users With a Chronic Spinal Cord Injury: Protocol for a Self-Controlled Interventional Study JO - JMIR Res Protoc SP - e19251 VL - 9 IS - 9 KW - assistive technology KW - locomotion KW - spinal cord injury KW - rehabilitation KW - robotics KW - osteoporosis N2 - Background: In wheelchair users with a chronic spinal cord injury (WUSCI), prolonged nonactive sitting time and reduced physical activity?typically linked to this mode of mobility?contribute to the development or exacerbation of cardiorespiratory, musculoskeletal, and endocrine-metabolic health complications that are often linked to increased risks of chronic pain or psychological morbidity. Limited evidence suggests that engaging in a walking program with a wearable robotic exoskeleton may be a promising physical activity intervention to counter these detrimental health effects. Objective: This study?s overall goals are as follows: (1) to determine the effects of a 16-week wearable robotic exoskeleton?assisted walking program on organic systems, functional capacities, and multifaceted psychosocial factors and (2) to determine self-reported satisfaction and perspectives with regard to the intervention and the device. Methods: A total of 20 WUSCI, who have had their injuries for more than 18 months, will complete an overground wearable robotic exoskeleton?assisted walking program (34 sessions; 60 min/session) supervised by a physiotherapist over a 16-week period (one to three sessions/week). Data will be collected 1 month prior to the program, at the beginning, and at the end as well as 2 months after completing the program. Assessments will characterize sociodemographic characteristics; anthropometric parameters; sensorimotor impairments; pain; lower extremity range of motion and spasticity; wheelchair abilities; cardiorespiratory fitness; upper extremity strength; bone architecture and mineral density at the femur, tibia, and radius; total and regional body composition; health-related quality of life; and psychological health. Interviews and an online questionnaire will be conducted to measure users? satisfaction levels and perspectives at the end of the program. Differences across measurement times will be verified using appropriate parametric or nonparametric analyses of variance for repeated measures. Results: This study is currently underway with active recruitment in Montréal, Québec, Canada. Results are expected in the spring of 2021. Conclusions: The results from this study will be essential to guide the development, implementation, and evaluation of future evidence-based wearable robotic exoskeleton?assisted walking programs offered in the community, and to initiate a reflection regarding the use of wearable robotic exoskeletons during initial rehabilitation following a spinal cord injury. Trial Registration: ClinicalTrials.gov NCT03989752; https://clinicaltrials.gov/ct2/show/NCT03989752 International Registered Report Identifier (IRRID): DERR1-10.2196/19251 UR - http://www.researchprotocols.org/2020/9/e19251/ UR - http://dx.doi.org/10.2196/19251 UR - http://www.ncbi.nlm.nih.gov/pubmed/32663160 ID - info:doi/10.2196/19251 ER - TY - JOUR AU - Saunder, Timothy AU - Kitsos, Alex AU - Radford, Jan AU - Jose, Kim AU - McKercher, Charlotte AU - Raj, Rajesh AU - Wiggins, Nadine AU - Stokes, Brian AU - Jose, D. Matthew PY - 2020/9/17 TI - Chronic Kidney Disease in Tasmania: Protocol for a Data Linkage Study JO - JMIR Res Protoc SP - e20160 VL - 9 IS - 9 KW - chronic kidney disease KW - dialysis KW - transplantation KW - data linkage. N2 - Background: Chronic kidney disease (CKD) is a significant and growing health burden globally. Tasmania has the highest state prevalence for non-Indigenous Australians and it has consistently had the lowest incidence and prevalence of dialysis in Australia. Objective: To examine the gap between the high community prevalence of CKD in Tasmania and the low use of dialysis. Methods: This is a retrospective cohort study using linked data from 5 health and 2 pathology data sets from the island state of Tasmania, Australia. The study population consists of any person (all ages including children) who had a blood measurement of creatinine with the included pathology providers between January 1, 2004, and December 31, 2017. This study population (N=460,737) includes within it a CKD cohort, which was detected via pathology or documentation of kidney replacement therapy (KRT; dialysis or kidney transplant). Kidney function (estimated glomerular filtration rate [eGFR]) was calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. Individuals with 2 measures of eGFR<60 mL/min/1.73 m2, at least 90 days apart, were identified as having CKD and were included in the CKD cohort. Individuals treated with dialysis or transplant were identified from the Australia and New Zealand Dialysis and Transplant Registry. Results: The study population consisted of 460,737 people (n=245,573 [53.30%] female, mean age 47.4 years) who were Tasmanian residents aged 18 years and older and were followed for a median of 7.8 years. During the later 5 years of the study period, 86.79% (355,622/409,729) of Tasmanian adults were represented. The CKD cohort consisted of 56,438 people (ie, 12.25% of the study population; 53.87% (30,405/56,438) female, mean age 69.9 years) followed for a median of 10.4 years with 56,039 detected via eGFR and 399 people detected via documentation of KRT. Approximately half (227,433/460,737, 49.36%) of the study population and the majority of the CKD cohort (41,448/56,438, 73.44%) had an admission episode. Of the 55,366 deaths recorded in the study population, 45.10% (24,970/55,366) had CKD. Conclusions: Whole-of-population approaches to examine CKD in the community can be achieved by data linkage. Over this 14-year period, CKD affected 12.25% (56,438/460,737) of Tasmanian adult residents and was present in 45.10% (24,970/55,366) of deaths. International Registered Report Identifier (IRRID): DERR1-10.2196/20160 UR - http://www.researchprotocols.org/2020/9/e20160/ UR - http://dx.doi.org/10.2196/20160 UR - http://www.ncbi.nlm.nih.gov/pubmed/32940614 ID - info:doi/10.2196/20160 ER - TY - JOUR AU - Vrijen, Charlotte AU - Ackermans, Alice Mégane AU - Bosma, Anna AU - Kretschmer, Tina PY - 2020/9/24 TI - Reward Responsiveness, Optimism, and Social and Mental Functioning in Children Aged 6-7: Protocol of a Cross-Sectional Pilot Study JO - JMIR Res Protoc SP - e18902 VL - 9 IS - 9 KW - optimism KW - reward responsiveness KW - risk-taking KW - children KW - mental health KW - social relations N2 - Background: There is evidence that reward responsiveness and optimism are associated with mental and social functioning in adolescence and adulthood, but it is unknown if this is also the case for young children. Part of the reason for this gap in the literature is that the instruments that are used to assess reward responsiveness and optimism in adolescents and adults are usually not suitable for young children. Objective: Two behavioral tasks to assess reward learning, a questionnaire on reward responsiveness, and a questionnaire on optimism/pessimism will be tested on their feasibility and reliability in children aged 6-7. Depending on their feasibility and reliability, these instruments will also be used to investigate if reward responsiveness and optimism are associated with mental and social functioning in young children. Methods: For this cross-sectional pilot study, we adapted a number of tasks and questionnaires to the needs of 6-7-year-old children, by simplification of items, oral rather than written assessment, and reducing the number of conditions and items. We will approach teachers and, with their help, aim to include 70 children aged 6-7 to assess the feasibility and reliability of the tasks and questionnaires. Feasibility measures that will be reported are the proportion of children completing the task/questionnaire, the proportion of children that were able to explain the instructions in their own words to the researcher, and the proportion of children that correctly answered the control questions. The reliability of the scales will be assessed by computing Cronbach ? and item-total score correlations and the reliability of the tasks by correlations between different consecutive blocks of trials. Ethics approval was obtained from the Ethics Committee of the Department of Pedagogy and Educational Sciences. Results: Data collection was originally planned in March and April 2020, but has been postponed due to Corona virus regulations. We expect to collect the data in the first half of 2021. The findings will be disseminated in preprints and peer-reviewed publications. Conclusions: The development of feasible and reliable instruments for assessing reward responsiveness and optimism in young children is expected to benefit future research on underlying mechanisms of mental and social functioning in young children. If the instruments assessed in this study are usable with young children, it would be particularly interesting to include them in cohort studies because this would enable investigating not only concurrent associations, but also prospective associations between reward responsiveness and optimism early in life and mental and social functioning later in life. If, as we hypothesize, reward responsiveness and optimism are not only associated with (prospective) mental and social functioning in adults and adolescents but also in young children, this could provide a way of identifying vulnerable children already at an early stage. International Registered Report Identifier (IRRID): PRR1-10.2196/18902 UR - http://www.researchprotocols.org/2020/9/e18902/ UR - http://dx.doi.org/10.2196/18902 UR - http://www.ncbi.nlm.nih.gov/pubmed/32969825 ID - info:doi/10.2196/18902 ER - TY - JOUR AU - Ndwandwe, Duduzile AU - Ngcobo, J. Ntombenhle AU - Adamu, A. Abdu AU - Nnaji, Chukwudi AU - Mashunye, Thandiwe AU - Leufak, M. Arlette AU - Cooper, Sara AU - Uthman, A. Olalekan AU - Wiysonge, S. Charles PY - 2020/9/28 TI - Country-Level Assessment of Missed Opportunities for Vaccination in South Africa: Protocol for Multilevel Analysis JO - JMIR Res Protoc SP - e16672 VL - 9 IS - 9 KW - South Africa KW - vaccination coverage KW - missed opportunities for vaccination KW - implementation science N2 - Background: Vaccination is one of the greatest public health interventions of all time. Vaccination coverage in South Africa has shown a steady improvement in reaching the national target. However, while there is progress nationally, there are districts within the country that are below the set target for vaccination coverage. One of the main drivers of suboptimal vaccination coverage is thought to be missed opportunities for vaccination. Objective: This study aims to understand the magnitude and determinants of missed opportunities for vaccination in South Africa. Methods: The 2016 South African Demographic and Health Survey will be used to conduct multilevel regression analyses to determine individual and contextual factors associated with missed opportunities for vaccination in South Africa. The perspectives of parents attending health care facilities in South Africa will be explored through exit interviews and focus group discussions. Similarly, perspectives of the health care providers will be sought to understand enablers and barriers to vaccination coverage at the facility level. Insights to such factors will aid in designing tailor-made interventions to improve vaccination coverage in South Africa. Results: Ethical review submission is planned for October 2020. Data collection is expected to be underway in January 2021. Conclusions: The extent of missed opportunities in South Africa coupled with the associated factors presents an opportunity for efforts to increase uptake in districts where vaccination coverage is below the national target. Population-level data such as those from the 2016 South African Demographic Health Survey will provide an idea of the magnitude of missed opportunities for vaccination in South Africa at the national and subnational levels. The findings of the study will inform national and subnational policy implementation on vaccinations and help to find context-specific interventions to improve vaccination coverage. International Registered Report Identifier (IRRID): PRR1-10.2196/16672 UR - http://www.researchprotocols.org/2020/9/e16672/ UR - http://dx.doi.org/10.2196/16672 UR - http://www.ncbi.nlm.nih.gov/pubmed/32985990 ID - info:doi/10.2196/16672 ER - TY - JOUR AU - Hesam-Shariati, Negin AU - Newton-John, Toby AU - Singh, K. Avinash AU - Tirado Cortes, A. Carlos AU - Do, Nguyen Tien-Thong AU - Craig, Ashley AU - Middleton, W. James AU - Jensen, P. Mark AU - Trost, Zina AU - Lin, Chin-Teng AU - Gustin, M. Sylvia PY - 2020/9/29 TI - Evaluation of the Effectiveness of a Novel Brain-Computer Interface Neuromodulative Intervention to Relieve Neuropathic Pain Following Spinal Cord Injury: Protocol for a Single-Case Experimental Design With Multiple Baselines JO - JMIR Res Protoc SP - e20979 VL - 9 IS - 9 KW - EEG neurofeedback KW - neuropathic pain KW - spinal cord injury KW - thalamus KW - serious games KW - brain-machine interface KW - brain-computer interface KW - single-case experimental design N2 - Background: Neuropathic pain is a debilitating secondary condition for many individuals with spinal cord injury. Spinal cord injury neuropathic pain often is poorly responsive to existing pharmacological and nonpharmacological treatments. A growing body of evidence supports the potential for brain-computer interface systems to reduce spinal cord injury neuropathic pain via electroencephalographic neurofeedback. However, further studies are needed to provide more definitive evidence regarding the effectiveness of this intervention. Objective: The primary objective of this study is to evaluate the effectiveness of a multiday course of a brain-computer interface neuromodulative intervention in a gaming environment to provide pain relief for individuals with neuropathic pain following spinal cord injury. Methods: We have developed a novel brain-computer interface-based neuromodulative intervention for spinal cord injury neuropathic pain. Our brain-computer interface neuromodulative treatment includes an interactive gaming interface, and a neuromodulation protocol targeted to suppress theta (4-8 Hz) and high beta (20-30 Hz) frequency powers, and enhance alpha (9-12 Hz) power. We will use a single-case experimental design with multiple baselines to examine the effectiveness of our self-developed brain-computer interface neuromodulative intervention for the treatment of spinal cord injury neuropathic pain. We will recruit 3 participants with spinal cord injury neuropathic pain. Each participant will be randomly allocated to a different baseline phase (ie, 7, 10, or 14 days), which will then be followed by 20 sessions of a 30-minute brain-computer interface neuromodulative intervention over a 4-week period. The visual analog scale assessing average pain intensity will serve as the primary outcome measure. We will also assess pain interference as a secondary outcome domain. Generalization measures will assess quality of life, sleep quality, and anxiety and depressive symptoms, as well as resting-state electroencephalography and thalamic ?-aminobutyric acid concentration. Results: This study was approved by the Human Research Committees of the University of New South Wales in July 2019 and the University of Technology Sydney in January 2020. We plan to begin the trial in October 2020 and expect to publish the results by the end of 2021. Conclusions: This clinical trial using single-case experimental design methodology has been designed to evaluate the effectiveness of a novel brain-computer interface neuromodulative treatment for people with neuropathic pain after spinal cord injury. Single-case experimental designs are considered a viable alternative approach to randomized clinical trials to identify evidence-based practices in the field of technology-based health interventions when recruitment of large samples is not feasible. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000556943; https://bit.ly/2RY1jRx International Registered Report Identifier (IRRID): PRR1-10.2196/20979 UR - http://www.researchprotocols.org/2020/9/e20979/ UR - http://dx.doi.org/10.2196/20979 UR - http://www.ncbi.nlm.nih.gov/pubmed/32990249 ID - info:doi/10.2196/20979 ER - TY - JOUR AU - Flanagan, W. Emily AU - Altazan, D. Abby AU - Comardelle, R. Natalie AU - Gilmore, Anne L. AU - Apolzan, W. John AU - St. Romain, Jessica AU - Hardee, C. Julie AU - Puyau, S. Renee AU - Mayet, L. Christy AU - Beyl, A. Robbie AU - Barlow, Ariel S. AU - Bounds, Surber Sarah AU - Olson, N. Kelsey AU - Kennedy, M. Betty AU - Hsia, S. Daniel AU - Redman, M. Leanne PY - 2020/9/10 TI - The Design of a Randomized Clinical Trial to Evaluate a Pragmatic and Scalable eHealth Intervention for the Management of Gestational Weight Gain in Low-Income Women: Protocol for the SmartMoms in WIC Trial JO - JMIR Res Protoc SP - e18211 VL - 9 IS - 9 KW - mobile health KW - mobile phone KW - maternal obesity KW - gestational weight gain KW - community health N2 - Background: Less than one-third of women gain an appropriate amount of weight during pregnancy, which can influence the long-term health of both the mother and the child. Economically disadvantaged women are the most vulnerable to maternal obesity, excessive weight gain during pregnancy, and poor birth outcomes. Effective and scalable health care strategies to promote healthy weight gain during pregnancy specifically tailored for these women are lacking. Objective: This paper presents the design and protocol of a biphasic, community-based eHealth trial, SmartMoms in WIC, to increase the adherence to healthy gestational weight gain (GWG) recommendations in low-income mothers receiving women, infant, and children (WIC) benefits. Methods: Phase 1 of the trial included using feedback from WIC mothers and staff and participants from 2 community peer advisory groups to adapt an existing eHealth gestational weight management intervention to meet the needs of women receiving WIC benefits. The health curriculum, the format of delivery, and incentive strategies were adapted to be culturally relevant and at an appropriate level of health literacy. Phase 2 included a pragmatic randomized controlled trial across the 9 health care regions in Louisiana with the goal of enrolling 432 women. The SmartMoms in WIC intervention is an intensive 24-week behavioral intervention, which includes nutrition education and exercise strategies, and provides the technology to assist with weight management, delivered through a professionally produced website application. Results: Phase 1 of this trial was completed in July 2019, and recruitment for phase 2 began immediately thereafter. All data are anticipated to be collected by Spring 2023. Conclusions: The SmartMoms in WIC curriculum was methodically developed using feedback from community-based peer advisory groups to create a culturally relevant, mobile behavioral intervention for mothers receiving WIC benefits. The randomized clinical trial is underway to test the effectiveness of a sustainable eHealth program on the incidence rates of appropriate GWG. SmartMoms in WIC may be able to offer an innovative, cost-effective, and scalable solution for GWG management in women served by WIC. Trial Registration: ClinicalTrials.gov NCT04028843; https://clinicaltrials.gov/ct2/show/NCT04028843 International Registered Report Identifier (IRRID): DERR1-10.2196/18211 UR - https://www.researchprotocols.org/2020/9/e18211 UR - http://dx.doi.org/10.2196/18211 UR - http://www.ncbi.nlm.nih.gov/pubmed/32909954 ID - info:doi/10.2196/18211 ER - TY - JOUR AU - Kylén, Maya AU - Schmidt, M. Steven AU - Jonsson, Oskar AU - Slaug, Björn AU - Iwarsson, Susanne PY - 2020/9/21 TI - Awareness of and Attitudes Toward User Involvement in Research on Aging and Health: Protocol for a Quantitative Large-Scale Panel Study JO - JMIR Res Protoc SP - e17759 VL - 9 IS - 9 KW - partnerships KW - public involvement KW - older people KW - UserAge program KW - user participation N2 - Background: User involvement is a requirement of most research funders. There is a growing body of literature exploring the benefits and challenges of user involvement in research, but such studies are scarce in the field of aging and health. Moreover, the majority of such research is qualitative, which limits the generalizability of results. The UserAge panel study will be instrumental in expanding knowledge that will benefit the quality and impact of user involvement in future research. Objective: The aim of this study is to determine the awareness and understanding of and attitudes toward user involvement in research among different categories of knowledge users and researchers over time. Methods: A panel study will be implemented with 3 different categories of knowledge users (people aged 60 years and older, informal carers, and professionals in health care and architecture) and researchers in aging and health. A professional survey company will collect data from all samples in parallel. Potential participants will be asked to complete the survey via telephone or online, or participants can request a paper survey to be sent to them in the post. A draft set of questions on attitudes and behavioral patterns related to research utilization and user involvement in research was compiled based on existing literature and input from the research team. Using a participatory approach, we engaged a user forum, where 8 older people and 3 researchers jointly refined the survey for time/length to complete, terminology, readability, and context. Data collected via the internet or telephone will be automatically processed, and data collected on paper forms will be entered in machine-readable forms. The survey company will store all data and deliver the quality-controlled database to the university for further storage. Analyses of frequencies and measures of central tendency will be used for descriptive purposes. To compare groups, state-of-the art statistical analyses will be used. Results: Data collection for the first study wave started in September 2019 and will be completed in spring 2020. Data will be ready for analysis following cleaning and quality control, which started during summer 2020 and will be completed autumn 2020. We anticipate the data collection for the second study wave to start in September 2021. Conclusions: This is the first quantitative large-scale panel study focusing on trends in attitudes toward, awareness of, and knowledge about user involvement in research on aging and health in Sweden. The results will generate new and important knowledge to advance the understanding of user needs and preferences as well as the relevance of user involvement in research on aging and health. International Registered Report Identifier (IRRID): DERR1-10.2196/17759 UR - http://www.researchprotocols.org/2020/9/e17759/ UR - http://dx.doi.org/10.2196/17759 UR - http://www.ncbi.nlm.nih.gov/pubmed/32955444 ID - info:doi/10.2196/17759 ER - TY - JOUR AU - Joska, A. John AU - Andersen, S. Lena AU - Smith-Alvarez, Rosana AU - Magidson, Jessica AU - Lee, S. Jasper AU - O'Cleirigh, Conall AU - Safren, A. Steven PY - 2020/9/28 TI - Correction: Nurse-Delivered Cognitive Behavioral Therapy for Adherence and Depression Among People Living With HIV (the Ziphamandla Study): Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e24074 VL - 9 IS - 9 UR - http://www.researchprotocols.org/2020/9/e24074/ UR - http://dx.doi.org/10.2196/24074 UR - http://www.ncbi.nlm.nih.gov/pubmed/32986563 ID - info:doi/10.2196/24074 ER - TY - JOUR AU - Milne-Ives, Madison AU - Lam, Ching AU - van Velthoven, Michelle AU - Meinert, Edward PY - 2020/9/23 TI - The Impact of Brexit on the Pharmaceutical Supply Chain of the United Kingdom: Scoping Review Protocol JO - JMIR Res Protoc SP - e17684 VL - 9 IS - 9 KW - Brexit KW - drug industry KW - pharmaceutical supply N2 - Background: The continuing uncertainty around Brexit has caused concern in the pharmaceutical industry and among health care professionals and patients. The exact consequences of Brexit on the pharmaceutical supply chain in the United Kingdom will depend on whether a deal is reached and what it entails, but it is likely to be affected by the withdrawal of the United Kingdom from the European Union. Regulatory issues and delays in supply have the potential to negatively affect the ability of UK residents to receive an adequate and timely supply of necessary medicines. Objective: The purpose of this protocol is to provide an overview and critical analysis of current perspectives on the effect of Brexit on the UK pharmaceutical supply chain. Methods: The PRISMA-ScR (Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews) guidelines will be used to structure this protocol. A systematic search of MEDLINE, EMBASE, PsycINFO, Healthcare Management Information Consortium (HMIC), Cochrane, Web of Science, Business Source Complete, EconLit, and Economist Intelligence Unit will be conducted, as well as a Google and Nexis.UK search for grey literature such as reports, opinion pieces, and press releases. Two reviewers will independently screen the titles and abstracts of identified references and select studies according to the eligibility criteria. Any discrepancies will then be discussed and resolved. One reviewer will extract data from the included studies into a standardized form, which will be validated by a second reviewer. Risk of bias will be assessed using the Cochrane Collaboration Risk of Bias tool for any randomized controlled trials; quality will be assessed using the relevant Critical Appraisal Skills Programme (CASP) checklists; and grey literature will be assessed using the Authority, Accuracy, Coverage, Objectivity, Date, Significance (AACODS) checklist. Outcomes include the agreement between sources on the potential, likelihood, and severity of the consequences of Brexit on the UK pharmaceutical supply chain. Results: Results will be included in the scoping review, which will be published in 2020. Conclusions: This scoping review will summarize the currently expected consequences of Brexit on the UK pharmaceutical supply chain. International Registered Report Identifier (IRRID): PRR1-10.2196/17684 UR - http://www.researchprotocols.org/2020/9/e17684/ UR - http://dx.doi.org/10.2196/17684 UR - http://www.ncbi.nlm.nih.gov/pubmed/32965239 ID - info:doi/10.2196/17684 ER - TY - JOUR AU - Hill, J. Brandon AU - Motley, N. Darnell AU - Rosentel, Kris AU - VandeVusse, Alicia AU - Garofalo, Robert AU - Kuhns, M. Lisa AU - Kipke, D. Michele AU - Reisner, Sari AU - Rupp, Betty AU - West Goolsby, Rachel AU - McCumber, Micah AU - Renshaw, Laura AU - Schneider, A. John PY - 2020/9/11 TI - Work2Prevent, an Employment Intervention Program as HIV Prevention for Young Men Who Have Sex With Men and Transgender Youth of Color (Phase 3): Protocol for a Single-Arm Community-Based Trial to Assess Feasibility and Acceptability in a Real-World Setting JO - JMIR Res Protoc SP - e18051 VL - 9 IS - 9 KW - HIV/AIDS KW - youth KW - young men who have sex with men KW - YMSM KW - young transgender women KW - YTW KW - gender nonconforming youth KW - LGBTQ KW - unemployment KW - homelessness KW - sex work N2 - Background: In the United States, young cisgender men who have sex with men (YMSM), young transgender women (YTW), and gender nonconforming (GNC) youth face elevated rates of HIV infection. However, racial and ethnic disparities in adolescent HIV infection cannot be attributed to individual-level factors alone and are situated within larger social and structural contexts that marginalize and predispose sexual and gender minority youth of color to HIV. Addressing broader ecological factors that drive transmission requires interventions that focus on the distal drivers of HIV infection, including violence exposure, housing, food insecurity, educational attainment, and employment. Given the ways that economic instability may make YMSM, YTW, and GNC youth of color vulnerable to HIV exposure, this study focuses on employment as an HIV prevention intervention. More specifically, the intervention, called Work2Prevent (W2P), targets economic stability through job readiness and employment as a means of preventing behaviors and factors associated with adolescent and young adult HIV, such as transactional sex work and homelessness. The intervention was adapted from iFOUR, an evidence-based employment program for HIV-positive adults in phase 1 of this study, and pilot tested in a university-based setting in phase 2. Objective: This paper aims to describe the protocol for the community-based test phase of W2P. The purpose of this phase was to pilot test a tailored, theoretically informed employment intervention program among YMSM, YTW, and GNC youth of color within a lesbian, gay, bisexual, transgender, and queer (LGBTQ) community setting. Methods: The employment intervention was pilot tested using a single-arm pretest-posttest trial design implemented among a sample of vulnerable YMSM, YTW, and GNC youth of color using services within a community-based LGBTQ center. Assessments will examine intervention feasibility, acceptability, and preliminary estimates of efficacy. Results: Phase 3 of W2P research activities began in May 2019 and was completed in December 2019. Overall, 41 participants were enrolled in the community-based pilot. Conclusions: This study will assess intervention feasibility and acceptability in the target populations and determine preliminary efficacy of the intervention to increase employment and reduce vulnerability to HIV when implemented in a community-based setting serving LGBTQ youth of color. Testing the intervention in a community setting is an opportunity to evaluate how recruitment, retention, and other outcomes are impacted by delivery in a venue akin to where this intervention could eventually be used by nonresearchers. If W2P demonstrates feasibility and acceptability, a larger multisite trial implemented in multiple community settings serving YMSM, YTW, and GNC youth of color is planned. Trial Registration: ClinicalTrials.gov NCT03313310; https://clinicaltrials.gov/ct2/show/NCT03313310 International Registered Report Identifier (IRRID): DERR1-10.2196/18051 UR - https://www.researchprotocols.org/2020/9/e18051 UR - http://dx.doi.org/10.2196/18051 UR - http://www.ncbi.nlm.nih.gov/pubmed/32915162 ID - info:doi/10.2196/18051 ER - TY - JOUR AU - Sheth, N. Anandi AU - Hussen, A. Sophia AU - Escoffery, Cam AU - Haddad, B. Lisa AU - Powell, Leah AU - Brown, Nakita AU - Filipowicz, R. Teresa AU - McCumber, Micah AU - Sanchez, Maria AU - Renshaw, Laura AU - Psioda, A. Matthew AU - Sales, M. Jessica PY - 2020/9/25 TI - Pre-Exposure Prophylaxis Integration Into Family Planning Services at Title X Clinics in the Southeastern United States: Protocol for a Mixed Methods Hybrid Type I Effectiveness Implementation Study (Phase 2 ATN 155) JO - JMIR Res Protoc SP - e18784 VL - 9 IS - 9 KW - HIV KW - pre-exposure prophylaxis KW - implementation science KW - family planning services N2 - Background: Adolescent and young adult women (AYAW), particularly racial and ethnic minorities, in the Southern United States are disproportionately affected by HIV. Pre-exposure prophylaxis (PrEP) is an effective, scalable, individual-controlled HIV prevention strategy that is grossly underutilized among women of all ages and requires innovative delivery approaches to optimize its benefit. Anchoring PrEP delivery to family planning (FP) services that AYAW already trust, access routinely, and deem useful for their sexual health may offer an ideal opportunity to reach women at risk for HIV and to enhance their PrEP uptake and adherence. However, PrEP has not been widely integrated into FP services, including Title X?funded FP clinics that provide safety net sources of care for AYAW. To overcome potential implementation challenges for AYAW, Title X clinics in the Southern United States are uniquely positioned to be focal sites for conceptually informed and thoroughly evaluated PrEP implementation science studies. Objective: The objective of this study is two-fold: to evaluate multilevel factors associated with the level of PrEP adoption and implementation (eg, PrEP screening, counseling, and prescription) within and across 3 FP clinics and to evaluate PrEP uptake, persistence, and adherence among female patients in these clinics over a 6-month follow-up period. Methods: Phase 2 of Planning4PrEP (Adolescent Medicine Trials Network for HIV/AIDS Interventions 155) is a mixed methods hybrid type 1 effectiveness implementation study to be conducted in three clinics in Metro Atlanta, Georgia, United States. Guided by the Exploration, Preparation, Implementation, and Sustainment framework, this study will prepare clinics for PrEP integration via clinic-wide trainings and technical assistance and will develop clinic-specific PrEP implementation plans. We will monitor and evaluate PrEP implementation as well as female patient PrEP uptake, persistence, and adherence over a 6-month follow-up period. Results: Phase 2 of Planning4PrEP research activities began in February 2018 and are ongoing. Qualitative data analysis is scheduled to begin in Fall 2020. Conclusions: This study seeks to evaluate factors associated with the level of PrEP adoption and implementation (eg, PrEP screening, counseling, and prescription) within and across 3 FP clinics following training and implementation planning and to evaluate PrEP uptake, persistence, and adherence among female patients over a 6-month follow-up period. This will guide future strategies to support PrEP integration in Title X?funded clinics across the Southern United States. Trial Registration: ClinicalTrials.gov NCT04097834; https://clinicaltrials.gov/ct2/show/NCT04097834 International Registered Report Identifier (IRRID): DERR1-10.2196/18784 UR - http://www.researchprotocols.org/2020/9/e18784/ UR - http://dx.doi.org/10.2196/18784 UR - http://www.ncbi.nlm.nih.gov/pubmed/32975528 ID - info:doi/10.2196/18784 ER -