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  RCTs - Protocols/Proposals (non-eHealth)

  Jul 11, 2019

  Effects of a School-Based Health Intervention Program in Marginalized Communities of Port Elizabeth, South Africa (the KaziBantu Study): Protocol for a...

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  Authors List:

  • Ivan Müller  
  • Danielle Smith  
  • Larissa Adams  
  • Ann Aerts  
  • Bruce P Damons  
  • Jan Degen  
  • Stefanie Gall  
  • Zaahira Gani  
  • Markus Gerber  
  • Annelie Gresse  
  • Darelle van Greunen  
  • Nandi Joubert  
  • Tracey Marais  
  • Siphesihle Nqweniso  
  • Nicole Probst-Hensch  
  • Rosa du Randt  
  • Harald Seelig  
  • Peter Steinmann  
  • Jürg Utzinger  
  • Christina Wadhwani  
  • Cheryl Walter  
  • Uwe Pühse  

  Abstract:

  Background: The burden of poverty-related infectious diseases remains high in low- and middle-income countries, while noncommunicable diseases (NCDs) are rapidly gaining importance. To address this dual disease burden, the KaziBantu project aims at improving and promoting health literacy as a means for a healthy and active lifestyle. The project implements a school-based health intervention package consisting of physical education, moving-to-music, and specific health and nutrition education lessons from the KaziKidz toolkit. It is complemented by the KaziHealth workplace health intervention program for teachers. Objectives: The aim of the KaziBantu project is to assess the effect of a school-based health intervention package on risk factors for NCDs, health behaviors, and psychosocial health in primary school children in disadvantaged communities in Port Elizabeth, South Africa. In addition, we aim to test a workplace health intervention for teachers. Methods: A randomized controlled trial (RCT) will be conducted in 8 schools. Approximately 1000 grade 4 to grade 6 school children, aged 9 to 13 years, and approximately 60 teachers will be recruited during a baseline survey in early 2019. For school children, the study is designed as a 36-week, cluster RCT (KaziKidz intervention), whereas for teachers, a 24-week intervention phase (KaziHealth intervention) is planned. The intervention program consists of 3 main components; namely, (1) KaziKidz and KaziHealth teaching material, (2) workshops, and (3) teacher coaches. After randomization, 4 of the 8 schools will receive the education program, whereas the other schools will serve as the control group. Intervention schools will be further randomized to the different combinations of 2 additional intervention components: teacher workshops and teacher coaching. Results: This study builds on previous experience and will generate new evidence on health intervention responses to NCD risk factors in school settings as a decision tool for future controlled studies that will enable comparisons among marginalized communities between South African and other African settings. Conclusions: The KaziKidz teaching material is a holistic educational and instructional tool designed for primary school teachers in low-resource settings, which is in line with South Africa’s Curriculum and Assessment Policy Statement. The ready-to-use lessons and assessments within KaziKidz should facilitate the use and implementation of the teaching material. Furthermore, the KaziHealth interventions should empower teachers to take care of their health through knowledge gains regarding disease risk factors, physical activity, fitness, psychosocial health, and nutrition indicators. Teachers as role models will be able to promote better health behaviors and encourage a healthy and active lifestyle for children at school. We conjecture that improved health and well-being increase teachers’ productivity with trickle-down effects on the children they teach and train. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 18485542; http://www.isrctn.com/ISRCTN18485542 International Registered Report Identifier (IRRID): DERR1-10.2196/14097

  • JMIR Res Protoc 2019;8(7):e14097

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  Non-randomized Protocols and Methods...

  Jul 11, 2019

  An Electronic Health Intervention for Dutch Women With Stress Urinary Incontinence: Protocol for a Mixed Methods Study

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  Authors List:

  • Lotte Firet  
  • Theodora Alberta Maria Teunissen  
  • Huub van der Vaart  
  • Willem Jan Jozef Assendelft  
  • Kim Josephina Bernadette Notten  
  • Rudolf Bertijn Kool  
  • Antoinette Leonarda Maria Lagro-Janssen  

  Abstract:

  Background: Stress urinary incontinence (SUI) is a common problem with a great potential influence on quality of life. Although SUI can be treated effectively with pelvic floor muscle training (PFMT), only a minority of women with this complaint seek help. An internet-based electronic health (eHealth) intervention could make care more accessible. The Swedish eHealth intervention Tät-treatment of Stress Urinary Incontinence offers PFMT and has shown to be effective in reducing symptoms in women with SUI. This intervention might be helpful for Dutch women too, but its adoption needs to be studied as the Netherlands differs from Sweden in terms of geographical characteristics and health care organization. Objective: The objective of this protocol is to investigate the barriers and facilitators to the adoption of an eHealth intervention for Dutch women with SUI and the effects of this intervention. Methods: We are conducting an explanatory sequential mixed methods study among 800 Dutch women with SUI who participate in the translated version of Tät-treatment of Stress Urinary Incontinence. This eHealth intervention takes 3 months. A pre-post study is conducted using surveys, which are sent at baseline (T0), 3 weeks after baseline (T1), posttreatment (T2), and 3 months posttreatment (T3). After the intervention, semistructured interviews will be held with 15 to 20 participants. The primary outcomes are barriers and facilitators to using the Tät-treatment of Stress Urinary Incontinence. This will also be analyzed among groups that differ in age and severity of incontinence. A thematic content analysis of the qualitative data will be performed. The secondary outcomes are: (1) effect on symptoms of urinary incontinence, (2) effect on quality of life, and (3) factors that are potentially associated with success. Effects will be analyzed by a mixed model analysis. Logistic regression analysis will be used to study what patient-related factors are associated with success. Results: Enrollment started in July 2018 and will be finished by December 2019. Data analysis will start in March 2020. Conclusions: An eHealth intervention for Dutch women with SUI is promising because it can make treatment more accessible. The strength of this study is that it explores the possibilities for an internet-based-only treatment for women with SUI by using both quantitative and qualitative research methodologies. The study elaborates on existing results by using a previously tested and effective eHealth program. Insight into the barriers and facilitators to using this program can enhance the implementation of the intervention in the Dutch health care system. Trial Registration: Netherlands Trial Registry (NTR) NTR6956; https://www.trialregister.nl/trial/6570. International Registered Report Identifier (IRRID): DERR1-10.2196/13164

  • JMIR Res Protoc 2019;8(7):e13164

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  Non-Randomized Study Protocols and...

  Jul 10, 2019

  Key Worker–Mediated Enhancement of Physical Health in First Episode Psychosis: Protocol For a Feasibility Study in Primary Care

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  Authors List:

  • Geoff McCombe  
  • Aine Harrold  
  • Katherine Brown  
  • Liam Hennessy  
  • Mary Clarke  
  • David Hanlon  
  • Sinead O'Brien  
  • John Lyne  
  • Ciaran Corcoran  
  • Patrick McGorry  
  • Walter Cullen  

  Abstract:

  Background: Studies have demonstrated that, for patients with psychosis, a majority of the decline in health status and functioning emerges during the first few years after the onset of illness. This knowledge led to the development of specialized early intervention services (EISs) targeting patients experiencing their first episode of psychosis. The central component of EISs is often assertive case management delivered by a multidisciplinary team, where an appointed key worker is responsible for coordinating treatment and delivering various psychosocial interventions to service users. Objective: This paper outlines the protocol for a feasibility study examining how key workers may enhance physical health by supporting integration between primary and secondary care. Methods: Semistructured interviews were conducted with key stakeholder groups (General Practitioners and health care professionals working in mental health services). The interviews informed the development of the complex intervention involving a longitudinal pre-post intervention in 8 general practices in 2 regions in Ireland (one urban and one rural). Patients with first episode psychosis (FEP) will be identified from clinical records at general practices and mental health services. Results: Baseline and follow-up data (at 6 months) will be collected, examining measures of feasibility, acceptability, and intervention effect size. Conclusions: Study findings will inform future practice by examining feasibility of key workers enhancing physical health through improved interaction between primary and secondary care. By identifying issues involved in enhancing recruitment and retention, as well as the likely effect size, the study will inform a future definitive intervention. International Registered Report Identifier (IRRID): DERR1-10.2196/13115

  • JMIR Res Protoc 2019;8(7):e13115

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  Non-Randomized Study Protocols and...

  Jul 9, 2019

  Impact of Early Medical Treatment for Transgender Youth: Protocol for the Longitudinal, Observational Trans Youth Care Study

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  Authors List:

  • Johanna Olson-Kennedy  
  • Yee-Ming Chan  
  • Robert Garofalo  
  • Norman Spack  
  • Diane Chen  
  • Leslie Clark  
  • Diane Ehrensaft  
  • Marco Hidalgo  
  • Amy Tishelman  
  • Stephen Rosenthal  

  Abstract:

  Background: Transgender children and adolescents (ie, those who experience incongruence between assigned sex at birth and internal gender identity) are poorly understood and an understudied population in the United States. Since 2008, medical care for transgender youth has generally followed guidelines developed by professional consensus, given the paucity of empirical research, particularly in the US setting. Objective: The objective of this research was to provide evidence-based data to inform clinical care for transgender youth. The study aims (1) to evaluate the impact of gonadotropin-releasing hormone agonists administered for puberty suppression on mental health, psychological well-being, and metabolic and physiologic parameters including bone health in a cohort of children and adolescents (Tanner stages 2-4) with gender dysphoria, comparing baseline and follow-up assessments, and (2) to determine the impact of gender-affirming hormones (eg, estradiol and testosterone) administered for phenotypic gender transition on mental health, psychological well-being, and metabolic and physiologic parameters in a cohort of adolescents with gender dysphoria, comparing baseline and follow-up assessments. Methods: The study uses a longitudinal observational design to examine the outcomes of existing medical treatment protocols for gender dysphoria in two distinct cohorts: youth initiating puberty suppression and youth pursuing a phenotypic gender transition. Data on routine anthropometric and physiologic parameters are collected through chart abstraction, questionnaires, and research interviews in the 24-month study period. Audio computer-assisted self-interview and individual interview survey instruments are used to collect demographic, mental health, psychosocial, and behavioral data from parents and youth in the blocker cohort and only from youth in the gender-affirming hormone cohort at baseline and 6, 12, 18, and 24 months. Results: Participant recruitment commenced in July 2016, and enrollment was completed in September 2018. A total of 90 participants were enrolled in the blocker cohort and 301 participants were enrolled in the gender-affirming hormone cohort. Findings based on baseline data are expected to be submitted for publication in 2019. Conclusions: This longitudinal, observational study is collecting critical data on the existing models of care for transgender youth that have been used in clinical settings for close to a decade, although with limited empirical research to support them. This research is a direct response to the Institute of Medicine report calling for such studies as well as the needs of clinicians and patients. Results from this study have the potential to significantly impact the medical and mental health services provided to transgender youth by making available rigorous scientific evidence on the impact and safety of early treatment based on the sexual development stage. Ultimately, we aim to understand if early medical intervention reduces the health disparities well known to disproportionately affect transgender individuals across their lifespan. International Registered Report Identifier (IRRID): PRR1-10.2196/14434

  • JMIR Res Protoc 2019;8(7):e14434

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  RCTs - Protocols/Proposals (eHealth)

  Jul 9, 2019

  Virtual Reality and Web-Based Growth Mindset Interventions for Adolescent Depression: Protocol for a Three-Arm Randomized Trial

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  Authors List:

  • Jessica Lee Schleider  
  • Michael C Mullarkey  
  • John R Weisz  

  Abstract:

  Background: Depression is the leading cause of disability in youth, with a global economic burden of US >$210 billion annually. However, up to 70% of youth with depression do not receive services. Even among those who do access treatment, 30% to 65% fail to respond and many dropout prematurely, demonstrating a need for more potent, accessible interventions. In a previous trial, a single-session Web-based growth mindset (GM) intervention significantly reduced depressive symptoms in high-symptom adolescents; however, this intervention did not benefit adolescents uniformly. For instance, the intervention reduced depression in adolescents who reported post intervention increases in perceived control, but it did not lead to significant depression reductions in adolescents who reported no significant post intervention increases in perceived control. Objective: The goal of this project is to test the acceptability and efficacy of a novel, single-session, virtual reality (VR) depression intervention—the VR Personality Project—teaching GM, the belief that personal attributes are malleable rather than fixed. The VR Personality Project was designed to systematically target and increase adolescents’ perceived control by offering a more immersive, engaging, user-directed intervention experience than the Web-based intervention can provide. By targeting an identified predictor of intervention response, the VR Personality Project may lead to larger reductions in depressive symptoms than existing Web-based mindset interventions. Methods: Adolescents with elevated depressive symptoms or a recent history of depression (N=159; ages 12 to 16 years) will be randomized to one of 3 intervention conditions: the VR Personality Project; the Web-based GM intervention tested previously; or an active, Web-based control. Adolescents and their parents will report on the adolescents’ depression symptoms, perceived control, and related domains of functioning at preintervention, postintervention, and at 3- and 9-month follow-up assessments. Results: We predict that the VR and Web-based mindset interventions will both lead to larger reductions in adolescent symptoms than the control intervention. Additionally, we predict that the VR-based single session intervention will lead to larger reductions in depression than the online mindset intervention and that these symptom reductions will be mediated by increases in adolescents’ perceived control from pre- to postintervention. Conclusions: The results may suggest an efficient strategy for reducing adolescent depressive symptoms: One that is mechanism-targeted, relatively affordable (less than US $200 for a commercially available VR headset, a fraction of the cost of long-term psychotherapy) and potentially engaging to adolescents experiencing mood-related distress. Trial Registration: ClinicalTrials.gov NCT0385881; https://clinicaltrials.gov/ct2/show/NCT03858881 (Archived by WebCite at http://www.webcitation.org/78C3roDgA). International Registered Report Identifier (IRRID): DERR1-10.2196/13368

  • JMIR Res Protoc 2019;8(7):e13368

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  RCTs - Protocols/Proposals (funded,...

  Jul 9, 2019

  Text Message Reminders and Unconditional Monetary Incentives to Improve Measles Vaccination in Western Kenya: Study Protocol for the Mobile and Scalable...

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  Authors List:

  • Dustin G Gibson  
  • E Wangeci Kagucia  
  • Joyce Were  
  • David Obor  
  • Kyla Hayford  
  • Benard Ochieng  

  Abstract:

  Background: Globally, 21 million children do not receive the measles vaccine each year. With high levels of mobile phone access and ownership, opportunities exist to leverage mobile health technologies to generate demand for immunization. Objective: The aim of the Mobile and Scalable Innovations for Measles Immunization trial is to determine if text message (short message service, SMS) reminders, either with or without mobile phone–based incentives, can improve measles immunization coverage and timeliness in rural western Kenya. Methods: This is a 3-arm, parallel, randomized controlled trial (RCT). Using simple randomization, caregivers in Siaya County, Kenya, will be randomized and evenly allocated to 1 of 3 study arms: (1) control, (2) SMS reminders only, and (3) SMS reminders plus a 150 Kenyan Shilling (KES) incentive. Participants assigned to the SMS group will be sent SMS reminders 3 days before and on the day before the measles immunization visit scheduled for when the child is 9 months of age. Participants in the incentive arm will, in addition to SMS reminders as above, be sent an unconditional 150 KES mobile-money incentive to their mobile phone 3 days before the child becomes 9 months of age. Children will be followed up to the age of 12 months to assess the primary outcome, a measles vaccination by 10 months of age. Log-binomial regressions will be used to calculate relative risks. Results: Enrollment was completed in March 2017. We enrolled 537 caregivers and their infants into the following groups: control (n=179), SMS reminders only (n=179), and SMS reminders plus 150 KES (n=179). Results will be made publicly available in 2020. Conclusions: Few RCTs have examined the effect of text message reminders to improve measles immunization coverage. This is the first study to assess the effect of SMS reminders with and without unconditionally provided mobile-money incentives to improve measles immunization coverage. Trial Registration: ClinicalTrials.gov NCT02904642; https://clinicaltrials.gov/ct2/show/NCT02904642 (Archived by WebCite® at http://www.webcitation.org/78r7AzD2X). International Registered Report Identifier (IRRID): RR1-10.2196/13221

  • JMIR Res Protoc 2019;8(7):e13221

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  RCTs - Protocols/Proposals (eHealth)

  Jul 9, 2019

  Comparing Telemedicine and Face-to-Face Consultation Based on the Standard Smoking Cessation Program for Nicotine Dependence: Protocol for a Randomized...

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  Authors List:

  • Tomoyuki Tanigawa  
  • Akihiro Nomura  
  • Maki Kuroda  
  • Tomoyasu Muto  
  • Eisuke Hida  
  • Kohta Satake  

  Abstract:

  Background: Smoking is a major public health concern. In Japan, a 12-week standard smoking cessation support program is available, however, its required face-to-face visits are a key obstacle in completing the program. Telemedicine is a useful way to provide medical treatment at a distance. Although telemedicine for smoking cessation using an internet-based video system has the potential for ensuring better clinical outcomes for patients with nicotine dependence, its efficacy is unclear. Objective: The aim of this study is to determine the efficacy and feasibility of a smoking cessation support program using an internet-based video system compared with a face-to-face program among patients with nicotine dependence. Methods: This study will be a randomized, controlled, open-label, multicenter trial. Participants randomized to the intervention arm will undergo an internet-based smoking cessation program, whereas control participants will undergo a standard face-to-face program. We will use the CureApp Smoking Cessation (CASC) for both arms, which consists of the CASC smartphone app for patients and a Web-based patient information management system for clinicians with a mobile carbon monoxide checking device. The primary endpoint will be the continuous abstinence rate (CAR) from weeks 9 to 12. Secondary endpoints will be: (1) the smoking cessation success rate at 4, 8, 12, and 24 weeks; (2) CAR from weeks 9 to 24; (3) changes in scores on the mood and physical symptoms scale and 12-Item French Version Of The Tobacco Craving Questionnaire; (4) Kano Test for Social Nicotine Dependence scores at 8, 12, and 24 weeks; (5) time to first lapse after the first visit; (6) nicotine dependence and cognition scale scores at 12 and 24 weeks; (7) usage rate of the CASC; (8) qualitative questionnaire about the usability and acceptability of telemedicine; and (9) presence of product problems or adverse events. Results: We will recruit 114 participants who are nicotine-dependent but otherwise healthy adults from March to July 2018 and follow up with them until January 2019 (24 weeks). We expect all study results to be available by the end of March 2019. Conclusions: This will be the first randomized controlled trial to evaluate the efficacy and feasibility of an internet-based (telemedicine) smoking cessation support program relative to a face-to-face program among patients with nicotine dependence. We expect that the efficacy of the telemedicine smoking cessation support program will not be clinically worse than the face-to-face program. If this trial demonstrates that telemedicine does not have clinically worse efficacy and feasibility than a conventional face-to-face program, physicians can begin to offer a more flexible smoking cessation program to patients who may otherwise give up on trying such programs. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry: UMIN000031620; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035975 International Registered Report Identifier (IRRID): DERR1-10.2196/12701

  • JMIR Res Protoc 2019;8(7):e12701

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  RCTs - Protocols/Proposals (non-eHealth)

  Jul 8, 2019

  Receipt of Curative Resection or Palliative Care for Hepatopancreaticobiliary Tumours (RICOCHET): Protocol for a Nationwide Collaborative Observational Study

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  Authors List:

  • The RICOCHET Study Group
  • West Midlands Research Collaborative West Midlands Research Collaborative

  Abstract:

  Background: There are variations in the management of patients with suspected pancreatic and periampullary cancers and/or malignant biliary obstruction. These differences may be due to a number of organizational, institutional, and patient factors that could affect outcomes for those with curable or incurable disease. The Receipt of Curative Resection or Palliative Care for Hepatopancreaticobiliary Tumours (RICOCHET) study will be the first to provide a snapshot of investigative pathways across the United Kingdom to reflect the real-world practice in these patients. The RICOCHET study is contemporary to new national and international clinical guidance and can potentially inform future local and national strategic planning to optimize care for patients with suspected hepatopancreaticobiliary (HPB) malignancies. Objective: The aim of this study is to define national variation in the investigative and management pathways of patients with suspected HPB malignancies and to determine the effect of these variations on patient outcomes. Methods: The RICOCHET study is a nationwide, multicenter, prospective study. It is led by trainees through collaboration between surgical and medical specialties. Patients with suspected pancreatic cancer, other periampullary cancer, or extrahepatic cholangiocarcinoma presenting to hospitals in the United Kingdom will be identified over 90 days. Each case will be followed up for 90 days to collect data on the mode of presentation, investigations, interventions, use of local and specialist multidisciplinary team meetings, and transfer of care between hub and spoke sites. Furthermore, the study will define dates and intervals between key points in the patient pathway. Results: The RICOCHET study results and analyses will be subject to peer review by presenting them at international cross-specialty conferences and by submitting them for publication in open-access journals. Moreover, our findings will be presented to patient groups and sponsoring charities (eg, Pancreatic Cancer UK), who in turn will disseminate key findings to the primary beneficiaries of the results: the patients. The RICOCHET study was funded in September 2017. Data collection started in April 2018 and the planned end date for data upload is spring 2019. Data analysis will take place in the summer of 2019 and the first results are expected to be published in late 2019 or early 2020. Conclusions: The RICOCHET study is a multidisciplinary, prospective, observational study that aims to highlight variability in practice and to determine whether these affect the outcomes of patients with HPB malignancies. This is a trainee-led initiative that utilizes a novel design to achieve full coverage of the differences in diagnostic and management pathways. The RICOCHET study may provide evidence to develop a more standardized approach to managing patients with suspected HPB malignancy. International Registered Report Identifier (IRRID): DERR1-10.2196/13566

  • JMIR Res Protoc 2019;8(7):e13566

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  CIHR funded proposals with...

  Jul 4, 2019

  Community-Directed Bacterial Sexually Transmitted Infection Testing Interventions Among Men Who Have Sex With Men: Protocol for an E-Delphi Study in Toronto,...

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  Authors List:

  • Ann N Burchell  
  • Ryan Lisk  
  • Anna Yeung  
  • Jayoti Rana  
  • Jean Bacon  
  • Jason Brunetta  
  • Mark Gilbert  
  • Dionne Gesink  
  • Ramandip Grewal  
  • Charlie B. Guiang  
  • Michael Kwag  
  • Carmen H Logie  
  • Leo Mitterni  
  • Rita Shahin  
  • Darrell HS Tan  

  Abstract:

  Background: HIV-positive and HIV-negative (gay, bisexual, and other) men who have sex with men (MSM) have experienced a dramatic increase in bacterial sexually transmitted infections (STIs)—syphilis, gonorrhea, and chlamydia. STI testing and treatment mitigate adverse health outcomes and substantially reduce transmission; yet, testing rates remain below recommended levels. Innovation is needed to produce the required increases in testing levels, frequency, and the use of appropriate testing technologies in ways that are engaging, nonstigmatizing, and acceptable to men. Objective: The aim of this study is to build consensus with regard to interventions with the greatest potential for improving local STI testing services for MSM communities in Toronto, Canada. Methods: Following a literature review of evidence regarding the effectiveness of novel testing interventions, and focus groups, and surveys to describe local barriers and facilitators of testing among MSM, we will conduct a Web-based, modified Delphi study (e-Delphi). We will form expert panels of community members and STI test providers. Panelists will rate potential interventions in terms of their priority, using a 7-point Likert scale from definitely not a priority to definitely a priority. They will also rank their preferences by selecting their top 3 preferred interventions. Surveys will be distributed in 3 rounds, with feedback on the distribution of responses from preceding rounds provided in rounds 2 and 3. We will define consensus as having ≥60% (18/30) members indicate a preference within 2 adjacent response points. Qualitative data on disagreements will be obtained using open-ended text responses to explain for ratings and rankings that are different from the majority. Results: On the basis of a literature review and identification of barriers and facilitators to STI testing among community members and test providers in Toronto, we have selected 8 potential interventions for inclusion in the e-Delphi panel surveys. These include 4 interventions that streamline STI testing for asymptomatic individuals, 2 interventions that are targeted at clients and 2 interventions that are targeted at providers. Conclusions: Findings will provide community direction for informed decision making regarding the implementation of STI testing interventions in this setting. They will characterize the intervention climate for innovation to STI testing services, including perceived needs for changes to test delivery, relative priorities for change, and readiness for implementation. These methods may be transferable to other urban jurisdictions experiencing similar epidemics and for other contexts where stakeholder input is needed to manage sensitive areas of concern. International Registered Report Identifier (IRRID): PRR1-10.2196/13801

  • JMIR Res Protoc 2019;8(7):e13801

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  RCTs - Protocols/Proposals (non-eHealth)

  Jul 4, 2019

  Motivational Interviewing to Reduce Drug Use and HIV Incidence Among Young Men Who Have Sex With Men in Relationships and Are High Priority for Pre-Exposure...

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  Authors List:

  • Tyrel J Starks  
  • Gabriel Robles  
  • Mark Pawson  
  • Ruben H Jimenez  
  • Monica Gandhi  
  • Jeffrey T Parsons  
  • Brett M Millar  

  Abstract:

  Background: Men who have sex with men (MSM) currently account for more than two-thirds of new HIV diagnoses in the United States and, among young MSM (YMSM) aged 20 to 29 years, as many as 79% to 84% of new infections occur between primary partners. Contributing to HIV risk, YMSM use drugs at comparatively high rates. To date, no interventions have been developed that specifically address the unique needs of partnered YMSM or incorporate a focus on relationship factors in addressing personal motivation for change. Objective: The study’s primary aim is to evaluate the efficacy of the PARTNER intervention and evaluate potential moderators or mediators of intervention effects. The study’s secondary aims were to gather ideographic data to inform a future effectiveness implementation study and develop a novel biomarker for pre-exposure prophylaxis (PrEP) adherence by analyzing PrEP drug levels in fingernails. Methods: PARTNER is a 4-session motivational interviewing–based intervention that integrates video-based communication training to address drug use and HIV prevention among partnered YMSM. This study utilizes a randomized controlled trial design to compare the PARTNER intervention with an attention-matched psychoeducation control arm that provides information about HIV-risk reduction, PrEP, and substance use. Participants are randomized in a 1-to-1 ratio stratified on age disparity between partners, racial composition of the couple, and relationship length. Follow-up assessments are conducted at 3-, 6-, 9-, and 12-months postbaseline. The study recruits and enrolls 240 partnered YMSM aged between 18 to 29 years at a research center in New York City. Participants will be HIV-negative and report recent (past 30-day) drug use and condomless anal sex with casual partners; a nonmonogamous primary partner (regardless of HIV status); or a serodiscordant primary partner (regardless of sexual agreement). Primary outcomes (drug use and HIV sexual transmission risk behavior) are assessed via a Timeline Follow-back interview. Biological markers of outcomes are collected for drug use (fingernail assay), sexual HIV transmission risk (rectal and urethral gonorrhea and chlamydia testing), and PrEP adherence (dried blood spots and fingernails for a novel PrEP drug level assay). Results: The study opened for enrollment in February 2018. Anticipated completion of enrollment is October 2021. Primary outcome analyses will begin after final follow-up completion. Conclusions: Existing research on partnered YMSM within the framework of Couples Interdependence Theory (CIT) has suggested that relationship factors (eg, dyadic functioning and sexual agreements) are meaningfully related to drug use and HIV transmission risk. Results pertaining to the efficacy of the proposed intervention and the identification of putative moderators and mediators will substantially inform the tailoring of interventions for YMSM in relationships and contribute to a growing body of relationship science focused on enhancing health outcomes. Trial Registration: ClinicalTrials.gov NCT03396367; https://clinicaltrials.gov/ct2/show/NCT03396367 (Archived by WebCite at http://www.webcitation.org/78ti7esTc. International Registered Report Identifier (IRRID): DERR1-10.2196/13015

  • JMIR Res Protoc 2019;8(7):e13015

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  Non-Randomized Studies (funded,...

  Jul 2, 2019

  A Modified Communication and Optimal Resolution Program for Intersystem Medical Error Discovery: Protocol for an Implementation Study

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  Authors List:

  • Lesly Dossett  
  • Jacquelyn Miller  
  • Reshma Jagsi  
  • Anne Sales  
  • Michael D Fetters  
  • Richard C Boothman  
  • Justin B Dimick  

  Abstract:

  Background: Preventable medical errors represent a major public health problem. To prevent future errors, improve disclosure, and mitigate malpractice risks, organizations have adopted strategies for transparent communication and emphasized quality improvement through peer review. These principles are incorporated into the Agency for Healthcare Research and Quality (AHRQ) Communication and Optimal Resolution (CANDOR) Toolkit, which facilitates (1) transparent communication, (2) error prevention, and (3) achieving optimal resolution with patients and families; however, how medical errors should be addressed when they are discovered between systems—intersystem medical error discovery (IMED)—remains unclear. Without mechanisms for disclosure and feedback on the part of the discovering provider, uncertainty remains as to the extent to which IMED is communicated with patients or responsible providers. Furthermore, known barriers to disclosure and reporting one’s own error may not be relevant or may be replaced by other unknown barriers when considering scenarios of IMED. Objective: This study aims to develop and test implementation of a modified CANDOR process for application to IMED scenarios. Methods: We plan a series of studies following an implementation framework. First, we plan a participatory, consensus-building stakeholder panel process to develop the modified CANDOR process. We will then conduct a robust preimplementation analysis to identify determinants of implementation of the modified process. Using the Consolidated Framework for Implementation Research as a theoretical framework, we will assess organizational readiness by key informant interviews and individual-level behaviors by a survey. Findings from this analysis will inform the implementation toolkit that will be developed and pilot-tested at 2 cancer centers, sites where IMED is hypothesized to occur more frequently than other settings. We will measure 5 implementation outcomes (acceptability, appropriateness, reach, adoption, and feasibility) using a combination of key informant interviews and surveys over the pre- and postimplementation phases. Results: This protocol was funded in August 2018 with support from the AHRQ. The University of Michigan Medical School Institutional Review Board has reviewed and approved the scope of activities described. As of April 2019, step 1 of aim 1 is underway, and aim 1 is projected to be completed by April 2020. Data collection is projected to begin in January 2020 for aim 2 and in August 2020 for aim 3. Conclusions: Providing a communication and resolution strategy applicable to IMED scenarios will help address the current blind spot in the patient safety movement. This work will provide important insights into the potential utility of an implementation toolkit to improve transparent communication and optimal resolution of IMED scenarios. The natural progression of this work will be to test the toolkit more broadly, understand the feasibility and barriers of implementation on a broader scale, and pilot the implementation in new organizations. International Registered Report Identifier (IRRID): PRR1-10.2196/13396

  • JMIR Res Protoc 2019;8(7):e13396

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  Non-Randomized Studies (funded,...

  Jun 27, 2019

  Integration of Gender-Affirming Primary Care and Peer Navigation With HIV Prevention and Treatment Services to Improve the Health of Transgender Women:...

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  Authors List:

  • Javier R Lama  
  • Kenneth H Mayer  
  • Amaya G Perez-Brumer  
  • Leyla Huerta  
  • Hugo Sanchez  
  • Jesse L Clark  
  • Jorge Sanchez  
  • Sari L Reisner  

  Abstract:

  Background: Public health strategies are urgently needed to improve HIV disparities among transgender women, including holistic intervention approaches that address those health needs prioritized by the community. Hormone therapy is the primary method by which many transgender women medically achieve gender affirmation. Peer navigation has been shown to be effective to engage and retain underserved populations living with HIV in stable primary medical care. Objective: This study aims to assess the feasibility and acceptability of an integrated innovative HIV service delivery model designed to improve HIV prevention and care by combining gender-affirming primary care and peer navigation with HIV prevention and treatment services. Methods: A 12-month, nonrandomized, single-arm cohort study was implemented in Lima, Peru, among adult individuals, assigned a male sex at birth, who identified themselves as transgender women, regardless of initiation or completion of medical gender affirmation, and who were unaware of their HIV serostatus or were living with HIV but not engaged in HIV treatment. HIV-negative participants received quarterly HIV testing and were offered to initiate pre-exposure prophylaxis. HIV-positive participants were offered to initiate antiretroviral treatment and underwent quarterly plasma HIV-1 RNA and peripheral CD4+ lymphocyte cell count monitoring. All participants received feminizing hormone therapy and adherence counseling and education on their use. Peer health navigation facilitated retention in care by visiting participants at home, work, or socialization venues, or by contacting them by social media and phone. Results: Patient recruitment started in October 2016 and finished in March 2017. The cohort ended follow-up on March 2018. Data analysis is currently underway. Conclusions: Innovative and culturally sensitive strategies to improve access to HIV prevention and treatment services for transgender women are vital to curb the burden of HIV epidemic for this key population. Findings of this intervention will inform future policies and research, including evaluation of its efficacy in a randomized controlled trial. Trial Registration: ClinicalTrials.gov NCT03757117; https://clinicaltrials.gov/ct2/show/NCT03757117 International Registered Report Identifier (IRRID): DERR1-10.2196/14091

  • JMIR Res Protoc 2019;8(6):e14091

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