JMIR Publications

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  RCTs - Protocols/Proposals (eHealth)

  Aug 19, 2019

  Technology-Enabled Self-Monitoring of Chronic Obstructive Pulmonary Disease With or Without Asynchronous Remote Monitoring: Protocol for a Randomized...

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  Authors List:

  • Vess Stamenova  
  • Rebecca Yang  
  • Katrina Engel  
  • Kyle Liang  
  • Florence van Lieshout  
  • Elizabeth Lalingo  
  • Angelica Cheung  
  • Adam Erwood  
  • Maria Radina  
  • Allen Greenwald  
  • Payal Agarwal  
  • Aman Sidhu  
  • R Sacha Bhatia  
  • James Shaw  
  • Roshan Shafai  
  • Onil Bhattacharyya  

  Abstract:

  Background: Chronic obstructive pulmonary disease (COPD) is the third leading cause of mortality worldwide. Reducing the number of COPD exacerbations is an important patient outcome and a major cost-saving approach. Both technology-enabled self-monitoring (SM) and remote monitoring (RM) programs have the potential to reduce exacerbations, but they have not been directly compared with each other. As RM is a more resource-intensive strategy, it is important to understand whether it is more effective than SM. Methods: This was a 3-arm open-label randomized controlled trial comparing SM, RM, and SC completed in an outpatient COPD clinic in a community hospital. Patients in the SM and RM groups recorded their vital signs (oxygen, blood pressure, temperature, and weight) and symptoms with the Cloud DX platform every day and were provided with a COPD action plan. Patients in the RM group also received access to a respiratory therapist (RT). The RT monitored their vital signs intermittently and contacted them when their vitals varied outside of predetermined thresholds. The RT also contacted patients once a week irrespective of their vital signs or symptoms. All patients were randomized to 1 of the 3 groups and assessed at baseline and 3 and 6 months after program initiation. The primary outcome was the Partners in Health scale, which measures self-management skills. Secondary outcomes included the St. George's Respiratory Questionnaire, Bristol COPD Knowledge Questionnaire, COPD Assessment Test, and modified-Medical Research Council Breathlessness Scale. Patients were also asked to self-report on health system usage. Results: A total of 122 patients participated in the study, 40 in the SC, 41 in the SM, and 41 in the RM groups. Out of those patients, 7 in the SC, 5 in the SM, and 6 in the RM groups did not complete the study. There were no significant differences in the rates of study completion among the groups (P=.80). Conclusions: Both SM and RM have shown promise in reducing acute care utilization and exacerbation frequencies. As far as we are aware, no studies to date have directly compared technology-enabled self-management with RM programs in COPD patients. We believe that this study will be an important contribution to the literature.

  • JMIR Res Protoc 2019;8(8):e13920

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  RCTs - Protocols/Proposals (non-eHealth)

  Aug 19, 2019

  Using Pharmacogenomic Testing in Primary Care: Protocol for a Pilot Randomized Controlled Study

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  Authors List:

  • Beatriz Manzor Mitrzyk  
  • Reema Kadri  
  • Karen B Farris  
  • Vicki L Ellingrod  
  • Michael S Klinkman  
  • Mack T Ruffin IV  
  • Melissa A Plegue  
  • Lorraine R Buis  

  Abstract:

  • JMIR Res Protoc 2019;8(8):e13848

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  Non-Randomized Study Protocols and...

  Aug 19, 2019

  Improving Mental Health in Pregnancy for Refugee Women: Protocol for the Implementation and Evaluation of a Screening Program in Melbourne, Australia

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  Authors List:

  • Jacqueline Anne Boyle  
  • Suzanne Willey  
  • Rebecca Blackmore  
  • Christine East  
  • Jacqueline McBride  
  • Kylie Gray  
  • Glenn Melvin  
  • Rebecca Fradkin  
  • Natahl Ball  
  • Nicole Highet  
  • Melanie Gibson-Helm  

  Abstract:

  Background: Identifying mental health disorders in migrant and refugee women during pregnancy provides an opportunity for interventions that may benefit women and their families. Evidence suggests that perinatal mental health disorders impact mother-infant attachment at critical times, which can affect child development. Postnatal depression resulting in suicide is one of the leading causes of maternal mortality postpartum. Routine screening of perinatal mental health is recommended to improve the identification of depression and anxiety and to facilitate early management. However, screening is poorly implemented into routine practice. This study is the first to investigate routine screening for perinatal mental health in a maternity setting designed for refugee women. This study will determine whether symptoms of depression and anxiety are more likely to be detected by the screening program compared with routine care and will evaluate the screening program’s feasibility and acceptability to women and health care providers (HCPs). Objective: The objectives of this study are (1) to assess if refugee women are more likely to screen risk-positive for depression and anxiety than nonrefugee women, using the Edinburgh Postnatal Depression Scale (EPDS); (2) to assess if screening in pregnancy using the EPDS enables better detection of symptoms of depression and anxiety in refugee women than current routine care; (3) to determine if a screening program for perinatal mental health in a maternity setting designed for refugee women is acceptable to women; and (4) to evaluate the feasibility and acceptability of the perinatal mental health screening program from the perspective of HCPs (including the barriers and enablers to implementation). Methods: This study uses an internationally recommended screening measure, the EPDS, and a locally developed psychosocial questionnaire, both administered in early pregnancy and again in the third trimester. These measures have been translated into the most common languages used by the women attending the clinic and are administered via an electronic platform (iCOPE). This platform automatically calculates the EPDS score and generates reports for the HCP and woman. A total of 119 refugee women and 155 nonrefugee women have been recruited to evaluate the screening program’s ability to detect depression and anxiety symptoms and will be compared with 34 refugee women receiving routine care. A subsample of women will participate in a qualitative assessment of the screening program’s acceptability and feasibility. Health service staff have been recruited to evaluate the integration of screening into maternity care. Results: The recruitment is complete, and data collection and analysis are underway. Conclusions: It is anticipated that screening will increase the identification and management of depression and anxiety symptoms in pregnancy. New information will be generated on how to implement such a program in feasible and acceptable ways that will improve health outcomes for refugee women. International Registered Report Identifier (IRRID): DERR1-10.2196/13271

  • JMIR Res Protoc 2019;8(8):e13271

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  RCTs - Protocols/Proposals (eHealth)

  Aug 15, 2019

  Mental Health Promotion Among University Students Using Text Messaging: Protocol for a Randomized Controlled Trial of a Mobile Phone–Based Intervention

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  Authors List:

  • Kristin Thomas  
  • Marcus Bendtsen  

  Abstract:

  Background: There is a growing understanding that well-being and mental illness are 2 separate dimensions of mental health. High well-being is associated with decreased risk of disease and mental illness and increased longevity. Objective: This study aims to test the efficacy of a mobile phone–based intervention on positive mental health. Methods: We are conducting a 2-armed randomized controlled trial of university students in Sweden. Recruitment will last for 6 months by digital advertising (eg, university websites). Participants will be randomly allocated to either an intervention (fully automated mobile phone–based mental health intervention) or control group (treatment as usual). The primary outcome will be self-assessed positive mental health (Mental Health Continuum Short Form). Secondary outcomes will be self-assessed depression anxiety symptomatology (Hospital Anxiety Depression Scale). Outcomes will be investigated at baseline, at 3, 6, and 12 months after randomization. Mediators (positive emotions and thoughts) will be investigated at baseline, midintervention, and at follow-ups using 2 single face-valid items. Results: Data will be collected between autumn 2018 and spring 2019. Results are expected to be published in 2020. Conclusions: Strengths of the study include the use of a validated comprehensive instrument to measure positive mental health. Mechanisms of change are also investigated. A potential challenge could be recruitment; however, by setting a prolonged recruitment period, we believe that the study will recruit a sufficient sample. Trial Registration: International Standard Randomized Controlled Trial Number: 54748632; http://www.isrctn.com/ ISRCTN54748632 International Registered Report Identifier (IRRID): PRR1-10.2196/12396

  • JMIR Res Protoc 2019;8(8):e12396

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  RCTs - Protocols/Proposals (funded,...

  Aug 14, 2019

  A Mobile App to Support Parents Making Child Mental Health Decisions: Protocol for a Feasibility Cluster Randomized Controlled Trial

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  Authors List:

  • Shaun Liverpool  
  • Helen Webber  
  • Rob Matthews  
  • Miranda Wolpert  
  • Julian Edbrooke-Childs  

  Abstract:

  Background: Shared decision making (SDM) is recognized as a person-centered approach to improving health care quality and outcomes. Few digital interventions to improve SDM have been tested in child and adolescent mental health (CAMH) settings. One such intervention is Power Up, a mobile phone app for young people (YP), which has shown some evidence of promise that YP who received Power Up reported greater levels of SDM. However, even though parents play a critical role in CAMH care and treatment, they often feel excluded from services. Objective: This protocol is for a pilot trial to determine the feasibility of a large-scale randomized trial to develop and evaluate a Web app called Power Up for Parents (PUfP) to support parents and promote involvement in CAMH decisions. Methods: A 2-stage process, consisting of the development stage and pilot-testing stage of the initial PUfP prototype, will be conducted. At the development stage, a qualitative study with parents and clinicians will be conducted. The interviews will aim to capture the experience of making CAMH decisions, preferences for involvement in SDM, and determine situations within which PUfP can be useful. At the pilot-testing stage, up to 90 parents and their clinicians will be invited to participate in the testing of the prototype. Parents will be randomly allocated to receive the intervention or be part of the control group. This study design will allow us to assess the acceptability and usefulness of PUfP in addition to examining the feasibility of a prospective randomized trial. Clinicians’ perceptions of the prototype and how it has influenced parents’ involvement in SDM will also be examined. Results: Recruitment began in January 2019 and is scheduled to last for 10 months. Interviews and baseline data collection are currently in progress. To date, 11 CAMH sites have been recruited to take part in the study. It is anticipated that data collection will be completed by October 2019. Conclusions: The lack of parents’ involvement in CAMH care and treatment can lead to higher rates of dropout from care and lower adherence to therapeutic interventions. There are significant benefits to be gained globally if digital SDM interventions are adopted by parents and shown to be successful in CAMH settings. Trial Registration: ISRCTN Registry ISRCTN39238984; http://www.isrctn.com/ISRCTN39238984 International Registered Report Identifier (IRRID): DERR1-10.2196/14571

  • JMIR Res Protoc 2019;8(8):e14571

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  Non-Randomized Studies (funded,...

  Aug 14, 2019

  Exploring Existential Loneliness Among Frail Older People as a Basis for an Intervention: Protocol for the Development Phase of the LONE Study

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  Authors List:

  • Anna-Karin Edberg  
  • Ingrid Bolmsjö  

  Abstract:

  Background: International research concerning end-of-life issues emphasizes the importance of health care professionals (HCPs) being prepared to deal with existential aspects, like loneliness, in order to provide adequate care. The last phase of life is often related to losses of different kinds, which might trigger feelings of isolation in general and existential loneliness (EL) in particular. There is a large body of research concerning loneliness among older people in general, but little is known about the phenomenon and concept of EL in old age. Objective: This study aims to describe the framing, design, and first results of the exploratory phase of an intervention study focusing on EL among older people: the LONE study. This stage of the study corresponds to the development phase, according to the Medical Research Council framework for designing complex interventions. Methods: The LONE study contains both theoretical and empirical studies concerning: (1) identifying the evidence base; (2) identifying and developing theory through individual and focus group interviews with frail older people, significant others, and HCPs; and (3) modeling process and outcomes for the intervention. This project involves sensitive issues that must be carefully reviewed. The topic in itself concerns a sensitive matter and the study group is vulnerable, therefore, an ethical consciousness will be applied throughout the project. Results: The results so far show that EL means being disconnected from life and implies a feeling of being fundamentally separated from others and the world, whether or not one has family, friends, or other close acquaintances. Although significant others highlighted things such as lack of activities, not participating in a social environment, and giving up on life as aspects of EL, the older people themselves highlighted a sense of meaningless waiting, a longing for a deeper connectedness, and restricted freedom as their origins of EL. The views of HCPs on the origin of EL, the place of care, and their own role differed between contexts. Conclusions: The studies focusing on identifying the evidence base and developing theory are published. These results will now be used to identify potential intervention components, barriers, and enablers for the implementation of an intervention aimed at supporting HCPs in encountering EL among older people. International Registered Report Identifier (IRRID): RR1-10.2196/13607

  • JMIR Res Protoc 2019;8(8):e13607

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  Non-Randomized Study Protocols and...

  Aug 12, 2019

  Safety and Efficacy of Bis-Glyceryl Ascorbate (Amitose DGA) to Prevent Hand-Foot Skin Reaction in Patients With Renal Cell Carcinoma Receiving Sunitinib...

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  Authors List:

  • Kazuhiro Yamamoto  
  • Takeshi Ioroi  
  • Kenichi Harada  
  • Satoshi Nishiyama  
  • Chikako Nishigori  
  • Ikuko Yano  

  Abstract:

  Background: Hand-foot skin reaction (HFSR) is a serious side effect induced by multiple-tyrosine kinase inhibitors (TKIs). HFSR can cause treatment interruption or decreased dosing. HFSR also markedly decreases quality of life and is associated with the therapeutic efficacy of multiple-TKIs. Therefore, the management and prevention of HFSR is an important issue; however, an effective method for its prevention has not been established. Specific ascorbic acid derivatives can reverse multiple-TKI-induced keratinocyte growth and pathological changes in vitro. Objective: This study was designed to evaluate the safety of bis-glyceryl ascorbate (Amitose DGA), a novel, hydrosoluble, and moisturizing ascorbic acid derivative, in patients with renal cell carcinoma (RCC) receiving sunitinib therapy. This study was also designed to evaluate Amitose DGA’s preventive efficacy for sunitinib-induced HFSR. Methods: This is a Phase I/II, single-center, uncontrolled, single-arm, open-label trial. We will recruit a total of 30 patients with RCC receiving sunitinib therapy, with a 2-week-on and 1-week-off schedule. The participants will apply Amitose DGA-containing cream over both palmar and plantar surfaces within two treatment cycles (ie, 6 weeks) of sunitinib in combination with a general moisturizing agent, in addition to standard-of-care processes. Safety assessments will include dermatological abnormalities, clinical laboratory tests, and incidence of adverse events. Efficacy assessments will include development of HFSR and therapeutic outcomes associated with sunitinib. Results: Recruitment to the study began in August 2017 and is ongoing in Japan. To date, 21 subjects have been recruited. Study completion is expected in 2021. Conclusions: This is the first clinical study of Amitose DGA-containing cream in patients with RCC who are receiving sunitinib therapy. The single-center, single-arm, open-label design was selected to maximize subject exposure and increase the likelihood of achieving our study endpoints. The results will provide valuable and preliminary evidence of the effects of Amitose DGA-containing cream on HFSR. Trial Registration: UMIN Clinical Trials Registry UMIN000027209; https://upload.umin.ac.jp/cgi-open-bin/ctr /ctr_view.cgi?recptno=R000031174 International Registered Report Identifier (IRRID): DERR1-10.2196/14636

  • JMIR Res Protoc 2019;8(8):e14636

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  Non-Randomized Studies (funded,...

  Aug 12, 2019

  Monitoring Immobilized Elderly Patients Using a Public Provider Online System for Pressure Ulcer Information and Registration (SIRUPP): Protocol for a Health...

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  Authors List:

  • Eugenio Vera-Salmerón  
  • Claudia Rutherford  
  • Carmen Dominguez-Nogueira  
  • María Pilar Tudela-Vázquez  
  • Victor J Costela-Ruiz  
  • Basilio Gómez-Pozo  

  Abstract:

  Background: Pressure ulcers represent a major challenge to patient safety in the health care context, presenting high incidence (from 7% to 14% in Spain) and increased financial costs (€400-600 million/year) in medical treatment. Moreover, they are a significant predictor of mortality. The prevention of pressure ulcers in long-term care centers and patients’ own homes is proposed as a priority indicator of health care quality. Early stage risk assessment and database recording are both crucial aspects of prevention, classification, diagnosis, and treatment. Objective: This project proposes a 3-year study of immobilized patients residing in the Granada-Metropolitan Primary Healthcare District (DSGM) and monitored via the Pressure Ulcer Information and Registration System (SIRUPP, Spanish initials). The project aims to estimate the incidence of PUs among immobilized elderly patients, analyze the health-related quality of life of these patients by using the Pressure Ulcer Quality of Life (PU-QoL) instrument in a sample of 250 patients, determine the average time to complete wound healing, estimate the rate of pressure ulcers–associated mortality, and assess the predictive value of the Braden and Mini Nutritional Assessment risk measurement scales in a sample of 1700 patients. Methods: The DSGM runs SIRUPP, which is linked to patients’ electronic health records. Currently, 17,104 immobilized patients are monitored under this system. Health-related quality of life will be measured by patient self-reports using the Spanish Pressure Ulcer Quality of Life questionnaire, following cross-cultural adaptation and psychometric validation with respect to the English-language version. Results: The project commenced in June 2017 and is expected to conclude in April 2020. Conclusions: This study addresses two main health outcomes—the time needed for wound healing and the mortality associated with pressure ulcers—both of which might be accounted for by variations in clinical practice and the health-related quality of life of patients with pressure ulcers. International Registered Report Identifier (IRRID): DERR1-10.2196/13701

  • JMIR Res Protoc 2019;8(8):e13701

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  Non-Randomized Study Protocols and...

  Aug 12, 2019

  Aortic Stenosis Prognostication in Patients With Type 2 Diabetes: Protocol for Testing and Validation of a Biomarker-Derived Scoring System

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  Authors List:

  • Suresh Giritharan  
  • Felino Cagampang  
  • Christopher Torrens  
  • Kareem Salhiyyah  
  • Simon Duggan  
  • Sunil Ohri  

  Abstract:

  Background: Type 2 diabetes mellitus (T2DM) has been established as an important independent risk factor for aortic stenosis. T2DM patients present with a higher degree of valve calcification and left ventricular dysfunction compared to patients without diabetes. This may be due to an increase in incidence and severity of myocardial fibrosis. Currently, there is no reliable method of determining the optimal timing of intervention for a patient with asymptomatic aortic stenosis or predicting when a patient will become symptomatic. Research into serum biomarkers to predict subclinical onset and track progression of aortic stenosis is hampered by the multimodal nature of the pathological processes ultimately responsible for aortic stenosis. Objective: The aim of this study is to prove that an approach using a combination of serum biomarkers and the echocardiographic parameter global longitudinal strain (GLS) can be used to establish baseline status of fibrocalcific aortic valve disease, predict rate of progression, and quantitatively assess any regression of these processes following aortic valve replacement in patients with T2DM. Methods: Validated serum biomarkers for the separate processes of calcification, inflammation, oxidative stress and fibrosis can be used to quantify onset and rate of progression of aortic stenosis. This, in combination with the echocardiographic parameter GLS, can be compared with other objective investigations of calcification and fibrosis with the aim of developing a quick, noninvasive one-stop assessment of aortic stenosis in patients with T2DM. The serum biomarkers BNP (B-type natriuretic peptide), Gal-3 (Galectin-3), GDF-15 (growth differentiation factor-15), sST2 (soluble suppression of tumorigenicity 2), OPG (osteoprotegerin), and microRNA 19b and 21 will be sampled from patients undergoing aortic valve replacement (with and without T2DM), patients with T2DM but without aortic valve disease and healthy volunteers. These patients will also undergo computed tomography (CT) scans for calcium scoring, magnetic resonance imaging (MRI) to quantify myocardial fibrosis, and myocardial strain imaging with speckle-tracking echocardiography. Samples of calcified native aortic valve and a biopsy of ventricular myocardium will be examined histologically to determine the quantity and distribution of calcification and fibrosis, and the secretome of these tissue samples will also be analyzed for levels of the same biomarkers as in the serum samples. All patients will be followed up with in 3 months and 12 months for repeat blood sampling, echocardiography, and CT and MRI imaging to assess disease progression or regression. The results of tissue analysis and CT and MRI scanning will be used to validate the findings of the serum biomarkers and echocardiographic assessment. Results: Using all of the information gathered throughout the study will yield a ranking scale for use in the clinic, which will provide each patient with a fibrocalcific profile. This can then be used to recommend an optimal time for intervention. Conclusion: A reliable, validated set of serum biomarkers combined with an inexpensive bedside echocardiographic examination can now form the basis of a one-stop outpatient-based assessment service, which will provide an accurate risk assessment in patients with aortic stenosis at first contact. International Registered Report Identifier (IRRID): PRR1-10.2196/13186

  • JMIR Res Protoc 2019;8(8):e13186

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  RCTs - Protocols/Proposals (non-eHealth)

  Aug 9, 2019

  Evaluation of a Collaborative Protocolized Approach by Community Pharmacists and General Medical Practitioners for an Australian Minor Ailments Scheme:...

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  Authors List:

  • Sarah Dineen-Griffin  
  • Victoria Garcia-Cardenas  
  • Kris Rogers  
  • Kylie Williams  
  • Shalom Isaac Benrimoj  

  Abstract:

  Background: Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MASs) promote efficiencies within the health care system. The cost savings and health outcomes demonstrated in the United Kingdom and Canada open up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. Objective: This trial aims to evaluate the clinical, economic, and humanistic impact of an Australian Minor Ailments Service (AMAS) compared with usual pharmacy care in a cluster randomized controlled trial (cRCT) in Western Sydney, Australia. Methods: The cRCT design has an intervention group and a control group, comparing individuals receiving a structured intervention (AMAS) with those receiving usual care for specific health ailments. Participants will be community pharmacies, general practices, and patients located in Western Sydney Primary Health Network (WSPHN) region. A total of 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments: reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhea, or low back pain. Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The coprimary outcomes are rates of appropriate recommendation of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, health services resource utilization, and EuroQoL Visual Analogue Scale. Differences in primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost-utility and cost-effectiveness analysis compared with usual care. Results: The study began in July 2018. Thirty community pharmacies were recruited. Pharmacists from the 15 intervention pharmacies were trained. A total of 27 general practices consented. Pharmacy patient recruitment began in August 2018 and was completed on March 31, 2019. Conclusions: This study may demonstrate the efficacy of a protocolized intervention to manage minor ailments in the community and will assess the clinical, economic, and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and appropriate self-medication may contribute to greater efficiency of health care resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a national MAS service in Australia, using a robust framework for management and referral for common ailments. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618000286246; http://www.anzctr.org.au/ACTRN12618000286246.aspx International Registered Report Identifier (IRRID): DERR1-10.2196/13973

  • JMIR Res Protoc 2019;8(8):e13973

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  Non-Randomized Study Protocols and...

  Aug 9, 2019

  Family Members’ Perspectives of Health Care System Interactions With Suicidal Patients and Responses to Suicides: Protocol for a Qualitative Research Study

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  Authors List:

  • Erin Bryksa  
  • Reham Shalaby  
  • Laura Friesen  
  • Kirsten Klingle  
  • Graham Gaine  
  • Liana Urichuk  
  • Shireen Surood  
  • Vincent Agyapong  

  Abstract:

  Background: Suicide is a major cause of preventable death globally and a leading cause of death by injury in Canada. To support people who experience suicidal thoughts and behaviors and ultimately prevent people from dying by suicide, it is important to understand the individual and familial experiences with the health care system. Objective: This study aims to explore how suicide victims, and their family members, interacted with the health care system. Methods: We will invite family members of 6 to 8 suicide victims to participate in the study by sharing their perspectives on both their relative’s as well as their own interactions with the health care system. Interviews will take place in-person and will be audio recorded, transcribed, and analyzed thematically. Results: The results of the study are expected to be available in 12 months. We expect the results to shed light on the experiences of suicide victims and their family members with the health care system. Conclusions: Our study results may inform practice, policy, and further research. They may shape how members of the health care system respond to people who are at risk of suicide and their families. International Registered Report Identifier (IRRID): PRR1-10.2196/13797

  • JMIR Res Protoc 2019;8(8):e13797

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  Theme Issue (2018): Adolescent...

  Aug 9, 2019

  Text-Messaging, Online Peer Support Group, and Coaching Strategies to Optimize the HIV Prevention Continuum for Youth: Protocol for a Randomized Controlled...

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  Authors List:

  • Dallas Swendeman  
  • Elizabeth Mayfield Arnold  
  • Danielle Harris  
  • Jasmine Fournier  
  • W Scott Comulada  
  • Cathy Reback  
  • Maryann Koussa  
  • Manuel Ocasio  
  • Sung-Jae Lee  
  • Leslie Kozina  
  • Maria Isabel Fernández  
  • Mary Jane Rotheram  
  • Adolescent Medicine Trials Network (ATN) CARES Team

  Abstract:

  Background: America’s increasing HIV epidemic among youth suggests the need to identify novel strategies to leverage services and settings where youth at high risk (YAHR) for HIV can be engaged in prevention. Scalable, efficacious, and cost-effective strategies are needed, which support youth during developmental transitions when risks arise. Evidence-based behavioral interventions (EBIs) have typically relied on time-limited, scripted, and manualized protocols that were often delivered with low fidelity and lacked evidence for effectiveness. Objective: This study aims to examine efficacy, implementation, and cost-effectiveness of easily mountable and adaptable, technology-based behavioral interventions in the context of an enhanced standard of care and study assessments that implement the guidelines of Centers for Disease Control and Prevention (CDC) for routine, repeat HIV, and sexually transmitted infection (STI) testing for high-risk youth. Methods: Youth aged between 12 and 24 years (n=1500) are being recruited from community-based organizations and clinics serving gay, bisexual, and transgender youth, homeless youth, and postincarcerated youth, with eligibility algorithms weighting African American and Latino youth to reflect disparities in HIV incidence. At baseline and 4-month intervals over 24 months (12 months for lower-risk youth), interviewers monitor uptake of HIV prevention continuum steps (linkage to health care, use of pre- or postexposure prophylaxis, condoms, and prevention services) and secondary outcomes of substance use, mental health, and housing security. Assessments include rapid diagnostic tests for HIV, STIs, drugs, and alcohol. The study is powered to detect modest intervention effects among gay or bisexual male and transgender youth with 70% retention. Youth are randomized to 4 conditions: (1) enhanced standard of care of automated text-messaging and monitoring (AMM) and repeat HIV/STI testing assessment procedures (n=690); (2) online group peer support via private social media plus AMM (n=270); (3) coaching that is strengths-based, youth-centered, unscripted, based on common practice elements of EBI, available over 24 months, and delivered by near-peer paraprofessionals via text, phone, and in-person, plus AMM (n=270); and (4) online group peer support plus coaching and AMM (n=270). Results: The project was funded in September 2016 and enrollment began in May 2017. Enrollment will be completed between June and August 2019. Data analysis is currently underway, and the first results are expected to be submitted for publication in 2019. Conclusions: This hybrid implementation-effectiveness study examines alternative models for implementing the CDC guidelines for routine HIV/STI testing for YAHR of acquiring HIV and for delivering evidence-based behavioral intervention content in modular elements instead of scripted manuals and available over 24 months of follow-up, while also monitoring implementation, costs, and effectiveness. The greatest impacts are expected for coaching, whereas online group peer support is expected to have lower impact but may be more cost-effective. Trial Registration: ClinicalTrials.gov NCT03134833; https://clinicaltrials.gov/ct2/show/NCT03134833 (Archived by WebCite at http://www.webcitation.org/76el0Viw9) International Registered Report Identifier (IRRID): DERR1-10.2196/11165

  • JMIR Res Protoc 2019;8(8):e11165

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