Testing the Efficacy of a Social Networking Gamification App to Improve Pre-Exposure Prophylaxis Adherence (P3: Prepared, Protected, emPowered): Protocol for a Randomized Controlled Trial.

HIV prevalence is high among young men who have sex with men (YMSM) and young transgender women who have sex with men (YTWSM), particularly among minorities. Despite its proven efficacy and safety, the uptake of and adherence to pre-exposure prophylaxis (PrEP) among YMSM and YTWSM is currently limited. To date, evidence-based interventions to promote and sustain PrEP adherence have been limited and not shown to be highly efficacious. Given the widespread adoption of smartphones, mobile apps can be utilized to increase PrEP adherence for many YMSM and YTWSM. The study consists of a formative research phase to develop an app-based intervention, P3 (Prepared, Protected, emPowered), to increase PrEP adherence, and a randomized controlled trial (RCT) to test its efficacy. P3 is a mobile app built on an established health platform, which includes social networking and game-based components to encourage PrEP adherence among YMSM and YTWSM. P3+ includes all P3 features plus adherence counseling delivered via two-way text messaging (short message service, SMS) through the app. The formative research phase includes usability testing to assess users' comprehension of P3's educational content, understanding and use of intervention features, and overall impressions of app functionality, followed by app refinements. A subsequent field trial will identify and resolve any remaining technical challenges. A three-arm RCT (P3, P3+, and standard of care) will then be conducted at 6 iTech subject recruitment venues to assess intervention efficacy and to conduct a comparison of costs to deliver the 2 intervention arms. This is an ongoing research project with initial results from the formative work expected in 2020 and those from the RCT in 2021. P3 aims to provide an engaging, interactive experience that is highly appealing for the target population, leveraging technology already heavily integrated into the lives of young people, and thus meeting users' needs in a familiar, stimulating way. If efficacious, P3 could be a sustainable, easily disseminated, lower-cost PrEP intervention for YMSM and YTWSM. Further, the research aims to determine the processes that are essential to developing and implementing future health-related gamification interventions. ClinicalTrials.gov NCT03320512; https://clinicaltrials.gov/ct2/show/NCT03320512 (Archived by WebCite at http://www.webcitation.org/74OVZkICl). DERR1-10.2196/10448.

LeGrand S ，Knudtson K ，Benkeser D ，Muessig K ，Mcgee A ，Sullivan PS ，Hightow-Weidman L ... -  《JMIR Research Protocols》

Epic Allies, a Gamified Mobile Phone App to Improve Engagement in Care, Antiretroviral Uptake, and Adherence Among Young Men Who Have Sex With Men and Young Transgender Women Who Have Sex With Men: Protocol for a Randomized Controlled Trial.

In the United States, young men who have sex with men (YMSM) and transgender women who have sex with men (YTWSM) bear a disproportionate burden of prevalent and incident HIV infections. Once diagnosed, many YMSM and YTWSM struggle to engage in HIV care, adhere to antiretroviral therapy (ART), and achieve viral suppression. Computer-based interventions, including those focused on behavior change, are recognized as effective tools for engaging youth. The purpose of the study described in this protocol is to evaluate the efficacy of Epic Allies, a theory-based mobile phone app that utilizes game mechanics and social networking features to improve engagement in HIV care, ART uptake, ART adherence, and viral suppression among HIV-positive YMSM and YTWSM. The study also qualitatively assesses intervention acceptability, perceived impact, and sustainability. This is a two-group, active-control randomized controlled trial of the Epic Allies app. YMSM and YTWSM aged 16 to 24 inclusive, with detectable HIV viral load are randomized 1:1 within strata of new to care (newly entered HIV medical care ≤12 months of baseline visit) or ART-nonadherent (first entered HIV medical care >12 months before baseline visit) to intervention or control conditions. The intervention condition addresses ART adherence barriers through medication reminders and adherence monitoring, tracking of select adherence-related behaviors (eg, alcohol and marijuana use), an interactive dashboard that displays the participant's adherence-related behaviors and provides tailored feedback, encouragement messages from other users, daily HIV/ART educational articles, and gamification features (eg, mini-games, points, badges) to increase motivation for behavior change and app engagement. The control condition features weekly phone-based notifications to encourage participants to view educational information in the control app. Follow-up assessments are administered at 13, 26, and 39 weeks for each arm. The primary outcome measure is viral suppression. Secondary outcome measures include engagement in care, ART uptake, ART adherence, and psychosocial barriers to engagement in care and ART adherence, including psychological distress, stigma, and social support. Baseline enrollment began in September 2015 and was completed in September 2016 (n=146), and assessment of intervention outcomes continued through August 2017. Results for primary and secondary outcome measures are expected to be reported in ClinicalTrials.gov by April 30, 2018. If successful, Epic Allies will represent a novel adherence intervention for a group disproportionately impacted by HIV in the United States. Adherent patients would require less frequent clinic visits and experience fewer HIV-related secondary infections, thereby reducing health care costs and HIV transmission. Epic Allies could easily be expanded and adopted for use among larger populations of YMSM and YTWSM, other HIV-positive populations, and for those diagnosed with other chronic diseases such as diabetes and hypertension. ClinicalTrials.gov NCT02782130; https://clinicaltrials.gov/ct2/show/NCT02782130 (Archived by Webcite at http://www.webcitation.org/6yGODyerk).

LeGrand S ，Muessig KE ，Platt A ，Soni K ，Egger JR ，Nwoko N ，McNulty T ，Hightow-Weidman LB ... -  《JMIR Research Protocols》

Developing a Mobile App (LYNX) to Support Linkage to HIV/Sexually Transmitted Infection Testing and Pre-Exposure Prophylaxis for Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial.

Young men who have sex with men (YMSM) in the United States have among the highest incidence of HIV and sexually transmitted infection (STI) and the lowest uptake of HIV and STI testing and pre-exposure prophylaxis (PrEP). Nearly universal mobile phone ownership among youth provides an opportunity to leverage mobile health apps to increase HIV/STI testing and PrEP uptake among YMSM. The goals of this project are to develop and refine LYNX, a novel mobile app to support linkage to HIV/STIs testing and PrEP services among YMSM in the United States, and to evaluate the acceptability and feasibility of LYNX in a pilot randomized controlled trial (RCT). This research protocol will be conducted in 3 phases: an iterative development phase with a series of 3 focus groups among 20 YMSM to refine the LYNX app; an open technical pilot among 15 YMSM to optimize usability of the app; and then a 6-month pilot RCT among 60 HIV-uninfected YMSM at risk for HIV acquisition. Developed using the Information, Motivation, and Behavioral skills theoretical model, the LYNX app includes an electronic diary to track sexual behaviors (information), a personalized risk score to promote accurate risk perception (information/motivation), testing reminders (motivation/behavioral skills), and access to home-based HIV/STI testing options and geospatial-based HIV/STI testing care sites (behavioral skills). Feasibility and acceptability will be assessed through app analytics of usage patterns and acceptability scales administered via computer-assisted self-interview at 3 and 6 months. We will also evaluate preliminary efficacy by comparing the proportion of YMSM who test at least once during the 6-month pilot and the proportion who successfully link to a PrEP provider in the intervention versus control groups. Formative work is currently underway. The LYNX pilot RCT will begin enrollment in October 2018, with study results available in 2019. The LYNX app is one of the first mobile apps designed to increase HIV/STI testing and PrEP uptake among YMSM. As low-perceived risk is a barrier to HIV/STI testing and PrEP use among youth, the personalized risk assessment and interactive sexual diary in LYNX could assist YMSM in better understanding their HIV risk and providing motivation to test for HIV/STIs and initiate PrEP. Coupled with community-based recruitment, this novel mobile app has great potential to reach and engage YMSM not currently involved in care and increase rates of HIV/STI testing and PrEP uptake in this vulnerable population. ClinicalTrials.gov NCT03177512; https://clinicaltrials.gov/ct2/show/NCT03177512 (Archived by WebCite at http://www.webcitation.org/73c917wAw). PRR1-10.2196/10659.

Liu A ，Coleman K ，Bojan K ，Serrano PA ，Oyedele T ，Garcia A ，Enriquez-Bruce E ，Emmanuel P ，Jones J ，Sullivan P ，Hightow-Weidman L ，Buchbinder S ，Scott H ... -  《JMIR Research Protocols》

Adaptation of a Theory-Based Social Networking and Gamified App-Based Intervention to Improve Pre-Exposure Prophylaxis Adherence Among Young Men Who Have Sex With Men in Bangkok, Thailand: Qualitative Study.

HIV disproportionately affects young Thai men who have sex with men (YMSM). Recent studies report a high incidence and prevalence of HIV among Thai YMSM. The Thai national guidelines have recommended pre-exposure prophylaxis (PrEP) since 2014 for key populations; free PrEP has been piloted since 2019. Smartphone-based mobile health (mHealth) interventions provide an optimal platform for innovative PrEP adherence interventions for Thai YMSM. This study aims to adapt the P3 (Prepared, Protected, emPowered) app, developed with YMSM and transwomen in the United States to improve PrEP adherence and persistence for YMSM in Thailand. The app aims to provide daily adherence support and addresses gaps in staff available for large-scale PrEP rollout needed to see population-level effects of HIV prevention. We conducted focus group discussions (FGDs) with YMSM and key informant interviews (KIIs) with PrEP care providers in Bangkok, Thailand, to investigate PrEP adherence facilitators and barriers, preferences for functions and features in mHealth apps among YMSM, and how to best adapt the P3 app to the Thai context. We conducted four FGDs with 4-8 participants per group and 15 KIIs. For FGDs, 23 YMSM participated with a mean age of 20 years (range 18-21), 96% (22/23) enrolled in full-time education, and all owned smartphones. The mean age of KII participants was 40 (range 26-60) years; most were state health service providers, with the majority being counselors (6/15, 40%) and physicians (6/15, 40%). Overall, the facilitators and barriers for PrEP adherence identified were similar to those of MSM and YMSM globally including the United States. Key themes included general recommendations for improving mHealth apps in Thailand, such as presenting reliable information in an appealing format, minimizing privacy risks, and addressing connectivity challenges. Additional themes focused on P3 Thailand adaptations and were related to cultural and stylistic preferences, engagement strategies, and recommendations for new functions. To develop the adapted app, P3 Thailand, these findings were balanced with resource limitations resulting in the prioritization of minor modifications: changes in app esthetics (color scheme, iconography, and imagery) and changes in the presentation of information in two of the app's features. FGDs identified similar PrEP adherence facilitators and barriers to those already addressed within the app. The core elements of the P3 app address major PrEP facilitators and barriers for Thai YMSM; however, changes to the app features, including stylistic presentation, were needed to appropriately customize the app to the Thai context. Given the similarities of facilitators and barriers for PrEP adherence globally, adapting existing PrEP mHealth solutions based on input from end users and key informants provides a promising approach. However, partnerships with local app designers and developers can improve the adaptation process and final product. ClinicalTrials.gov NCT04413708; http://clinicaltrials.gov/ct2/show/NCT04413708.

Songtaweesin WN ，LeGrand S ，Bandara S ，Piccone C ，Wongharn P ，Moonwong J ，Jupimai T ，Saisaengjan C ，Theerawit T ，Muessig K ，Hightow-Weidman L ，Puthanakit T ，Phanuphak N ，Tangmunkongvorakul A ... -  《JOURNAL OF MEDICAL INTERNET RESEARCH》

Adapting Effective mHealth Interventions to Improve Uptake and Adherence to HIV Pre-Exposure Prophylaxis Among Thai Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial.

Young men who have sex with men (YMSM) are the fastest-growing HIV-positive population worldwide. Thailand has the highest adult HIV seroprevalence in Asia; over 25% of men having sex with men in Bangkok are HIV positive. Pre-exposure prophylaxis (PrEP) is an efficacious HIV prevention strategy recommended for all at-risk individuals. PrEP is highly effective when taken as prescribed, but PrEP utilization rate has been low, and adherence is often inadequate. We propose to develop and pilot a multicomponent, technology-based intervention to promote motivation to begin PrEP ("uptake") and sustained adherence to PrEP among HIV-negative Thai YMSM. We will adapt an existing 2-session technology-delivered, motivational interviewing-based intervention to focus on PrEP use in YMSM in Thailand. The resulting intervention is called the Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP). We will also develop motivational text messaging (MTM) to send two-way motivational messages to promote PrEP use. The proposed study includes 3 phases. Phase 1 includes in-depth interviews with HIV-negative Thai YMSM and providers to explore barriers and facilitators of PrEP initiation and adherence, aiming to inform intervention content. Phase 2 consists of adapting and beta-testing MES-PrEP and MTM for functionality and feasibility using a youth advisory board of Thai YMSM. In Phase 3, we will conduct a pilot randomized controlled trial to evaluate the feasibility, acceptability, and preliminary efficacy of MES-PrEP and MTM to increase PrEP uptake and adherence among Thai YMSM. A total of 60 HIV-negative Thai YMSM who have not started PrEP and 60 YMSM who are on PrEP but not adherent to it will be randomized 2:1 to receive MES-PrEP and MTM (n=40) or standard PrEP counseling (n=20). The feasibility and acceptability of the intervention will be assessed through usage patterns and the System Usability Scale. The preliminary impact will be assessed by evaluating the proportion of PrEP initiation and level of adherence to PrEP. Participants will complete the assessments at baseline and at 1-, 3-, and 6-month postintervention. Biomarkers of adherence to PrEP and biomarkers of HIV and sexually transmitted infections will be collected. Recruitment for this study began in January 2022 for phase 1. Qualitative interviews were completed with 30 YMSM and 5 clinical providers in May 2022. Phase 3, the pilot feasibility and acceptability trial, began in July 2023. Upon project completion, we shall have developed a highly innovative mobile health intervention to support YMSM using PrEP, which will be ready for testing in a larger efficacy trial. This study addresses a critical problem (ie, high HIV incidence and low PrEP use) among Thai YMSM. We are developing 2 potentially synergistic technology-based, theory-driven interventions aimed at maximizing PrEP use. The proposed project has the potential to make significant contributions to advancing HIV prevention research and implementation science. ClinicalTrials.gov NCT05243030; https://clinicaltrials.gov/ct2/show/NCT05243030. DERR1-10.2196/46435.

Wang B ，Janamnuaysook R ，MacDonell K ，Rongkavilit C ，Schieber E ，Naar S ，Phanuphak N ... -  《JMIR Research Protocols》