Clinic-Based Delivery of the Young Men's Health Project (YMHP) Targeting HIV Risk Reduction and Substance Use Among Young Men Who Have Sex with Men: Protocol for a Type 2, Hybrid Implementation-Effectiveness Trial.

Young men who have sex with men (YMSM) are disproportionately at risk for HIV and sexually transmitted infections. Adapting and testing the effectiveness of the Young Men's Health Project (YMHP), an efficacious intervention designed to reduce substance use and condomless anal sex (CAS) among YMSM, at clinics in Miami, Detroit, and Philadelphia has the potential to reduce HIV and STI disparities among urban YMSM. This study (Adolescent Medicine Trials Network for HIV/AIDS Interventions [ATN] 145 YMHP) aims to adapt YMHP for clinic and remote delivery by existing clinic staff and compare their effectiveness in real-world adolescent HIV clinics. This protocol is part of the ATN Scale It Up program described in a recently published article by Naar et al. This is a comparative effectiveness hybrid type-2 trial of the YMHP intervention with 2 delivery formats-clinic-based versus remote delivery-offered following HIV counseling and testing. Phase 1 includes conducting focus groups with youth to obtain implementation feedback about the delivery of the YMHP intervention and intervention components to ensure culturally competent, feasible, and scalable implementation. Phase 2 includes recruitment and enrollment of 270 YMSM, aged 15 to 24 years, 90 at each of the 3 sites. Enrollment will be limited to HIV-negative YMSM who report recent substance use and either CAS or a positive STI test result. Participants will be randomized to receive the YMHP intervention either in person or by remote delivery. Both conditions involve completion of the 4 YMHP sessions and the delivery of pre-exposure prophylaxis information and navigation services. A minimum of 2 community health workers (CHWs) will be trained to deliver the intervention sessions at each site. Sessions will be audio-recorded for Motivational Interviewing Treatment Integrity (MITI) fidelity coding, and CHWs and supervisors will be given implementation support throughout the study period. Phase 1 focus groups were completed in July 2017 (n=25). Feedback from these focus groups at the 3 sites informed adaptations to the YMHP intervention manual, implementation of the intervention, and recruitment plans for phase 2. Baseline enrollment for phase 2 began in November 2018, and assessments will be at immediate posttest (IP)-, 3-, 6-, 9-, and 12-months after the intervention. Upon collection of both baseline and follow-up data, we will compare the effectiveness and cost-effectiveness of clinic-based versus remote delivery of YMHP in the context of health care access. We are conducting YMHP in 3 cities with high rates of YMSM at risk for HIV and STIs. When adapted for real-world clinics, this study will help substance-using YMSM at risk for HIV and STIs and allow us to examine differences in effectiveness and cost by the method of delivery. ClinicalTrials.gov NCT03488914; https://clinicaltrials.gov/ct2/show/NCT03488914 (Archived by WebCite at http://www.webcitation.org/770WaWWfi). DERR1-10.2196/11184.

Parsons JT ，Starks T ，Gurung S ，Cain D ，Marmo J ，Naar S ... -  《JMIR Research Protocols》

Adolescent Male Couples-Based HIV Testing Intervention (We Test): Protocol for a Type 1, Hybrid Implementation-Effectiveness Trial.

Young men who have sex with men (YMSM), particularly those who are partnered, are at unique risk for HIV. YMSM are among those at highest risk for HIV. Meanwhile, despite the fact that primary partners account for many-possibly most-new HIV infections, partnered men who have sex with men perceive themselves to be at much lower risk for HIV infection and therefore test less often than single men. In response to the risk of primary partner HIV transmission, couples HIV testing and counseling (CHTC) procedures have been developed for use in adult populations. Although promising, YMSM couples may require additional support to complete CHTC given their developmental context in which sexual and romantic relationships are relatively new, and communication skills are emergent. The aim of this study was to test the additive benefit of adjunct treatment components tailored for YMSM, which enhance communication skills before the completion of CHTC. The intervention tests a continuum of prevention packages including assertive communication training videos and motivational interviewing focused on assisting with identification and development (MI-AID) before entering into the dyadic intervention components. This protocol is part of the Adolescent Medicine Trials Network (ATN) Scale It Up program described in this issue. This is a comparative effectiveness trial that will be executed in 3 phases. Phase 1 will gather qualitative data related to intervention development and implementation from partnered YMSM at 4 subject recruitment venues (SRVs). Phase 2 will compare a continuum of these interventions in a pilot randomized controlled trial (RCT) at 2 SRVs. Phase 3 will compare the most successful adapted intervention package from phase 2 to CHTC as usual in a larger RCT at 4 SRVs. This phase is focused on implementation and sustainment phases of the Exploration, Preparation, Implementation, and Sustainment framework. Phase 1 data will be drawn from qualitative interviews with partnered YMSM (n=24) and staff from ATN sites (n=20). Baseline enrollment for phase 2 is expected to begin across 2 SRVs in June 2018 (ncouples=36). In phase 2, survey data collection along with HIV and sexually transmitted infection (STI) testing will occur at baseline, and 1- and 3-month (postintervention) follow-ups. Phase 3 will begin enrollment across 4 SRVs in September 2019 (ncouples=144) and follow-ups will occur at 1, 3, 6, and 9 months postintervention. Although MI-AID, video-based assertive communication training, and CHTC have established efficacy when administered on their own, this study will be the first to evaluate the strongest adjunctive version of these interventions to address the specific developmental needs of partnered YMSM. ClinicalTrials.gov NCT03386110; http://clinicaltrials.gov/ct2/show/NCT03386110 (Archived by WebCite at http://www.webcitation.org/75mlO7GCx). DERR1-10.2196/11186.

Starks TJ ，Feldstein Ewing SW ，Lovejoy T ，Gurung S ，Cain D ，Fan CA ，Naar S ，Parsons JT ... -  《JMIR Research Protocols》

Novel Machine Learning HIV Intervention for Sexual and Gender Minority Young People Who Have Sex With Men (uTECH): Protocol for a Randomized Comparison Trial.

Sexual and gender minority (SGM) young people are disproportionately affected by HIV in the United States, and substance use is a major driver of new infections. People who use web-based venues to meet sex partners are more likely to report substance use, sexual risk behaviors, and sexually transmitted infections. To our knowledge, no machine learning (ML) interventions have been developed that use web-based and digital technologies to inform and personalize HIV and substance use prevention efforts for SGM young people. This study aims to test the acceptability, appropriateness, and feasibility of the uTECH intervention, a SMS text messaging intervention using an ML algorithm to promote HIV prevention and substance use harm reduction among SGM people aged 18 to 29 years who have sex with men. This intervention will be compared to the Young Men's Health Project (YMHP) alone, an existing Centers for Disease Control and Prevention best evidence intervention for young SGM people, which consists of 4 motivational interviewing-based counseling sessions. The YMHP condition will receive YMHP sessions and will be compared to the uTECH+YMHP condition, which includes YMHP sessions as well as uTECH SMS text messages. In a study funded by the National Institutes of Health, we will recruit and enroll SGM participants (aged 18-29 years) in the United States (N=330) to participate in a 12-month, 2-arm randomized comparison trial. All participants will receive 4 counseling sessions conducted over Zoom (Zoom Video Communications, Inc) with a master's-level social worker. Participants in the uTECH+YMHP condition will receive curated SMS text messages informed by an ML algorithm that seek to promote HIV and substance use risk reduction strategies as well as undergoing YMHP counseling. We hypothesize that the uTECH+YMHP intervention will be considered acceptable, appropriate, and feasible to most participants. We also hypothesize that participants in the combined condition will experience enhanced and more durable reductions in substance use and sexual risk behaviors compared to participants receiving YMHP alone. Appropriate statistical methods, models, and procedures will be selected to evaluate primary hypotheses and behavioral health outcomes in both intervention conditions using an α<.05 significance level, including comparison tests, tests of fixed effects, and growth curve modeling. This study was funded in August 2019. As of June 2024, all participants have been enrolled. Data analysis has commenced, and expected results will be published in the fall of 2025. This study aims to develop and test the acceptability, appropriateness, and feasibility of uTECH, a novel approach to reduce HIV risk and substance use among SGM young adults. ClinicalTrials.gov NCT04710901; https://clinicaltrials.gov/study/NCT04710901. DERR1-10.2196/58448.

Holloway IW ，Wu ESC ，Boka C ，Young N ，Hong C ，Fuentes K ，Kärkkäinen K ，Beikzadeh M ，Avendaño A ，Jauregui JC ，Zhang A ，Sevillano L ，Fyfe C ，Brisbin CD ，Beltran RM ，Cordero L ，Parsons JT ，Sarrafzadeh M ... -  《JMIR Research Protocols》

A Multilevel Tailored Web App-Based Intervention for Linking Young Men Who Have Sex With Men to Quality Care (Get Connected): Protocol for a Randomized Controlled Trial.

HIV epidemic among young men who have sex with men (YMSM) is characterized by strong racial disparities and concerns about the availability and access to culturally appropriate HIV prevention and care service delivery. Get Connected, a Web-based intervention that employs individual- and system-level tailoring technology to reduce barriers to HIV prevention care (eg, HIV or sexually transmitted infection [STI] testing, pre-exposure prophylaxis [PrEP]), was developed for YMSM (age 15-24 years). This protocol details the design and procedures of a 2-phase project that includes mystery shopping and a randomized controlled trial (RCT) to test the efficacy of Get Connected among YMSM in Philadelphia, Atlanta, and Houston. The objective of mystery shopping is to examine the quality of HIV test counseling and PrEP-related referrals for YMSM within local HIV or STI testing sites. The objective of the RCT is to test the efficacy of Get Connected for increasing HIV-negative or HIV-unknown YMSM's successful uptake of HIV prevention services (eg, routine HIV or STI testing), PrEP awareness, and likelihood to start PrEP (PrEP willingness), compared with those in the control condition, over a 12-month period. For Phase 1, we will create a master list of HIV and STI testing sites in each city. We will enroll and train 10-15 mystery shoppers per city; each testing site will be separately visited and assessed by 2 mystery shoppers. After each site visit, the mystery shoppers will complete a site evaluation to record their perceptions of various measures including lesbian, gay, bisexual, transgender, queer visibility and inclusivity, privacy and confidentiality, provider-patient interactions, and clinic environment. For Phase 2, we will enroll 480 YMSM for 12 months across the 3 iTech cities into a 2-arm prospective RCT. Participants randomized to the control condition are directed to the AIDSVu.org testing site locator. Participants randomized to the intervention condition will be granted access to a Web app with content tailored to their specific demographic characteristics (eg, age, race or ethnicity, location, and relationship status), HIV and STI risk behaviors (eg, HIV and STI testing history, substance use, communication with partners regarding status) and sociocultural context (eg, homelessness, incarceration). Study assessments will occur at enrollment and at 1, 3, 6, 9, and 12 months postenrollment. Get Connected research activities began in September 2016 and are ongoing. To date, institutional review board (IRB) submission is complete and IRB authorization agreements are pending at several other universities. The deployment of Get Connected through a mobile-optimized Web app seeks to optimize the intervention's acceptability, accessibility, availability, and long-term affordability among YMSM. ClinicalTrials.gov (NCT03132415); https://clinicaltrials.gov/ct2/show/NCT03132415 (Archived by WebCite at http://www.webcitation.org/70j4gSFbZ). RR1-10.2196/10444.

Bauermeister JA ，Golinkoff JM ，Horvath KJ ，Hightow-Weidman LB ，Sullivan PS ，Stephenson R ... -  《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》