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Journal article
Transgender Men and Transmasculine One-on-One and Group-Delivered Empowerment for Targeted HIV Reduction (TOGETHR) Study: Protocol for a Digital Factorial Randomized Controlled Trial
JMIR research protocols, v 14, e76831
20 Oct 2025
PMID: 41115262
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
In the United States, transgender men and transmasculine people who have sex with men (TMSM) face an increased risk of HIV and encounter unique barriers to HIV prevention services, including preexposure prophylaxis (PrEP). Peer-based, digitally delivered support interventions that address these barriers in 1-on-1 or small-group settings may be effective in increasing PrEP engagement.
This study aims to compare the efficacy of digitally delivered individual and small-group peer-based strategies for improving PrEP uptake and adherence among at-risk adult TMSM without HIV.
The Transmasculine One-on-One and Group Empowerment for Targeted HIV Reduction (TOGETHR) study was a digital, open-label, randomized 2×2 factorial trial (1:1:1:1 randomization) of peer-delivered HIV prevention strategies designed to increase PrEP engagement in 300 PrEP-indicated TMSM without HIV. Participants were randomized to 1 of 4 conditions: (A) standard of care (SOC) package (information and PrEP locator tools), (B) SOC + PrEP for TMSM (PrEP4T; individual peer-based HIV prevention intervention), (C) SOC + LifeSkills for TMSM (LS4TM; group peer-based HIV prevention intervention), or (D) SOC + PrEP4T and LS4TM (both individual and group interventions). Interventions were delivered over a 6-week period. The study enrolled adults 18 years or older who were "transgender men or transmasculine," sexually active with 1 or more partners who had a penis and were assigned male sex at birth, living without HIV, behaviorally at risk for HIV acquisition, and residing in geographic hot spots identified in the US Ending the HIV Epidemic initiative.
Study protocols and procedures were codeveloped with our community advisory board, including eligibility criteria, operationalization of geographic stratification, study branding, and detailed recruitment plans. Recruitment and enrollment began on April 1, 2024, and as of March 20, 2025, 103 TMSM had been enrolled. The median age was 26 (IQR 24-31) years. Among the 103 participants, 39 (37.9%) identified as Black, Indigenous, and People of Color, and 18 (17.5%) as Latine; 36 (35.0%) identified as "transgender man or trans man"; 31 (30.1%) as transmasculine; and 15 (14.6%) as nonbinary, genderqueer, or gender nonconforming. Additionally, 69 (67.0%) had at least a four-year college degree, and only 7 (6.8%) had no health insurance. Granger causality tests indicated that recruitment activities via social media (P=.006) and transgender-inclusive dating platforms (P=.02) were most effective and predicted higher baseline enrollment survey completion 2 weeks later. On March 21, 2025, the National Institutes of Health terminated the grant award, citing gender ideology and stating, "it is the policy of NIH not to prioritize such research programs."
This study was part of a critical research pathway to identify effective strategies for preventing HIV acquisition in TMSM, a group traditionally underserved in HIV prevention, and to inform prevention packages that incorporate peer-delivered interventions. Strong engagement with the TMSM community was central to the study's success and provided valuable insights for future HIV prevention research and practice.
ClinicalTrials.gov NCT06182280; https://clinicaltrials.gov/ct2/show/NCT06182280.
DERR1-10.2196/76831.
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Details
- Title
- Transgender Men and Transmasculine One-on-One and Group-Delivered Empowerment for Targeted HIV Reduction (TOGETHR) Study: Protocol for a Digital Factorial Randomized Controlled Trial
- Creators
- Sari L Reisner (Corresponding Author) - University of MichiganAyden I Scheim - Drexel UniversityS Wilson Cole - Johns Hopkins UniversityAndrea L Wirtz - Johns Hopkins UniversityTonia Poteat - Duke UniversityMatthew J Mimiaga - University of California, Los AngelesMark A Marzinke - Johns Hopkins MedicineAlek I Meyer - Fenway HealthKevin Smith - Fenway HealthDavid R Pletta - University of MichiganKenneth H Mayer - Beth Israel Deaconess Medical Center
- Publication Details
- JMIR research protocols, v 14, e76831
- Publisher
- JMIR
- Number of pages
- 23
- Grant note
- National Institute of Mental Health of the National Institutes of Health (NIH): R01MH129175 National Institutes of Health
The authors thank the following individuals for their contributions to TOGETHR (listed alphabetically): Aisha Ghorashian, Nathan Holstein-Johnson, MegQuint, Mick Rehrig, and the TOGETHR Community Advisory Board (Dana Pardee, Mikah Thomas, Tre'Andre Valentine, and CAB members who choseto remain anonymous). This research was supported by the National Institute of Mental Health of the National Institutes of Health (NIH) under award number R01MH129175 (principal investigator: SLR). On March 21, 2025, the National Institutes of Health terminated the grant award, citing gender ideology and stating, "it is the policy of NIH not to prioritize such research programs, as revealed in a February 28, 2025 NIH memo published by Nature on March 6, 2025 [57]. In April 2025, the American Civil Liberties Union (ACLU), Protect Democracy, and the Center for Science in the Public Interest filed a lawsuit on behalf of researchers, the American Public Health Association (APHA), and others challenging the abrupt termination of research grants on disfavored topics and populations by NIH. The current grant (R01MH129175) was included in the lawsuit; litigation is ongoing. More information about the lawsuit and timeline of events can be found online [103]. The content is solely the responsibility of the authors and does not necessarily represent the official views of the funder. The sponsor had no role in the conduct of the research or preparation of this publication.
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Urban Health Collaborative; Epidemiology and Biostatistics
- Web of Science ID
- WOS:001600509900001
- Other Identifier
- 991022124350004721
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- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Health Care Sciences & Services
- Public, Environmental & Occupational Health