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.

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.

Duke Scholars

Author Tonia Poteat School of Nursing