JMIR Publications

ABSTRACT

Background:

In the United States (U.S.), transgender men and transmasculine people who have sex with men (TMSM) face an increased risk of HIV and unique barriers to HIV prevention services, including pre-exposure prophylaxis (PrEP). Peer-based, digitally delivered support interventions, addressing barriers to HIV prevention in one-on-one or small-group settings, may be effective in increasing PrEP engagement.

Objective:

To compare the efficacy of digitally delivered individual and small-group peer-based strategies to improve PrEP uptake and adherence among at-risk adult TMSM without HIV.

Methods:

The Transmasculine One-on-One and Group Empowerment for Targeted HIV Reduction (TOGETHR) study was a digital, open-label, randomized 2x2 factorial trial (1:1:1:1 randomization) of peer-delivered HIV prevention strategies to increase PrEP engagement in 300 PrEP-indicated TMSM without HIV. Participants were randomized to one of four conditions: [A] standard of care (SOC) package (information and PrEP locator tools), [B] SOC and PrEP4T (individual peer-based HIV prevention intervention), [C] SOC + LS4TM (group peer-based HIV prevention intervention), or [D] SOC + PrEP4T and LS4TM (both individual and group interventions). Interventions were delivered over a six-week period. The study enrolled adults ages >=18 who were transgender men or transmasculine, sexually active with one or more partners who had a penis and were assigned a male sex at birth, living without HIV, behaviorally at-risk for HIV acquisition, and residing in geographic hotspots in the U.S. Ending the HIV Epidemic initiative.

Results:

Study protocols and procedures were co-developed with our community advisory board (CAB), including eligibility criteria, operationalization of geographic stratification, study branding, and detailed recruitment plans. Recruitment and enrollment commenced on April 1, 2024, and as of March 20, 2025, 103 TMSM were enrolled. The median age was 26 years (interquartile range=24-31). Of these participants, 37.9% identified as BIPOC (39/103), and 17.5% (18/103) as Latine; 35.0% (36/103) identified as a transgender man or trans man, 30.1% (31/103) as transmasculine, and 14.6% (15/103) as nonbinary, genderqueer, or gender nonconforming. Additionally, 67.0% (69/103) had at least a four-year college degree. Only 6.8% (7/103) had no health insurance. Granger causality tests indicated that recruitment activities via social media and trans-inclusive dating platforms were most effective and predicted higher baseline enrollment survey completion two-weeks later (p<0.05). On March 21, 2025, the National Institutes of Health terminated the grant award due to gender ideology, stating “it is the policy of NIH not to prioritize such research programs.”

Conclusions:

This study was part of a critical path of research to identify effective strategies to prevent HIV acquisition in TMSM, a group traditionally underserved in HIV prevention, and inform HIV prevention packages that include peer-delivered interventions. Our strong TMSM community engagement was key to the success of the study and provided valuable insights for future HIV prevention research and practice. Clinical Trial: NCT06182280