Transmaculine One-on-One and Group Empowerment for Targeted HIV Reduction

Transgender masculine and gender diverse people who have sex with men (TMSM) have an increased risk of HIV and face unique barriers engaging in prevention services. Digitally delivered support interventions addressing HIV prevention barriers delivered by peers in one-on-one or small-group settings may be effective at increasing PrEP engagement. This study examines the independent and combined effects of individual and group-based peer-support interventions on PrEP outcomes. Participants will be randomly assigned to receive: (i) standard-of-care HIV prevention information, (ii) a one-on-one healthy lifestyle intervention tailored for transgender masculine people, (iii) a peer-group based healthy lifestyle intervention for transgender masculine people, or (iv) both the one-on-one and group-based interventions delivered together. The hypotheses are that the individual group-based interventions will result in higher PrEP uptake and persistence than the standard of care and that the combined interventions will be more effective than receiving one individual intervention.

NCT Number	NCT06182280
Lead Sponsor	Fenway Community Health Collaborators: National Institute of Mental Health (NIMH)
Conditions	HIV Infections, Adherence, Medication
Enrollment	375 participants
Start Date	2024-01
Primary Completion	2026-07 (estimated)
Study Completion	2027-06 (estimated)
Updated on ClinicalTrials.gov	2023-12-26