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

This study will comprise a digitally delivered, open-label randomized 2x2 factorial trial (1:1:1:1 randomization) of peer-delivered HIV prevention strategies. The 2x2 factorial design has two actors: individualized, one-on-one peer navigation (PrEP4T vs none) (Condition B) and group-based behavioral intervention (LS4TM vs none) (Condition C). The trial will compare the efficacy of the interventions to increase PrEP uptake.

Participants in Conditions B and C will receive 6 weeks of their assigned intervention in addition to SOC. Participants in Condition D will be assigned to receive both interventions which may not occur simultaneously. Follow-up will continue another 15 months after the intervention ends to assess effects. In the final 6 months of this 5 years study, PrEP4T and LS4TM will be offered to all participants, regardless of study group assignment. We will ask which intervention participants prefer and gather implementation data.

Randomization and intervention allocation will be automated and computer-generated through an electronic system; the allocation sequence will be concealed. Stratified randomization by race/ethnicity (BIPOC and white) and Movement Advancement Project state LGBTQ equality policy tally (high, medium, or fair overall policy tally as of October 2023, and low or negative overall policy tally as of October 2023) will ensure balance across groups and allow subgroup analyses.49 Blinding will occur at the statistician and investigator levels, 50 but is not possible for participants or staff in the intervention. Participants will be followed for 18 months.

Inclusion criteria

• Age 18 or over
• Assigned female sex at birth
• Identifies as a man, trans man, or another transmasculine identity
• Has had sex with a partner assigned male sex at birth with a flesh penis in the last 3 months
• Has access to a smartphone or computer with internet access
• Is HIV-uninfected
• Resides in one of the Ending the Epidemic targeted geographic hotspots in the United States
• Willing and able to provide informed consent in English
• Meets CDC guidelines for PrEP indications in the last 3 months (adapted for TMSM) including:
• Condomless receptive vaginal/frontal or anal sex with a partner assigned male at birth with a flesh penis
• Sharing needles or syringes for illicit drug use and/or hormones
• Self-reported anogenital sexually transmitted infection diagnosis

Exclusion criteria

• Less than age 18
• Not assigned female sex at birth
• Does not identify as a man, trans man, or another transmasculine identity
• Does not have access to a smartphone or computer
• Is living with HIV (HIV positive)
• Does not reside in one of the Ending the Epidemic geographic hotspots in the United States
• Will not or cannot provide written informed consent in English
• Does not meet the trans-adapted CDC guidelines for PrEP indications