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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFenway Community Health

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • PrEP4T
  • LS4TM

Treatment groups

375 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Fenway Community Health

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator