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
This trial accepts healthy volunteersQualifiers
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
Design model
Factorial
Treatments tested in this trial
PrEP4T
BehavioralPrEP4T is an individualized TMSM-specific intervention adapted from The Fenway Model. PrEP4T consists of online one-on-one sessions between a peer and a participant using a strengths-based case management manualized curriculum. Peer navigators (PNs) share transmasculine community membership with participants and are trained to provide linkages. They use an individualized approach to navigate barriers, apply an assets-based frame to promote resiliencies, and pragmatically leverage these to improve biomedical HIV prevention outcomes. PNs utilize techniques from established behavior change models (e.g., Motivational Interviewing; Transtheoretical Model) in PrEP decision-making.
LS4TM
BehavioralLS4TM is a theory-based peer-delivered small group-based behavioral intervention to reduce HIV risk and address mental health-related effects of stigma for TMSM. Groups will be led by trained peer navigator staff and comprise no more than 10 participants per cohort.
Treatment groups
375 Participants
are divided into 4 treatment groupsGroup A: Condition A: Standard of Care (SOC)No intervention 0 interventions
Group B: Condition B: Online one-on-one peer navigation (SOC + PrEP4T)Experimental treatment 1 intervention
Group C: Condition C: Online peer-delivered small group-based behavioral intervention (SOC + LS4TM)Experimental treatment 1 intervention
Group D: Condition D: Peer-delivered and group-based intervention (SOC + PrEP4T + LS4TM)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
PrEP uptake
Uptake of new PrEP prescriptions during the study intervention and follow-up period as measured by biomarker sampling collected by dried blood spots.
Time frame
18 monthsSecondary outcomes
1
PrEP adherence and persistence
Measurement of PrEP use or disuse across the intervention and follow-up periods as measured by biomarker sampling collected by dried blood spots.
Time frame
18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Fenway Community Health
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov
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