Clinical trial NCT06182280: Transmaculine One-on-One and Group Empowerment for Targeted HIV Reduction
Official title: Strategies to Prevent HIV Acquisition Among Transgender Men Who Have Sex With Men (TMSM)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV Infections
Adherence, Medication
Keywords: Transgender
Men who have sex with men
pre-exposure prophylaxis
behavioral intervention
HIV prevention
Lead sponsor: Fenway Community Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-12-26
Enrollment: 375
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The 2x2 factorial design has two actors: individualized, one-on-one peer navigation (PrEP4T vs none) and group-based behavioral intervention (LS4TM vs none). The comparator is standard-of-care information and resources on HIV prevention and linkage to care.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: PrEP uptake
timeFrame: 18 months
Secondary outcomes:
measure: PrEP adherence and persistence
timeFrame: 18 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Fenway Community Health
state: Massachusetts
Study officials:
References: