Transmaculine One-on-One and Group Empowerment for Targeted HIV Reduction (TOGETHR)

Fenway Community Health

Status: Not yet enrolling

Conditions: Adherence, Medication; HIV Infections

Treatments: Behavioral: PrEP4T; Behavioral: LS4TM

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06182280

1R01MH129175-01A1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 375 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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375 participants in 4 patient groups

Condition A: Standard of Care (SOC)

No Intervention group

Description:

SOC will include linkage to the CDC's HIV Prevention Services Locator, a US directory of HIV testing and PrEP services. A Digital Library of HIV prevention, sexual health, and anti-stigma materials (written and video media) will be provided. This content is curated from CDC, Gate Trans Men \& HIV Project, UCSF Center for Excellence in Trans Health, and National LGBTQIA+ Health Education Center, among other sources.

Condition B: Online one-on-one peer navigation (SOC + PrEP4T)

Experimental group

Description:

PrEP4T is an individualized TMSM-specific intervention consisting of online one-on-one sessions between a peer and a participant. PrEP4T has 9 hours of content: 6 1.5-hour sessions conducted weekly for 6 weeks. Participants will also receive access to the SOC materials.

Treatment:

Behavioral: PrEP4T

Condition C: Online peer-delivered small group-based behavioral intervention (SOC + LS4TM)

Experimental group

Description:

LS4TM is a theory-based peer-delivered small group-based behavioral intervention. The LS4TM manualized intervention is comprised of 9 hours of content: 6 2-hour small-group sessions with up to 12 participants per group delivered weekly for 6 weeks. Participants will also receive access to the SOC materials.

Treatment:

Behavioral: LS4TM

Condition D: Peer-delivered and group-based intervention (SOC + PrEP4T + LS4TM)

Experimental group

Description:

Both PrEP4T and LS4TM will be delivered to participants. Group D will receive 21 hours of content: 6 2-hour LS4TM sessions and 6 1.5-hour PrEP4T sessions. Group D participants may not receive both interventions simultaneously within 6 weeks.

Treatment:

Behavioral: LS4TM

Behavioral: PrEP4T