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

NCT06182280 | Not Yet Recruiting DMC

• 1 other identifier: 1R01MH129175-01A1
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Adherence, Medication

Keywords

Transgender; Men who have sex with men; pre-exposure prophylaxis; behavioral intervention; HIV prevention

Outcome Measures

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.

  18 months

Secondary Outcomes (1)

• PrEP adherence and persistence

  18 months

Study Arms (4)

Condition A: Standard of Care (SOC)

NO INTERVENTION

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

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.

Behavioral: PrEP4T

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

EXPERIMENTAL

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.

Behavioral: LS4TM

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

EXPERIMENTAL

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.

Behavioral: PrEP4T; Behavioral: LS4TM

Interventions

PrEP4T BEHAVIORAL

PrEP4T 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.

Condition B: Online one-on-one peer navigation (SOC + PrEP4T); Condition D: Peer-delivered and group-based intervention (SOC + PrEP4T + LS4TM)

LS4TM BEHAVIORAL

LS4TM 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.

Condition C: Online peer-delivered small group-based behavioral intervention (SOC + LS4TM); Condition D: Peer-delivered and group-based intervention (SOC + PrEP4T + LS4TM)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Identify as a man, trans man, or another transmasculine identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fenway Community Health: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Fenway Community Health

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Reisner SL, Scheim AI, Cole SW, Wirtz AL, Poteat T, Mimiaga MJ, Marzinke MA, Meyer AI, Smith K, Pletta DR, Mayer KH. Transgender Men and Transmasculine One-on-One and Group-Delivered Empowerment for Targeted HIV Reduction (TOGETHR) Study: Protocol for a Digital Factorial Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 20;14:e76831. doi: 10.2196/76831.

  PMID: 41115262 DERIVED

MeSH Terms

Conditions

HIV Infections; Medication Adherence; Homosexuality

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Sexuality; Sexual Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding will occur at the statistician and investigator levels, but is not possible for participants or staff in the intervention. Participants will be followed for 18 months.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 26, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)