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

December 13, 2023 updated by: Sari Reisner, ScD, Fenway Community Health

Strategies to Prevent HIV Acquisition Among Transgender Men Who Have Sex With Men (TMSM)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

375

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Fenway Community Health
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sari Reisner, ScD
        • Sub-Investigator:
          • Ken Mayer, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Condition A: Standard of Care (SOC)
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.
Experimental: Condition B: Online one-on-one peer navigation (SOC + PrEP4T)
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
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.
Experimental: Condition C: Online peer-delivered small group-based behavioral intervention (SOC + LS4TM)
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
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.
Experimental: Condition D: Peer-delivered and group-based intervention (SOC + PrEP4T + LS4TM)
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
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.
Behavioral: LS4TM
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PrEP uptake
Time Frame: 18 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
PrEP adherence and persistence
Time Frame: 18 months
Measurement of PrEP use or disuse across the intervention and follow-up periods as measured by biomarker sampling collected by dried blood spots.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fenway Community Health

Collaborators

National Institute of Mental Health (NIMH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

December 13, 2023

First Submitted That Met QC Criteria

December 13, 2023

First Posted (Actual)

December 26, 2023

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01MH129175-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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