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Behavioral Intervention

Empowerment Programs for HIV Prevention (TOGETHR Trial)

N/A

Waitlist Available

Research Sponsored by Fenway Community Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Is HIV-uninfected

Age 18 or over

Must not have

Not assigned female sex at birth

Does not identify as a man, trans man, or another transmasculine identity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying ways to increase engagement in HIV prevention services, specifically for transgender masculine and gender diverse people who have sex with men. The trial will compare different interventions, including one-on-one support and

Who is the study for?

This trial is for transgender masculine and gender diverse individuals who have sex with men, at increased risk of HIV. Participants should be interested in prevention services but haven't yet engaged effectively. Specific eligibility details are not provided, so it's assumed that participants must meet certain health criteria to join.

What is being tested?

The study tests the effectiveness of digital peer-support interventions on PrEP engagement for HIV prevention. It compares standard HIV prevention info with one-on-one (PrEP4T) and group-based (LS4TM) support interventions, individually or combined, to see which method increases PrEP uptake and persistence among participants.

What are the potential side effects?

Since this trial focuses on behavioral interventions rather than medications, traditional side effects like those seen with drugs may not apply. However, participants might experience emotional or psychological impacts from discussing sensitive topics related to their lifestyle and health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have HIV.

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I am 18 years old or older.

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I was assigned female at birth.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I was not assigned female at birth.

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I do not identify as a man, trans man, or any transmasculine identity.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PrEP uptake

Secondary study objectives

PrEP adherence and persistence

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Condition D: Peer-delivered and group-based intervention (SOC + PrEP4T + LS4TM)Experimental Treatment2 Interventions

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.

Group II: Condition C: Online peer-delivered small group-based behavioral intervention (SOC + LS4TM)Experimental Treatment1 Intervention

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.

Group III: Condition B: Online one-on-one peer navigation (SOC + PrEP4T)Experimental Treatment1 Intervention

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.

Group IV: Condition A: Standard of Care (SOC)Active Control1 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.

0 / 6Eligibility criteria met