Empowerment Programs for HIV Prevention

(TOGETHR Trial)

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Fenway Community Health

Must be taking: PrEP

Disqualifiers: HIV positive, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to help transgender masculine and gender-diverse individuals who have sex with men engage more effectively with HIV prevention services, particularly through PrEP (a medication to prevent HIV). The study tests different types of support: some participants receive standard HIV prevention information, while others receive one-on-one or group-based peer support, or a combination of both. This approach aims to identify which method most effectively boosts PrEP use. Individuals who have had sex with a male partner in the past three months, are HIV-negative, and live in certain areas of the U.S. may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to important research that could enhance HIV prevention strategies for the community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that PrEP4T and LS4TM are designed to help prevent HIV in transgender masculine and gender diverse people. PrEP4T has proven very effective in reducing the risk of HIV when taken as directed. It is considered safe, having been tested in various studies and already approved in many countries for preventing HIV.

LS4TM, however, is a program that supports healthy lifestyle changes in small groups. Although less detailed safety information exists for LS4TM, its setup as a peer-support program suggests it is generally safe and unlikely to cause serious side effects.

Using PrEP4T and LS4TM together aims to enhance their effectiveness. Studies have shown that peer-support programs like these can safely and effectively encourage more people to use PrEP, the medication that helps prevent HIV.

Overall, both treatments are expected to be safe and well-accepted, based on existing research and their focus on supportive, non-invasive methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Empowerment Programs for HIV Prevention trial because it explores new, personalized ways to prevent HIV, particularly among transgender men who have sex with men (TMSM). Unlike standard options that mainly focus on providing resources and information, this trial introduces two unique interventions: PrEP4T and LS4TM. PrEP4T offers one-on-one online peer support tailored to individual needs, enhancing personal connection and guidance. Meanwhile, LS4TM facilitates small group sessions, encouraging peer interaction and shared learning experiences. By combining personalized peer support with group-based learning, these programs aim to create a more engaging and supportive environment, potentially increasing the effectiveness of HIV prevention efforts.

What evidence suggests that this trial's interventions could be effective for HIV prevention in transgender masculine and gender diverse people?

Research shows that PrEP (pre-exposure prophylaxis) effectively prevents HIV, especially with regular use. Studies indicate that consistent PrEP use can lower the risk of HIV by up to 93%. In this trial, participants in different arms will receive various interventions. LS4TM, a peer-led group program, aims to improve PrEP use and support mental health, though its effectiveness is still under study. PrEP4T, another intervention, provides individualized peer support. Combining PrEP with peer support programs like PrEP4T and LS4TM may enhance results by addressing challenges to starting and continuing PrEP. Overall, using PrEP with supportive programs shows promise in reducing HIV risk for transgender masculine and gender diverse individuals. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I do not have HIV.

I was assigned female at birth.

Exclusion Criteria

Is living with HIV (HIV positive)

Does not meet the trans-adapted CDC guidelines for PrEP indications

Does not reside in one of the Ending the Epidemic geographic hotspots in the United States

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive assigned interventions: SOC, PrEP4T, LS4TM, or both, over 6 weeks

6 weeks

6 weekly sessions

Follow-up

Participants are monitored for PrEP uptake and adherence for 15 months after intervention

15 months

Open-label extension

PrEP4T and LS4TM offered to all participants, regardless of initial assignment, in the final 6 months

6 months

What Are the Treatments Tested in This Trial?

Interventions

• LS4TM
• PrEP4T

Trial Overview

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.

How Is the Trial Designed?

Group I: Condition D: Peer-delivered and group-based intervention (SOC + PrEP4T + LS4TM) Experimental Treatment 2 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 Treatment 1 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 Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

Fenway Community Health

Lead Sponsor

Trials

36

Recruited

5,833,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Adherence to antiretroviral-based pre-exposure prophylaxis (PrEP) is crucial for preventing new HIV infections, and understanding how to support sustained adherence is essential for effective PrEP programs.

Key recommendations from four major PrEP trials emphasize the importance of participant-centered approaches, tailored strategies beyond just education, and addressing individual contexts to enhance adherence to PrEP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence support approaches in biomedical HIV prevention trials: experiences, insights and future directions from four multisite prevention trials. Amico, KR., Mansoor, LE., Corneli, A., et al.[2023]

In a study involving 1456 participants across 14 sites in Sub-Saharan Africa, monitoring the fidelity of counseling for the dapivirine vaginal ring was feasible and effective, with 54.1% of expected counseling sessions being audio-recorded.

The majority of reviewed sessions (83.9%) were rated as 'good' or 'fair', indicating that consistent and high-quality counseling can be maintained, which is crucial for supporting adherence to PrEP interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a fidelity monitoring process to assess delivery of an evidence-based adherence counseling intervention in a multi-site biomedical HIV prevention study. Balán, IC., Lentz, C., Giguere, R., et al.[2021]

Antiretroviral pre-exposure prophylaxis (PrEP) using oral emtricitabine-tenofovir disoproxil fumarate has been proven effective and safe in preventing HIV infection, leading to regulatory approval in nearly 70 countries.

Ongoing development of next-generation PrEP formulations aims to simplify access and increase user choice, which could enhance coverage and further reduce HIV infection rates at the population level.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PrEP for HIV Prevention: Evidence, Global Scale-up, and Emerging Options. Celum, C., Baeten, J.[2020]

In a systematic review of 59 studies involving 43,917 participants, it was found that 41% of individuals discontinued HIV pre-exposure prophylaxis (PrEP) within 6 months, with the highest rates observed in sub-Saharan Africa (47.5%).

Implementing adherence interventions significantly reduced discontinuation rates (24.7% vs 36.7%), and offering flexible dosing options (daily or non-daily) led to lower discontinuation among gay or bisexual men and transgender women (21.6% vs 31.5%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discontinuation, suboptimal adherence, and reinitiation of oral HIV pre-exposure prophylaxis: a global systematic review and meta-analysis. Zhang, J., Li, C., Xu, J., et al.[2023]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41115262/

Protocol for a Digital Factorial Randomized Controlled Trial

Objective: This study aims to compare the efficacy of digitally delivered individual and small-group peer-based strategies for improving PrEP ...

2.

researchprotocols.org

researchprotocols.org/2025/1/e76831

Transgender Men and Transmasculine One-on ...

Objective: This study aims to compare the efficacy of digitally delivered individual and small-group peer-based strategies for improving PrEP ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06182280

Study Details | NCT06182280 | Transmaculine One-on- ...

LS4TM is a theory-based peer-delivered small group-based behavioral intervention to reduce HIV risk and address mental health-related effects of ...

4.

researchprotocols.org

researchprotocols.org/2025/1/e76831/PDF

Transgender Men and Transmasculine One-on-One and

A pilot study of LifeSkills for Men (LS4M) [20], a small group–based behavioral intervention designed to reduce HIV risk and the mental health ...

5.

researchgate.net

researchgate.net/publication/396710697_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_Preprint

Transgender Men and Transmasculine ...

We recently found that compared to HIV treatment as usual, three sessions of in-person motivational interviewing (MI) substantially reduced ...

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researchgate.net

researchgate.net/publication/396710504_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

Protocol for a Digital Factorial Randomized Controlled Trial

HIV-related clinical outcomes include pre-exposure prophylaxis uptake (patients without HIV), viral suppression (patients with HIV), and ...

7.

researchgate.net

researchgate.net/figure/Projected-sample-sizes-across-HIV-prevention-and-treatment-cascade-outcomes_tbl1_333474646

Projected sample sizes across HIV prevention and ...

Results: Seventy-seven (16.4%) individuals had PDR (95% CI: 13.2 to 20.0); most resistance was likely TDR since 63% were incident infections. SDRM were present ...

8.

reporter.nih.gov

reporter.nih.gov/project-details/11015850

Statistical Methods for Advancing HIV Prevention

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