Empowerment Programs for HIV Prevention

(TOGETHR Trial)

Recruiting in Boston (>99 mi)

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

375 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment LS4TM, PrEP4T for HIV prevention?

The MOVE intervention, which is similar to LS4TM, showed that participants had increased confidence in managing HIV risk and reduced risky behaviors. Additionally, PrEP, like PrEP4T, has been shown to be highly effective in preventing HIV when patients are engaged and adhere to the treatment. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

The treatment, known as PrEP, has been shown to be safe in studies for preventing HIV infection, with regulatory approval in nearly 70 countries. Some users may experience side effects, but overall, it is considered safe for human use. ^{6 7 8 9 10}

What makes the Empowerment Programs for HIV Prevention treatment unique?

This treatment is unique because it focuses on empowerment, helping individuals take control of their health and address social and structural challenges related to HIV prevention. Unlike traditional treatments that focus solely on medication, this approach includes community mobilization and empowerment strategies to improve health outcomes. ^{5 11 12 13 14}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

EVOLUTION--taking charge and growing stronger: the design, acceptability, and feasibility of a secondary prevention empowerment intervention for young women living with HIV. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Pilot Trial of a Critical Consciousness-Based Intervention for Black Young Gay and Bisexual Men Living with HIV: Mobilizing Our Voices for Empowerment (MOVE). [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Adherence support approaches in biomedical HIV prevention trials: experiences, insights and future directions from four multisite prevention trials. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Is HIV Pre-Exposure Prophylaxis among Men Who Have Sex with Men Effective in a Real-World Setting? Experience with One-On-One Counseling and Support in a Sexual Health Center in Paris, 2018-2020. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Community empowerment paradigm drift and the primary prevention of HIV/AIDS. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Discontinuation, suboptimal adherence, and reinitiation of oral HIV pre-exposure prophylaxis: a global systematic review and meta-analysis. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. Netherlands pubmed.ncbi.nlm.nih.gov

Prioritising the values of potential users to promote uptake of HIV pre-exposure prophylaxis. [2023]

9. England 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. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

State of the science of adherence in pre-exposure prophylaxis and microbicide trials. [2021]

11. England pubmed.ncbi.nlm.nih.gov

An intervention to help community-based organizations implement an evidence-based HIV prevention intervention: the Mpowerment Project technology exchange system. [2012]

12. England pubmed.ncbi.nlm.nih.gov

Social self-value intervention for empowerment of HIV infected people using antiretroviral treatment: a randomized controlled trial. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

Effect of an Empowerment Intervention on Antiretroviral Drug Adherence in Thai Youth. [2021]

14. England pubmed.ncbi.nlm.nih.gov

Do combination HIV prevention programmes result in increased empowerment, inclusion and agency to demand equal rights for marginalised populations in low-income and middle-income countries? A systematic review. [2022]