CompletedPhase 2/3

Pre-Exposure Prophylaxis for Transgender Women in the US and South America

United States, Brazil304 participantsStarted 2021-03-26

Plain-language summary

A study to assess the feasibility, acceptability, and preliminary impact of a multi-component strategy to improve pre-exposure prophylaxis (PrEP) uptake and adherence that integrates delivery of biomedical HIV prevention co-located with gender-affirming transgender care (hormonal therapy and medical monitoring) and Peer Health Navigation (PHN) using Strengths-Based Case Management (SBCM) professional supervision. Multi-site, open-label study with each participant randomized 1:1 to Immediate Intervention vs. 6-month Deferred Intervention Arms. Both arms will be provided PrEP and sexually transmitted infection (STI) screening and treatment. Participants in the Immediate Intervention Arm will receive co-located gender-affirming medical care and PHN using SBCM starting at the Enrollment Visit. Participants in the Deferred Intervention Arm will receive linkage to external gender-affirming medical care and case management services during the deferred period and will transition to the study intervention six months following the Enrollment Visit.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Any anal or vaginal sex with one or more serodiscordant or HIV-unknown serostatus sexual partners in the previous 3 months, regardless of condom use.
. Anal or vaginal sex in exchange for money, food, shelter, or other goods or favors in the previous 3 months.
. History of STI(s) in the past 6 months.
. Calculated creatinine clearance ≥ 60 mL/minute using the Cockcroft-Gault equation.
. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 times the upper limit of normal (ULN.)
. HBV surface antigen (HBsAg) negative.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PrEP Uptake

Timeframe: 0-18 months

PrEP Adherence

Timeframe: 0-18 months

Acceptability and Feasibility of Co-located Services

Timeframe: 0-18 months

Participant Retention at Weeks 26, 52 and 78

Timeframe: Weeks 26, 52, 78

Acceptability and Feasibility of Peer Health Navigation

Timeframe: 0-18 months

Acceptability and Feasibility of Peer Health Navigation

Timeframe: 0-18 months

Acceptability and Feasibility of Co-located Services

Timeframe: 0-18 months

PrEP Adherence

Timeframe: 0-18 months

Trial details

NCT IDNCT04742491

SponsorHIV Prevention Trials Network

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2024-08-16

Results submitted2025-08-15

View on ClinicalTrials.gov More HIV Prevention trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Any anal or vaginal sex with one or more serodiscordant or HIV-unknown serostatus sexual partners in the previous 3 months, regardless of condom use.
. Anal or vaginal sex in exchange for money, food, shelter, or other goods or favors in the previous 3 months.
. History of STI(s) in the past 6 months.
. Calculated creatinine clearance ≥ 60 mL/minute using the Cockcroft-Gault equation.
. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 times the upper limit of normal (ULN.)
. HBV surface antigen (HBsAg) negative.

Exclusion criteria

What they're measuring

PrEP Uptake

Timeframe: 0-18 months

PrEP Adherence

Timeframe: 0-18 months

Acceptability and Feasibility of Co-located Services

Timeframe: 0-18 months

Participant Retention at Weeks 26, 52 and 78

Timeframe: Weeks 26, 52, 78

Acceptability and Feasibility of Peer Health Navigation

Timeframe: 0-18 months

Acceptability and Feasibility of Peer Health Navigation

Timeframe: 0-18 months

Acceptability and Feasibility of Co-located Services

Timeframe: 0-18 months

PrEP Adherence

Timeframe: 0-18 months