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Pre-Exposure Prophylaxis for Transgender Women in the US and South America
NCT04742491 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Immediate Intervention Arm
- DRUG Deferred Intervention Arm
Study Locations (5)
California
- Bridge HIV CRS — San Francisco
New York
- Harlem Prevention Center CRS — New York
Pennsylvania
- Penn Prevention CRS — Philadelphia
Texas
- Houston AIDS Research Team CRS — Houston
Rio de Janeiro
- Instituto de Pesquisa Clinicaq Evandro Chagas CRS — Manguinhos
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 304 participants |
| Start Date | 2021-03-26 |
| Est. Completion | 2024-08-16 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04742491
The ClinicalTrials.gov registry entry for NCT04742491 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 304 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is HIV Prevention Trials Network, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with HIV Prevention appearing as the primary indexed condition, and to 2 interventions — of which Immediate Intervention Arm is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04742491 reports 5 study locations spanning 5 distinct geographic areas — top geographies include California, New York, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04742491 about?
NCT04742491 is a clinical study titled "Pre-Exposure Prophylaxis for Transgender Women in the US and South America". 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...
What is the current status of trial NCT04742491?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 304 participants. The study started on 2021-03-26. Estimated completion is 2024-08-16.
What conditions does trial NCT04742491 study?
This clinical trial studies the following conditions: HIV Prevention. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04742491?
The interventions under investigation include: Immediate Intervention Arm (DRUG), Deferred Intervention Arm (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04742491?
This trial is sponsored by HIV Prevention Trials Network, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04742491 being conducted?
This trial has 5 study locations across California, New York, Pennsylvania, Texas, Rio de Janeiro. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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