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NCT04742491 · ClinicalTrials.gov registry record · Phase 2
Pre-Exposure Prophylaxis for Transgender Women in the US and South America
A Phase 2 study of HIV Prevention, sponsored by HIV Prevention Trials Network.
- Completed
- Registry status
- Phase 2
- Development phase
- 304
- Enrollment target
- 5
- Study locations
NCT04742491: Completed Phase 2 study of HIV Prevention, sponsored by HIV Prevention Trials Network.
NCT04742491 is a Phase 2 study of HIV Prevention that has completed, run by HIV Prevention Trials Network. The registered enrollment target is 304 participants, below the 372-participant average among 32 other HIV Prevention trials with a reported enrollment target (18% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04742491, a Phase 2 study of HIV Prevention, has completed, sponsored by HIV Prevention Trials Network.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 304 participants
- Enrollment target
- 5
- Study locations
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.
Primary Outcome
Time to PrEP initiation is defined as the duration from enrollment to the PrEP start date.
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 |
What the finished NCT04742491 record still lists
NCT04742491 is an interventional study that assigns participants to a tested intervention. The registered 304 participants enrollment target is mid-sized for trials with a published cap, below the 372-participant average among 32 other HIV Prevention trials with a reported enrollment target (18% lower).
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.
NCT04742491 lists 5 locations in 5 states (California, New York, Pennsylvania).
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.
What interventions are being tested in trial NCT04742491?
The interventions under investigation include: Immediate Intervention Arm (DRUG), Deferred Intervention Arm (DRUG).
Who is sponsoring clinical trial NCT04742491?
This trial is sponsored by HIV Prevention Trials Network, which has 10 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for HIV Prevention
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04742491's enrollment target sits among peer trials
304 9th of 32 higher than 24 of 32 other HIV Prevention trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Prevention trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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