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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 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.

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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.

Conditions Studied

HIV Prevention

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

FieldValue
Enrollment Target 304 participants
Start Date 2021-03-26
Est. Completion 2024-08-16
Phase Phase 2

Sponsor

HIV Prevention Trials Network

10 total trials

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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, categorized as Phase 2. The registered enrollment target is 304 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 372-participant average among 32 other HIV Prevention trials with a reported enrollment target (18% lower). The listed sponsor is HIV Prevention Trials Network, which has 10 total studies on file at ClinicalTrials.gov.

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 reports 5 study locations spanning 5 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.