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NCT04533386 · ClinicalTrials.gov registry record · NA

A Multicomponent Intervention to Increase HIV Risk Perceptions and PrEP Initiation Among Black Men Who Have Sex With Men

A NA study, sponsored by George Washington University.

Completed
Registry status
NA
Development phase
69
Enrollment target

NCT04533386: Completed NA study, sponsored by George Washington University.

NCT04533386 is a NA study that has completed, run by George Washington University. The registered enrollment target is 69 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04533386, a NA study, has completed, sponsored by George Washington University.

COMPLETED
Registry status
NA
Development phase
69 participants
Enrollment target

Study Summary

Tragically, HIV infections among Black sexual minority men (BSMM) in the U.S. persist. Despite the availability of pre-exposure prophylaxis (PrEP) for HIV prevention, effective uptake among BSMM remains low. It is imperative to support PrEP initiation among this group. The proposed multi-component interventional study is designed to increase HIV risk perceptions and subsequent PrEP initiation through the use of our team's existing mobile application called PrEPme and a peer change agent (PCA) to record and review sexual risk behaviors and subsequent PrEP interest. Few have studied whether reviewing sexual diaries with a PCA increases HIV risk perceptions and PrEP initiation among BSMM. This strategy will allow BSMM who are not using PrEP to record their sexual behaviors using a PrEPme-based diary, review their sexual histories with a PCA, and assess PrEP interest. The PCA will be trained in motivational interviewing techniques to facilitate discussions. The PCA will provide HIV prevention education, sexual risk evaluation, and PrEP navigation. BSMM who become interested in initiating PrEP will be referred to our team's ongoing PrEP tele-medicine study (PI: Jason Farley, co-investigator) or other PrEP care services in the greater Baltimore area. The proposed intervention targets a high priority population in HIV prevention and mitigates structural barriers to PrEP uptake such as perceived judgement, stigma, and discrimination from clinical providers.

Primary Outcome

The Perceived Risk of HIV Scale is an 8-item scale with each item being scored from 1-5 (e.g., "Extremely likely" to "Extremely Unlikely," "Rarely" to "All of the time," etc.). Overall score ranges from 10 to 40 where higher scores signify increased perception of risk.

Interventions

  • BEHAVIORAL Multi-component intervention strategy

Trial Details

FieldValue
Enrollment Target 69 participants
Start Date 2020-09-05
Est. Completion 2022-06-02
Phase NA
George Washington University

133 total trials

What the finished NCT04533386 record still lists

NCT04533386 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 1 intervention - of which Multi-component intervention strategy is the first listed.

NCT04533386 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04533386 about?

NCT04533386 is a clinical study titled "A Multicomponent Intervention to Increase HIV Risk Perceptions and PrEP Initiation Among Black Men Who Have Sex With Men". Tragically, HIV infections among Black sexual minority men (BSMM) in the U.S. persist. Despite the availability of pre-exposure prophylaxis (PrEP) for HIV prevention, effective uptake among BSMM remains low. It is imperative to support PrEP initiation among this group. The proposed multi-component i...

What is the current status of trial NCT04533386?

This trial is currently completed. It is a NA study. The enrollment target is 69 participants. The study started on 2020-09-05. Estimated completion is 2022-06-02.

What interventions are being tested in trial NCT04533386?

The interventions under investigation include: Multi-component intervention strategy (BEHAVIORAL).

Who is sponsoring clinical trial NCT04533386?

This trial is sponsored by George Washington University, which has 133 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04533386's enrollment target sits among peer trials

69 1133rd of 2000 higher than 868 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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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Source: ClinicalTrials.gov NCT04533386, the US trial registry maintained by the National Library of Medicine. NCT04533386 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.