PrEP US NoW: PrEP Utilization Through Increasing Social Capital Among YBMSM Networks With Women

NCT ID: NCT07024745

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-09

Study Completion Date

2025-12-30

Brief Summary

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This project is a randomized intervention looking at PrEP uptake among young, black men who identify as gay, bisexual, or same gender loving, utilizing black females within the community to help deliver study related topics. All participants will download the Us\*Now mHealth app that was created specifically for this project. Participants randomized to the Intervention arm will interact with the Us\*Now mHealth app and will be invited to attend 4 weekly sessions led by a black female facilitator where the topic are pre-selected by the study team. Participants randomized to the Control arm will interact with the Us\*Now mHealth app only.

Detailed Description

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Conditions

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PrEP Uptake

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Female Facilitator

Group Type OTHER

Intervention Group

Intervention Type BEHAVIORAL

The Intervention is 1) interact with the Us\*Now mHealth app for 1 month; 2) participate in 4 weekly sessions with other group members and led by a Female Facilitator. Each week will cover a different topic - Week 1: Intersectional Stigma, Week 2: Sexual Health, Week 3: HIV Prevention, Week 4: Engagement in PrEP Care.

Control Participants

Group Type OTHER

Control (Standard treatment)

Intervention Type BEHAVIORAL

The Control group will be asked to interact with the Us\*Now mHealth app for 1 month.

Intervention Participants

Group Type OTHER

Intervention Group

Intervention Type BEHAVIORAL

The Intervention is 1) interact with the Us\*Now mHealth app for 1 month; 2) participate in 4 weekly sessions with other group members and led by a Female Facilitator. Each week will cover a different topic - Week 1: Intersectional Stigma, Week 2: Sexual Health, Week 3: HIV Prevention, Week 4: Engagement in PrEP Care.

Interventions

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Intervention Group

The Intervention is 1) interact with the Us\*Now mHealth app for 1 month; 2) participate in 4 weekly sessions with other group members and led by a Female Facilitator. Each week will cover a different topic - Week 1: Intersectional Stigma, Week 2: Sexual Health, Week 3: HIV Prevention, Week 4: Engagement in PrEP Care.

Intervention Type BEHAVIORAL

Control (Standard treatment)

The Control group will be asked to interact with the Us\*Now mHealth app for 1 month.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Female Facilitators: 1) Black/African American; 2) age 18-80 years old; 3) Female; 4) able to lead weekly sessions with participants; 5) able to download the Us\*Now mHealth app
* Participants: 1) Black/African American; 2) age 18-29 years old; 3) Male; 4) Identifies as gay, bisexual, or same gender loving; 5) able to download the Us\*Now mHealth app

Exclusion Criteria

* Female Facilitators: 1) does not identify as Black/African American; 2) not Female; 3) not able to lead the weekly sessions or attend the study training
* Participants: 1) does not identify as Black/African American; 2) age 30 years or older; 3) Identifies as Straight or Heterosexual; 4) not able to download the Us\*Now mHealth app
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Michael J Mugavero, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

References

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Sohail M, Hussen SA, Dougherty Sheff S, Mugavero M, Schneider J, Hightow-Weidman L, Turan JM, Lynam M, Elopre L. An mHealth App-Based Social Capital Intervention (PrEP US NoW) to Improve Sexual Health and Uptake of Pre-Exposure Prophylaxis Among Young, Black, Sexual Minority Men: Protocol for Intervention Development and a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 18;14:e66326. doi: 10.2196/66326.

Reference Type DERIVED
PMID: 40966683 (View on PubMed)

Other Identifiers

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R34MH128072

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-300007813

Identifier Type: -

Identifier Source: org_study_id