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OpenTrials
Completed

NCT Number: NCT07024745

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

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.

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Key information

Conditions

PrEP Uptake

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35222, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention Group

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 (Standard treatment)

Behavioral

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

Primary outcomes

  1. Intervention Feasibility and Acceptability

    Time frame: 6 months

    Participants will complete the Feasibility of Intervention Measure (FIM), Acceptability of Intervention Measure (AIM), and Intervention Appropriateness Measure (IAM) at T1 (1 month post Intervention) and T3 (3 month after T1) surveys. All measures are 4 questions, scaled responses from Completely Disagree to Completely Agree

  2. Change in Social Capital and Internalized Homonegativity

    Time frame: 6 months

    Participants will complete the Personal Social Capital Scale and Internalized Homophobia Scale at T0 (baseline), T1 (1 month after Intervention), and T3 (3 months after T1) surveys. The Personal Social Capital Scale a 10 question measure, responses range from 1 (all/Alot) to 5 (None). The Internalized Homophobia Scale is a 12 question measure with True, False, and Don't Know responses.

Secondary outcomes

  1. PrEP uptake

    Time frame: 6 months

    Participants will be asked if they are on PrEP at T0 (baseline), T1 (1 month after Intervention), and T3 (3 months after T1) surveys.

  2. Change in sexual practices

    Time frame: 6 months

    Participants will be asked a Sexual Behavior Assessment at T0 (baseline), T1 (1 month after Intervention), and T3 (3 months after T1) surveys. This is a 4 question measure asking if they have had sex in past 3 months, and if it was condomless sex

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 17, 2025
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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