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

Not Applicable

• Conditions: PrEP Uptake

• Registration Number: NCT07024745
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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

Not available

Study Timeline

• Study Start: 2024-05-09
• Study First Submitted: 2025-05-22
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-09
• Last Update Submitted: 2025-06-09
• Study First Posted: 2025-06-17
• Last Update Posted: 2025-06-17
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intervention Feasibility and Acceptability	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
Change in Social Capital and Internalized Homonegativity	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 Outcome Measures

Name	Time	Method
PrEP uptake	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.
Change in sexual practices	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

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States