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

NCT07024745 | Completed

• 2 other identifiers: IRB-300007813R34MH128072
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

PrEP Uptake

Outcome Measures

Primary Outcomes (2)

• Intervention Feasibility and Acceptability

  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

  6 months

• Change in Social Capital and Internalized Homonegativity

  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.

  6 months

Secondary Outcomes (2)

• PrEP uptake

  6 months

• Change in sexual practices

  6 months

Study Arms (3)

Female Facilitator

OTHER

Behavioral: Intervention Group

Control Participants

OTHER

Behavioral: Control (Standard treatment)

Intervention Participants

OTHER

Behavioral: Intervention Group

Interventions

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.

Female Facilitator; Intervention Participants

Control (Standard treatment) BEHAVIORAL

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

Control Participants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35222, United States

Location

Related Publications (1)

• 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.

  PMID: 40966683 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: June 17, 2025
• Study Start: May 9, 2024
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

US (1)