Using PrEP, Doing It for Ourselves

Not Applicable

Not yet recruiting

• Conditions: HIV Prevention; PrEP

• Registration Number: NCT06638892
• Lead Sponsor: Duke University

Brief Summary

The aim of this study is to test the effectiveness of the Using PrEP, Doing it for Ourselves (UPDOs) intervention is to improve pre-exposure prophylaxis (PrEP) uptake for Black women using the Motivational PrEP Cascade framework within a community engaged cluster-randomized controlled trial of intervention and control salon clusters. It is expected that compared to control, women in the UPDOs intervention will have higher PrEP uptake. Additionally, this study aims to examine the barriers and facilitators underlining PrEP decision-making among a subsample of Black women in both intervention and control groups using quantitative surveys and qualitative individual interviews. Lastly, the study aims to understand the facilitators influencing implementation of UPDOs for future scalability using quantitative surveys and qualitative interviews grounded in the CFIR (Consolidated Framework for Implementation Research) framework.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-09
• Study First Submitted QC: 2024-10-09
• Study First Posted: 2024-10-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-03
• Study Start: 2025-09
• Primary Completion: 2029-06
• Study Completion: 2030-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

• Black
• Cisgender female
• Ages 18+

Exclusion Criteria

• Under 18 years of age
• Does not identify as Black
• Not a cisgender female

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pre-exposure prophylaxis (PrEP) Contemplation Ladder total score	12, 24, 32, and 52 weeks post-intervention	The PrEP Contemplation Ladder is a 1-item survey designed to measure Motivational PrEP Cascade (MPC) stages of behavior change that represent one's PrEP intentions by a score of 1-10. Scores correspond to MPC stages. Lower numbers indicate PrEP is not being used to prevent HIV and the participant is not really thinking of ever starting to use PrEP. Higher numbers indicate that PrEP is being used daily and the participant is returning for provider checkups and HIV/STI testing every 3 months, as recommended.

Secondary Outcome Measures

Name	Time	Method
Change in pre-exposure prophylaxis (PrEP) Contemplation Ladder total score - 12 to 24 weeks	12 to 24 weeks post-intervention	The PrEP Contemplation Ladder is a 1-item survey designed to measure Motivational PrEP Cascade (MPC) stages of behavior change that represent one's PrEP intentions by a score of 1-10. Scores correspond to MPC stages. Lower numbers indicate PrEP is not being used to prevent HIV and the participant is not really thinking of ever starting to use PrEP. Higher numbers indicate that PrEP is being used daily and the participant is returning for provider checkups and HIV/STI testing every 3 months, as recommended.
Change in pre-exposure prophylaxis (PrEP) Contemplation Ladder total score - 24 to 32 weeks	24 to 32 weeks post-intervention	The PrEP Contemplation Ladder is a 1-item survey designed to measure Motivational PrEP Cascade (MPC) stages of behavior change that represent one's PrEP intentions by a score of 1-10. Scores correspond to MPC stages. Lower numbers indicate PrEP is not being used to prevent HIV and the participant is not really thinking of ever starting to use PrEP. Higher numbers indicate that PrEP is being used daily and the participant is returning for provider checkups and HIV/STI testing every 3 months, as recommended.
Change in pre-exposure prophylaxis (PrEP) Contemplation Ladder total score - 32 to 52 weeks	32 to 52 weeks post-intervention	The PrEP Contemplation Ladder is a 1-item survey designed to measure Motivational PrEP Cascade (MPC) stages of behavior change that represent one's PrEP intentions by a score of 1-10. Scores correspond to MPC stages. Lower numbers indicate PrEP is not being used to prevent HIV and the participant is not really thinking of ever starting to use PrEP. Higher numbers indicate that PrEP is being used daily and the participant is returning for provider checkups and HIV/STI testing every 3 months, as recommended.