NCT07173816

Optimizing PrEP Uptake for African American Women in the South by Empowering Women to Make Informed HIV Prevention and Sexual Health Choices

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Georgia · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Pilot testing of EMPOWER, a group sexual health intervention, to increase uptake and persistence of PrEP

Detailed description

This study will pilot test the telehealth intervention EMPOWER (Enhancing and Motivating PrEP Options among Women through Empowerment and Resilience) by adapting an evidence-informed intervention, POWER (Progressing Our Well-Being, Emotions, and Relationships) based on mindfulness and cognitive behavioral therapy, to improve PrEP uptake and persistence by Black women in the South. Conduct a waitlist-controlled, randomized pilot trial of the 6-session group intervention using a crossover design with 80 Black women. Clinical outcomes will be the PrEP uptake and PrEP persistence measured by TDF via the dried blood spot at baseline, 3- and 6-months post-intervention. We will also assess the intervention's feasibility, acceptability, and usability. The outcomes will be compared with the usual standard of care (opt-out PrEP) at the intervention site.

Conditions

• HIV Pre-exposure Prophylaxis

Interventions

Type	Name	Description
BEHAVIORAL	EMPOWER	EMPOWER, a group-based 6 sessions telehealth behavioral intervention, will comprise sexual health goals and values elicitation, sexual health plan development, and motivational enhancement skills will be used to promote effective HIV prevention decision-making within the relationship context, incorporating the sexual values of each participant. This will allow each participant to develop a personalized, tailored sexual health plan that includes PrEP deliberation to enhance PrEP decision-making, uptake and persistence within a culturally congruent and empowering program that aims to reduce stigma around HIV and barriers to access.

Timeline

• Start date: 2026-08-01
• Primary completion: 2027-03-31
• Completion: 2027-08-31
• First posted: 2025-09-15
• Last updated: 2025-09-15

Locations

1 site across 1 country: United States