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

University of Georgia (UGA)

Status: Begins enrollment in 5 months

Conditions: HIV Pre-exposure Prophylaxis

Treatments: Behavioral: EMPOWER

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07173816

R34MH137775 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Identification as cis-gendered Black woman;
2. Age 18 and older;
3. Engaging in risky sexual behavior in prior 3 months (condomless vaginal or anal sex with a non-main partner, or a partner with known or suspected risk behavior such as injection drug use or HIV/STI, multiple sex partners, transactional sex);
4. Access to a device with a screen, a web browser, and adequate internet speed (e.g., smartphone, computer) for videoconferencing;
5. Able to speak and read English; and
6. No plans to leave the Atlanta, GA area during the duration of study participation.

Exclusion criteria

1. Cognitive or mental health condition that limits the ability to provide informed consent;
2. Self-reported use of PrEP or PEP medication in the past three months;
3. Unable to speak and read English; and
4. Currently living with HIV.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Intervention Arm

Active Comparator group

Description:

This arm will receive the intervention first.

Treatment:

Behavioral: EMPOWER

Waitlist Control

Active Comparator group

Description:

This arm will receve the intervention after the wait period

Treatment:

Behavioral: EMPOWER