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

NCT07173816 | Not Yet Recruiting DMC

• 1 other identifier: R34MH137775
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HIV Pre-exposure Prophylaxis

Outcome Measures

Primary Outcomes (2)

• Feasibility of EMPOWER Intervention

  Enrollment rate will be used an indicator of the feasibility of the intervention

  From enrollment to the end of data collection and analysis at 6 months

• Acceptability of EMPOWER Intervention

  Acceptability of the intervention based on participant satisfaction using the Client Satisfaction Questionnaire scores

  From enrollment to the end of data collection and analysis at 6 months

Study Arms (2)

Intervention Arm

ACTIVE COMPARATOR

This arm will receive the intervention first.

Behavioral: EMPOWER

Waitlist Control

ACTIVE COMPARATOR

This arm will receve the intervention after the wait period

Behavioral: EMPOWER

Interventions

EMPOWER BEHAVIORAL

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.

Intervention Arm; Waitlist Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cisgender women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Identification as cis-gendered Black woman;
• Age 18 and older;
• 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);
• Access to a device with a screen, a web browser, and adequate internet speed (e.g., smartphone, computer) for videoconferencing;
• Able to speak and read English; and
• No plans to leave the Atlanta, GA area during the duration of study participation.

You may not qualify if:

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

Sponsors & Collaborators

• University of Georgia: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Empowerment Resource Center

Atlanta, Georgia, 30303, United States

Location

Central Study Contacts

Mohammad Rifat Haider, Ph.D.

CONTACT

803-477-4289; haider@uga.edu

Study Design

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

Model Details: Investigators will recruit 80 Black women from HIV testing sites who have engaged in HIV risk behavior in the prior three months and randomly assign them to either the EMPOWER intervention condition (n=40) or a standard of care control condition (n=40). Standard of care includes provision of opt-out PrEP. Both conditions will receive EMPOWER. However, the standard of care control condition will receive the intervention after the 3-month follow-up assessment. The active intervention period will last 9 weeks (5 weekly sessions and a booster session after 4 weeks).

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 15, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)