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NCT Number: NCT07173816

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

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Empowerment Resource Center

Atlanta, Georgia, 30303, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of EMPOWER Intervention

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

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

  2. Acceptability of EMPOWER Intervention

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammad Rifat Haider, Ph.D.

CONTACT

[email protected]

803-477-4289

Sponsors and collaborators

Lead sponsor

University of Georgia

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Acronym: EMPOWER

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 15, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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