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Clinical Trial NCT07173816 (EMPOWER) for HIV Pre-exposure Prophylaxis is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Optimizing PrEP Uptake for African American Women in the South by Empowering Women to Make Informed HIV Prevention and Sexual Health Choices (EMPOWER) 80 Prevention

Not yet recruiting
Clinical Trial NCT07173816 (EMPOWER) is an interventional study for HIV Pre-exposure Prophylaxis and is currently not yet recruiting. Enrollment is planned to begin on August 1, 2026 and continue until the study accrues 80 participants. Led by University of Georgia, this study is expected to complete by August 31, 2027. The latest data from ClinicalTrials.gov was last updated on September 15, 2025.
Brief 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, rand...

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Official Title

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

Conditions
HIV Pre-exposure Prophylaxis
Other Study IDs
NCT ID Number
NCT07173816
Start Date (Actual)
2026-08-01
Last Update Posted
2025-09-15
Completion Date (Estimated)
2027-08-31
Enrollment (Estimated)
80
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorIntervention Arm
This arm will receive the intervention first.
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 sexu...Show More
Active ComparatorWaitlist Control
This arm will receve the intervention after the wait period
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 sexu...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
Accepts Healthy Volunteers
Yes
  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.

  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.
University of Georgia logoUniversity of Georgia
National Institute of Mental Health (NIMH) logoNational Institute of Mental Health (NIMH)
Study Responsible Party
Mohammad Rifat Haider, Principal Investigator, Assistant Professor, University of Georgia
Study Central Contact
Contact: Mohammad Rifat Haider, Ph.D., 803-477-4289, [email protected]
1 Study Locations in 1 Countries

Georgia

Empowerment Resource Center, Atlanta, Georgia, 30303, United States