Optimizing PrEP Uptake for African American Women in the South by Empowering Women to Make Informed HIV Prevention and Sexual Health Choices
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EMPOWER.
- Who it may be relevant to
- Registry conditions: HIV Pre-exposure Prophylaxis. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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,
Primary outcome measures
- Feasibility of EMPOWER Intervention [Time frame: From enrollment to the end of data collection and analysis at 6 months]
- Acceptability of EMPOWER Intervention [Time frame: From enrollment to the end of data collection and analysis at 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Empowerment Resource Center — Atlanta
Identifiers
NCT: NCT07173816 · R34MH137775 · R34MH137775