HIV Pre-exposure Prophylaxis
Conditions
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, 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
BEHAVIORALEMPOWER
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.
Sponsors
University of Georgia
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of EMPOWER Intervention | 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 |
| Acceptability of EMPOWER Intervention | 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 |
Countries
United States
Contacts
CONTACTMohammad Rifat Haider, Ph.D.
Outcome results
None listed