Empowerment Resource Center
Atlanta, Georgia, 30303, United States
NCT Number: NCT07173816
Pilot testing of EMPOWER, a group sexual health intervention, to increase uptake and persistence of PrEP
Trial opening soon.
Get Notified18 year and older
Female
Interventional
Not applicable
Atlanta, Georgia, 30303, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
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
Contact information is provided by the study sponsor or research team.
University of Georgia
Other
Acronym: EMPOWER
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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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