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SEPA+PrEP-Women Pilot Trial for HIV Prevention Among Women at Risk for HIV
Sponsor: University of Miami
Summary
The purpose of this randomized pilot trial is to evaluate the preliminary efficacy of SEPA+PrEP-Women (Salud/Health, Educación/Education, Prevención/Prevention, Autocuidado/Self-Care plus Pre-Exposure Prophylaxis \[PrEP\]). The study will assess whether women assigned to SEPA+PrEP-Women demonstrate higher PrEP uptake than controls and will generate initial effect size estimates to inform a future definitive trial.
Official title: Pilot Testing the Efficacy and Implementation of SEPA+PrEP-Women Intervention for Women at Risk of HIV
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2026-11
Completion Date
2027-05
Last Updated
2026-10-13
Healthy Volunteers
Yes
Conditions
Interventions
SEPA+PrEP Women
Participants will receive the SEPA+PrEP-Women intervention, consisting of three weekly group sessions delivered via Zoom. The intervention focuses on HIV testing, PrEP awareness, PrEP decision-making, partner communication, HIV risk perception, stigma, relationship dynamics, intimate partner violence and safety considerations, substance use, and navigation of healthcare and community resources. Sessions include facilitated discussion, skills-building activities, role-play, interactive exercises, and peer support.
Locations (1)
University of Miami School of Nursing and Health Studies
Coral Gables, Florida, United States