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A program to support HIV prevention medicine use among women at risk of HIV

Tests a behavioral program to increase PrEP use in women at risk of HIV.

Plain-language title generated from the registry record
Registry title: SEPA+PrEP-Women Pilot Trial for HIV Prevention Among Women at Risk for HIV

Key facts

Where
Coral Gables, United StatesSee the site

Where in United States

  • University of Miami School of Nursing and Health StudiesCoral Gables, United StatesNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
University of Miami
Trial code
NCT07864766
Record updated
13 October 2026
Original description
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.Read full original descriptionShow less

Pilot Testing the Efficacy and Implementation of SEPA+PrEP-Women Intervention for Women at Risk of HIV

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.

Inclusion: Self-identify as a woman; Age 18 years or older; HIV-negative or unknown HIV status; Report vaginal or anal sex with a male partner within the past 6 months; Report at least one HIV risk factor; Not currently using PrEP; Able to provide informed consent.

Exclusion: Currently using PrEP; Does not meet the applicable inclusion criteria; Unable to provide informed consent.

ClinicalTrials.gov NCT07864766