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NCT07864766Not yet recruiting

SEPA+PrEP-Women Pilot Trial for HIV Prevention Among Women at Risk for HIV

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

Source: ClinicalTrials.gov · Last updated 13 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
70 (estimated)
First submitted
2 Oct 2026
Start date
Nov 2026
Primary completion date
May 2027
Lead sponsor
University of Miami
Diseases
HIV
NCT number
NCT07864766

What you commit to

  • Study type: Interventional
  • Planned participants: 70
  • From Nov 2026 to the primary completion date, May 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Currently using PrEP

Other

  • Does not meet the applicable inclusion criteria
  • Unable to provide informed consent

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Miami School of Nursing and Health Studies
Coordinator of this site? Confirm its status
Coral GablesUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.