SEPA+PrEP-Women Pilot Trial for HIV Prevention Among Women at Risk for HIV
Public ClinicalTrials.gov record NCT07864766. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Pilot Testing the Efficacy and Implementation of SEPA+PrEP-Women Intervention for Women at Risk of HIV
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the preliminary efficacy of SEPA (SEPA (Salud/Health, Educación/Education, Prevención/Prevention, Autocuidado/Self-Care) +PrEP (Pre-Exposure Prophylaxis) -Women in a randomized pilot trial (N=70 women at risk for HIV; 35 intervention, 35 control). The primary outcome is PrEP uptake (attendance at a PrEP initiation appointment and/or receipt of a PrEP prescription, and intention to use PrEP), measured at baseline, 1-month post-intervention, and 3 months post-intervention. The control group will receive SEPA+PrEP-Women after the 3-month assessment (delayed intervention). We hypothesize that women assigned to SEPA+PrEP-Women will demonstrate higher PrEP uptake than controls, yielding initial effect size estimates to power a future definitive trial. Secondary outcomes include changes in sexual HIV risk behaviors, PrEP knowledge, and PrEP intentions.
Study identification
- NCT ID
- NCT07864766
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 70 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2026 (Estimated)
- Primary completion
- May 2027 (Estimated)
- Completion
- May 2027 (Estimated)
- Last update posted
- Oct 8, 2026
2026 – 2027
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Miami School of Nursing and Health Studies | Coral Gables | Florida | 33147 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07864766, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 8, 2026 · Synced Oct 9, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07864766 live on ClinicalTrials.gov.