An interventional study of SEPA+PrEP Women in HIV Infections, sponsored by University of Miami. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by University of Miami · Not applicable, Interventional, and Prevention
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's planned enrollment of 70 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →University of Miami is the lead sponsor of 821 studies on the registry; 162 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive the the SEPA+PrEP-Women intervention, consisting of three weekly group sessions delivered via Zoom. Each session lasting approximately 2 hours.
Behavioral: SEPA+PrEP Women
Participants assigned to this arm will complete baseline, 1-month, and 3-month follow-up assessments and will not receive the SEPA+PrEP-Women intervention during the 3-month study period. After completing the 3-month follow-up assessment, participants will be offered the SEPA+PrEP-Women intervention, which consists of three weekly group sessions delivered via Zoom, with each session lasting approximately 2 hours.
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.
PreP Uptake
PrEP uptake is a binary composite endpoint defined as attendance at a PrEP initiation appointment and/or receipt of a PrEP prescription.
Time frame: 1 month post-intervention, 3 months post-intervention
Intention to Initiate PrEP
Intention to initiate PrEP will be assessed using the 3-item PrEP Intention Scale. Scores range from 1 (Very unlikely) to 5 (Very likely), with higher scores indicating a greater intention to initiate PrEP.
Time frame: Baseline, 1 month post-intervention, and 3 months post-intervention
Safe Sex Behavior Questionnaire (SSBQ) Total Score
Sexual HIV risk behaviors will be assessed using the 27-item Safe Sex Behavior Questionnaire (SSBQ), a validated self-report measure of HIV risk-reduction and safer sex behaviors. Items are scored from 1 (Never) to 5 (Always), with higher scores indicating greater engagement in safer sexual behaviors and lower sexual HIV risk.
Time frame: Baseline, 1 month post-intervention, and 3 months post-intervention.
PrEP Knowledge Scale Total score
PrEP knowledge will be measured using the 13-item PrEP Knowledge Questionnaire. Scores range from 0 to 13, with higher scores indicating greater knowledge of PrEP.
Time frame: Baseline, 1 month post-intervention, and 3 months post-intervention.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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