SEPA+PrEP-Women Pilot Trial for HIV Prevention Among Women at Risk for HIV
ConditionHIV Infections
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Miami
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Does not meet the applicable inclusion criteria
Currently using PrEP
Unable to provide informed consent
Trial design
Design model
Parallel
Treatments tested in this trial
SEPA+PrEP Women
BehavioralParticipants 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: SEPA+PrEP-Women InterventionExperimental treatment 1 intervention
Group B: Delayed SEPA+PrEP-Women Intervention (Wait-List Control)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
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-intervention2
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-interventionSecondary outcomes
1
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.2
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.Sponsors and contacts
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Source ClinicalTrials.gov
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