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

University of Miami

Summary

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

Age range: 18+ years
Sex: Female
Healthy volunteers: Yes

Detailed criteria

Inclusion Criteria: * 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 Criteria: * Does not meet the applicable inclusion criteria * Currently using PrEP * Unable to provide informed consent

Interventions

Behavioral
SEPA+PrEP Women
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.

Location

University of Miami School of Nursing and Health Studies
Coral Gables, Florida

Summary

Eligibility

Age range

18+ years

Sex

Female

Healthy volunteers

Yes

Detailed criteria

Interventions

Behavioral

SEPA+PrEP Women

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.