Optimizing PrEP Uptake for African American Women in the South by Empowering Women to Make Informed HIV Prevention and Sexual Health Choices

ConditionHIV Pre-exposure Prophylaxis

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorUniversity of Georgia

About this trial

Pilot testing of EMPOWER, a group sexual health intervention, to increase uptake and persistence of PrEP

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Identification as cis-gendered Black woman;

Age 18 and older;

Engaging in risky sexual behavior in prior 3 months (condomless vaginal or anal sex with a non-main partner, or a partner with known or suspected risk behavior such as injection drug use or HIV/STI, multiple sex partners, transactional sex);

Access to a device with a screen, a web browser, and adequate internet speed (e.g., smartphone, computer) for videoconferencing;

Disqualifiers

Cognitive or mental health condition that limits the ability to provide informed consent;

Self-reported use of PrEP or PEP medication in the past three months;

Unable to speak and read English; and

Currently living with HIV.

Trial design

Design model

Crossover

Treatments tested in this trial

EMPOWER
Behavioral
EMPOWER, a group-based 6 sessions telehealth behavioral intervention, will comprise sexual health goals and values elicitation, sexual health plan development, and motivational enhancement skills will be used to promote effective HIV prevention decision-making within the relationship context, incorporating the sexual values of each participant. This will allow each participant to develop a personalized, tailored sexual health plan that includes PrEP deliberation to enhance PrEP decision-making, uptake and persistence within a culturally congruent and empowering program that aims to reduce stigma around HIV and barriers to access.

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: Intervention ArmActive comparator 1 intervention

Group B: Waitlist ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

Feasibility of EMPOWER Intervention

Enrollment rate will be used an indicator of the feasibility of the intervention

Time frame

From enrollment to the end of data collection and analysis at 6 months

Acceptability of EMPOWER Intervention

Acceptability of the intervention based on participant satisfaction using the Client Satisfaction Questionnaire scores

Time frame

From enrollment to the end of data collection and analysis at 6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Georgia

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov

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