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

N/ANot Yet RecruitingNCT07173816

University of Georgia80 enrolled

Overview

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

This study will pilot test the telehealth intervention EMPOWER (Enhancing and Motivating PrEP Options among Women through Empowerment and Resilience) by adapting an evidence-informed intervention, POWER (Progressing Our Well-Being, Emotions, and Relationships) based on mindfulness and cognitive behavioral therapy, to improve PrEP uptake and persistence by Black women in the South. Conduct a waitlist-controlled, randomized pilot trial of the 6-session group intervention using a crossover design with 80 Black women. Clinical outcomes will be the PrEP uptake and PrEP persistence measured by TDF via the dried blood spot at baseline, 3- and 6-months post-intervention. We will also assess the intervention's feasibility, acceptability, and usability. The outcomes will be compared with the usual standard of care (opt-out PrEP) at the intervention site.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

HIV Pre-exposure Prophylaxis

Interventions

EMPOWERBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Identification as cis-gendered Black woman; 2. Age 18 and older; 3. 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); 4. Access to a device with a screen, a web browser, and adequate internet speed (e.g., smartphone, computer) for videoconferencing; 5. Able to speak and read English; and 6. No plans to leave the Atlanta, GA area during the duration of study participation. Exclusion Criteria: 1. Cognitive or mental health condition that limits the ability to provide informed consent; 2. Self-reported use of PrEP or PEP medication in the past three months; 3. Unable to speak and read English; and 4. Currently living with HIV.

Locations (1)

Empowerment Resource Center

Atlanta, Georgia, United States

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

Central Contacts

Mohammad Rifat Haider, Ph.D.

CONTACT

803-477-4289 haider@uga.edu

Data from ClinicalTrials.gov

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