Addressing Health Disparities in Engagement, Retention, and Utilization of PrEP Among South Florida Women of Color

Florida International University (FIU)

Status: Completed

Conditions: PrEP Adherence; HIV Prevention

Treatments: Behavioral: iENGAGE for PrEP

Study type: Interventional

Funder types: Other

Identifiers

NCT05338996

IRB-21-0499

Details and patient eligibility

About

Women of color (WOC) in South Florida, the region with the highest HIV rates in the U.S., experience significant barriers to accessibility, uptake, and utilization of Pre-exposure prophylaxis (PrEP) for HIV prevention, despite FDA approval since 2012. The purpose of this study is to use a Community-Based Participatory Research (CBPR) approach to finalize, and pilot-test a multi-component evidence-based intervention to reduce health disparities in engagement, utilization, and retention in PrEP care, with the goal of improving HIV prevention outcomes for the target population of WOC in S. Florida, primarily African American, Latina, and Haitian women in 3 designated Ending the HIV Epidemic (EHE) counties: Miami-Dade, Broward, and Palm Beach counties.

Full description

The purpose of this study is to use a Community-Based Participatory Research (CBPR) approach to finalize, and pilot-test a multi-component evidence-based intervention to reduce health disparities in engagement, utilization, and retention in PrEP care, with the goal of improving HIV prevention outcomes for the target population of WOC in S. Florida. We will conduct an exploratory pilot of the PrEP intervention, using a quasi-experimental design, among 80 multi-ethnic WOC in Miami-Dade, Broward, and Palm Beach counties to evaluate feasibility, acceptability, and fidelity. PrEP uptake, adherence, and retention in care will be measured over a 4-month period, including biomarkers of adherence. Adult women initiating or returning to PrEP services at our collaborating sites will be recruited, consented, enrolled and complete baseline assessments. They will participate in an adapted Integrating ENGagement and Adherence Upon Entry (iENGAGE) intervention to address social determinants of health barriers to maintaining PrEP care.

Enrollment: 72 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. >=18 years of age;
2. female and identifying as female gender;
3. able to provide informed consent;
4. willing to document a negative HIV antibody test before starting PrEP;
5. reporting recent sexual risk (e.g., sex without condoms in last 3 months, sexually transmitted infection (STI) diagnosis in the last 6 months, post-exposure prophylaxis (PEP) use in the last 12 months, transactional sex, partners who are HIV+);
6. report history of alcohol and other drug (AOD) use in last 3 months;
7. willing to screen for medical contraindications to PrEP according to Florida Health Department guidelines;
8. currently not cognitively impaired;
9. reporting no history of bipolar disorder, psychosis, or current need for inpatient psychiatric hospitalization.

Exclusion criteria

1. Less than 18 years of age;
2. not female at birth
3. unable to provide informed consent;
4. unwilling to document a negative HIV antibody test before starting PrEP;
5. unwilling to screen for medical contraindications to PrEP according to Florida Health Department guidelines;
6. currently cognitively impaired;
7. reporting recent history of bipolar disorder, psychosis, or inpatient psychiatric hospitalization

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 1 patient group

iENGAGE for PrEP

Experimental group

Description:

We will conduct an exploratory pilot of the PrEP intervention, using a quasi-experimental design, among 80 multi-ethnic WOC in Miami-Dade, Broward, and Palm Beach counties to evaluate feasibility, acceptability, and fidelity. PrEP uptake, adherence, and retention in care will be measured over a 4-month period, including biomarkers of adherence.

Treatment:

Behavioral: iENGAGE for PrEP