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

NCT ID: NCT05338996

Last Updated: 2023-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2023-05-31

Brief Summary

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.

Detailed 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.

Conditions

HIV Prevention; PrEP Adherence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

iENGAGE for PrEP

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.

Group Type: EXPERIMENTAL

iENGAGE for PrEP

Intervention Type: BEHAVIORAL

This intervention originally developed for people living with HIV (PLWH), is designed to promote engagement, retention, and adherence to treatment by addressing the social determinants of health that often act as barrier to remaining in care and achieving viral suppression. Based on our experience with this intervention we believe that it is well suited to similarly promote engagement, retention, and utilization of PrEP care among our proposed target population of WOC by a) removing barriers to care and b) addressing unmet needs by providing c) point-to-point linkage to care services delivered by multi-disciplinary teams of individuals within or outside of the health facility, and d) the use of telehealth visits to facilitate engagement in care and improve health visit attendance. The original iENGAGE is a 4-session, in-clinic behavioral intervention.

Interventions

iENGAGE for PrEP

This intervention originally developed for people living with HIV (PLWH), is designed to promote engagement, retention, and adherence to treatment by addressing the social determinants of health that often act as barrier to remaining in care and achieving viral suppression. Based on our experience with this intervention we believe that it is well suited to similarly promote engagement, retention, and utilization of PrEP care among our proposed target population of WOC by a) removing barriers to care and b) addressing unmet needs by providing c) point-to-point linkage to care services delivered by multi-disciplinary teams of individuals within or outside of the health facility, and d) the use of telehealth visits to facilitate engagement in care and improve health visit attendance. The original iENGAGE is a 4-session, in-clinic behavioral intervention.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Care 4 U Management, Inc.

UNKNOWN

Sponsor Role: collaborator

Care Resource Community Health Centers, Inc.

UNKNOWN

Sponsor Role: collaborator

Monarch Health Services, Inc.

UNKNOWN

Sponsor Role: collaborator

Florida International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessy G Dévieux, PHD

Role: PRINCIPAL_INVESTIGATOR

Florida International Univ.

Locations

Care 4 U Community Health Center

Miami, Florida, United States

Care Resource, Inc.

Miami, Florida, United States

Monarch Health Services, Inc.

West Palm Beach, Florida, United States

Countries

United States

Other Identifiers

IRB-21-0499

Identifier Type: -

Identifier Source: org_study_id