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

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.

Study Overview

• Status: Completed
• Conditions: HIV Prevention; PrEP Adherence
• Intervention / Treatment: Behavioral: iENGAGE for PrEP

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michele Jean-Gilles, PHD; Phone Number: 3052189065; Email: gillesm@fiu.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33137
      • Care Resource, Inc.
    • Miami, Florida, United States, 33127
      • Care 4 U Community Health Center
    • West Palm Beach, Florida, United States, 33407
      • Monarch Health Services, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of women	We will measure the percentage of women who, having been invited for screening, complete the screening and enroll in the study.	Baseline
Monthly Change in self-reported PrEP Adherence from Baseline to 4 month follow up	In measuring adherence, we will use a self-report questionnaire to assess the of number of missed doses in the last 7 days assessed at baseline, at each monthly intervention session and at the 4 month follow-up.	Monthly through study completion, an average of 4 months
Monthly Change in concentration of Tenofovir measured by urine biomarker	In measuring adherence, we will also use point of care urine testing to evaluate short-term Tenofovir concentration (for those prescribed Tenofovir) at each monthly visit to compare with self-report data.	Monthly through study completion, an average of 4 months
Concentration of Tenofovir measured by dried blood spot test	In measuring adherence, we will also use dried blood spot testing for longer-term Tenofovir levels (for those prescribed Tenofovir) at the 4-month follow up assessment.	4 month follow up
Percentage of participants retained in PrEP Care	Retention in PrEP Care will be considered the percentage of women who complete the 4-month follow up assessment from those who enrolled in the study.	4 month follow up from those enrolled in the study.

Collaborators and Investigators

• Sponsor: Florida International University
• Collaborators: Care 4 U Management, Inc.; Care Resource Community Health Centers, Inc.; Monarch Health Services, Inc.
• Investigators: Principal Investigator: Jessy G Dévieux, PHD, Florida International Univ.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: April 20, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IRB-21-0499

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In accordance with NIH guidelines, a data set will be created that cab be obtained by other investigators that does not include participants' identifying information. Investigators whose proposed use of the data has been approved by their institution's IRB will be allowed to request the dataset.
• IPD Sharing Time Frame: When the primary data analysis of the study is finished.
• IPD Sharing Access Criteria: Institutional Review Board (IRB) approval; commitment to using data only for research purposes; commitment to securing the data using appropriate computer technology; commitment to destroying or returning the data when analyses are completed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No