Clinical trial NCT05338996: Addressing Health Disparities in Engagement, Retention, and Utilization of PrEP Among South Florida Women of Color
Official title: Addressing Health Disparities in Engagement, Retention, and Utilization of PrEP Among South Florida Women of Color
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Prevention
PrEP Adherence
Lead sponsor: Florida International University
Sponsor class: OTHER
Collaborators: name: Care 4 U Management, Inc.
name: Care Resource Community Health Centers, Inc.
name: Monarch Health Services, Inc.
First posted: 2022-04-21
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Percentage of women
timeFrame: Baseline
measure: Monthly Change in self-reported PrEP Adherence from Baseline to 4 month follow up
timeFrame: Monthly through study completion, an average of 4 months
measure: Monthly Change in concentration of Tenofovir measured by urine biomarker
timeFrame: Monthly through study completion, an average of 4 months
measure: Concentration of Tenofovir measured by dried blood spot test
timeFrame: 4 month follow up
measure: Percentage of participants retained in PrEP Care
timeFrame: 4 month follow up from those enrolled in the study.
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Care 4 U Community Health Center
state: Florida
city: Miami
country: United States
facility: Care Resource, Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Monarch Health Services, Inc.
state: Florida
Study officials:
affiliation: Florida International Univ.
name: Jessy G Dévieux, PHD
role: PRINCIPAL_INVESTIGATOR
References: