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Completed

NCT Number: NCT05338996

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.

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Key information

Conditions

HIV Prevention PrEP Adherence

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Care 4 U Community Health Center, Miami, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >=18 years of age;
  • female and identifying as female gender;
  • able to provide informed consent;
  • willing to document a negative HIV antibody test before starting PrEP;
  • 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+);
  • report history of alcohol and other drug (AOD) use in last 3 months;
  • willing to screen for medical contraindications to PrEP according to Florida Health Department guidelines;
  • currently not cognitively impaired;
  • reporting no history of bipolar disorder, psychosis, or current need for inpatient psychiatric hospitalization.

Exclusion criteria

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

Treatment and study plan

iENGAGE for PrEP

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.

Primary outcomes

  1. Percentage of women

    Time frame: Baseline

    We will measure the percentage of women who, having been invited for screening, complete the screening and enroll in the study.

  2. Monthly Change in self-reported PrEP Adherence from Baseline to 4 month follow up

    Time frame: Monthly through study completion, an average of 4 months

    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.

  3. Monthly Change in concentration of Tenofovir measured by urine biomarker

    Time frame: Monthly through study completion, an average of 4 months

    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.

  4. Concentration of Tenofovir measured by dried blood spot test

    Time frame: 4 month follow up

    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.

  5. Percentage of participants retained in PrEP Care

    Time frame: 4 month follow up from those enrolled in the study.

    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.

Sponsors and collaborators

Lead sponsor

Florida International University

Other

Collaborators

  • Care 4 U Management, Inc.
  • Care Resource Community Health Centers, Inc.
  • Monarch Health Services, Inc.

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 21, 2022
Registry last updated
Jun 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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