Optimizing PrEP Utilization Among Alcohol and Other Drug (AOD) Using Women of Color

NCT04018651 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2023-09-13

No results posted yet for this study

Summary

Nationally, the HIV case rate among black/ African American (AA) women is nearly 20 times higher than in white women; for Hispanic/Latino women it is 4.5 times higher. Moreover, according to findings in the HIV Prevention Trials Network (HPTN) Study 064 (The Women's HIV SeroIncidence Study), HIV incidence among women who live in communities with high HIV prevalence and poverty is about 6 times higher than for black/AA women. South Florida's new HIV diagnoses are now triple the national average due to rates in Miami-Dade and Broward counties in its AA, Latino and Haitian communities. Black women follow black men who have sex with men (MSM) as the most crisis-ridden of the communities in South Florida, the state as a whole, the South, and the U.S. Women overall have been at a disadvantage in the HIV epidemic due to gender differences and norms that shape biological, social and economic vulnerability. Racial and ethnic disparities magnify the risk. Co-factors such as alcohol and other drug (AOD) use intersect and reinforce other comorbidities. Living in a high prevalence area significantly hardens the risk and makes it tougher to overcome. Options to help women stay HIV negative have been limited, and the absence of practical female-controlled prevention strategies and relative dependence on cooperative use of the male condom continue to keep women's HIV vulnerability high. This obstacle shifted several years ago with FDA approval and Centers for Disease Control and Prevention's (CDC) endorsement of oral pre-exposure prophylaxis (PrEP). However, women do not know about PrEP. Despite FDA approval in 2012, followed by expansions in recommended use from the CDC and World Health Organization (WHO), the majority of women in the U.S. are not aware of oral PrEP as an HIV prevention strategy that applies to them. This study utilizes community-based participatory research (CBPR) to develop an intervention program that will promote optimal PrEP utilization among women of color in South Florida. The overall goal is to determine how best to target and improve PrEP utilization among women of color with substantial risks for HIV, including alcohol use.

Conditions

  • HIV Prevention

Interventions

BEHAVIORAL

PrEP Master Adherence Intervention

The PrEP Master Adherence Intervention consists of 4 face to face individual education sessions and a series of telephone contacts to identify barriers and facilitators to optimal PrEP adherence over a six-month period. Each PrEP Master education session includes a review of an individualized plan to reduce risk, review of information about PrEP, and different discussion points. Key messages include: 1. Importance of daily adherence; 2. Three week delay for full effectiveness describing PrEP like taking the birth control pill; 3. Condom use for other sexually transmitted infection (STI) prevention; 4. Pregnancy prevention plans; 5. Plans for follow up calls 6. Referral to other treatment services if necessary

Sponsors & Collaborators

  • Florida International University

    lead OTHER

Principal Investigators

  • Jessy G Dévieux, Ph.D. · Florida International Univ.

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-31
Primary Completion
2022-08-31
Completion
2022-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04018651 on ClinicalTrials.gov