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

Completed · Not applicable

Conditions studied: HIV Prevention

In brief

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.

Key facts

Study ID

NCT04018651

Run by

Florida International University

People needed

38

Starts

2019-05-31

Expected to finish

2022-08-31

Last updated by the study team

2023-09-13

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 18 + years of age;
• born female;
• Identifies as female;
• Identifies as African American, Hispanic/Latina or Haitian (self or parent);
• Able to provide informed consent;
• HIV uninfected;
• Sexual risk (previous STI, inconsistent condom use, transactional sex, HIV infected partner);
• History of alcohol or drug use in last 3 months;
• No uncleared PrEP contraindications;
• No psychosis.

You may not qualify if…

• Less than 18 years of age
• male gender assignment at birth
• current male gender identity
• does not identify as African American, Haitian or Hispanic/Latina (self or parent)
• reports history of or current untreated psychosis
• unable to provide informed consent
• HIV infected
• Refuses PrEP medication
• Untreated medical contraindication for PrEP

Where it is running

• Florida International University Biscayne Bay Campus — North Miami, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.