Optimizing PrEP Utilization Among Alcohol and Other Drug (AOD) Using Women of Color
Public ClinicalTrials.gov record NCT04018651. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04018651
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 38 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 45 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 30, 2019
- Primary completion
- Aug 30, 2022
- Completion
- Aug 30, 2022
- Last update posted
- Sep 12, 2023
2019 – 2022
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Florida International University Biscayne Bay Campus | North Miami | Florida | 33181 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04018651, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 12, 2023 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04018651 live on ClinicalTrials.gov.