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NCT04018651 · ClinicalTrials.gov registry record · NA
Optimizing PrEP Utilization Among Alcohol and Other Drug (AOD) Using Women of Color
A NA study, sponsored by Florida International University.
- Completed
- Registry status
- NA
- Development phase
- 38
- Enrollment target
NCT04018651: Completed NA study, sponsored by Florida International University.
NCT04018651 is a NA study that has completed, run by Florida International University. The registered enrollment target is 38 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04018651, a NA study, has completed, sponsored by Florida International University.
- COMPLETED
- Registry status
- NA
- Development phase
- 38 participants
- Enrollment target
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 i
Primary Outcome
Number of Participants who receive 3 refills of medication for PrEP
Interventions
- BEHAVIORAL PrEP Master Adherence Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2019-05-31 |
| Est. Completion | 2022-08-31 |
| Phase | NA |
What the finished NCT04018651 record still lists
NCT04018651 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which PrEP Master Adherence Intervention is the first listed.
NCT04018651 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04018651 about?
NCT04018651 is a clinical study titled "Optimizing PrEP Utilization Among Alcohol and Other Drug (AOD) Using Women of Color". 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 inc...
What is the current status of trial NCT04018651?
This trial is currently completed. It is a NA study. The enrollment target is 38 participants. The study started on 2019-05-31. Estimated completion is 2022-08-31.
What interventions are being tested in trial NCT04018651?
The interventions under investigation include: PrEP Master Adherence Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT04018651?
This trial is sponsored by Florida International University, which has 89 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04018651's enrollment target sits among peer trials
38 1538th of 2000 higher than 461 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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