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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 is a NA study that has completed, run by Florida International University. The registered enrollment target is 38 participants.

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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

Interventions

  • BEHAVIORAL PrEP Master Adherence Intervention

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2019-05-31
Est. Completion 2022-08-31
Phase NA

Sponsor

Florida International University

89 total trials

What the Registry Record Tells You About NCT04018651

The ClinicalTrials.gov registry entry for NCT04018651 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Florida International University, which has 89 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which PrEP Master Adherence Intervention is the first listed.

NCT04018651 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.