- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04018651
Optimizing PrEP Utilization Among Alcohol and Other Drug (AOD) Using Women of Color
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A singular limitation in the fight against HIV has been the absence of practical female-controlled prevention strategies and relative dependence on cooperative use of the male condom. Since 2012, medication for pre-exposure prophylaxis or PrEP has been FDA-approved in the U.S., with guidance for its use extended to all individuals at substantial risk in 2014 by the CDC and in 2015 by the WHO. In June 2016, the American Medical Association (AMA) instituted policies in concurrence, and in July 2016 an updated National HIV/AIDS Strategy was released making PrEP one of the four pillars in the nation's effort against HIV. To date, the largest uptake and implementation has been among the MSM population, which still bears the primary burden of the epidemic in the U.S. However, women continue to face a highly disproportionate risk and significant barriers to progress due to gender and structural disparities and biological susceptibility. Many of these barriers revolve around disparities that limit agency, most pointedly in negotiation of safe sex. Yet, existing studies indicate that very few of the women at substantial risk in the U.S. have awareness of PrEP, either from community sources or their doctors. Moreover, a recent national survey showed that PrEP awareness is suboptimal among a majority of providers. Clearly, PrEP as a viable female-controlled method is a long way from being a key part of the country's HIV strategy, and will require a community-driven approach to address demand and supply, uptake and accessibility, to shift the terms of women's agency in HIV prevention. This need is greatest among women of color, particularly when the use of alcohol and other drugs (AOD) severely compounds their risk.
This U34 utilizes community-based participatory research (CBPR) to build upon a Pre-Meeting of Community Stakeholders from the greater Miami and Fort Lauderdale areas, to develop an intervention program that will promote optimal PrEP utilization among women of color in South Florida who engage in risky sex and alcohol use. What is most potent in a CBPR-based study, is community participation in defining problems and intervention components, identifying applicable theories and evidence-based interventions (EBIs), and interpreting data and outcomes. The research team is currently conducting an exploratory pilot test in Miami-Dade County in South Florida, which leads the state in new HIV infections, and has a large multiethnic distribution of Black and Latino women in its population. Florida currently ranks 1st in HIV diagnoses among all states in the U.S. 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.
The investigator's Specific Aims are:
Aim 1: Identify perceived needs, priorities, barriers, and community strengths in the implementation of HIV prevention programs, with the development of a PrEP continuum care model, by conducting a summit to engage a diverse range of HIV- and HIV+ women of color, health care providers and community stakeholders.
Aim 2: Produce a replicable implementation program, including manuals, materials, screening and assessment instruments, and procedures, through the formation of a Community Advisory and Advocacy Board (CAAB) from summit participants, who will participate in a 2-day orientation training workshop and form working groups with research team members to formulate study methods and the intervention model.
Aim 3: Conduct an exploratory pilot of the PrEP model, implemented by the CAAB, in Broward and Miami-Dade for fidelity, feasibility, and acceptability, among 120 multi-ethnic women of color in South Florida (primarily African American (AA), Latina, Haitian). PrEP uptake and adherence and retention in care will be measured over a 6 month period. Results will inform a future U01, including the design of target and comparison groups.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
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North Miami, Florida, United States, 33181
- Florida International University Biscayne Bay Campus
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PrEP Master Adherence Intervention
The intervention consists of an introductory session and 4 individual sessions led by the PrEP Master, over an 8 week period.
Between the sessions, the PrEP Master will conduct weekly check-in calls to participants to encourage adherence and assist with difficulties.
During the weekly check-in, side effects and their impact will be assessed using assessment measures.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants receiving 3 Medication Appointments
Time Frame: 3 months
|
Number of Participants who receive 3 refills of medication for PrEP
|
3 months
|
Percentage Adherence to PrEP Medication
Time Frame: 3 months
|
Percentage adherence based on Pill count of remaining prescription medication at 3 months
|
3 months
|
Self reported PrEP Adherence
Time Frame: 3 months
|
Percentage Adherence to daily PrEP medication via self report at 3 months
|
3 months
|
Number of Participants reporting Adherence to HIV testing recommendation
Time Frame: 3 months
|
Number of Participants Receiving HIV test at 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jessy G Dévieux, Ph.D., Florida International Univ.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FIU IRB 105978
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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