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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04018651
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Information provided by (Responsible Party):
jessy g devieux, Florida International University

Brief 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 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.

Condition or disease Intervention/treatment Phase
HIV Prevention Behavioral: PrEP Master Adherence Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Optimizing PrEP Utilization Among Alcohol and Other Drug (AOD) Using Women of Color
Actual Study Start Date : May 31, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.
Behavioral: PrEP Master Adherence Intervention

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:

  1. Importance of daily adherence;
  2. Three week delay for full effectiveness describing PrEP like taking the birth control pill;
  3. Condom use for other sexually transmitted infection (STI) prevention;
  4. Pregnancy prevention plans;
  5. Plans for follow up calls
  6. Referral to other treatment services if necessary

Primary Outcome Measures :
  1. Number of Participants receiving 3 Medication Appointments [ Time Frame: 3 months ]
    Number of Participants who receive 3 refills of medication for PrEP

  2. Percentage Adherence to PrEP Medication [ Time Frame: 3 months ]
    Percentage adherence based on Pill count of remaining prescription medication at 3 months

  3. Self reported PrEP Adherence [ Time Frame: 3 months ]
    Percentage Adherence to daily PrEP medication via self report at 3 months

  4. Number of Participants reporting Adherence to HIV testing recommendation [ Time Frame: 3 months ]
    Number of Participants Receiving HIV test at 3 months

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female gender identity
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04018651

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Contact: Michele Jean-Gilles, Ph.D. 3059194207

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United States, Florida
Florida International University Biscayne Bay Campus Recruiting
North Miami, Florida, United States, 33181
Contact: Amanda Ichite, MPH         
Sponsors and Collaborators
Florida International University

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Responsible Party: jessy g devieux, Principal Investigator, Florida International University Identifier: NCT04018651     History of Changes
Other Study ID Numbers: FIU IRB 105978
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by jessy g devieux, Florida International University:
Pre-Exposure Prophylaxis