Optimizing PrEP Utilization Among Alcohol and Other Drug (AOD) Using Women of Color
Condition: HIV Prevention
Study type: Interventional

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.
    

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.
    

Intervention name(s): PrEP Master Adherence Intervention
Intervention type(s): Behavioral
Intervention description(s): 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:
Importance of daily adherence;
Three week delay for full effectiveness describing PrEP like taking the birth control pill;
Condom use for other sexually transmitted infection (STI) prevention;
Pregnancy prevention plans;
Plans for follow up calls
Referral to other treatment services if necessary
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pre-Exposure Prophylaxis; PrEP