As we edge closer to the half century mark of the HIV epidemic, the disproportionate effect on women of color in the U.S. continues to be jolting. Women overall have been at a disadvantage in the 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. However, this obstacle shifted several years ago with FDA approval and CDC endorsement of oral pre-exposure prophylaxis (PrEP). Yet, the majority of U.S. women do not know that PrEP can be a female-controlled strategy or that it applies to them?and backup has not been forthcoming from providers or their communities. What is most disturbing, however, is the absence of PrEP as an accessible strategy among women of color in high impact regions of the country. This developmental U34 responds to RFA-AA-17-013, which prioritizes community based participatory research (CBPR) to develop implementation models for women that address alcohol and HIV in high impact regions and communities. The proposed study will produce an evidence- and CBPR-driven PrEP implementation intervention to enhance uptake and optimize use among women of color in South Florida, which is currently the highest impact region of the U.S. with HIV rates recently determined by the CDC to be the highest in the nation. The study builds upon the team?s experience in alcohol/HIV intervention and CBPR in South Florida and preliminary work with stakeholders from the greater Miami and Fort Lauderdale areas to develop a multi- level PrEP intervention program for African American, Latina, and Haitian women who engage in risky sex and AOD use. The study includes researchers from the Southern HIV and Alcohol Research Consortium (SHARC) and will inform the design of target and comparison groups and other features of a U01 for further study within the NIAAA CHAART Consortia. Guided by the social ecological framework, the study will: identify needs, priorities, and community strengths and develop a PrEP continuum during a summit to engage stakeholders (Aim 1); produce a replicable implementation program, including manuals, materials, instruments, and procedures, through the formation of a Community Advisory and Advocacy Board (Aim 2); and conduct an exploratory pilot among 120 multi-ethnic women of color in Broward and Miami-Dade counties to test fidelity, feasibility and acceptability and measure PrEP uptake and adherence and retention in care over a 6 month period. The study will utilize biomarkers in a subsample to compare with self-reports and pharmacy refill measures. It will be among the first to develop a PrEP intervention in the South for women of color, and is thus in line with the specific high funding priorities of the Office of AIDS Research on cross-cutting research to reduce health disparities in developing implementation approaches for bio-behavioral strategies such as PrEP.
Despite FDA approval in 2012, followed by recommendations from the CDC and WHO, the majority of women in the U.S. are not aware of oral pre-exposure prophylaxis (PrEP) as an HIV prevention strategy that applies to them. The purpose of this study is to use a Community-Based Participatory Research (CBPR) model to develop and preliminarily test an intervention program that will optimize oral PrEP utilization among women of color in South Florida, the region with the highest HIV rates in the U.S. The intervention will evaluate fidelity, feasibility and acceptability, determine patterns of PrEP uptake and adherence and retention in care, and explore the known correlates of risk such as AOD use.
