Strategies to uncover undiagnosed HIV infection among heterosexuals at high risk and link them to HIV care with high retention: a “seek, test, treat, and retain” study

Registered May Strategies to uncover undiagnosed HIV infection among heterosexuals at high risk and link them to HIV care with high retention: a seek, test, treat, and retain study Marya Gwadz 0 Charles M. Cleland 0 Holly Hagan 0 Samuel Jenness 2 Alexandra Kutnick 0 Noelle R. Leonard 0 Elizabeth Applegate 0 Amanda S. Ritchie 0 Angela Banfield 0 Mindy Belkin 0 Bridget Cross 0 Montserrat Del Olmo 0 Katharine Ha 0 Belkis Y. Martinez 0 Talaya McCright-Gill 0 Quentin L. Swain 0 David C. Perlman 1 Ann E. Kurth 0 the BCAP Collaborative Research Team 0 NYU College of Nursing, Center for Drug Use and HIV Research (CDUHR) , 433 First Avenue, 7th Floor, New York, NY 10010 , USA 1 Mount Sinai Beth Israel, Baron Edmond de Rothschild Chemical Dependency Institute , 120 Water Street, Floor 24, New York, NY 10038 , USA 2 Department of Epidemiology, University of Washington , Box 357236, Seattle, WA 98195 , USA Background: Over 50,000 individuals become infected with HIV annually in the U.S., and over a quarter of HIV infected individuals are heterosexuals. Undiagnosed HIV infection, as well as a lack of retention in care among those diagnosed, are both primary factors contributing to ongoing HIV incidence. Further, there are racial/ethnic disparities in undiagnosed HIV and engagement in care, with African Americans/Blacks and Latinos remaining undiagnosed longer and less engaged in care than Whites, signaling the need for culturally targeted intervention approaches to seek and test those with undiagnosed HIV infection, and link them to care with high retention. Methods/Design: The study has two components: one to seek out and test heterosexuals at high risk for HIV infection, and another to link those found infected to HIV care with high retention. We will recruit sexually active African American/Black and Latino adults who have opposite sex partners, negative or unknown HIV status, and reside in locations with high poverty and HIV prevalence. The Seek and Test component will compare the efficacy and cost effectiveness of two strategies to uncover undiagnosed HIV infection: venue-based sampling and respondent-driven sampling (RDS). Among those recruited by RDS and found to have HIV infection, a Treat and Retain component will assess the efficacy of a peer-driven intervention compared to a control arm with respect to time to an HIV care appointment and health indicators using a cluster randomized controlled trial design to minimize contamination. RDS initial seeds will be randomly assigned to the intervention or control arm at a 1:1 ratio and all recruits will be assigned to the same arm as the recruiter. Participants will be followed for 12 months with outcomes assessed using medical records and biomarkers, such as HIV viral load. Discussion: Heterosexuals do not test for HIV as frequently as and are diagnosed later than other risk groups. The study has the potential to contribute an efficient, innovative, and sustainable multi-level recruitment approach and intervention to the HIV prevention portfolio. Because the majority of heterosexuals at high risk are African American/ Black or Latino, the study has great potential to reduce racial/ethnic disparities in HIV/AIDS. Protocol; Health status disparities; HIV; Undiagnosed HIV; Engagement in care; Venue-based sampling; Respondent-driven sampling; Peer-driven intervention; African American; Latino - Background Despite advances in antiretroviral treatment, prevention strategies, and HIV diagnostic testing technologies, HIV disease incidence in the United States has remained steady, with over 50,000 individuals becoming infected annually [1]. Undiagnosed HIV infection is a major driver of these incident infections, although only 18 % of infected persons nationally are unaware of their HIV status [24]. In fact, 44 to 66 % of new HIV infections are attributed to this modest proportion of individuals with undiagnosed HIV [3, 5]. Moreover, there are serious racial/ethnic disparities in undiagnosed HIV, with African Americans/Blacks and Latinos remaining undiagnosed longer than Whites [6]. Further, undiagnosed HIV is more common in males compared to females, and among heterosexual males compared to men who have sex with men (MSM) [6]. (Acronyms used in this protocol description are defined in Table 1.) In 2010, the National Institute on Drug Abuse (NIDA) at the National Institutes of Health called for research on new approaches to seek out persons with undiagnosed HIV, provide them with counseling and testing, and link those found to be HIV infected into medical care, with high retention, which are referred to as Seek, Test, Treat, and Retain (STTR) studies. This paper summarizes the study protocol for our STTR study funded under this initiative, which is being conducted in the borough of Brooklyn in New York City, called the Brooklyn Community Action Project (BCAP). High-risk heterosexuals in the U.S The National HIV Behavioral Surveillance (NHBS) system estimates the prevalence of HIV infection in three highTable 1 Acronyms used Audio Computer-Assisted Interviewing format Brooklyn Community Action Project Centers for Disease Control and Prevention Heterosexuals at high risk (for HIV) Men who have sex with men National HIV Behavioral Surveillance Persons who inject drugs Seek, Test, Treat and Retain risk populations on a rotating basis in 20 Metropolitan Statistical Areas across the U.S.: heterosexuals at high risk (HHR), men who have sex with men (MSM), and persons who inject drugs (PWID). The NHBS studies use two main sampling frames across study locations, as determined by the CDC: venue-based sampling (VBS), generally used for the MSM studies, and respondent-driven sampling (RDS), used to enroll PWID and HHR [7]. However, VBS and RDS have never been directly compared in the same Metropolitan Statistical Area in terms of recruiting populations who may benefit from STTR interventions. Nationally, over 25 % of incident HIV infections have been attributed to heterosexual activity [8]. In 2010, the national NHBS with HHR found an estimated HIV prevalence of 2.3 % [8]. The NHBS study design for HHR targets adults who are sexually active with opposite sex partners and who are socially and geographically connected to areas with high HIV prevalence, which also happen to be high-poverty areas, in which African American/Black and Latino persons are the predominant race/ethnicity [9, 10]. Indeed, the HIV disease burden in these communities is much higher in these geographical areas than across the U.S. generally, where the overall HIV prevalence is estimated at 0.6 % [11]. Locally, in the 2006 New York City NHBS study of HHR, for which detailed data have been published, HIV prevalence was 8.6 %, with an estimated HIV incidence in this population of 3.31 % per year and 2.59 % per year among those with no history of drug injection or male-to-male sex [12]. Further, Brooklyn had the highest HIV prevalence and the highest rates of risk factors (...truncated)