Abstract
BackgroundAn estimated 14 % of the 1.2 million individuals living with HIV in the U.S. are unaware of their status. Yet this modest proportion of individuals with undiagnosed HIV is linked to 44–66 % of all new infections. Thus innovative intervention approaches are needed to seek out and test those with undiagnosed HIV, and link them to HIV treatment with high retention, an approach referred to as “Seek, Test, Treat, and Retain” (STTR). The present protocol describes a creative “hybrid” STTR approach that uses anonymous HIV testing followed by confidential care linkage, focused on heterosexuals at high risk (HHR) for HIV, who do not test as frequently as, and are diagnosed later, than other risk groups.Methods/DesignThis is a single-arm exploratory intervention efficacy trial. The study has two phases: one to seek out and test HHR, and another to link those found infected to HIV treatment in a timely fashion, with high retention. We will recruit African American/Black and Latino adult HHR who reside in urban locations with high poverty and HIV prevalence. Participants will be recruited with respondent-driven sampling, a peer recruitment method. The “Seek and Test” phase is comprised of a brief, convenient, single-session, anonymous HIV counseling and testing session. The “Treat and Retain” component will engage those newly diagnosed with HIV into a confidential research phase and use a set of procedures called care navigation to link them to HIV primary care. Participants will be followed for 6 months with objective assessment of outcomes (using medical records and biomarkers).DiscussionUndiagnosed HIV infection is a major public health problem. While anonymous HIV testing is an important part of the HIV testing portfolio, it does not typically include linkage to care. The present study has potential to produce an innovative, brief, cost-effective, and replicable STTR intervention, and thereby reduce racial/ethnic disparities in HIV/AIDS.Trial RegistrationClinicalTrials.gov, NCT02421159, Registered April 15, 2015.
Highlights
An estimated 14 % of the 1.2 million individuals living with HIV in the U.S are unaware of their status
African Americans/Black and Latinos remain undiagnosed longer than Whites [2] and undiagnosed HIV is more common in males compared to females, and among heterosexual males compared to men who have sex with men (MSM) [2]. (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 HIV 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 (e.g., RFADA-11-001) [6]
The present study focuses on African American/Black and Latino/Hispanic populations, there is no race/ethnicity eligibility criterion to allow respondent-driven sampling (RDS) recruitment chains to evolve with minimal restrictions
Summary
An estimated 14 % of the 1.2 million individuals living with HIV in the U.S are unaware of their status. An estimated 14 % of the 1.2 million individuals living with HIV in the United States are unaware of their HIV status [3] This modest proportion of individuals with undiagnosed HIV is linked to an estimated 44–66 % of all new HIV infections annually [4, 5], and uncovering this hidden group is an important public health priority. (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 HIV 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 (e.g., RFADA-11-001) [6]. The present protocol describes one such study focused on uncovering undiagnosed HIV infection
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