The authors declare that they have no competing interests.
MG conceived of the overall study concept and design and played a primary role in writing the manuscript. CMC participated in the design of the study, planned the statistical analyses, and helped draft the manuscript. NRL participated in the design of the study and study implementation procedures. AK designed study procedures and helped draft the manuscript. ASR participated in the design of HIV testing and regulatory procedures. AB participated in the design of intervention manuals and procedures. HH participated in the design of the study. DP participated in aspects of the study having to do with the HIV health care system and lab tests. TMG participated in the design of intervention manuals and procedures. DS created data management procedures. BYM participated in the design of participant tracking, retention, and monitoring procedures. All authors read and approved the final manuscript.
An 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.
This 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).
Undiagnosed 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.
ClinicalTrials.gov, NCT02421159, Registered April 15, 2015.