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BackgroundMore than half of persons living with HIV (PLWH) in the United States are insufficiently engaged in HIV primary care and not taking antiretroviral therapy (ART), mainly African Americans/Blacks and Hispanics. In the proposed project, a potent and innovative research methodology, the multiphase optimization strategy (MOST), will be employed to develop a highly efficacious, efficient, scalable, and cost-effective intervention to increase engagement along the HIV care continuum. Whereas randomized controlled trials are valuable for evaluating the efficacy of multi-component interventions as a package, they are not designed to evaluate which specific components contribute to efficacy. MOST, a pioneering, engineering-inspired framework, addresses this problem through highly efficient randomized experimentation to assess the performance of individual intervention components and their interactions. We propose to use MOST to engineer an intervention to increase engagement along the HIV care continuum for African American/Black and Hispanic PLWH not well engaged in care and not taking ART. Further, the intervention will be optimized for cost-effectiveness. A similar set of multi-level factors impede both HIV care and ART initiation for African American/Black and Hispanic PLWH, primary among them individual- (e.g., substance use, distrust, fear), social- (e.g., stigma), and structural-level barriers (e.g., difficulties accessing ancillary services). Guided by a multi-level social cognitive theory, and using the motivational interviewing approach, the study will evaluate five distinct culturally based intervention components (i.e., counseling sessions, pre-adherence preparation, support groups, peer mentorship, and patient navigation), each designed to address a specific barrier to HIV care and ART initiation. These components are well-grounded in the empirical literature and were found acceptable, feasible, and promising with respect to efficacy in a preliminary study.Methods/designStudy aims are: 1) using a highly efficient fractional factorial experimental design, identify which of five intervention components contribute meaningfully to improvement in HIV viral suppression, and secondary outcomes of ART adherence and engagement in HIV primary care; 2) identify mediators and moderators of intervention component efficacy; and 3) using a mathematical modeling approach, build the most cost-effective and efficient intervention package from the efficacious components. A heterogeneous sample of African American/Black and Hispanic PLWH (with respect to age, substance use, and sexual minority status) will be recruited with a proven hybrid sampling method using targeted sampling in community settings and peer recruitment (N = 512).DiscussionThis is the first study to apply the MOST framework in the field of HIV prevention and treatment. This innovative study will produce a culturally based HIV care continuum intervention for the nation's most vulnerable PLWH, optimized for cost-effectiveness, and with exceptional levels of efficacy, efficiency, and scalability.Trial registrationClinicalTrials.gov, NCT02801747 , Registered June 8, 2016.

BackgroundOver 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/designThe 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.DiscussionHeterosexuals 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.Trial registrationClinicalTrials.gov, NCT01607541, Registered May 23, 2012.

Background: 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.Methods/design: 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).Discussion: 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.Trial Registration: ClinicalTrials.gov, NCT02421159 , Registered April 15, 2015. [ABSTRACT FROM AUTHOR]