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Background/Aims HIV continues to be a major public health threat in the United States, and mathematical modeling has demonstrated that the universal effective use of antiretroviral therapy among all HIV-positive individuals (i.e. the “test and treat” approach) has the potential to control HIV. However, to accomplish this, all the steps that define the HIV care continuum must be achieved at high levels, including HIV testing and diagnosis, linkage to and retention in clinical care, antiretroviral medication initiation, and adherence to achieve and maintain viral suppression. The HPTN 065 (Test, Link-to-Care Plus Treat [TLC-Plus]) study was designed to determine the feasibility of the “test and treat” approach in the United States. Methods HPTN 065 was conducted in two intervention communities, Bronx, NY, and Washington, DC, along with four non-intervention communities, Chicago, IL; Houston, TX; Miami, FL; and Philadelphia, PA. The study consisted of five components: (1) exploring the feasibility of expanded HIV testing via social mobilization and the universal offer of testing in hospital settings, (2) evaluating the effectiveness of financial incentives to increase linkage to care, (3) evaluating the effectiveness of financial incentives to increase viral suppression, (4) evaluating the effectiveness of a computer-delivered intervention to decrease risk behavior in HIV-positive patients in healthcare settings, and (5) administering provider and patient surveys to assess knowledge and attitudes regarding the use of antiretroviral therapy for prevention and the use of financial incentives to improve health outcomes. The study used observational cohorts, cluster and individual randomization, and made novel use of the existing national HIV surveillance data infrastructure. All components were developed with input from a community advisory board, and pragmatic methods were used to implement and assess the outcomes for each study component. Results A total of 76 sites in Washington, DC, and the Bronx, NY, participated in the study: 37 HIV test sites, including 16 hospitals, and 39 HIV care sites. Between September 2010 and December 2014, all study components were successfully implemented at these sites and resulted in valid outcomes. Our pragmatic approach to the study design, implementation, and the assessment of study outcomes allowed the study to be conducted within established programmatic structures and processes. In addition, it was successfully layered on the ongoing standard of care and existing data infrastructure without disrupting health services. Conclusion The HPTN 065 study demonstrated the feasibility of implementing and evaluating a multi-component “test and treat” trial that included a large number of community sites and involved pragmatic approaches to study implementation and evaluation.

Objectives. In June 2006, the District of Columbia (DC) Department of Health launched a citywide rapid HIV screening campaign. Goals included raising HIV awareness, routinizing rapid HIV screening, identifying previously unrecognized infections, and linking positives to care. We describe findings from this seminal campaign and identify lessons learned. Methods. We applied a mixed-methods approach using quantitative analysis of client data forms (CDFs) and qualitative evaluation of focus groups with DC residents. We measured characteristics and factors associated with client demographics, test results, and community perceptions regarding the campaign. Results. Data were available on 38,586 participants tested from July 2006 to September 2007. Of those, 68% had previously tested for HIV (44% within the last 12 months) and 23% would not have sought testing had it not been offered. Overall, 662 (1.7%) participants screened positive on the OraQuick® Advance™ rapid HIV test, with non-Hispanic black people, transgenders, and first-time testers being significantly more likely to screen positive for HIV than white people, males, and those tested within the last year, respectively. Of those screening positive for HIV, 47% had documented referrals for HIV care and treatment services. Focus groups reported continued stigma regarding HIV and minimal community saturation of the campaign. Conclusions. This widespread campaign tested thousands of people and identified hundreds of HIV-infected individuals; however, referrals to care were lower than anticipated, and awareness of the campaign was limited. Lessons learned through this scale-up of population-based HIV screening resulted in establishing citywide HIV testing processes that laid the foundation for the implementation of test-and-treat activities in DC.