The success of global HIV control efforts for men who have sex with men (MSM) will depend on how effective and sustainable the interventions are, but also how efficiently the intervention programs are implemented. A testable hypothesis is that a package of prevention interventions may have a substantial impact even if single approaches are less impressive. We further hypothesize that combination interventions will be even more sustainable than isolated interventions, due to improved community support of a popular package of services. One package of HIV-specific interventions has been termed """"""""test-and-linkage-to-care"""""""" (TLC). The theory behind TLC is that the increase in the proportion of HIV-infected persons who know their status, are bridged to HIV combination antiretroviral therapy (cART)-based care, and who adhere to cART will reduce the amount of virus circulating in a community. TLC integrated with risk reduction intervention and formulated at the individual-level can facilitate one's engagement and commitment in care, reducing infectiousness to others at the same time that personal health is enhanced and restored. TLC seeks to reduce """"""""community viral load,"""""""" reducing the risk to uninfected persons by reducing the infectiousness of HIV-infected individuals. Our goal in this one-year clinical trial planning (R34) grant is to prepare for a community-level randomized clinical trial (RCT) to test the efficacy of our multicomponent TLC intervention package to reduce HIV incidence among MSM in China. By collaborating with Chinese CDC networks and local MSM community based organizations, we will develop all documents required for initiation of an RCT, complete all local, federal, and international human subjects and regulatory approvals necessary for implementation of the trial, and identify clinical trial sites and establish community advisory boards for a clinical trial. At the end of the study, we will have a RCT protocol ready for testing two research hypotheses: (1) MSM in communities receiving 24 months of TLC intervention will achieve a reduction in HIV incidence relative to MSM in standard prevention communities;and (2) TLC intervention will improve secondary and intermediary indicators of treatment success and risk reduction, compared to the standard prevention approaches.
Our study proposal represents an innovative adaptation of an integration of biomedical and behavioral methods of HIV prevention whose promise is supported by epidemiological data, but has never been tested in a clinical trial design in China. This grant will prepare a clinical trial in which men who have sex with men (MSM) in China who are unaware of their status will be tested and those HIV-infected MSM will benefit from prolonged life by available cART. The patient-centered prevention will be able to target the unrecognized individuals with HIV infections or at high risk of contracting HIV such that the further transmission can be prevented effectively.
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