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HIV Prevention Trials Network (HPTN) Protocol 078

Enhancing Recruitment, Linkage to Care and Treatment for HIV-Infected Men Who Have Sex with Men (MSM) in the United States

HPTN 078 is an NIH supported study is to develop and assess the efficacy of an integrated strategy that includes feasible and scalable interventions to identify, recruit, link to care, retain in care, attain, and maintain viral suppression among HIV-infected men who have sex with men (MSM) in the United States (US). Chris Beyrer MD, MPH, serves as protocol chair. HPTN 078 is being conducted among gay, bisexual and other MSM in 4 US cities: Baltimore, Boston, Birmingham, and Atlanta. It has been designed in accord with the US National Strategy on HIV/AIDS and seeks to address and overcome barriers to HIV treatment and the achievement of viral suppression through a case management intervention.

Design: This study uses deep-chain respondent driven sampling (DC-RDS) to identify and recruit HIV-infected MSM who are not virally suppressed. A subset of these men will be enrolled into one of two study arms. The intervention arm will provide a Case Manager (CM) intervention package designed to enhance linkage to care, antiretroviral treatment (ART) initiation, treatment adherence and retention in care. The control arm will provide the standard of care (SOC) for linkage to care, initiation of ART, treatment adherence and retention in care. The primary outcome of the study is viral suppression 24 months after enrollment. Phylogenetic methods will be used to evaluate the relationship between social and sexual networks identified through DC-RDS and viral networks. Mathematical modeling will be performed using demographic, behavioral, and clinical data generated from this study and other sources to estimate the population-level impact of the CM intervention on HIV incidence and to estimate the level of identification, linkage, ART coverage and viral suppression that would be required to achieve a substantial reduction in HIV incidence among MSM in the US settings where the study is conducted