HTPN 078: an enhanced case management study to achieve viral suppression among viremic HIV-positive men who have sex with men in the United States

Objectives: After identifying and recruiting men who have sex with men living with HIV and virally unsuppressed, this study attempted to enhance treatment and care via case management to increase the proportion who achieved viral suppression.

Design: Participants were randomized into one of two study arms: standard of care (SOC) or enhanced case management (CM) intervention. Participants were followed for 12 months with quarterly study assessments, with blood collected for CD4+ cell count testing, HIV viral load testing (primary prespecified outcome), and plasma storage.
Methods: Participants identified via respondent-driven sampling and direct recruitment and were invited to participate in the randomized controlled trial. The CM intervention provided a wide range of support services including, health education, clinical care coordination, medication adherence support, and social service assistance. The month-12 assessment included questions about healthcare utilization, stigma, substance use, and mental health.