CCTG 594 was a controlled, un-blinded, two-arm, randomized (1:1) clinical trial to evaluate the effectiveness of a clinic-based HIV Active Linkage, Engagement, and Retention to Treatment (ALERT) specialist on improving endpoints of retention in care and maintenance of antiretroviral therapy (ART) as compared to the current standard of care (SOC) in HIV primary care clinics.
Each subject received follow-up of at least 48 weeks. Follow-up for enrolled patients continued until the last enrolled patients has been on study for 48 weeks
Approximately 300 subjects were randomized, 150 per arm.
Eligible subjects included 1) newly diagnosed HIV-infected individuals entering primary HIV care at one of the CCTG clinics, or 2) previously diagnosed HIV-infected individuals who are “out of care” defined as having no visit with a prescribing HIV provider in the last 180 days and not on a stable ARV regimen.
Subjects were stratified based on study site and if they are newly diagnosed or returning to care.
Subjects were randomized (1:1) to either the ALERT Enhanced Retention Intervention Arm or the SOC Arm. Subjects placed into the ALERT Intervention Arm received aggressive engagement efforts by the ALERT specialist to ensure visit continuity and retention into care. The ALERT specialist also administered an education intervention consisting of 5 retention modules designed to improve HIV knowledge and self-efficacy, and also monitored health care visits and intervene via methods to track, find, and re-engage patients during the study. Patients placed into the SOC arm received the HIV care clinic’s current standard of care retention services.
The CCTG 594 primary outcome is time to “lost to follow up” (LTFU) defined as the time from study entry to no visit with a prescribing HIV provider in the last 180 days.