Task Shifting for Initiation and Monitoring of Antiretroviral Therapy for HIV-Infected Adults in Uganda: The SHARE Trial

BACKGROUND:With countries moving towards the World Health Organization’s “Treat All” recommendation, there is need to initiate more HIV-infected persons on antiretroviral therapy (ART). In resource-limited settings, task shifting is one approach that can address clinician shortages. SETTING:Uganda METHODS:We conducted a randomized controlled trial to test if nurse-initiated and monitored antiretroviral therapy (NIMART) is non-inferior to clinician-initiated and monitored ART (CIMART) in HIV-infected adults in Uganda. Study participants were HIV-infected, ART-naïve, and clinically stable adults. The primary outcome was a composite endpoint of any of the followingall-cause mortality, virological failure, toxicity, and loss to follow up at 12 months post-ART initiation. RESULTS:Over half of the study cohort (1,760) was female (54.9%). The mean age was 35.1 years (standard deviation 9.51). Five hundred and thirty-three (31.6%) participants experienced the composite endpoint. At 12 months post-ART initiation, NIMART was non-inferior to CIMART. The intention-to-treat site-adjusted risk differences for the composite endpoint were -4.1 (97.5% CI = -9.8 to 0.2) with complete case analysis (CCA) and -3.4 (97.5% CI = -9.1 to 2.5) with multiple imputation analysis (MIA). Per-protocol site-adjusted risk differences were -3.6 (97.5% CI = -10.5 to 0.6) for CCA and -3.1 (-8.8 to 2.8) for MIA. This difference was within hypothesized margins (6%) for non-inferiority. CONCLUSIONS:Nurses were non-inferior to clinicians for initiation and monitoring of ART. Task shifting to trained nurses is a viable means to increase access to ART. Future studies should evaluate NIMART for other groups (e.g., children, adolescents, and unstable patients).