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

Background: With countries moving toward the World Health Organization's "Treat All" recommendation, there is a need to initiate more HIV-infected persons into antiretroviral therapy (ART). In resource-limited settings, task shifting is 1 approach that can address clinician shortages.
Setting: Uganda.
Methods: We conducted a randomized controlled trial to test if nurse-initiated and monitored ART (NIMART) is noninferior to clinician-initiated and monitored ART in HIV-infected adults in Uganda. Study participants were HIV-infected, ART-naive, and clinically stable adults. The primary outcome was a composite end point of any of the following: all-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 women (54.9%). The mean age was 35.1 years (SD 9.51). Five hundred thirty-three (31.6%) participants experienced the composite end point. At 12 months post-ART initiation, nurse-initiated and monitored ART was noninferior to clinician-initiated and monitored ART. The intention-to-treat site-adjusted risk differences for the composite end point were -4.1 [97.5% confidence interval (CI): = -9.8 to 0.2] with complete case analysis and -3.4 (97.5% CI: = -9.1 to 2.5) with multiple imputation analysis. Per-protocol site-adjusted risk differences were -3.6 (97.5% CI: = -10.5 to 0.6) for complete case analysis and -3.1 (-8.8 to 2.8) for multiple imputation analysis. This difference was within hypothesized margins (6%) for noninferiority.
Conclusions: Nurses were noninferior 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).
Competing Interests: The authors have no conflicts of interest to disclose.
(Copyright © 2020 Written work prepared by employees of the Federal Government as part of their official duties is, under the U.S. Copyright Act, a “work of the United States Government” for which copyright protection under Title 17 of the United States Code is not available. As such, copyright does not extend to the contributions of employees of the Federal Government.)