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


ABSTRACT:

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).

SUBMITTER: Sekiziyivu BA 

PROVIDER: S-EPMC7879828 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

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Publications

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

Sekiziyivu Brian Arthur BA   Bancroft Elizabeth E   Rodriguez Evelyn M EM   Sendagala Samuel S   Nasirumbi Muniina Pamela MP   Najjengo Marjorie Sserunga MS   Kiragga Agnes N AN   Musaazi Joseph J   Musinguzi Joshua J   Sande Enos E   Brad Bartholow B   Dalal Shona S   Byakika-Jayne Tusiime T   Kambugu Andrew A  

Journal of acquired immune deficiency syndromes (1999) 20210301 3


<h4>Background</h4>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.<h4>Setting</h4>Uganda.<h4>Methods</h4>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  ...[more]

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