The effectiveness and cost-effectiveness of 3- vs. 6-monthly dispensing of antiretroviral treatment (ART) for stable HIV patients in community ART-refill groups in Zimbabwe: study protocol for a pragmatic, cluster-randomized trial

Autor: Geoffrey Fatti, Nicoletta Ngorima-Mabhena, Frank Chirowa, Benson Chirwa, Kudakwashe Takarinda, Taurayi A. Tafuma, Nyikadzino Mahachi, Rudo Chikodzore, Simon Nyadundu, Charles A. Ajayi, Tsitsi Mutasa-Apollo, Owen Mugurungi, Eula Mothibi, Risa M. Hoffman, Ashraf Grimwood
Jazyk: angličtina
Rok vydání: 2018
Předmět:
Zdroj: Trials, Vol 19, Iss 1, Pp 1-10 (2018)
Druh dokumentu: article
ISSN: 1745-6215
DOI: 10.1186/s13063-018-2469-y
Popis: Abstract Background Sub-Saharan Africa is the world region with the greatest number of people eligible to receive antiretroviral treatment (ART). Less frequent dispensing of ART and community-based ART-delivery models are potential strategies to reduce the load on overburdened healthcare facilities and reduce the barriers for patients to access treatment. However, no large-scale trials have been conducted investigating patient outcomes or evaluating the cost-effectiveness of extended ART-dispensing intervals within community ART-delivery models. This trial will assess the clinical effectiveness, cost-effectiveness and acceptability of providing ART refills on a 3 vs. a 6-monthly basis within community ART-refill groups (CARGs) for stable patients in Zimbabwe. Methods In this pragmatic, three-arm, parallel, unblinded, cluster-randomized non-inferiority trial, 30 clusters (healthcare facilities and associated CARGs) are allocated using stratified randomization in a 1:1:1 ratio to either (1) ART refills supplied 3-monthly from the health facility (control arm), (2) ART refills supplied 3-monthly within CARGs, or (3) ART refills supplied 6-monthly within CARGs. A CARG consists of 6–12 stable patients who meet in the community to receive ART refills and who provide support to one another. Stable adult ART patients with a baseline viral load
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