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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.

作者信息

Fatti Geoffrey, Ngorima-Mabhena Nicoletta, Chirowa Frank, Chirwa Benson, Takarinda Kudakwashe, Tafuma Taurayi A, Mahachi Nyikadzino, Chikodzore Rudo, Nyadundu Simon, Ajayi Charles A, Mutasa-Apollo Tsitsi, Mugurungi Owen, Mothibi Eula, Hoffman Risa M, Grimwood Ashraf

机构信息

Kheth'Impilo AIDS Free Living, 11th floor, Metlife Centre, 7 Walter Sisulu Ave, Cape Town, 8000, South Africa.

Kheth'Impilo AIDS Free Living, 7 Albany Road, Alexandra Park, Harare, Zimbabwe.

出版信息

Trials. 2018 Jan 29;19(1):79. doi: 10.1186/s13063-018-2469-y.


DOI:10.1186/s13063-018-2469-y
PMID:29378662
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5789674/
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 < 1000 copies/ml will be invited to participate (1920 participants per arm). The primary outcome is the proportion of participants alive and retained in care 12 months after enrollment. Secondary outcomes (measured at 12 and 24 months) are the proportions achieving virological suppression, average provider cost per participant, provider cost per participant retained, cost per participant retained with virological suppression, and average patient-level costs to access treatment. Qualitative research will assess the acceptability of extended ART-dispensing intervals within CARGs to both providers and patients, and indicators of potential facility-level decongestion due to the interventions will be assessed. DISCUSSION: Cost-effective health system models that sustain high levels of patient retention are urgently needed to accommodate the large numbers of stable ART patients in sub-Saharan Africa. This will be the first trial to evaluate extended ART-dispensing intervals within a community-based ART distribution model, and results are intended to inform national and regional policy regarding their potential benefits to both the healthcare system and patients. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03238846 . Registered on 27 July 2017.

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3f69/5789674/b6aeaa9b0179/13063_2018_2469_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3f69/5789674/c96ee8131b10/13063_2018_2469_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3f69/5789674/b6aeaa9b0179/13063_2018_2469_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3f69/5789674/c96ee8131b10/13063_2018_2469_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3f69/5789674/b6aeaa9b0179/13063_2018_2469_Fig2_HTML.jpg

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本文引用的文献

[1]
Effect of Community ART Groups on retention-in-care among patients on ART in Tete Province, Mozambique: a cohort study.

BMJ Open. 2017-8-11

[2]
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PLoS One. 2013-6-28

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