Abstract
BackgroundSub-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.MethodsIn 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.DiscussionCost-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 registrationClinicalTrials.gov, ID: NCT03238846. Registered on 27 July 2017.
Highlights
Sub-Saharan Africa is the world region with the greatest number of people eligible to receive antiretroviral treatment (ART)
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
The rationale for this study is to provide evidence regarding the effectiveness and cost-effectiveness of extended dispensing intervals for ART patients within Community antiretroviral treatment-refill group (CARG), and whether these are suitable strategies that can be implemented on a larger scale to help overburdened health facilities with the large numbers of patients and reduce the burden and cost to patients of frequent clinic visits
Summary
Sub-Saharan Africa is the world region with the greatest number of people eligible to receive antiretroviral treatment (ART). 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. In 2016, the World Health Organization (WHO) broadened its guidelines to recommend that all identified people living with HIV should initiate antiretroviral treatment (ART) as soon as possible after diagnosis, irrespective of clinical or immunological status [2] This policy is expected to reduce AIDS-related mortality, morbidity and new HIV infections. It does, substantially impact already overburdened health systems in sub-Saharan Africa which need to accommodate substantially increased numbers of ART patients at a time when resources for HIV are constrained globally and there is a severe shortage of professional health workers [3, 4]. Clinics that are decongested of stable ART patients may find place to increase the rate of new ART initiations and scale up ART coverage [13]
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