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

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, 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

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.

Keywords: Antiretroviral treatment; Cluster-randomized trial; Community ART-refill groups; Cost-effectiveness; Effectiveness; Extended dispensing interval; HIV; Multimonth dispensing; Sub-Saharan Africa; Zimbabwe.

Conflict of interest statement

Ethics approval and consent to participate

This study has received ethical approval from the Medical Research Council of Zimbabwe, reference number MRCZ/A/2168. All participants will provide written informed consent prior to participation. The informed consent forms were also approved by the Ethics Committee under the same reference number. Any relevant amendments to the protocol will be communicated to the study investigators, study participants and the trial registry.

Consent for publication

Not applicable

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Cluster allocation schema of multimonth dispensing of antiretroviral treatment cluster-randomized trial in Zimbabwe. CARGs community antiretroviral treatment-refill groups
Fig. 2
Fig. 2
Enrollment, interventions and assessment schedule according to Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)

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Source: PubMed

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