Outcomes of community-based differentiated models of multi-month dispensing of antiretroviral medication among stable HIV-infected patients in Lesotho: a cluster randomised non-inferiority trial protocol

I O Faturiyele, T Appolinare, N Ngorima-Mabhena, G Fatti, I Tshabalala, V J Tukei, P T Pisa, I O Faturiyele, T Appolinare, N Ngorima-Mabhena, G Fatti, I Tshabalala, V J Tukei, P T Pisa

Abstract

Background: Current World Health Organization (WHO) guidelines recommend early initiation of HIV positive patients on antiretroviral therapy (ART) irrespective of their clinical or immunological status known as the test and start approach. Lesotho, like many other countries introduced this approach in 2016 as a strategy to reach epidemic control. There will be rapidly growing number of HIV-infected individuals initiating treatment leading to practical challenges on health systems such as congestion, long waiting time for patients and limited time to provide quality services to patients. Differentiated models of ART delivery is an innovative solution that helps to increase access to care, while reducing the burden on existing health systems. Ultimately this model will help to achieve retention and viral suppression. We describe a demonstration study designed to evaluate a community-based differentiated model of multi-month dispensing (MMD) approaches of ART among stable HIV patients in Lesotho.

Methods: This study will be a three-arm cluster randomised trial, which will enrol approximately 5760 HIV-infected individuals who are stable on ART in 30 selected clusters. The clusters, which are health facilities, will be randomly assigned into the following differentiated model of care arms: (i) 3 monthly ART supply at facilities (Control), (ii) 3 monthly ART supply through community ART groups (CAGs) and (iii) 6 monthly ART supply through community ART distribution points (CAD). Primary outcomes are retention in care and virologic suppression, and secondary outcomes include feasibility and cost effectiveness.

Discussion: Important lessons will be learnt to allow for improved implementation of such demonstration projects, including various needs for reliable supply of medication, access to quality clinical data including access to viral loads (VLs) results, frameworks to support lay worker cadre, involvement of community stakeholders, and reliable data systems including records of key indicators. MMD will have positive implications including improved retention, virologic suppression, convenience and access to medication.

Trial registration: ClinicalTrials.gov Identifier: NCT03438370 . Accepted on 16 February 2018.

Keywords: Antiretroviral therapy; Cost-effectiveness; Differentiated models of care; HIV; Lesotho; Retention; Virologic suppression.

Conflict of interest statement

Ethics approval and consent to participate

The study protocol was developed using the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Checklist (see Additional file 1) and adheres to the SPIRIT recommendations. The trial is registered with ClinicalTrials.gov as NCT03438370 and has received ethical clearance from the Lesotho National Health Research Ethics based at the Ministry of Health as well as Chesapeake Institutional Review Board in the USA [Number: ID49–2017 and MOD00231007 respectively]. Written informed consent will be obtained from all study participants prior to enrolment.

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
Multi-Month Community Dispensing of ART: Examining the Role of Differentiated models of ART Supply on Retention and Virologic Suppression

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