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
Date
2018-08-29
Journal Title
Journal ISSN
Volume Title
Publisher
BMC (part of Springer Nature)
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.
Description
CITATION: Faturiyele, I. O., et al. 2018. 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. BMC Public Health, 18:1069, doi:10.1186/s12889-018-5961-0.
The original publication is available at https://bmcpublichealth.biomedcentral.com
The original publication is available at https://bmcpublichealth.biomedcentral.com
Keywords
Medical care, HIV-positive persons
Citation
Faturiyele, I. O., et al. 2018. 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. BMC Public Health, 18:1069, doi:10.1186/s12889-018-5961-0