Abstract
BackgroundCurrent 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.MethodsThis 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.DiscussionImportant 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 registrationClinicalTrials.gov Identifier: NCT03438370. Accepted on 16 February 2018.
Highlights
MethodsThis study will be a three-arm cluster randomised trial, which will enrol approximately 5760 Human immunodeficiency virus (HIV)-infected individuals who are stable on antiretroviral therapy (ART) in 30 selected clusters
Current World Health Organization (WHO) guidelines recommend early initiation of Human immunodeficiency virus (HIV) positive patients on antiretroviral therapy (ART) irrespective of their clinical or immunological status known as the test and start approach
Potential benefits for this approach includes (i) higher adherence to ART and retention in care, (ii) reduced per-patient cost of providing ART, by reducing the number of clinic visits required, (iii) decongestion of clinics to allow for increased capacity to manage patients newly diagnosed with HIV, those with infectious complications, treatment failure, and other co-morbidities and (iv) decreased waiting time and improved efficiency at clinics allowing for improved quality of care and patient satisfaction [7, 8]
Summary
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
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