A comparison of different community models of antiretroviral therapy delivery with the standard of care among stable HIV+ patients: rationale and design of a non-inferiority cluster randomized trial, nested in the HPTN 071 (PopART) study

Abstract

Background Following the World Health Organization’s (WHO) 2015 guidelines recommending initiation of antiretroviral therapy (ART) irrespective of CD4 count for all people living with HIV (PLHIV), many countries in sub-Saharan Africa have adopted this strategy to reach epidemic control. As the number of PLHIV on ART rises, maintenance of viral suppression on ART for over 90% of PLHIV remains a challenge to government health systems in resource-limited high HIV burden settings. Non facility-based antiretroviral therapy (ART) delivery for stable HIV+ patients may increase sustainable ART coverage in resource-limited settings. Within the HPTN 071 (PopART) trial, two models, home-based delivery (HBD) or adherence clubs (AC), were offered to assess whether they achieved similar viral load suppression (VLS) to standard of care (SoC). In this paper, we describe the trial design and discuss the methodological issues and challenges. Methods A three-arm cluster randomized non-inferiority trial, nested in two urban HPTN 071 trial communities in Zambia, randomly allocated 104 zones to SoC (35), HBD (35), or AC (34). ART and adherence support were delivered 3-monthly at home (HBD), adherence clubs (AC), or clinic (SoC). Adult HIV+ patients defined as “stable” on ART were eligible for inclusion. The primary endpoint was the proportion of PLHIV with virological suppression (≤ 1000 copies HIV RNA/ml) at 12 months (± 3months) after study entry across all three arms. Viral load measurement was done at the routine government laboratories in accordance with national guidelines, annually. The study was powered to determine if either of the community-based interventions would yield a viral suppression rate drop compared to SoC of no more than 5% in its absolute value. Both community-based interventions were delivered by community HIV providers (CHiPs). An additional qualitative study using observations, interviews with PLHIV, and FGDs with community HIV providers was nested in this study to complement the quantitative data. Discussion This trial was designed to provide rigorous randomized evidence of safety and efficacy of non-facility-based delivery of ART for stable PLHIV in high-burden resource-limited settings. This trial will inform policy regarding best practices and what is needed to strengthen scale-up of differentiated models of ART delivery in resource-limited settings. Trial registration ClinicalTrials.gov NCT03025165. Registered on 19 January 2017

Changes in HIV treatment differentiated care uptake during the COVID‐19 pandemic in Zambia: interrupted time series analysis

“…1 Section of Infectious Diseases, Department of Medicine, Boston Medical Center, Boston, Massachusetts, USA; 2 Department of Global Health, Boston University School of Public Health, Boston, Massachusetts, USA; 3 Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; 4 Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts, USA; 5 Clinton Health Access Initiative, Lusaka, Zambia; 6 Ministry of Health, Lusaka, Zambia; 7 The Centre for Infectious Disease Research in Zambia, Lusaka, Zambia; 8 Department of Medical Microbiology, Amsterdam University Medical Centre, Amsterdam, The Netherlands…”

“…Group of ±6 people, based on residential proximity or client preference, meet monthly at a designated place in the community. Members collect medication at clinical appointments for other CAG members, in a rotating fashion [4].…”

“…Home ART delivery Trained community health workers (CHWs) linked to facilities conduct home visits to deliver ART, conduct health screening, monitor adherence and refer clients as required. All community services are captured on a tablet-based SmartCare linked Community HTC (HIV testing and counseling) or Community ART module [4].…”

“…facility visits and adjusting the location of service delivery [4]. These adjustments also minimise client contact with healthcare facilities and other clients [5], a high priority during the COVID-19 pandemic.…”

“…One potential solution to the disruptions caused by COVID‐19 is differentiated service delivery (DSD), a “client‐centered approach that simplifies and adapts HIV services across the cascade to serve the needs of PLHIV better and reduce unnecessary burdens on the health system” [ 3 ]. DSD has emerged as a key strategy for HIV programmes in resource‐limited settings, as DSD models can lessen the burden of HIV treatment on clients and providers by extending medication dispensing intervals, reducing requirements for facility visits and adjusting the location of service delivery [ 4 ]. These adjustments also minimise client contact with healthcare facilities and other clients [ 5 ], a high priority during the COVID‐19 pandemic.…”