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A comparison of different community models of antiretroviral therapy delivery with the standard of care among stable HIV plus patients: rationale and design of a non-inferiority cluster randomized trial, nested in the HPTN 071 (PopART) study
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A comparison of different community models of antiretroviral therapy delivery with the standard of care among stable HIV+ pa.pdf | Published version | 737.46 kB | Adobe PDF | View/Open |
Title: | A comparison of different community models of antiretroviral therapy delivery with the standard of care among stable HIV plus patients: rationale and design of a non-inferiority cluster randomized trial, nested in the HPTN 071 (PopART) study |
Authors: | Limbada, M Bwalya, C Macleod, D Floyd, S Schaap, A Situmbeko, V Hayes, R Fidler, S Ayles, H |
Item Type: | Journal Article |
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 |
Issue Date: | 12-Jan-2021 |
Date of Acceptance: | 29-Dec-2020 |
URI: | http://hdl.handle.net/10044/1/87421 |
DOI: | 10.1186/s13063-020-05010-w |
ISSN: | 1745-6215 |
Publisher: | BioMed Central |
Start Page: | 1 |
End Page: | 12 |
Journal / Book Title: | Trials |
Volume: | 22 |
Issue: | 1 |
Copyright Statement: | © The Author(s). 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
Sponsor/Funder: | National Institutes of Health |
Funder's Grant Number: | PO15001410 (UMIAI068619) |
Keywords: | Science & Technology Life Sciences & Biomedicine Medicine, Research & Experimental Research & Experimental Medicine HIV Anti-retroviral therapy Home-based ART delivery Adherence clubs Zambia SUB-SAHARAN AFRICA RETENTION PROGRAMS SERVICES BARRIERS Adherence clubs Anti-retroviral therapy HIV Home-based ART delivery Zambia HPTN 071 (PopART) Study Team Science & Technology Life Sciences & Biomedicine Medicine, Research & Experimental Research & Experimental Medicine HIV Anti-retroviral therapy Home-based ART delivery Adherence clubs Zambia SUB-SAHARAN AFRICA RETENTION PROGRAMS SERVICES BARRIERS Cardiovascular System & Hematology General & Internal Medicine 1102 Cardiorespiratory Medicine and Haematology 1103 Clinical Sciences |
Publication Status: | Published |
Article Number: | ARTN 52 |
Online Publication Date: | 2021-01-12 |
Appears in Collections: | Department of Infectious Diseases |
This item is licensed under a Creative Commons License