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A cluster randomized controlled trial of extending ART refill intervals to six-monthly for anti-retroviral adherence clubs
BACKGROUND: The antiretroviral therapy (ART) adherence club (AC) differentiated service delivery model, where clinically stable ART patients receive their ART refills and psychosocial support in groups has supported clinically stable patients’ retention and viral suppression. Patients and health sys...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6664572/ https://www.ncbi.nlm.nih.gov/pubmed/31362715 http://dx.doi.org/10.1186/s12879-019-4287-6 |
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author | Wilkinson, Lynne Grimsrud, Anna Cassidy, Tali Orrell, Catherine Voget, Jacqueline Hayes, Helen Keene, Claire Steele, Sarah Jane Gerstenhaber, Rodd |
author_facet | Wilkinson, Lynne Grimsrud, Anna Cassidy, Tali Orrell, Catherine Voget, Jacqueline Hayes, Helen Keene, Claire Steele, Sarah Jane Gerstenhaber, Rodd |
author_sort | Wilkinson, Lynne |
collection | PubMed |
description | BACKGROUND: The antiretroviral therapy (ART) adherence club (AC) differentiated service delivery model, where clinically stable ART patients receive their ART refills and psychosocial support in groups has supported clinically stable patients’ retention and viral suppression. Patients and health systems could benefit further by reducing visit frequency and increasing ART refills. We designed a cluster-randomized control trial comparing standard of care (SoC) ACs and six-month ART refill (Intervention) ACs in a large primary care facility in Khayelitsha, South Africa. METHODS: Existing ACs were randomized to either the control (SOC ACs) or intervention (Intervention ACs) arm. SoC ACs meet five times annually, receiving two-month ART refills with a four-month ART refill over year-end. Blood is drawn at the AC visit ahead of the clinical assessment visit. Intervention ACs meet twice annually receiving six-month ART refills, with a third individual visit for routine blood collection anytime two-four weeks before the annual clinical assessment AC visit. Primary outcomes will be retention in care, annual viral load assessment completion and viral load suppression. (<400copies/mL) after 2 years. Ethics approval has been granted by the University of Cape Town (HREC 652/2016) and the Medecins Sans Frontieres (MSF) Ethics Review Board (#1639). Results will be published in peer-reviewed journals and made widely available through presentations and briefing documents. DISCUSSION: Evaluation of an extended ART refill interval in adherence clubs will provide evidence towards novel model adaptions that can be made to further improve convenience for patients and leverage health system efficiencies. TRIAL REGISTRATION: Registered with the Pan African Clinical Trial Registry: PACTR201810631281009. Registered 11 September 2018. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12879-019-4287-6) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-6664572 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-66645722019-08-05 A cluster randomized controlled trial of extending ART refill intervals to six-monthly for anti-retroviral adherence clubs Wilkinson, Lynne Grimsrud, Anna Cassidy, Tali Orrell, Catherine Voget, Jacqueline Hayes, Helen Keene, Claire Steele, Sarah Jane Gerstenhaber, Rodd BMC Infect Dis Study Protocol BACKGROUND: The antiretroviral therapy (ART) adherence club (AC) differentiated service delivery model, where clinically stable ART patients receive their ART refills and psychosocial support in groups has supported clinically stable patients’ retention and viral suppression. Patients and health systems could benefit further by reducing visit frequency and increasing ART refills. We designed a cluster-randomized control trial comparing standard of care (SoC) ACs and six-month ART refill (Intervention) ACs in a large primary care facility in Khayelitsha, South Africa. METHODS: Existing ACs were randomized to either the control (SOC ACs) or intervention (Intervention ACs) arm. SoC ACs meet five times annually, receiving two-month ART refills with a four-month ART refill over year-end. Blood is drawn at the AC visit ahead of the clinical assessment visit. Intervention ACs meet twice annually receiving six-month ART refills, with a third individual visit for routine blood collection anytime two-four weeks before the annual clinical assessment AC visit. Primary outcomes will be retention in care, annual viral load assessment completion and viral load suppression. (<400copies/mL) after 2 years. Ethics approval has been granted by the University of Cape Town (HREC 652/2016) and the Medecins Sans Frontieres (MSF) Ethics Review Board (#1639). Results will be published in peer-reviewed journals and made widely available through presentations and briefing documents. DISCUSSION: Evaluation of an extended ART refill interval in adherence clubs will provide evidence towards novel model adaptions that can be made to further improve convenience for patients and leverage health system efficiencies. TRIAL REGISTRATION: Registered with the Pan African Clinical Trial Registry: PACTR201810631281009. Registered 11 September 2018. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12879-019-4287-6) contains supplementary material, which is available to authorized users. BioMed Central 2019-07-30 /pmc/articles/PMC6664572/ /pubmed/31362715 http://dx.doi.org/10.1186/s12879-019-4287-6 Text en © The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. 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. |
spellingShingle | Study Protocol Wilkinson, Lynne Grimsrud, Anna Cassidy, Tali Orrell, Catherine Voget, Jacqueline Hayes, Helen Keene, Claire Steele, Sarah Jane Gerstenhaber, Rodd A cluster randomized controlled trial of extending ART refill intervals to six-monthly for anti-retroviral adherence clubs |
title | A cluster randomized controlled trial of extending ART refill intervals to six-monthly for anti-retroviral adherence clubs |
title_full | A cluster randomized controlled trial of extending ART refill intervals to six-monthly for anti-retroviral adherence clubs |
title_fullStr | A cluster randomized controlled trial of extending ART refill intervals to six-monthly for anti-retroviral adherence clubs |
title_full_unstemmed | A cluster randomized controlled trial of extending ART refill intervals to six-monthly for anti-retroviral adherence clubs |
title_short | A cluster randomized controlled trial of extending ART refill intervals to six-monthly for anti-retroviral adherence clubs |
title_sort | cluster randomized controlled trial of extending art refill intervals to six-monthly for anti-retroviral adherence clubs |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6664572/ https://www.ncbi.nlm.nih.gov/pubmed/31362715 http://dx.doi.org/10.1186/s12879-019-4287-6 |
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