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    Apr 18, 2021
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    A cluster randomized controlled trial of extending ART refill intervals to six-monthly for anti-retroviral adherence clubs.

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    Wilkinson et al 2019 A cluster ...
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    Authors
    Wilkinson, L
    Grimsrud, A
    Cassidy, T
    Orrell, C
    Voget, J
    Hayes, H
    Keene, C
    Steele, SJ
    Gerstenhaber, R
    Issue Date
    2019-07-30
    Submitted date
    2019-10-24
    
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    Journal
    BMC Infectious Disease
    Abstract
    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.
    Publisher
    BioMed Central
    URI
    http://hdl.handle.net/10144/619487
    DOI
    10.1186/s12879-019-4287-6
    PubMed ID
    31362715
    Language
    en
    ISSN
    1471-2334
    ae974a485f413a2113503eed53cd6c53
    10.1186/s12879-019-4287-6
    Scopus Count
    Collections
    HIV/AIDS

    entitlement

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