Abstract
BackgroundThe 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.MethodsExisting 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.DiscussionEvaluation 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 registrationRegistered with the Pan African Clinical Trial Registry: PACTR201810631281009. Registered 11 September 2018.
Highlights
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
South Africa is home to the largest number of people living with HIV (PLHIV), an estimated 7.9 million people
In 2017, it was estimated that 55.7% of PLHIV in South Africa were on antiretroviral therapy (ART) [1]
Summary
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. Differentiated models of ART delivery for patients that are otherwise healthy and clinically stable on ART, attempt to make ongoing access to ART refills and clinical management more convenient and accessible in order to support continued adherence to treatment on a long-term basis Such models have been shown to be feasible to implement, acceptable to patients with good retention and viral suppression outcomes. Wilkinson et al BMC Infectious Diseases (2019) 19:674 can be leveraged to improve health system efficiency in an era with limited resources to achieve ambitious targets [4,5,6,7,8] One such differentiated ART delivery model is the ART adherence club (AC), originally a demonstration project by Médecins Sans Frontières (MSF) in Khayelitsha, South Africa. It has been endorsed in a number of sub-Saharan African country policies [15,16,17], including South Africa, where it has been implemented at scale [18]
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