Scaling up ART adherence clubs in the public sector health system in the Western Cape, South Africa: a study of the institutionalisation of a pilot innovation.

BACKGROUND: In 2011, a decision was made to scale up a pilot innovation involving 'adherence clubs' as a form of differentiated care for HIV positive people in the public sector antiretroviral therapy programme in the Western Cape Province of South Africa. In 2016 we were involved in the qualitative aspect of an evaluation of the adherence club model, the overall objective of which was to assess the health outcomes for patients accessing clubs through epidemiological analysis, and to conduct a health systems analysis to evaluate how the model of care performed at scale. In this paper we adopt a complex adaptive systems lens to analyse planned organisational change through intervention in a state health system. We explore the challenges associated with taking to scale a pilot that began as a relatively simple innovation by a non-governmental organisation. RESULTS: Our analysis reveals how a programme initially representing a simple, unitary system in terms of management and clinical governance had evolved into a complex, differentiated care system. An innovation that was assessed as an excellent idea and received political backing, worked well whilst supported on a small scale. However, as scaling up progressed, challenges have emerged at the same time as support has waned. We identified a 'tipping point' at which the system was more likely to fail, as vulnerabilities magnified and the capacity for adaptation was exceeded. Yet the study also revealed the impressive capacity that a health system can have for catalysing novel approaches. CONCLUSIONS: We argue that innovation in largescale, complex programmes in health systems is a continuous process that requires ongoing support and attention to new innovation as challenges emerge. Rapid scaling up is also likely to require recourse to further resources, and a culture of iterative learning to address emerging challenges and mitigate complex system errors. These are necessary steps to the future success of adherence clubs as a cornerstone of differentiated care. Further research is needed to assess the equity and quality outcomes of a differentiated care model and to ensure the inclusive distribution of the benefits to all categories of people living with HIV.

High rates of retention and viral suppression in the scale-up of antiretroviral therapy adherence clubs in Cape Town, South Africa.

INTRODUCTION: Increasingly, there is a need for health authority scale up of successfully piloted differentiated models of antiretroviral therapy (ART) delivery. However, there is a paucity of evidence on system-wide outcomes after scale-up. In the Cape Town health district, stable adult patients were referred to adherence clubs (ACs) - a group model of ART delivery with five visits per year. By the end of March 2015, over 32,000 ART patients were in an AC. We describe patient outcomes of a representative sample of AC patients during this scale-up. METHODS: Patients enrolled in an AC at non-research supported sites between 2011 and 2014 were eligible for analysis. We sampled 10% of ACs (n = 100) in quintets proportional to the number of ACs at each facility, linking each patient to city-wide laboratory and service access data to validate retention and virologic outcomes. We digitized registers and used competing risks regression and cross-sectional methods to estimate outcomes: mortality, transfers, loss to follow-up (LTFU) and viral load suppression (≤400 copies/mL). Predictors of LTFU and viral rebound were assessed using Cox proportional hazards models. RESULTS: Of the 3216 adults contributing 4019 person years of follow-up (89% in an AC, median 1.1 years), 70% were women. Retention was 95.2% (95% CI, 94.0-96.4) at 12 months and 89.3% (95% CI, 87.1-91.4) at 24 months after AC enrolment. In the 13 months prior to analysis closure, 88.1% of patients had viral load assessments and of those, viral loads ≤400 copies/mL were found in 97.2% (95% CI, 96.5-97.8) of patients. Risk of LTFU was higher in younger patients and in patients accessing ART from facilities with larger ART cohorts. Risk of viral rebound was higher in younger patients, those that had been on ART for longer and patients that had never sent a buddy to collect their medication. CONCLUSIONS: This is the first analysis reporting patient outcomes after health authorities scaled-up a differentiated care model across a high burden district. The findings provide substantial reassurance that stable patients on long-term ART can safely be offered care options, which are more convenient to patients and less burdensome to services.