title: Realist evaluation of the antiretroviral treatment adherence club programme in selected primary healthcare facilities in the metropolitan area of Western Cape Province, South Africa: a study protocol.
abstract: BACKGROUND
  Suboptimal retention in care and poor treatment adherence are key challenges to antiretroviral therapy (ART) in sub-Saharan Africa. Community-based approaches to HIV service delivery are recommended to improve patient retention in care and ART adherence. The implementation of the adherence clubs in the Western Cape province of South Africa was with variable success in terms of implementation and outcomes. The need for operational guidelines for its implementation has been identified. Therefore, understanding the contexts and mechanisms for successful implementation of the adherence clubs is crucial to inform the roll-out to the rest of South Africa. The protocol outlines an evaluation of adherence club intervention in selected primary healthcare facilities in the metropolitan area of the Western Cape Province, using the realist approach.
  
  
  METHODS
  In the first phase, an exploratory study design will be used. Document review and key informant interviews will be used to elicit the programme theory. In phase two, a multiple case study design will be used to describe the adherence clubs in five contrastive sites. Semistructured interviews will be conducted with purposively selected programme implementers and members of the clubs to assess the context and mechanisms of the adherence clubs. For the programme's primary outcomes, a longitudinal retrospective cohort analysis will be conducted using routine patient data. Data analysis will involve classifying emerging themes using the context-mechanism-outcome (CMO) configuration, and refining the primary CMO configurations to conjectured CMO configurations. Finally, we will compare the conjectured CMO configurations from the cases with the initial programme theory. The final CMOs obtained will be translated into middle range theories.
  
  
  BACKGROUND
  The study will be conducted according to the principles of the declaration of Helsinki (1964). Ethics clearance was obtained from the University of the Western Cape. Dissemination will be done through publications and curation.
authors.affiliation: School of Public Health, University of the Western Cape, Cape Town, Western Cape, South Africa.
authors.forename: Ferdinand C
authors.initials: FC
authors.lastname: Mukumbang
authors.affiliation: Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium Institute of Development and Management, University of Antwerp, Antwerp, Belgium.
authors.forename: Sara
authors.initials: S
authors.lastname: Van Belle
authors.affiliation: School of Public Health, University of the Western Cape, Cape Town, Western Cape, South Africa Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium.
authors.forename: Bruno
authors.initials: B
authors.lastname: Marchal
authors.affiliation: School of Public Health, University of the Western Cape, Cape Town, Western Cape, South Africa.
authors.forename: Brian
authors.initials: B
authors.lastname: Van Wyk
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D011320:Primary Health Care / Q000458:organization & administration; D015397:Program Evaluation; D012107:Research Design; D012189:Retrospective Studies; D012657:Self-Help Groups; D013019:South Africa; D055815:Young Adult; D016903:Drug Monitoring
keywords: PRIMARY CARE