Mukumbang Ferdinand C, Van Belle Sara, Marchal Bruno, Van Wyk Brian
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 Institute of Development and Management, University of Antwerp, Antwerp, Belgium.
BMJ Open. 2016 Apr 4;6(4):e009977. doi: 10.1136/bmjopen-2015-009977.
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.
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.
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.
在撒哈拉以南非洲地区，抗逆转录病毒疗法（ART）面临的主要挑战是护理留存率欠佳和治疗依从性差。建议采用基于社区的艾滋病毒服务提供方式，以提高患者的护理留存率和抗逆转录病毒疗法依从性。南非西开普省实施的依从性俱乐部在实施情况和成果方面成效不一。已确定需要实施操作指南。因此，了解依从性俱乐部成功实施的背景和机制对于在南非其他地区推广至关重要。该方案概述了采用现实主义方法对西开普省大都市区选定的初级卫生保健设施中的依从性俱乐部干预措施进行评估。
在第一阶段，将采用探索性研究设计。通过文献回顾和关键信息人访谈来引出项目理论。在第二阶段，将采用多案例研究设计来描述五个对比地点的依从性俱乐部。将对有目的地挑选的项目实施者和俱乐部成员进行半结构化访谈，以评估依从性俱乐部的背景和机制。对于该项目的主要成果，将使用常规患者数据进行纵向回顾性队列分析。数据分析将包括使用背景-机制-结果（CMO）配置对新出现的主题进行分类，并将主要的CMO配置提炼为推测的CMO配置。最后，我们将把各案例中得到的推测CMO配置与初始项目理论进行比较。获得的最终CMO将转化为中程理论。
本研究将按照《赫尔辛基宣言》（1964年）的原则进行。已获得西开普大学的伦理批准。将通过出版物和策展进行传播。
