Research Article: Towards Developing an Initial Programme Theory: Programme Designers and Managers Assumptions on the Antiretroviral Treatment Adherence Club Programme in Primary Health Care Facilities in the Metropolitan Area of Western Cape Province, South Africa

Date Published: August 25, 2016

Publisher: Public Library of Science

Author(s): Ferdinand C. Mukumbang, Sara van Belle, Bruno Marchal, Brian van Wyk, Omar Sued.


The antiretroviral adherence club intervention was rolled out in primary health care facilities in the Western Cape province of South Africa to relieve clinic congestion, and improve retention in care, and treatment adherence in the face of growing patient loads. We adopted the realist evaluation approach to evaluate what aspects of antiretroviral club intervention works, for what sections of the patient population, and under which community and health systems contexts, to inform guidelines for scaling up of the intervention. In this article, we report on a step towards the development of a programme theory—the assumptions of programme designers and health service managers with regard to how and why the adherence club intervention is expected to achieve its goals and perceptions on how it has done so (or not).

We adopted an exploratory qualitative research design. We conducted a document review of 12 documents on the design and implementation of the adherence club intervention, and key informant interviews with 12 purposively selected programme designers and managers. Thematic content analysis was used to identify themes attributed to the programme actors, context, mechanisms, and outcomes. Using the context-mechanism-outcome configurational tool, we provided an explanatory focus of how the adherence club intervention is roll-out and works guided by the realist perspective.

We classified the assumptions of the adherence club designers and managers into the rollout, implementation, and utilisation of the adherence club programme, constructed around the providers, management/operational staff, and patients, respectively. Two rival theories were identified at the patient-perspective level. We used these perspectives to develop an initial programme theory of the adherence club intervention, which will be tested in a later phase.

The perspectives of the programme designers and managers provided an important step towards developing an initial programme theory, which will guide our realist evaluation of the adherence club programme in South Africa.

Partial Text

Starting from a few isolated HIV cases in the late 1980s, South Africa had one of the fastest infection rates in the world, reaching the 7 million mark at the end of 2015 [1]. The South African Ministry of Health responded to the HIV epidemic by rolling out antiretroviral drugs at no direct financial cost to patients in 2004 and subsequently decentralising antiretroviral care and treatment to primary health care facilities nationwide [2]. Through this strategy, an estimated 3.1 million (32.2%) people living with HIV/AIDS (PLWHA) in South Africa have been initiated on antiretroviral treatment (ART) as of April 2015 [3].

For identification of the information source and anonymity, the key informant interviews are coded as KIIx where x represents an arbitrary number from 1–12. In a similar manner, information obtained from a document are coded as ‘DRx’ for document review and ‘X’ for the document number.

We applied a realist philosophical ‘lens’ to the data analysis process, applying the CMO configurations as the analytical tool. The goal of the analysis process at this stage was to identify CMO configurations that represent the vision, goals and thought processes of the adherence club programme designers and managers (implementers). Information from both the document analysis and the semi-structured in-depth interviews were used to formulate CMO configurations that would inform the further development of the adherence club programme theory. This process was first applied to the document analysis for two purposes: (a) to identify gaps and (b) for the identification of themes and the construction of the tentative CMO configurations (Fig 1).

This study is part of a larger project “A realist evaluation of the antiretroviral treatment adherence club programme in selected primary health care facilities in the metropolitan area of Western Cape Province, South Africa” which has received ethics clearance from the University of the Western Cape Research Ethics Committee (UWC REC) (Registration No: 15/6/28). The University’s research ethics committees are registered with the National Health Research Ethics Committee in South Africa. We explained the study aim and objectives to the potential participants and asked them to sign a consent form before their participation in the interview sessions. We also used codes to report the findings of the study and safely stored the data to ensure that the informants were kept anonymous and their information confidential. While conducting the document review, we followed the relevant standards of utility, usefulness, feasibility, propriety, accuracy, and accountability as outlined by Pawson et al. [42]. The study findings will be shared with the HAST Directorate in a feedback meeting.

In this section, we present the findings of the realist evaluation interviews with the key informant interviews combined with information from the document review. We first present the main findings in terms of Outcomes, Context, and Mechanism, and in a second part show how we proceeded to identify the CMO configurations.

The rigour and trustworthiness of the study findings were improved by applying the following principles. We conducted a pilot of the interview guide, which helped us to assess the type of information that the questions we asked were likely to produce. We applied the processes of method and source triangulation. The document analysis allowed us to triangulate the information from the interviews. In addition, a wide range of stakeholders was recruited as study participants. We conducted iterative questioning in data collection dialogues with the study participants. We conducted member checks with the study participants of the theories that were formulated if they reflected their views. In conventional qualitative studies, researchers are required to apply the principle of bracketing (neutral territory) during the entire study by which we acknowledged and side-lined our preconceptions before engaging in the study [48], on the contrary, conducting a realist interview requires the investigators to engage with the respondents [21]. Conducting a document review provided us with relevant concepts and theories to engage with the study participants. In this process, we took neither an insider nor an outsider perspective about the programme [21]. Trustworthiness was enforced by actively searching for disconfirming evidence through negative case analysis [49] or deviant case analysis [26] and by keeping an audit trail. Finally, we followed the relevant aspects of the Criteria for Reporting Qualitative Research (COREQ) outlined by Tong, Sainsbury, and Craig [50].

We applied the process of iterative consultation with the stakeholders during the configurational analysis process. We do acknowledge that this process has the potential to introduce confirmation bias, whereby, with subsequent consultations, the stakeholders tend to agree with whatever the evaluators have presented. We limited this bias by asking the stakeholders to think differently or in a way to improve the theories. Another limitation of the study is related to the fact that while obtaining the assumptions of the programme designers and managers, we did not include stakeholders such as facility managers, the operational staff and patients. Consequently, the programme users’ perspectives were obtained on the basis of interviews with managers and providers rather than the programme users.

Based on the interviews with the adherence club programme designers and managers and a document review, three perspectives of how the adherence club intervention is expected to be successfully implemented and achieve the goals of patient retention in care, adherence, and clinic decongestion were identified. This represents the first step towards developing programme theories that explain how the adherence club intervention is expected to work, for whom and under what circumstance. The next step is to assess the evidence on the various mechanisms of action working in other group-based adherence interventions and review the literature on theories that have been explored to explain retention in care and adherence to ART. This will allow us to formulate a programme theory that represents a hypothesis of how the adherence club works which we will subsequently test in empirical studies.