Study setting

This will be a cohort study taking place in one ‘one-stop’ integrated care clinic per country. In Tanzania, the selected site is Temeke Regional Referral Hospital in Dar Es Salaam, a public tertiary health facility, with 465 staff, and serving a population of over 1 million. In Uganda, the selected site is the Kasangati Health Centre IV, Kasangati, a public district health facility located in the Wakiso District serving a population of over 2 million. Both provide a range of services to the community (primary care, HIV/AIDs, NCDs, surgical, maternal and child health, health education, dental and pharmacy).

Study design

This protocol describes procedures for a qualitative process evaluation of the INTE-AFRICA pragmatic parallel arm cluster randomised trial comparing integrated health service provision for HIV-infection, DM and hypertension with the current standard vertical care delivery model. The process evaluation works in tandem with the collection of selected clinical outcomes (eg, clinical efficacy of different treatments) and health economic data (eg, costs and benefits of different approaches) to estimate the potential benefits to patients and health services at clinic and country level (protocol reported elsewhere).

Patient and public involvement

Patient and public involvement (PPI) throughout a programme of research enhances research quality and relevance by providing different perspectives and a sense of ownership. This protocol will adhere to the same principles, and will allow the voice of ‘service users’ and those affected to be heard, and utilised. Key stakeholders such as patients as service users and their families will be fully involved in guiding the research, acting as research participants, and in implementation of change in health service delivery and integrated care planning. All aspects of the process evaluation are underpinned by participatory action health research and its success and usefulness will be grounded in PPI, participation and engagement in the form of patient/professional identification of research priorities, collaborations and partnerships, expert steering, community participation around health needs and optimal integrated services, awareness raising activities, development of print materials, toolkits and training for healthcare professionals.

It will use three qualitative research techniques: in-depth interviews with stakeholders (patients, healthcare provider, policy-maker, NGO/international organisation, and clinical researcher); focus group discussions (FGD) with community leaders and community members; and clinic-based observations in one site per country. This design permits an assessment of the fidelity of INTE-AFRICA’s implementation, a detailed description of the processes, relationships, and contexts involved in the delivery of integrated care, and the identification of factors attributing to the failure or success of the programme. It thus addresses the ‘black box’ problem in interpreting trial results by improving understanding of the mechanisms that connect particular intervention components to particular outcomes.50 The chosen approach will enhance social construction and acceptability of chosen decentralised integrated approaches, link outcomes to policy and advocacy and impact sustainability of HIV, DM and hypertension chronic disease service integration in two low and middle income countries. It provides the opportunity to document and refine INTE-AFRICA activities prior to a larger pragmatic trial or scale-up by Tanzanian and Ugandan governments. These synergistic approaches to evaluate, understand and respond will support integration, support affordability, address barriers to government scale up and funding barriers for chronic care, inform surveillance, policy and practice development and improve efforts to involve and educate communities in Tanzania and Uganda. It will create a model and a platform of best practices and lessons learnt for other countries implementing integrated and decentralised community health services for HIV and chronic disease. The process evaluation methods for each objective are described in table 3, including how each method maps onto the three different contextual levels.

Study population and recruitment

wenty-five patients and 10 healthcare providers in Temeke Regional Referral Hospital in Dar Es Salaam, Tanzania and Kasangati Health Centre IV, Kasangati, Uganda will be purposely selected and invited; at 6, 12 and 18 months after the start of the trial, to reflect retrospectively on their experience of integration. Healthcare providers include the hospital/health centre overall in charge and pharmacist, and the ‘one-stop’ medical officers in-charge, trained clinicians managing HIV, diabetes and hypertension patients, pharmacist, laboratory technician, counsellors or nurses providing health education and counselling, and nurses in the registration desk who are also responsible in taking vital signs from patients. We will also collect qualitative data from interviews with Ministerial policy-makers and provincial/regional/district level clinical/health senior management (directors for NCD, HIV and curative services); NGO and international organisations (eg, WHO Country office, Joint United Nations Programme on HIV/AIDS (UNAIDS), President’s Emergency Plan for AIDS Relief (PEPFAR), Centers for Disease Control and Prevention (CDC)) and clinical researchers; and conduct FGD with community leaders and community members. These numbers are expected to reach saturation (ie, the point that further information does not provide any additional variation in observed themes). We may replace participants, for example patients if there is significant loss to follow-up or refusal for repeated interviews. For instance, if a participant drops out at 12 months, we still have their 6-month experience documented, and we can replace with a new participant, invited to reflect on their 12-month retrospective experience. Where possible we will gender match interviewers with participants (particularly patients). Participants (patients, healthcare providers and others) will not be directly compensated bur rather they will be compensated for incurred transport costs to attend the interview/FGD, and provided with refreshments during the interview/FGD.

The following recruitment procedures will take place at each ‘one-stop’ integrated care clinic:

• Observations will be made in the integrated clinic in consultation with the hospital/health centre and ‘one-stop’ clinic in-charges.

• Recruitment of patients will be supported by clinic nurses who will identify and approach selected participants who have a minimum of 6 months experience of integration, and will be asked to consent to partake in an in-depth interview on the day they attend the clinic. INTE-AFRICA researchers will purposively sample women and men of different ages and explore any age/gender and condition ((HIV/hypertensive/DM/multi/comorbid) related differences.

• Healthcare providers at the integrated clinic will be approached to participate in an in-depth interview on the day the INTE-AFRICA team are scheduled to attend.

• Ministerial policy-makers and provincial/regional/district level clinical/health senior management will be identified and requested to participate in a semistructured interview (face to face, online using Zoom or telephone).

• NGO and international organisations will be identified and requested to participate in a semistructured interview (face to face or telephone).

• Community leaders will be identified in the clinic catchment areas by virtue of their position while community members will be identified in consultation with the community leaders and invited to participate in the FGDs.

• Clinical researchers will be invited to participate in an in depth interview at the 24-month end point.

Data collection

We will use the Empirical Phenomenological Psychological (EPP) five-step method,51 which combines psychological, interpretative and idiographic components, to collect data. The data will garner an understanding of the complex social processes, of social, aged, gendered and culturally/community specific meanings and broaden the incremental understanding of the distinct lived experience of policy-makers, patients, healthcare providers, researchers and communities. We will balance the description of phenomena with the interpretation of insights and are cognisant of participant experiential phenomena and authors’ interpretation of associated meanings. It will yield an in-depth sociocultural understanding of patient-reported/participant-reported outcomes, their motivations, preferences, beliefs, expectations, identities, hopes and views on conditions, related stigma and of decision-making processes. This will provide better understanding of stakeholder and community positioning during integration. This understanding will inform policy and practice, ensure effective patient/service user education, position service users and their families to understand these conditions and interpret study outcomes and facilitate future HIV and chronic disease clinical studies.

Both descriptive patient-level data and rich sociobehavioural qualitative/observational data will be collected by a team of trained researchers in Tanzania and Uganda. Data collection will entail exploring the experiences, attitudes and practices of a wide variety of stakeholders during the process of INTE-AFRICA programme implementation and will develop an understanding of the impact of broader structural and contextual factors on the implementation process.10 45We will collect data on social behavioural and cultural aspects impacting implementation (eg, individual and community health risks, protective behaviours and health responses) within the broader social and political frameworks (government resources and barriers to sustaining integration), the practicalities of accessing, providing and sustaining integrated services (eg, staff time, resources, equity of access, supply chain dynamics and pharmacy components pertaining to drug types, drug/reagent availability and costs for integrated patients, catchment area/populations, quality of care, waiting room dynamics, record keeping and retention across multi/comorbidities, training gaps); and process indicators (eg, perceived stigma, acceptability of vertical vs integrated service designs, lay knowledge and awareness, the dynamics of public vs private sector integration (where relevant to the participant), and bottlenecks to accessing services). We will also describe implementation of the intervention in terms of fidelity to the intended model of care, adaptations to the intervention during implementation, and dose and reach of intervention components actually delivered and received (such as numbers and proportions of eligible staff who received integrated care training, numbers of proportions of patient participants who received all or most of their care from integrated services, and frequency of drug stock-outs). The latter data will be complemented by routinely collected quantitative data such as training attendance and medical records. We will document changes in healthcare provider roles, attitudes and patient relationships.

Interviews with patients/service users, healthcare provider and policy-maker/senior manager will include specific questions about their experience and management of individuals with multimorbid HIV, hypertension and/or diabetes. These include their perceptions of INTE-AFRICA; impacts of INTE-AFRICA on the provision of integrated HIV/AIDS care and NCD care, and relationships with NGO and international organisations; changes in health provider roles, attitudes and patient relationships; impacts of the INTE-AFRICA implementation context on trial and health economic cost outcomes; impacts of the INTE-AFRICA intervention on an integrated health systems approach to care (medicine supplies, record keeping, service user education, clinical care pathways, data management, staff training); and barriers to and facilitators of change and future sustainability of integrated care provision. We will assume a more pragmatic approach when garnering perspectives from higher level stakeholders involved in health policy and practice generation, and NGO and international organisations (eg, WHO country offices, UNAIDS, PEPFAR, CDC) providing peripheral supports and guidance. We are especially interested in better understanding the complexities around government scale up and resource allocation for chronic care (eg, decentralisation, financial planning, identification of potential funding sources at ministry levels, subsidised NCD drugs and by international donors (CDC, PEPFAR, UNAIDS) (table 3).

Data analysis and synthesis

The analysis of qualitative data will be iterative, moving between data collection and analysis to test emerging theories. Field notes of observations will be analysed thematically to provide a description of the process and content involved in adapting and delivering the intervention. Audio recordings of interviews and FGDs will be transcribed verbatim by competent and experienced social scientists, with a subsample transcribed using conversation analytic conventions. Translation from local languages (eg, Swahili, Luganda) into English will be performed for easy sharing with the study partners. Translation will occur using a back-translation method for consistency. An electronic data management package (eg, NVivo) will be used to manage the qualitative data analysis at the respective country levels. The analysis of the observational data will require knowledge obtained from health professional interviews at different levels to compare how reported experience, and different accounts of patient and professional perspectives relate to actual implementation of INTE-AFRICA scenarios: (1) when DM and hypertension services are integrated with HIV-infection services and (2) comparing countries. Care will be taken to identify and follow up deviant cases which do not fit into emerging theories. Reliability and validity of the analysis is optimised through iterative data collection, the use of a multi-method design incorporating interviews, FGD and observations and the ongoing discussion of findings within the research team for scrutiny and feedback.52 53

The chosen phenomenological approach (EPP) to collecting and analysing data, usually used in psychological research, reveals the structures of subjective experience and meaning of a lived phenomenon (in first person point of view). It follows to some extent Husserl’s principle of active efforts to ‘bracket out’ the researchers’ theoretical preunderstanding in the first steps of a text analysis.51 The ‘bracketing’, however, does not exclude an empathetic, psychological focus in the analysis on the experiences of the researched phenomenon as it is lived by the informant and what it means is to her or him. In the context of INTE-AFRICA, researchers in both countries will strive to get an empathetic understanding of the text, and hence do not apply their professional prior knowledge about integration. The analysis of the observational data will also require knowledge from health professional interviews to compare how reported experience relates to actual implementation of integration at the clinic level.

We will conduct a stepwise EPP analysis in five steps. First, the text will be read several times to get a good grasp of how the informant spoke about the researched phenomenon of integration. In this step, theoretical reflection will be withheld. Second, the whole text will be divided into meaning units of a whole paragraph or a single word. Third, the informant’s personal language will be transformed, unit by unit, to the researchers’ language. The researchers will discuss the transcription unit by unit. When different interpretations occur, the researchers will return to the interview text and discuss in a free, imaginative process until agreement can be reached through negotiated consensus. Fourth, the text will be screened in a search for comprehensive themes. The text will be interpreted with connection to the researchers’ theoretical knowledge in an interchange between the original data, the transformed units and the researchers’ theoretical preunderstanding about integration. The meaning units will be assorted into appropriate themes and thus constitute a general structure of the phenomenon of integrated care. Fifth, this essential structure will penetrate all the revealed themes and thus the meaning of the researched phenomenon of integrated care to the informant.

Credibility and transferability

The process evaluation protocol adheres to recommendations intended to facilitate the standardisation of process evaluation design and reporting.43 It provides a unique opportunity to document implementation and collaboratively refine integrated care in two SSA countries. This makes possible the synthesis of results of similar studies elsewhere in the SSA region in future. In order to ensure credibility, while we use different methods of data collection (qualitative/observational), and operate concurrently with clinical outcomes data and health economics analysis, we will also add a further layer of triangulation of sources in terms of perspectives across stakeholders and across conditions (HIV/hypertension/DM/multi/comorbidity) when raising the abstraction level. Triangulation of sociobehavioural qualitative and observational data during analysis will occur in order to understand how different types of evidence enhance the overall interpretation of how INTE-AFRICA was implemented, and what the additional health economic and clinical data are, drawing case comparisons across clinics and across countries, and developing possible explanations for implementation variation. The data, when combined and triangulated across these multi stakeholder perspectives, will provide a ‘thick description’, of how the intervention was delivered, maintained and experienced by stakeholders.10 45 It will also offer explanations for observed variation over time and between countries, and detailed insight into the interaction between different contextual features and components of integration of NCD or HIV/NCD services. It will also facilitate triangulation of information across stakeholders, clinics and countries. This approach will help to support transferability to other settings, by identifying factors which are plausibly and/or consistently related to successful or unsuccessful delivery of intervention components. We recognise the potential for selection and information bias as limitations of the trial itself, and mitigate by using a random sampling approach, defining characteristics in a cohort, using a standardised approach to collecting data with continual assessment of information bias, and ensuring that research personnel are unaware of participant disease status. We will address social desirability in the process evaluation by only providing brief information at the outset of the evaluation in order to avoid priming, using an interview schedule approved by a panel of INTE-AFRICA experts in terms of sensitivity, conducting qualitative research using skilled interviewers with limited power relationship between interviewer and participant, conducting the interviews in a safe and secure setting where the participant feels comfortable, briefing them that there is no right and wrong answer, and finally by encouraging them to use anecdotes and experiential evidence to support their views.

Emerging theories and the relationship of the data to the conceptual literature underpinning the intervention will be discussed and refined at INTE-AFRICA research team meetings throughout the project. We envisage utilising the public understanding of science theory54 to unpack how patients and their communities in Tanzania and Uganda understand and use different knowledge on HIV and NCDs in their lives. This could be facilitated by understanding how they create meaning from scientific findings relating to NCDs and HIV and if, how, and to what degree they incorporate these findings into their everyday lives. This theory has the capacity to shift public attitudes by connecting and communicating the development of innovative scientific concepts in the medical field (in this instance integration of HIV/NCD services in Tanzania and Uganda) to the non-scientific public, and thereby enhance education, training cascade, health policy and practice, and ultimately public understanding of multimorbidities and sustainable routes to care. Further, it will create a platform for the sharing of lessons learnt, best practices and context adaptation of the final integrated model of care in other African countries (clinical care policies and practice, staff cascade of training, service user education and community awareness raising).