Managing hypertension in rural Gambia and Kenya: Protocol for a qualitative study exploring the experiences of patients, health care workers, and decision-makers

Study aims and objectives

The overarching aim of this study is to understand the experiences, needs, and practices at the individual, organisational, and system levels to detect, treat, and control hypertension in rural Gambia and Kenya. The specific objectives are to:

Patient and Public Involvement

Community members and stakeholders have been involved in different stages of developing the IHCoR-Africa study project and its implementation. In the Gambia, this included community health volunteers, managers of health facilities, and representatives of the regional health directorates and the Ministry of Health. In Kenya, this included representatives of community advisory groups, community health volunteers, facility managers, county health managers, Ministry of Health representatives, and NCD partners. We held consultative meetings to discuss the research ideas with members of the community advisory board in Kilifi (Kenya) prior to submitting the study proposal for funding. When funding was granted, planned studies were discussed with various stakeholders at different levels in both countries and their feedback was incorporated into the study protocols before seeking scientific and ethical approvals. Upon securing the necessary approvals implementation of the study activities involved community members and sub-national and national health authorities. In both countries, community members are actively involved in sensitisation and consenting of study participants. The findings of this study will also be discussed with community members and stakeholders for validation during meetings. Furthermore, dissemination workshops will be organised at different levels in both countries.

Conceptual framing

Our overall approach to this study places people with hypertension (and their family carers) at the centre of the hypertension care pathway. It recognises that availability of, and access to services that are necessary for successful hypertension management while noting that the social and economic contexts within which people live greatly impact their capacity to seek care and self-manage their conditions. This creates a ‘treatment burden’ interacting with and complicating clinical care³³. High burdens will likely result in poorer health care outcomes for individuals. Our analytical approach will be guided by the Cumulative Complexity Model (CCM)³⁴. The CCM distinguishes the demands placed upon people with chronic health problems to (self-) manage their conditions alongside other daily tasks that are associated with living with a chronic disease. This involves users having to engage with health services (‘patient workload’) and the capacity of health facilities to meet patients’ needs given their physical and mental well-being, levels of literacy and beliefs, and importantly, their wider social and economic environment and resources available to them (‘patient capacity’). Patient workload and capacity are dynamic and interact; an imbalance between these will create compounded risks in care-seeking (e.g., low adherence to treatment) and outcomes (such as complications). Emerging evidence drawing on this model in SSA found how clinical and social factors accumulate and interact to complicate care for people with chronic conditions^35–38.

We will also draw on components of implementation research, in particular theories of organisational readiness and the dissemination of innovations^39,40. This will enable us to understand the motivations for and capacity to implement the changes required at the organisational and system levels to improve hypertension management in rural Kenya and Gambia.

Settings

This study will be conducted in the Lower River Region of the Gambia (West Africa) and in Kilifi County in Kenya (East Africa). Both settings have high levels of hypertension, estimated to range from 18.3%–32.4% in The Gambia⁴¹ and 12.6–36.9% in Kenya⁴². Documented prevalence rates are likely to be underestimated with data from The Gambia suggesting that almost 70% of those with hypertension may be undiagnosed⁴³. Treatment and control rates are low; for example, in The Gambia, in 2018, an estimated 32.5% of hypertensive patients were on treatment and only 10% had their BP controlled⁴⁴. In Kilifi County, only 3% of those diagnosed have their BP controlled⁴⁵.

Both settings have a well-developed research infrastructure which is critical for the overall project activities: Medical Research Council (MRC) Unit The Gambia at LSHTM in Kiang West, and KEMRI Wellcome Trust Research Programme (KWTRP) in Kilifi.

The Gambia. The Gambian operates a three-tier system for the delivery of public health services. The primary level (village health services) is the first point of contact and is run by two community health volunteers, village health workers (VHW) and community birth companions (CBC)⁴⁶. Some communities also have a community clinic run by community health nurses (CHN) or a minor health centre, providing a wider range of services to people who cannot be managed by the VHWs/CBCs⁴⁶. The secondary level comprises (i) major health centres that receive patients on referral from community clinics and minor health centres⁴⁶ and (ii) district hospitals which are referral points for minor and major health centres; they offer comprehensive emergency obstetric and surgery services including caesarean section and blood transfusion. The tertiary level consists of thegeneral, teaching and, specialised hospitals; teaching and specialised hospitals are the highest level of the referral system. District hospitals are supervised by the Regional Health Directorate, whereas general and teaching hospitals are semi-autonomous⁴⁶.

The population of the Lower River Region was estimated at 89,157 in 2020⁴⁷. It is mainly rural, with high levels of poverty, at around 60% in 2020⁴⁸. Health services are provided by 13 public health facilities, including 7 community clinics, 5 minor health centres and one district hospital. Facility staffing (skilled health workers) is at 1.54/1000 population, slightly higher than the national average at 1.53/1000 population⁴⁷ but significantly lower than the WHO recommended standard of 4.45/1000⁴⁹.

Kenya. The delivery of public health services in Kenya is organised in six levels: community health services (level 1), primary care services provided by dispensaries (level 2) and health centres (level 3), primary referral hospitals (level 4), secondary referral hospitals (level 5) and tertiary (national) referral hospitals (level 6) that provide highly specialised services including specialist medical care, laboratory support, blood product services, and research^50,51. In Kenya, health facility staffing is at 3.01/1,000 individuals⁵², which is lower than the WHO recommendation of 4.45/1,000⁴⁹.

Kilifi County has a population of about 1.4 million (2019)⁵³. Mainly rural, with main economic activities being subsistence farming, fishing, and tourism⁵⁴, Kilifi is among the poorest counties in Kenya, with around half of the population unable to afford the basic basket of goods in 2021⁵⁵. Health care services in Kilifi County are provided by 150 public health facilities, including 132 dispensaries, 9 health centres, and 9 primary referral hospitals⁵⁶. The County has a total of 1,522 health care workers as of December 2022, with 5.96 skilled health workers per 10,000 people^52,57.

Data collection methods

The following data collection methods will be used: in-depth interviews with patients, health care workers, decision-makers and NCD partners, focus group discussions with patients, and document review. Different data types will contribute to different objectives.

Focus group discussions (FGD) (Objective 1). Focus group discussions (FGD) aim to understand how people living with hypertension interact with health care services, from the point of symptom recognition, screening, and diagnosis to ongoing treatment. This first step will allow us to generate a mapping of the hypertension patient journey, assuming a ‘typical patient’, but noting important variations or divergences as well as gaps in the journey where necessary. It will inform work for Objectives 2–4, and a detailed explanatory analysis, which will be important in understanding points of variation in the journey, major overlaps and gaps as well as giving insights into how the journey is experienced.

In-depth interviews (IDI) (Objectives 2–4). We will use in-depth interviews to enable a detailed understanding of the views and experiences of those living with hypertension (Objective 2) and of those providing and/or overseeing care for people with hypertension (Objective 3) as well as exploration of the readiness for and capacity of health facilities to introduce new ways of working to improve hypertension management in the two study settings (Objective 4). In-depth interviews provide a suitable approach to engage with people’s accounts of their experiences and help understand the context (home, family, work) in which study participants deal with issues related to their health condition. This approach will generate data on how patients pass through the health care system and the challenges they encounter along the care pathway, from the service user, provider, and decision-maker perspectives, for managing their hypertension, access to and use of services, treatment adherence, and patients’ and health care workers’ preferences for care.

Document review (Objectives 1 and 3). The document review aims to map service delivery structures, policies and frameworks and the journey of patients with hypertension through health care system in both countries. We will review (i) the principal organisation of the service delivery structures in Kilifi (Kenya) and Lower River Region (The Gambia), including current strategies for and approaches to referral generally and (ii) national/local level guidance on hypertension screening, diagnosis, and management specifically. We will analyse published and unpublished documents including national-level strategy and policy documents, hypertension guidelines issued by professional associations, local standard operating procedures, and other relevant documentation in each study site. Documents will be identified through targeted searches of the websites of governmental and non-governmental agencies and organisations with a remit in health service and system organisation, financing, and governance, and NCDs specifically, including Departments of Ministry of Health in both countries, The Gambia Alcohol Policy Alliance, Pan African Society of Cardiology, the Kenya Cardiac Society, and the NCD Alliance of Kenya. These organisations are project partners; we will consult with them directly to identify any additional information that is not in the public domain. We will also conduct Google Scholar searches to identify any additional documents of relevance to the study aim using the following search terms “guideline/s or protocol”, “hypertension”, “diagnosis”, “treatment”, “control” and “sub-Sahara/n Africa”. Furthermore, we will approach individual health facilities in the study locations in Kenya and The Gambia to collate clinical protocols and standard operating procedures relating to the management of hypertension where these are available. For the purposes of this study, we understand ‘management’ to encompass the diagnosis and treatment of hypertension We will use a template to extract data from the included documents for the analysis.

Data collection

Recruitment of FGD and interview participants. We will use a combination of purposive and snowball sampling to identify FGD (people with hypertension and their family carers) and interview participants (people with hypertension/carers, health care workers involved in the delivery of hypertension care, community health volunteers, and decision-makers).

Patients. We will recruit a range of patients from different socio-demographic backgrounds, their location in the patient journey (newly diagnosed, commenced treatment, with complications, drop out, etc.), as well as geographic location (distance to health facilities). For both focus group discussions and in-depth interviews, patients will be identified through the following ways.

Health care workers. We will recruit a purposive sample of health care workers involved in the diagnosis, treatment, and control of hypertension across the different levels of service delivery, including physicians, clinical officers, nurses, and community health volunteers in both study settings.

In The Gambia (Lower River Region), we will invite health care workers involved in hypertension management at village health services, community clinics and minor health centres (level 1), and the district hospital (level 2). In Kenya (Kilifi), we will consider all levels of health service delivery, including community health services (level 1), dispensaries (level 2), health centres (level 3), as well as sub-county and county hospitals (levels 4 and 5).

In both study sites, the selection of facilities to be included in the study will be discussed with the relevant health authorities (Gambia Lower River Regional health authorities and Kilifi County health authorities in Kenya) to identify those with active hypertension management clinics. At each level of health facility, the number of health care workers to include in the data collection will be 1-3 individuals.

Decision-makers. These will include those representing the different governance levels in each study site, that is, senior executives (stakeholders involved in NCD/hypertension policy including policy formulation, adoption, implementation, and oversight at national and sub-national levels), managers of health facilities, and members of professional organisations involved in hypertension care programmes. We anticipate that a small number of health care workers identified above will also be facility managers; interviewing them will aim to explore their dual role as both service providers and decision-makers.

The sampling frame for this study is purposive rather than representative. It is intended to capture the range of perspectives of those directly or indirectly involved in hypertension diagnosis and management. Table 1 indicates the sampling for this study.

In total, eight focus group discussions (FGDs) with patients assisted by their adult family carers (where feasible) will be conducted. The overall number of participants for the eight FGDs across the two countries will be 40 – 64 individuals, that is, 20 – 32 participants in each study site.

Regarding in-depth interviews, we anticipate including 110 – 150 participants in total across the two countries, that is, 55 – 75 participants in each.

Qualitative sample sizes are best determined iteratively when themes generated in interviews approach saturation, based on the judgement and experience of interviewers⁵⁸. Data saturation will be assessed on the basis of whether the study team is not able to identify any new themes after conducting a certain number of consecutive interviews in each category of informants in each study setting. This means that recruitment will stop when data that has been collected is viewed as adequate in relation to the study objectives and that any further data collection will not generate any additional insights. Therefore, for all participant categories, the final number of informants may vary, which means, we might include a higher or lower number of participants in each category as data collection progresses. This means that additional participants may be identified during data collection who will then be approached for interviews.

FGD and interview process

We developed five topic guides for the different stakeholder groups and interview forms (FGD, IDI) to gain insight into the lived experiences of patients, health care workers, and decision-makers with hypertension care with regard to service use, provision, and oversight, drawing on phenomenological enquiry.

The development of topic guides for patients was informed by the Cumulative Complexity Model³⁴ to further explore the experienced burdens of people with chronic diseases such as hypertension in managing their conditions alongside their daily tasks in their communities. The tools further explore people’s journey through the system from the first time they were diagnosed, follow-up visits, treatment, and medication, and management of any complications related to their condition to the involvement of community health volunteers in the diagnosis and management of hypertension in their communities.

Topic guides for interviews with village health workers/community health promoters, health care workers and decision-makers seek to understand their views on the services for hypertension management, including existing treatment protocols and guidelines; experiences of the organisation and delivery of health services for the diagnosis, treatment, and control of hypertension, as well as perceptions of barriers and opportunities to improve current approaches to hypertension care in rural Gambia and Kenya. We also explore perceptions of the capacity and readiness of health systems to improve the delivery of hypertension care. Topic guide development drew on theories of organisational readiness and the dissemination of innovations^39,40, enabling us to understand how services in both countries may be able to accommodate or implement the changes required at the organisational and system level to improve hypertension management in rural Kenya and Gambia.

An FGD session will convene 5–8 people with hypertension and family carers (depending on the willingness of the patient to be assisted) and will last between 60 to 90 minutes. Four FGDs will be organised in both sites, two FGDs with females and two others with males, in each site.

In-depth interviews will last between 30 to 60 minutes and be carried out face-to-face.

An experienced team in qualitative research will collect data from participants in local languages (Swahili or Giriama in Kenya and Mandinka or Wolof in The Gambia) or in English depending on the participant’s language preference. Both in-depth interviews and focus group discussions will take place in a location most convenient for participants. During fieldwork, we will hold review meetings to reflect on our findings and experiences and adjust data collection strategies as needed.

Data analysis

Interviews and focus group discussions will be recorded, with participants’ permission, and transcribed verbatim in English. Transcripts will be imported into the software NVivo 12 for processing and the data will be analysed thematically. Transcripts will be read repeatedly to familiarise ourselves with the data; data will be inductively coded to develop the coding frame. The resulting coding frame will be applied iteratively across the transcripts and modifications will be made depending on the data, as themes reoccur and appear important about the lived experiences of study participants. These codes will then be grouped into overarching themes, which will be analysed to compare findings across cases. This stage of analysis will involve discussions within the research team to refine the themes and to group them into meaningful conceptual categories. This will allow us to draw tentative conclusions about aspects of the lived experiences of patients with hypertension and their care-seeking from health facilities, experiences and expectations of health care workers and decision-makers about better organisation and delivery of hypertension care in rural settings. The data analysis will further be guided by the Cumulative Complexity Model³⁴, organisational readiness, and the dissemination of innovations theories^39,40 as indicated above.

Ethical approval

Approvals have been granted by the MRCG Scientific Coordination Committee and The Gambia Government – MRCG joint Ethics Committee in The Gambia (ref. 28313, January 4^th, 2023); the KEMRI Scientific Committee and the Scientific and Ethics Review Unit (SERU) in Kenya (ref. 4631, February 27^th 2023); the LSHTM Ethics Committee in the UK (ref. 28313, 7 February 7^th, 2023).

Informed consent will be obtained from all participants in this study through their signatures or fingerprints on an informed consent form, in which participants confirm that they have read and understood the project information sheet. Additionally, at the beginning of each interview or FGD, the interviewer/FGD moderator will seek confirmation from participants that they are willing to participate in the data collection and that they agree that the interview and FGD will be audio recorded and transcribed. In case participants are unable to read the information sheet and consent form, these will be read out to them in their native language in the presence of a witness and their consent will be sought and obtained through their signatures or fingerprints on the forms; where a suitable witness cannot be identified, the participant will not be interviewed. After the consenting, a copy of the forms will be given to the participant to keep, and the study team will keep another copy for their record.

Data collected in each study country will be kept in a secure password-protected environment and any hard copies of interview transcripts and consent forms will be kept in a locked cabinet. Once data have been processed and databases created, they will be encrypted, password-protected and saved on a secured server under each institutional data protection policies, i.e. MRC Gambia (MRCG) and KEMRI-Wellcome Trust Research Programme (KWTRP). Encrypted data from both study sites excluding any personal identifiers will later be transferred to a secure server at LSHTM to be used by researchers across different sites for cross-country analysis.

Dissemination

The findings of this study will inform the development of a community-based intervention in a separate study protocol using a participatory action research approach⁵⁹ to be implemented for the diagnosis, treatment, and control of hypertension in rural Gambia and Kenya, as part of the broader IHCoR-Africa research project. Findings and learning will be shared with health care workers, community members, administrative and political stakeholders involved in decision-making about hypertension management policies and guidelines, and members of professional organisations involved in hypertension care programmes through workshops at national and subnational levels. The findings will also be made available on the IHCoR-Africa website. Furthermore, findings will be disseminated via peer-reviewed publications, conferences, media, and lay reports.

Study status

Ethics approvals have been secured in both countries and participants' recruitment to the study began in July 2023 as well as data collection. In Kenya, the data collection is ongoing but was completed in The Gambia in October 2023. The transcription of audio files is ongoing in both countries, after which the data analysis will take place.