Decentralising chronic disease management in sub-Saharan Africa: a protocol for the qualitative process evaluation of community-based integrated management of HIV, diabetes and hypertension in Tanzania and Uganda.

INTRODUCTION: Sub-Saharan Africa continues to experience a syndemic of HIV and non-communicable diseases (NCDs). Vertical (stand-alone) HIV programming has provided high-quality care in the region, with almost 80% of people living with HIV in regular care and 90% virally suppressed. While integrated health education and concurrent management of HIV, hypertension and diabetes are being scaled up in clinics, innovative, more efficient and cost-effective interventions that include decentralisation into the community are required to respond to the increased burden of comorbid HIV/NCD disease. METHODS AND ANALYSIS: This protocol describes procedures for a process evaluation running concurrently with a pragmatic cluster-randomised trial (INTE-COMM) in Tanzania and Uganda that will compare community-based integrated care (HIV, diabetes and hypertension) with standard facility-based integrated care. The INTE-COMM intervention will manage multiple conditions (HIV, hypertension and diabetes) in the community via health monitoring and adherence/lifestyle advice (medicine, diet and exercise) provided by community nurses and trained lay workers, as well as the devolvement of NCD drug dispensing to the community level. Based on Bronfenbrenner's ecological systems theory, the process evaluation will use qualitative methods to investigate sociostructural factors shaping care delivery and outcomes in up to 10 standard care facilities and/or intervention community sites with linked healthcare facilities. Multistakeholder interviews (patients, community health workers and volunteers, healthcare providers, policymakers, clinical researchers and international and non-governmental organisations), focus group discussions (community leaders and members) and non-participant observations (community meetings and drug dispensing) will explore implementation from diverse perspectives at three timepoints in the trial implementation. Iterative sampling and analysis, moving between data collection points and data analysis to test emerging theories, will continue until saturation is reached. This process of analytic reflexivity and triangulation across methods and sources will provide findings to explain the main trial findings and offer clear directions for future efforts to sustain and scale up community-integrated care for HIV, diabetes and hypertension. ETHICS AND DISSEMINATION: The protocol has been approved by the University College of London (UK), the London School of Hygiene and Tropical Medicine Ethics Committee (UK), the Uganda National Council for Science and Technology and the Uganda Virus Research Institute Research and Ethics Committee (Uganda) and the Medical Research Coordinating Committee of the National Institute for Medical Research (Tanzania). The University College of London is the trial sponsor. Dissemination of findings will be done through journal publications and stakeholder meetings (with study participants, healthcare providers, policymakers and other stakeholders), local and international conferences, policy briefs, peer-reviewed journal articles and publications. TRIAL REGISTRATION NUMBER: ISRCTN15319595.

Implementing integrated care clinics for HIV-infection, diabetes and hypertension in Uganda (INTE-AFRICA): process evaluation of a cluster randomised controlled trial.

BACKGROUND: Sub-Saharan Africa is experiencing a dual burden of chronic human immunodeficiency virus and non-communicable diseases. A pragmatic parallel arm cluster randomised trial (INTE-AFRICA) scaled up 'one-stop' integrated care clinics for HIV-infection, diabetes and hypertension at selected facilities in Uganda. These clinics operated integrated health education and concurrent management of HIV, hypertension and diabetes. A process evaluation (PE) aimed to explore the experiences, attitudes and practices of a wide variety of stakeholders during implementation and to develop an understanding of the impact of broader structural and contextual factors on the process of service integration. METHODS: The PE was conducted in one integrated care clinic, and consisted of 48 in-depth interviews with stakeholders (patients, healthcare providers, policy-makers, international organisation, and clinical researchers); three focus group discussions with community leaders and members (n = 15); and 8 h of clinic-based observation. An inductive analytical approach collected and analysed the data using the Empirical Phenomenological Psychological five-step method. Bronfenbrenner's ecological framework was subsequently used to conceptualise integrated care across multiple contextual levels (macro, meso, micro). RESULTS: Four main themes emerged; Implementing the integrated care model within healthcare facilities enhances detection of NCDs and comprehensive co-morbid care; Challenges of NCD drug supply chains; HIV stigma reduction over time, and Health education talks as a mechanism for change. Positive aspects of integrated care centred on the avoidance of duplication of care processes; increased capacity for screening, diagnosis and treatment of previously undiagnosed comorbid conditions; and broadening of skills of health workers to manage multiple conditions. Patients were motivated to continue receiving integrated care, despite frequent NCD drug stock-outs; and development of peer initiatives to purchase NCD drugs. Initial concerns about potential disruption of HIV care were overcome, leading to staff motivation to continue delivering integrated care. CONCLUSIONS: Implementing integrated care has the potential to sustainably reduce duplication of services, improve retention in care and treatment adherence for co/multi-morbid patients, encourage knowledge-sharing between patients and providers, and reduce HIV stigma. TRIAL REGISTRATION NUMBER: ISRCTN43896688.

Applying systems thinking to identify enablers and challenges to scale-up interventions for hypertension and diabetes in low-income and middle-income countries: protocol for a longitudinal mixed-methods study.

INTRODUCTION: There is an urgent need to reduce the burden of non-communicable diseases (NCDs), particularly in low-and middle-income countries, where the greatest burden lies. Yet, there is little research concerning the specific issues involved in scaling up NCD interventions targeting low-resource settings. We propose to examine this gap in up to 27 collaborative projects, which were funded by the Global Alliance for Chronic Diseases (GACD) 2019 Scale Up Call, reflecting a total funding investment of approximately US$50 million. These projects represent diverse countries, contexts and adopt varied approaches and study designs to scale-up complex, evidence-based interventions to improve hypertension and diabetes outcomes. A systematic inquiry of these projects will provide necessary scientific insights into the enablers and challenges in the scale up of complex NCD interventions. METHODS AND ANALYSIS: We will apply systems thinking (a holistic approach to analyse the inter-relationship between constituent parts of scaleup interventions and the context in which the interventions are implemented) and adopt a longitudinal mixed-methods study design to explore the planning and early implementation phases of scale up projects. Data will be gathered at three time periods, namely, at planning (TP), initiation of implementation (T0) and 1-year postinitiation (T1). We will extract project-related data from secondary documents at TP and conduct multistakeholder qualitative interviews to gather data at T0 and T1. We will undertake descriptive statistical analysis of TP data and analyse T0 and T1 data using inductive thematic coding. The data extraction tool and interview guides were developed based on a literature review of scale-up frameworks. ETHICS AND DISSEMINATION: The current protocol was approved by the Monash University Human Research Ethics Committee (HREC number 23482). Informed consent will be obtained from all participants. The study findings will be disseminated through peer-reviewed publications and more broadly through the GACD network.

Integrated healthcare services for HIV, diabetes mellitus and hypertension in selected health facilities in Kampala and Wakiso districts, Uganda: A qualitative methods study.

Health policies in Africa are shifting towards integrated care services for chronic conditions, but in parts of Africa robust evidence on effectiveness is limited. We assessed the integration of vertical health services for HIV, diabetes and hypertension provided in a feasibility study within five health facilities in Uganda. From November 2018 to January 2020, we conducted a series of three in-depth interviews with 31, 29 and 24 service users attending the integrated clinics within Kampala and Wakiso districts. Ten healthcare workers were interviewed twice during the same period. Interviews were conducted in Luganda, translated into English, and analysed thematically using the concepts of availability, affordability and acceptability. All participants reported shortages of diabetes and hypertension drugs and diagnostic equipment prior to the establishment of the integrated clinics. These shortages were mostly addressed in the integrated clinics through a drugs buffer. Integration did not affect the already good provision of anti-retroviral therapy. The cost of transport reduced because of fewer clinic visits after integration. Healthcare workers reported that the main cause of non-adherence among users with diabetes and hypertension was poverty. Participants with diabetes and hypertension reported they could not afford private clinical investigations or purchase drugs prior to the establishment of the integrated clinics. The strengthening of drug supply for non-communicable conditions in the integrated clinics was welcomed. Most participants observed that the integrated clinic reduced feelings of stigma for those living with HIV. Sharing the clinic afforded privacy about an individual's condition, and users were comfortable with the waiting room sitting arrangement. We found that integrating non-communicable disease and HIV care had benefits for all users. Integrated care could be an effective model of care if service users have access to a reliable supply of basic medicines for both HIV and non-communicable disease conditions.

Strengthening integration of chronic care in Africa: protocol for the qualitative process evaluation of integrated HIV, diabetes and hypertension care in a cluster randomised controlled trial in Tanzania and Uganda.

INTRODUCTION: In sub-Saharan Africa, the burden of non-communicable diseases (NCDs), particularly diabetes mellitus (DM) and hypertension, has increased rapidly in recent years, although HIV infection remains a leading cause of death among young-middle-aged adults. Health service coverage for NCDs remains very low in contrast to HIV, despite the increasing prevalence of comorbidity of NCDs with HIV. There is an urgent need to expand healthcare capacity to provide integrated services to address these chronic conditions. METHODS AND ANALYSIS: This protocol describes procedures for a qualitative process evaluation of INTE-AFRICA, a cluster randomised trial comparing integrated health service provision for HIV infection, DM and hypertension, to the current stand-alone vertical care. Interviews, focus group discussions and observations of consultations and other care processes in two clinics (in Tanzania, Uganda) will be used to explore the experiences of stakeholders. These stakeholders will include health service users, policy-makers, healthcare providers, community leaders and members, researchers, non-governmental and international organisations. The exploration will be carried out during the implementation of the project, alongside an understanding of the impact of broader structural and contextual factors. ETHICS AND DISSEMINATION: Ethical approval was granted by the Liverpool School of Tropical Medicine (UK), the National Institute of Medical Research (Tanzania) and TASO Research Ethics Committee (Uganda) in 2020. The evaluation will provide the opportunity to document the implementation of integration over several timepoints (6, 12 and 18 months) and refine integrated service provision prior to scale up. This synergistic approach to evaluate, understand and respond will support service integration and inform monitoring, policy and practice development efforts to involve and educate communities in Tanzania and Uganda. It will create a model of care and a platform of good practices and lessons learnt for other countries implementing integrated and decentralised community health services. TRIAL REGISTRATION NUMBER: ISRCTN43896688; Pre-results.

Integrated care for human immunodeficiency virus, diabetes and hypertension in Africa.

The rising burden from non-communicable diseases (NCDs) poses a huge challenge for health care delivery in Africa, where health systems are already struggling with the long-term care requirements for the millions of people now on antiretroviral therapy requiring regular visits to health facilities for monitoring, adherence support and drugs. The HIV chronic disease management programme is comparatively well-funded, well-organised and well-informed and offers many insights and opportunities for the expansion of NCD prevention and treatment services. Some degree of human immunodeficiency virus (HIV) and NCD service integration is essential, but how to do this without risking the HIV treatment gains is unclear. Both HIV and NCD services must expand within a resource-constrained environment and policymakers are in urgent need of evidence to guide cost-effective and acceptable changes in these health services.

A new strategy and its effect on adherence to intermittent preventive treatment of malaria in pregnancy in Uganda.

BACKGROUND: Few women in Uganda access intermittent preventive treatment of malaria in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP). Previous studies have shown that high costs, frequent stock-out of drugs, supplies and poor quality of care are the greatest hindrance for women to access health services. In order to increase adherence to IPTp, we conceptualised an intervention that offset delivery care costs through providing a mama kit, created awareness on health benefits of IPTp and built trust between the provider and the client. METHODS: The new strategy was conceived along four constructs namely: 1) creating awareness by training midwives to explain the benefits of SP and the importance of adhering to the two doses of SP as IPTp to all pregnant women who attended ANC and consented to the study. Midwives were trained for two days in customer care and to provide a friendly environment. The pregnant women were also informed of the benefits of attending ANC and delivering at health facilities. 2) Each woman was promised a mama kit during ANC; 3) trust was built by showing the mama kit to each woman and branding it with her name; 4) keeping the promise by providing the mama kit when women came to deliver. The strategy to increase adherence to two doses of SP and encourage women to deliver at health facilities was implemented at two health facilities in Mukono district (Kawolo hospital and Mukono health centre IV). The inclusion criteria were women who: i) consented to the study and ii) were in the second trimester of pregnancy. All pregnant women in the second trimester (4-6 months gestation) who attended ANC and consented to participate in the study were informed of the benefits of SP, the importance of delivering at health facilities, were advised to attend the scheduled visits, promised a mama kit and ensured the kit was available at delivery. The primary outcome was the proportion of pregnant women adhering to a two dose SP regimen. RESULTS: A total of 2,276 women received the first dose of SP and 1,656 (72.8%) came back for the second dose. 1,069 women were involved in the evaluation (384 had participated in the intervention while 685 had not). The main reasons that enabled those who participated in the intervention to adhere to the two doses of IPTp and deliver at the study facilities were: an explanation provided on the benefits of IPTp and delivering at health facilities (25.1%), availability of a mama kit at delivery (24.6%), kind midwives (19.8%) and fearing complications of pregnancy (8.5%). Overall, 78.0% of these women reported that they were influenced to adhere to IPTp by the intervention. In a multivariable regression, nearby facility, P = 0. 007, promising a mama kit, P = 0.002, kind midwives, P = 0.0001 and husbands' encouragement, P = 0.0001 were the significant factors influencing adherence to IPTp with SP. CONCLUSION: The new strategy was a good incentive for women to attend scheduled ANC visits, adhere to IPTp and deliver at the study facilities. Policy implications include the urgent need for developing a motivation package based on the Health-Trust Model to increase access and adherence to IPTp.

ABC for people with HIV: responses to sexual behaviour recommendations among people receiving antiretroviral therapy in Jinja, Uganda.

People living with HIV who are taking antiretroviral therapy (ART) are increasingly involved in 'positive prevention' initiatives. These are generally oriented to promoting abstinence, 'being faithful' (partner reduction) and condom use (ABC). We conducted a longitudinal qualitative study with people living with HIV using ART, who were provided with adherence education and counselling support by a Ugandan non-governmental organisation, The AIDS Support Organisation (TASO). Forty people were selected sequentially as they started ART, stratified by sex, ART delivery mode (clinic- or home-based) and HIV progression stage (early or advanced) and interviewed at enrollment and at 3, 6, 18 and 30 months. At initiation of ART, participants agreed to follow TASO's positive-living recommendations. Initially poor health prevented sexual activity. As health improved, participants prioritised resuming economic production and support for their children. With further improvements, sexual desire resurfaced and people in relationships cemented these via sex. The findings highlight the limitations of HIV prevention based on medical care/personal counselling. As ART leads to health improvements, social norms, economic needs and sexual desires increasingly influence sexual behaviour. Positive prevention interventions need to seek to modify normative and economic influences on sexual behaviour, as well as to provide alternatives to condoms.

Density of healthcare providers and patient outcomes: evidence from a nationally representative multi-site HIV treatment program in Uganda.

OBJECTIVE: We examined the association between density of healthcare providers and patient outcomes using a large nationally representative cohort of patients receiving combination antiretroviral therapy (cART) in Uganda. DESIGN: We obtained data from The AIDS Support Organization (TASO) in Uganda. Patients 18 years of age and older who initiated cART at TASO between 2004 and 2008 contributed to this analysis. The number of healthcare providers per 100 patients, the number of patients lost to follow-up per 100 person years and number of deaths per 100 person years were calculated. Spearman correlation was used to identify associations between patient loss to follow-up and mortality with the healthcare provider-patient ratios. RESULTS: We found no significant associations between the number of patients lost to follow-up and physicians (p = 0.45), nurses (p = 0.93), clinical officers (p = 0.80), field officers (p = 0.56), and healthcare providers overall (p = 0.83). Similarly, no significant associations were observed between mortality and physicians (p = 0.65), nurses (p = 0.49), clinical officers (p = 0.73), field officers (p = 0.78), and healthcare providers overall (p = 0.73). CONCLUSIONS: Patient outcomes, as measured by loss to follow-up and mortality, were not significantly associated with the number of doctors, nurses, clinical officers, field officers, or healthcare providers overall. This may suggest that that other factors, such as the presence of volunteer patient supporters or broader political or socioeconomic influences, may be more closely associated with outcomes of care among patients on cART in Uganda.