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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.

ABSTRACT: 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.

SUBMITTER: Van Hout MC

PROVIDER: S-EPMC7542920 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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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.

Van Hout Marie-Claire MC Bachmann Max M Lazarus Jeffrey V JV Shayo Elizabeth Henry EH Bukenya Dominic D Picchio Camila A CA Nyirenda Moffat M Mfinanga Sayoki Godfrey SG Birungi Josephine J Okebe Joseph J Jaffar Shabbar S

BMJ open 20201007 10

<h4>Introduction</h4>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 ad ...[more]

PMID: 33033029

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Project description:IntroductionHIV programmes in sub-Saharan Africa are well funded but programmes for diabetes and hypertension are weak with only a small proportion of patients in regular care. Healthcare provision is organised from stand-alone clinics. In this cluster randomised trial, we are evaluating a concept of integrated care for people with HIV infection, diabetes or hypertension from a single point of care.Methods and analysis32 primary care health facilities in Dar es Salaam and Kampala regions were randomised to either integrated or standard vertical care. In the integrated care arm, services are organised from a single clinic where patients with either HIV infection, diabetes or hypertension are managed by the same clinical and counselling teams. They use the same pharmacy and laboratory and have the same style of patient records. Standard care involves separate pathways, that is, separate clinics, waiting and counselling areas, a separate pharmacy and separate medical records. The trial has two primary endpoints: retention in care of people with hypertension or diabetes and plasma viral load suppression. Recruitment is expected to take 6 months and follow-up is for 12 months. With 100 participants enrolled in each facility with diabetes or hypertension, the trial will provide 90% power to detect an absolute difference in retention of 15% between the study arms (at the 5% two-sided significance level). If 100 participants with HIV infection are also enrolled in each facility, we will have 90% power to show non-inferiority in virological suppression to a delta=10% margin (ie, that the upper limit of the one-sided 95% CI of the difference between the two arms will not exceed 10%). To allow for lost to follow-up, the trial will enrol over 220 persons per facility. This is the only trial of its kind evaluating the concept of a single integrated clinic for chronic conditions in Africa.Ethics and disseminationThe protocol has been approved by ethics committee of The AIDS Support Organisation, National Institute of Medical Research and the Liverpool School of Tropical Medicine. Dissemination of findings will be done through journal publications and meetings involving study participants, healthcare providers and other stakeholders.Trial registration numberISRCTN43896688.

Project description:BackgroundIn regions with weak healthcare systems, critical shortages of the healthcare workforce, and increasing prevalence of dual disease burdens, there is an urgent need for the implementation of proven effective interventions and strategies to address these challenges. Our mixed-methods hybrid type II effectiveness-implementation study is designed to fill this evidence-to-practice gap. This study protocol describes a cluster randomized controlled trial which evaluates the effectiveness of an implementation strategy, practice facilitation (PF), on the integration, adoption, and sustainability of a task-strengthening strategy for hypertension control (TASSH) intervention within primary healthcare centers (PHCs) in Lagos State, Nigeria.DesignGuided by the Consolidated Framework for Implementation Research (CFIR) and the Reach Effectiveness Adoption Implementation and Maintenance (RE-AIM), this study tests the impact of a proven effective implementation strategy to integrate hypertension management into the HIV care cascade, across 30 PHCs. The study will be conducted in three phases: (1) a pre-implementation phase that will use CFIR to develop a tailored PF intervention for integrating TASSH into HIV clinics; (2) an implementation phase that will use RE-AIM to compare the clinical effectiveness of PF vs. a self-directed condition (receipt of information on TASSH without PF) on BP reduction; and (3) a post-implementation phase that will use RE-AIM to evaluate the effect of PF vs. self-directed condition on adoption and sustainability of TASSH. The PF intervention components comprise (a) an advisory board to provide leadership support for implementing TASSH in PHCs; (b) training of the HIV nurses on TASSH protocol; and (c) training of practice facilitators, who will serve as coaches, provide support, and performance feedback to the HIV nurses.DiscussionThis study is one of few, if any trials, to evaluate the impact of an implementation strategy for integrating hypertension management into HIV care, on clinical and implementation outcomes. Findings from this study will advance implementation science research on the effectiveness of tailoring an implementation strategy for the integration of an evidence-based, system-level hypertension control intervention into HIV care and treatment.Trial registrationClinicalTrials.gov ( NCT04704336 ). Registered on 11 January 2021.

Project description:BackgroundChildren in Sub-Saharan Africa (SSA) comprise half of the total regional population, yet existing mental health services are severely under-equipped to meet their needs. Although effective interventions for the treatment of disruptive behavioral disorders (DBDs) in youth have been tested in high-poverty and high-stress communities in developed countries, and are relevant for widespread dissemination in low- and middle-income countries (LMICs), most of these evidence-based practices (EBPs) have not been utilized in SSA, a region heavily impacted by poverty, diseases including HIV/AIDS, and violence. Thus, this paper presents a protocol for a scale-up longitudinal experimental study that uses a mixed-methods, hybrid type II, effectiveness implementation design to test the effectiveness of an EBP, called Multiple Family Group (MFG) aimed at improving child behavioral challenges in Uganda while concurrently examining the multi-level factors that influence uptake, implementation, sustainment, and youth outcomes.MethodsThe MFG intervention will be implemented and tested via a longitudinal experimental study conducted across 30 public primary schools located in both semi-urban and rural communities. The schools will be randomly assigned to three study conditions (n = 10 per study condition): (1) MFG delivered by trained family peers; (2) MFG delivered by community health workers; or; (3) comparison: usual care comprising mental health care support materials, bolstered with school support materials. A total of 3000 children (ages 8 to 13 years; grades 2 to 7) and their caregivers (N = 3000 dyads); 60 parent peers, and 60 community health workers will be recruited. Each study condition will comprise of 1000 child-caregiver dyads. Data will be collected at baseline, 8 and 16 weeks, and 6-month follow-up.DiscussionThis project is the first to test the effectiveness of the MFG intervention while concurrently examining multi-level factors that influence overall implementation of a family-based intervention provided in schools and aimed at reaching the large child population with mental health service needs in Uganda. Moreover, the study draws upon an EBP that has already been tested for delivery by parent peers and community facilitators, and hence will take advantage of the advancing science behind task-shifting. If successful, the project has great potential to address global child mental health needs.Trial registrationClinicalTrials.gov, ID: NCT03081195 . Registered on 16 March 2017.

Project description:Large increases in health sector investment and policies favoring upgrading and expanding the public sector health network have prioritized maternal and child health in Mozambique and, over the past decade, Mozambique has achieved substantial improvements in maternal and child health indicators. Over this same period, the government of Mozambique has continued to decentralize the management of public sector resources to the district level, including in the health sector, with the aim of bringing decision-making and resources closer to service beneficiaries. Weak district level management capacity has hindered the decentralization process, and building this capacity is an important link to ensure that resources translate to improved service delivery and further improvements in population health. A consortium of the Ministry of Health, Health Alliance International, Eduardo Mondlane University, and the University of Washington are implementing a health systems strengthening model in Sofala Province, central Mozambique.The Mozambique Population Health Implementation and Training (PHIT) Partnership focuses on improving the quality of routine data and its use through appropriate tools to facilitate decision making by health system managers; strengthening management and planning capacity and funding district health plans; and building capacity for operations research to guide system-strengthening efforts. This seven-year effort covers all 13 districts and 146 health facilities in Sofala Province.A quasi-experimental controlled time-series design will be used to assess the overall impact of the partnership strategy on under-5 mortality by examining changes in mortality pre- and post-implementation in Sofala Province compared with neighboring Manica Province. The evaluation will compare a broad range of input, process, output, and outcome variables to strengthen the plausibility that the partnership strategy led to health system improvements and subsequent population health impact.The Mozambique PHIT Partnership expects to provide evidence on the effect of efforts to improve data quality coupled with the introduction of tools, training, and supervision to improve evidence-based decision making. This contribution to the knowledge base on what works to enhance health systems is highly replicable for rapid scale-up to other provinces in Mozambique, as well as other sub-Saharan African countries with limited resources and a commitment to comprehensive primary health care.

Project description:Integration of mental health into routine primary health care (PHC) services in low-and middle-income countries is globally accepted to improve health outcomes of other conditions and narrow the mental health treatment gap. Yet implementation remains a challenge. The aim of this study was to identify implementation strategies that improve implementation outcomes of an evidence-based depression care collaborative implementation model integrated with routine PHC clinic services in South Africa. An iterative, quasi-experimental, observational implementation research design, incorporating the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework, was applied to evaluate implementation outcomes of a strengthened package of implementation strategies (stage two) compared with an initial evaluation of the model (stage one). The first stage package was implemented and evaluated in 10 PHC clinics and the second stage strengthened package in 19 PHC clinics (inclusive of the initial 10 clinics) in one resource-scarce district in the province of KwaZulu-Natal, South Africa. Diagnosed service users were more likely to be referred for counselling treatment in the second stage compared with stage one (OR 23.15, SE = 18.03, z = 4.04, 95%CI [5.03-106.49], p < .001). Training in and use of a validated, mandated mental health screening tool, including on-site educational outreach and technical support visits, was an important promoter of nurse-level diagnosis rates (OR 3.75, 95% CI [1.19, 11.80], p = 0.02). Nurses who perceived the integrated care model as acceptable were also more likely to successfully diagnose patients (OR 2.57, 95% CI [1.03-6.40], p = 0.043). Consistent availability of a clinic counsellor was associated with a greater probability of referral (OR 5.9, 95%CI [1.29-27.75], p = 0.022). Treatment uptake among referred service users remained a concern across both stages, with inconsistent co-located counselling services associated with poor uptake. The importance of implementation research for strengthening implementation strategies along the cascade of care for integrating depression care within routine PHC services is highlighted.

Project description:BackgroundThe burden of hypertension among people with HIV is high, particularly in low-and middle-income countries, yet gaps in hypertension screening and care in these settings persist. This study aimed to identify facilitators of and barriers to hypertension screening, treatment, and management among people with HIV in primary care clinics in Johannesburg, South Africa. Additionally, different stakeholder groups were included to identify discordant perceptions.MethodsUsing a cross-sectional study design, data were collected via interviews (n = 53) with people with HIV and hypertension and clinic managers and focus group discussions (n = 9) with clinic staff. A qualitative framework analysis approach guided by COM-B and the Theoretical Domains Framework were used to identify and compare determinants of hypertension care across stakeholder groups.ResultsData from clinic staff and managers generated three themes characterizing facilitators of and barriers to the adoption and implementation of hypertension screening and treatment: 1) clinics have limited structural and operational capacity to support the implementation of integrated care models, 2) education and training on chronic care guidelines is inconsistent and often lacking across clinics, and 3) clinicians have the goal of enhancing chronic care within their clinics but first need to advocate for health system characteristics that will sustainably support integrated care. Patient data generated three themes characterizing existing facilitators of and barriers to clinic attendance and chronic disease self-management: 1) the threat of hypertension-related morbidity and mortality as a motivator for lifestyle change, 2) the emotional toll of clinic's logistical, staff, and resource challenges, and 3) hypertension self-management as a patchwork of informational and support sources. The main barriers to hypertension screening, treatment, and management were related to environmental resources and context (i.e., lack of enabling resources and siloed flow of clinic operations) and patients' knowledge and emotions (i.e., lack of awareness about hypertension risk, fear, and frustration). Clinical actors and patients differed in perceived need to prioritize HIV versus hypertension care.ConclusionsThe convergence of multi-stakeholder data highlight key areas for improvement, where tailored implementation strategies targeting motivations of clinic staff and capacity of patients may address challenges to hypertension screening, treatment, and management recognized across groups.

Project description:IntroductionIn Tanzania, inadequate access to comprehensive emergency obstetric and newborn care (CEmONC) services is the major bottleneck for perinatal care and results in high maternal and perinatal mortality. From 2015 to 2019, the Accessing Safe Deliveries in Tanzania project was implemented to study how to improve access to CEmONC services in underserved rural areas.MethodsA five-year longitudinal cohort study was implemented in seven health centres (HCs) and 21 satellite dispensaries in Morogoro region. Five of the health centres received CEmONC interventions and two served as controls. Forty-two associate clinicians from the intervention HCs were trained in teams for three months in CEmONC and anaesthesia. Managers of 20 intervention facilities, members of the district and regional health management teams were trained in leadership and management. Regular supportive supervision was conducted.ResultsInterventions resulted in improved responsibility and accountability among managers. In intervention HCs, the mean monthly deliveries increased from 183 (95% CI 174-191) at baseline (July 2014 -June 2016) to 358 (95% CI 328-390) during the intervention period (July 2016 -June 2019). The referral rate to district hospitals in intervention HCs decreased from 6.0% (262/4,392) with 95% CI 5.3-6.7 at baseline to 4.0% (516/12,918) with 95% CI 3.7-4.3 during the intervention period while it increased in the control group from 0.8% (48/5,709) to 1.5% (168/11,233). The obstetric case fatality rate decreased slightly from 1.5% (95% CI 0.6-3.1) at baseline to 1.1% (95% CI 0.7-1.6) during the intervention period (not statistically significant). Active engagement strategies and training in leadership and management resulted in uptake and improvement of CEmONC and anaesthesia curricula, and contributed to scale up of CEmONC at health centre level in the country.ConclusionsIntegration of leadership and managerial capacity building, with CEmONC-specific interventions was associated with health systems strengthening and improved quality of services.

Project description:INTRODUCTION:Type 2 diabetes (T2D) is increasingly contributing to the global burden of disease. Health systems in most parts of the world are struggling to diagnose and manage T2D, especially in low-income and middle-income countries, and among disadvantaged populations in high-income countries. The aim of this study is to determine the added benefit of community interventions onto health facility interventions, towards glycaemic control among persons with diabetes, and towards reduction in plasma glucose among persons with prediabetes. METHODS AND ANALYSIS:An adaptive implementation cluster randomised trial is being implemented in two rural districts in Uganda with three clusters per study arm, in an urban township in South Africa with one cluster per study arm, and in socially disadvantaged suburbs in Stockholm, Sweden with one cluster per study arm. Clusters are communities within the catchment areas of participating primary healthcare facilities. There are two study arms comprising a facility plus community interventions arm and a facility-only interventions arm. Uganda has a third arm comprising usual care. Intervention strategies focus on organisation of care, linkage between health facility and the community, and strengthening patient role in self-management, community mobilisation and a supportive environment. Among T2D participants, the primary outcome is controlled plasma glucose; whereas among prediabetes participants the primary outcome is reduction in plasma glucose. ETHICS AND DISSEMINATION:The study has received approval in Uganda from the Higher Degrees, Research and Ethics Committee of Makerere University School of Public Health and from the Uganda National Council for Science and Technology; in South Africa from the Biomedical Science Research Ethics Committee of the University of the Western Cape; and in Sweden from the Regional Ethical Board in Stockholm. Findings will be disseminated through peer-reviewed publications and scientific meetings. TRIAL REGISTRATION NUMBER:ISRCTN11913581; Pre-results.

Dataset Information

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.

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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.

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