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.

Integrated management of HIV, diabetes, and hypertension in sub-Saharan Africa (INTE-AFRICA): a pragmatic cluster-randomised, controlled trial.

BACKGROUND: In sub-Saharan Africa, health-care provision for chronic conditions is fragmented. The aim of this study was to determine whether integrated management of HIV, diabetes, and hypertension led to improved rates of retention in care for people with diabetes or hypertension without adversely affecting rates of HIV viral suppression among people with HIV when compared to standard vertical care in medium and large health facilities in Uganda and Tanzania. METHODS: In INTE-AFRICA, a pragmatic cluster-randomised, controlled trial, we randomly allocated primary health-care facilities in Uganda and Tanzania to provide either integrated care or standard care for HIV, diabetes, and hypertension. Random allocation (1:1) was stratified by location, infrastructure level, and by country, with a permuted block randomisation method. In the integrated care group, participants with HIV, diabetes, or hypertension were managed by the same health-care workers, used the same pharmacy, had similarly designed medical records, shared the same registration and waiting areas, and had an integrated laboratory service. In the standard care group, these services were delivered vertically for each condition. Patients were eligible to join the trial if they were living with confirmed HIV, diabetes, or hypertension, were aged 18 years or older, were living within the catchment population area of the health facility, and were likely to remain in the catchment population for 6 months. The coprimary outcomes, retention in care (attending a clinic within the last 6 months of study follow-up) for participants with either diabetes or hypertension (tested for superiority) and plasma viral load suppression for those with HIV (>1000 copies per mL; tested for non-inferiority, 10% margin), were analysed using generalised estimating equations in the intention-to-treat population. This trial is registered with ISCRTN 43896688. FINDINGS: Between June 30, 2020, and April 1, 2021 we randomly allocated 32 health facilities (17 in Uganda and 15 in Tanzania) with 7028 eligible participants to the integrated care or the standard care groups. Among participants with diabetes, hypertension, or both, 2298 (75·8%) of 3032 were female and 734 (24·2%) of 3032 were male. Of participants with HIV alone, 2365 (70·3%) of 3365 were female and 1000 (29·7%) of 3365 were male. Follow-up lasted for 12 months. Among participants with diabetes, hypertension, or both, the proportion alive and retained in care at study end was 1254 (89·0%) of 1409 in integrated care and 1457 (89·8%) of 1623 in standard care. The risk differences were -0·65% (95% CI -5·76 to 4·46; p=0·80) unadjusted and -0·60% (-5·46 to 4·26; p=0·81) adjusted. Among participants with HIV, the proportion who had a plasma viral load of less than 1000 copies per mL was 1412 (97·0%) of 1456 in integrated care and 1451 (97·3%) of 1491 in standard care. The differences were -0·37% (one-sided 95% CI -1·99 to 1·26; pnon-inferiority<0·0001 unadjusted) and -0·36% (-1·99 to 1·28; pnon-inferiority<0·0001 adjusted). INTERPRETATION: In sub-Saharan Africa, integrated chronic care services could achieve a high standard of care for people with diabetes or hypertension without adversely affecting outcomes for people with HIV. FUNDING: European Union Horizon 2020 and Global Alliance for Chronic Diseases.

Management of chronic conditions in resource limited settings: multi stakeholders' perception and experiences with receiving and providing integrated HIV, diabetes and hypertension services in Tanzania.

BACKGROUND: The rising prevalence of non-communicable diseases (NCDs) alongside the continuing high burden of HIV poses a serious challenge to middle- and low-income countries' healthcare systems. Pilot studies of integrated models of service delivery for HIV, hypertension and diabetes have demonstrated that they are feasible and acceptable among patients and care providers. This study assessed multi-stakeholders' perspectives of the delivery and receipt of integrated care in Tanzania. METHODS: A qualitative process evaluation was conducted in Dar es Salaam region of Tanzania where the integrated service delivery model was implemented from July to November 2021. In-depth interviews were held with seven key informants at the national, regional and district levels, eight healthcare providers, two researchers working at the integrated clinic and forty patients benefiting from integrated services at a large hospital. Three focus group discussions were held with community leaders and residents of the hospital's catchment area, and clinic level observations were conducted. Thematic analysis was conducted followed by the use of Bronfenbrenner's ecological model to identify factors pertinent to sustaining and scaling up of the integrated model. RESULTS: Participants of the study at all levels were aware of the increased prevalence of NCDs specifically for hypertension and diabetes and were concerned about the trend of increasing co-morbid conditions among people living with HIV (PLHIV). The integrated service delivery model was positively perceived by stakeholders because of its multiple benefits for both patients and the healthcare system. These include stigma and discrimination reduction, improved quality of care, efficient use of limited resources, cost and time saving, reduced duplication of services and fostering of early detection for undiagnosed conditions. The organisation of the clinic was critical in increased satisfaction. Several challenges were observed, which included costs for NCD services relative to free care for HIV and inconsistent availability of NCD medications. CONCLUSION: Stakeholders reported numerous benefits of the integrated service delivery model that are fundamental in improving the health of many Tanzanians living with NCDs and HIV. These benefits highlight the need for policy and decision-makers to sustain and expand the integrated service delivery model as a solution to many challenges facing the health system especially at the primary care level.

Reduction in mortality from HIV-related CNS infections in routine care in Africa (DREAMM): a before-and-after, implementation study.

BACKGROUND: Four decades into the HIV epidemic, CNS infection remains a leading cause of preventable HIV-related deaths in routine care. The Driving Reduced AIDS-associated Meningo-encephalitis Mortality (DREAMM) project aimed to develop, implement, and evaluate pragmatic implementation interventions and strategies to reduce mortality from HIV-related CNS infection. METHODS: DREAMM took place in five public hospitals in Cameroon, Malawi, and Tanzania. The main intervention was a stepwise algorithm for HIV-related CNS infections including bedside rapid diagnostic testing and implementation of WHO cryptococcal meningitis guidelines. A health system strengthening approach for hospitals was adopted to deliver quality care through a co-designed education programme, optimised clinical and laboratory pathways, and communities of practice. DREAMM was led and driven by local leadership and divided into three phases: observation (including situational analyses of routine care), training, and implementation. Consecutive adults (aged ≥18 years) living with HIV presenting with a first episode of suspected CNS infection were eligible for recruitment. The primary endpoint was the comparison of 2-week all-cause mortality between observation and implementation phases. This study completed follow-up in September, 2021. The project was registered on ClinicalTrials.gov, NCT03226379. FINDINGS: From November, 2016 to April, 2019, 139 eligible participants were enrolled in the observation phase. From Jan 9, 2018, to March 25, 2021, 362 participants were enrolled into the implementation phase. 216 (76%) of 286 participants had advanced HIV disease (209 participants had missing CD4 cell count), and 340 (69%) of 494 participants had exposure to antiretroviral therapy (ART; one participant had missing ART data). In the implementation phase 269 (76%) of 356 participants had a probable CNS infection, 203 (76%) of whom received a confirmed microbiological or radiological diagnosis of CNS infection using existing diagnostic tests and medicines. 63 (49%) of 129 participants died at 2 weeks in the observation phase compared with 63 (24%) of 266 in the implementation phase; and all-cause mortality was lower in the implementation phase when adjusted for site, sex, age, ART exposure (adjusted risk difference -23%, 95% CI -33 to -13; p<0·001). At 10 weeks, 71 (55%) died in the observation phase compared with 103 (39%) in the implementation phase (-13%, -24 to -3; p=0·01). INTERPRETATION: DREAMM substantially reduced mortality from HIV-associated CNS infection in resource-limited settings in Africa. DREAMM scale-up is urgently required to reduce deaths in public hospitals and help meet Sustainable Development Goals. FUNDING: European and Developing Countries Clinical Trials Partnership, French Agency for Research on AIDS and Viral Hepatitis. TRANSLATIONS: For the French and Portuguese translations of the abstract see Supplementary Materials section.

Scaling up integrated care for HIV and other chronic conditions in routine health care settings in sub-Saharan Africa: Field notes from Uganda.

Introduction: Integration of HIV and non-communicable disease (NCD) services is proposed to increase efficiency and coverage of NCD care in sub-Saharan Africa. Description: Between October 2018 to January 2020 in Tanzania and Uganda, working in partnership with health services, we introduced an integrated chronic care model for people with HIV, diabetes and hypertension. In this model, patients were able to access care from a single point of care, as opposed to the standard of siloed care from vertical clinics. When the study ended, routine clinical services adopted the integrated model. In this article, we discuss how the model transitioned post hand-over in Uganda and draw lessons to inform future scale-up. Discussion: The findings suggest potential for successful uptake of integrated chronic care by routine clinical services in sub-Saharan Africa. This approach may appeal to health care service providers and policy makers when they can quantify benefits that accrue from it, such as optimal utilization of health resources. For patients, integrated care may not appeal to all patients due to HIV-related stigma. Key considerations include good communication with patients, strong leadership, maintaining patient confidentiality and incorporating patient needs to facilitate successful uptake. Conclusion: Evidence on the benefits of integrated care remains limited. More robust evidence will be essential to guide scale-up beyond research sites.

Metformin for the prevention of diabetes among people with HIV and either impaired fasting glucose or impaired glucose tolerance (prediabetes) in Tanzania: a Phase II randomised placebo-controlled trial.

AIMS/HYPOTHESIS: In sub-Saharan Africa (SSA), 5% of adults are living with type 2 diabetes and this is rising sharply, with a greater increase among people with HIV. Evidence on the efficacy of prevention strategies in this cohort is scarce. We conducted a Phase II double-blind placebo-controlled trial that aimed to determine the impact of metformin on blood glucose levels among people with prediabetes (defined as impaired fasting glucose [IFG] and/or impaired glucose tolerance [IGT]) and HIV in SSA. METHODS: Adults (≥18 years old) who were stable in HIV care and found to have prediabetes (IFG and/or IGT) and who were attending hospitals in Dar es Salaam, Tanzania, were randomised to receive sustained-release metformin, 2000 mg daily, or matching placebo between 4 November 2019 and 21 July 2020. Randomisation used permuted blocks. Allocation was concealed in the trial database and made visible only to the Chief Pharmacist after consent was taken. All participants, research and clinical staff remained blinded to the allocation. Participants were provided with information on diet and lifestyle and had access to various health information following the start of the coronavirus disease 2019 (COVID-19) pandemic. Participants were followed up for 12 months. The primary outcome measure was capillary blood glucose measured 2 h following a 75 g glucose load. Analyses were by intention-to-treat. RESULTS: In total, 364 participants (182 in each arm) were randomised to the metformin or placebo group. At enrolment, in the metformin and placebo arms, mean fasting glucose was 6.37 mmol/l (95% CI 6.23, 6.50) and 6.26 mmol/l (95% CI 6.15, 6.36), respectively, and mean 2 h glucose levels following a 75 g oral glucose load were 8.39 mmol/l (95% CI 8.22, 8.56) and 8.24 mmol/l (95% CI 8.07, 8.41), respectively. At the final assessment at 12 months, 145/182 (79.7%) individuals randomised to metformin compared with 158/182 (86.8%) randomised to placebo indicated that they had taken >95% of their medicines in the previous 28 days (p=0.068). At this visit, in the metformin and placebo arms, mean fasting glucose levels were 6.17 mmol/l (95% CI 6.03, 6.30) and 6.30 mmol/l (95% CI 6.18, 6.42), respectively, and mean 2 h glucose levels following a 75 g oral glucose load were 7.88 mmol/l (95% CI 7.65, 8.12) and 7.71 mmol/l (95% CI 7.49, 7.94), respectively. Using a linear mixed model controlling for respective baseline values, the mean difference between the metformin and placebo group (metformin-placebo) was -0.08 mmol/l (95% CI -0.37, 0.20) for fasting glucose and 0.20 mmol/l (95% CI -0.17, 0.58) for glucose levels 2 h post a 75 g glucose load. Weight was significantly lower in the metformin arm than in the placebo arm: using the linear mixed model adjusting for baseline values, the mean difference in weight was -1.47 kg (95% CI -2.58, -0.35). In total, 16/182 (8.8%) individuals had a serious adverse event (Grade 3 or Grade 4 in the Division of Acquired Immunodeficiency Syndrome [DAIDS] adverse event grading table) or died in the metformin arm compared with 18/182 (9.9%) in the placebo arm; these events were either unrelated to or unlikely to be related to the study drugs. CONCLUSIONS/INTERPRETATION: Blood glucose decreased over time in both the metformin and placebo arms during the trial but did not differ significantly between the arms at 12 months of follow up. Metformin therapy was found to be safe for use in individuals with HIV and prediabetes. A larger trial with longer follow up is needed to establish if metformin can be safely used for the prevention of diabetes in people who have HIV. TRIAL REGISTRATION: The trial is registered on the International Standard Randomised Controlled Trial Number (ISRCTN) registry ( www.isrctn.com/ ), registration number: ISCRTN76157257. FUNDING: This research was funded by the National Institute for Health Research using UK aid from the UK Government to support global health research.

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.

Retention in care for type 2 diabetes management in Sub-Saharan Africa: A systematic review.

OBJECTIVE: Diabetes prevalence has risen rapidly in Sub-Saharan Africa, but rates of retention in diabetes care are poorly understood. We conducted a systematic review and meta-analysis to determine rates of retention in care of persons with type 2 diabetes. METHODS: We searched MEDLINE, Global Health and CINAHL online databases for cohort studies and randomised control trials (RCTs) published up to 12 October 2021, that reported retention in or attrition from care for patients with type 2 diabetes in Sub-Saharan Africa. Retention was defined as persons diagnosed with diabetes who were alive and in care or with a known outcome, while attrition was defined as loss from care. RESULTS: From 6559 articles identified, after title and abstract screening, 209 articles underwent full text review. Forty six papers met the inclusion criteria, comprising 22,610 participants. Twenty one articles were of RCTs of which 8 trials had 1 year or more of follow-up and 25 articles were of non-randomised studies of which 19 had 12 months or more of follow-up. A total of 11 studies (5 RCTs and 6 non-randomised) were assessed to be of good quality. Sixteen RCTs were done in secondary or tertiary care settings. Their pooled retention rate (95% CI) was 80% (77%, 84%) in the control arm. Four RCTs had been done in primary care settings and their pooled retention rate (95% CI) was 53% (45%, 62%) in the control arm. The setting of one trial was unclear. For non-randomised studies, retention rates (95% CI) were 68% (62%, 75%) among 19 studies done in secondary and tertiary care settings, and 40% (33%, 49%) among the 6 studies done in primary care settings. CONCLUSION: Rates of retention in care of people living with diabetes are poor in primary care research settings.

"After all, we are all sick": multi-stakeholder understanding of stigma associated with integrated management of HIV, diabetes and hypertension at selected government clinics in Uganda.

BACKGROUND: Integrated care is increasingly used to manage chronic conditions. In Uganda, the integration of HIV, diabetes and hypertension care has been piloted, to leverage the advantages of well facilitated and established HIV health care provision structures. This qualitative study aimed to explore HIV stigma dynamics whilst investigating multi-stakeholder perceptions and experiences of providing and receiving integrated management of HIV, diabetes and hypertension at selected government clinics in Central Uganda.  METHODS: We adopted a qualitative-observational design. Participants were purposively selected. In-depth interviews were conducted with patients and with health care providers, clinical researchers, policy makers, and representatives from international nongovernmental organizations (NGOs). Focus group discussions were conducted with community members and leaders. Clinical procedures in the integrated care clinic were observed. Data were managed using Nvivo 12 and analyzed thematically. RESULTS: Triangulated findings revealed diverse multi-stakeholder perceptions around HIV related stigma. Integrated care reduced the frequency with which patients with combinations of HIV, diabetes, hypertension visited health facilities, reduced the associated treatment costs, increased interpersonal relationships among patients and healthcare providers, and increased the capacity of health care providers to manage multiple chronic conditions. Integration reduced stigma through creating opportunities for health education, which allayed patient fears and increased their resolve to enroll for and adhere to treatment. Patients also had an opportunity to offer and receive psycho-social support and coupled with the support they received from healthcare worker. This strengthened patient-patient and provider-patient relationships, which are building blocks of service integration and of HIV stigma reduction. Although the model significantly reduced stigma, it did not eradicate service level challenges and societal discrimination among HIV patients. CONCLUSION: The study reveals that, in a low resource setting like Uganda, integration of HIV, diabetes and hypertension care can improve patient experiences of care for multiple chronic conditions, and that integrated clinics may reduce HIV related stigma.

Cost-effectiveness of single, high-dose, liposomal amphotericin regimen for HIV-associated cryptococcal meningitis in five countries in sub-Saharan Africa: an economic analysis of the AMBITION-cm trial.

BACKGROUND: HIV-associated cryptococcal meningitis is a leading cause of AIDS-related mortality. The AMBITION-cm trial showed that a regimen based on a single high dose of liposomal amphotericin B deoxycholate (AmBisome group) was non-inferior to the WHO-recommended treatment of seven daily doses of amphotericin B deoxycholate (control group) and was associated with fewer adverse events. We present a five-country cost-effectiveness analysis. METHODS: The AMBITION-cm trial enrolled patients with HIV-associated cryptococcal meningitis from eight hospitals in Botswana, Malawi, South Africa, Uganda, and Zimbabwe. Taking a health service perspective, we collected country-specific unit costs and individual resource-use data per participant over the 10-week trial period, calculating mean cost per participant by group, mean cost-difference between groups, and incremental cost-effectiveness ratio per life-year saved. Non-parametric bootstrapping and scenarios analyses were performed including hypothetical real-world resource use. The trial registration number is ISRCTN72509687, and the trial has been completed. FINDINGS: The AMBITION-cm trial enrolled 844 participants, and 814 were included in the intention-to-treat analysis (327 from Uganda, 225 from Malawi, 107 from South Africa, 84 from Botswana, and 71 from Zimbabwe) with 407 in each group, between Jan 31, 2018, and Feb 17, 2021. Using Malawi as a representative example, mean total costs per participant were US$1369 (95% CI 1314-1424) in the AmBisome group and $1237 (1181-1293) in the control group. The incremental cost-effectiveness ratio was $128 (59-257) per life-year saved. Excluding study protocol-driven cost, using a real-world toxicity monitoring schedule, the cost per life-year saved reduced to $80 (15-275). Changes in the duration of the hospital stay and antifungal medication cost showed the greatest effect in sensitivity analyses. Results were similar across countries, with the cost per life-year saved in the real-world scenario ranging from $71 in Botswana to $121 in Uganda. INTERPRETATION: The AmBisome regimen was cost-effective at a low incremental cost-effectiveness ratio. The regimen might be even less costly and potentially cost-saving in real-world implementation given the lower drug-related toxicity and the potential for shorter hospital stays. FUNDING: European Developing Countries Clinical Trials Partnership, Swedish International Development Cooperation Agency, Wellcome Trust and Medical Research Council, UKAID Joint Global Health Trials, and the National Institute for Health Research. TRANSLATIONS: For the Chichewa, Isixhosa, Luganda, Setswana and Shona translations of the abstract see Supplementary Materials section.

Clinical characteristics and outcomes of confirmed COVID-19 patients in the early months of the pandemic in Tanzania: a multicenter cohort study.

Background: A prospective cohort study of the clinical presentations and management outcomes of laboratory-confirmed COVID-19 patients in the early months of the pandemic was performed at two hospitals in Dar es Salaam, Tanzania. Methods: Between April 1 and May 31, 2020, laboratory-confirmed COVID-19 patients seen at two tertiary facilities were consecutively enrolled in the study and followed up for 21 days. Results: 121 COVID-19 patients were enrolled; 112 (92.6%) were admitted while nine (7.4%) were seen as outpatients. The median (IQR) age of patients was 41 (30-54) years; 72 (59.5%) were male. The median (IQR) reported days from hospital admission to recovery and to death were 10 (6-18) and 5.5 (3-9), respectively. Forty-four (36.4%) patients had at least one underlying condition. Of the 112 admissions, 17 (15.2%) went to ICU, of whom 14 (82.3%) died. At the end of follow-up, 93 (76.9%) recovered, 18 (14.9%) died, seven (5.8%) remained asymptomatic, and one (0.8%) remained ill. Conclusion: Three-quarters of all COVID-19 patients were less than 60 years, reflecting Africa's young population . High ICU admissions and mortality were observed.

The acceptability of integrated healthcare services for HIV and non-communicable diseases: experiences from patients and healthcare workers in Tanzania.

BACKGROUND: In sub-Saharan Africa, the prevalence of non-communicable diseases (NCDs) has risen sharply amidst a high burden of communicable diseases. An integrated approach to HIV and NCD care offers the potential of strengthening disease control programmes. We used qualitative methods to explore patients' and care-providers' experiences and perspectives on the acceptability of integrated care for HIV-infection, diabetes mellitus (DM), and hypertension (HT) in Tanzania. METHODS: A qualitative study was conducted in selected health facilities in Dar es Salaam and Coastal regions, which had started to provide integrated care and management for HIV, DM, and HT using a single research clinic for patients with one or more of these conditions. In-depth interviews were held with patients and healthcare providers at three time points: At enrolment (prior to the patient receiving integrated care, at the mid-line and at the study end). A minimum of 16 patients and 12 healthcare providers were sampled for each time point. Observation was also carried out in the respective clinics during pre- and mid-line phases. The Theoretical Framework of Acceptability (TFA) underpinned the structure and interpretation of the combined qualitative and observational data sets. RESULTS: Patients and healthcare providers revealed a positive attitude towards the integrated care delivery model at the mid-line and at study end-time points. High acceptability was related to increased exposure to service integration in terms of satisfaction with the clinic setup, seating arrangements and the provision of medical care services. Satisfaction also centred on the patients' freedom to move from one service point to another, and to discuss the services and their own health status amongst themselves. Adherence to medication and scheduling of clinic appointments appeared central to the patient-provider relationship as an aspect in the provision of quality services. Multi-condition health education, patient time and cost-saving, and detection of undiagnosed disease conditions emerged as benefits. On the other hand, a few challenges included long waiting times and limited privacy in lower and periphery health facilities due to infrastructural limitations. CONCLUSION: The study reveals a continued high level of acceptability of the integrated care model among study participants in Tanzania. This calls for evaluation in a larger and a comparative study. Nevertheless, much more concerted efforts are necessary to address structural challenges and maximise privacy and confidentiality.

Single-Dose Liposomal Amphotericin B Treatment for Cryptococcal Meningitis.

BACKGROUND: Cryptococcal meningitis is a leading cause of human immunodeficiency virus (HIV)-related death in sub-Saharan Africa. Whether a treatment regimen that includes a single high dose of liposomal amphotericin B would be efficacious is not known. METHODS: In this phase 3 randomized, controlled, noninferiority trial conducted in five African countries, we assigned HIV-positive adults with cryptococcal meningitis in a 1:1 ratio to receive either a single high dose of liposomal amphotericin B (10 mg per kilogram of body weight) on day 1 plus 14 days of flucytosine (100 mg per kilogram per day) and fluconazole (1200 mg per day) or the current World Health Organization-recommended treatment, which includes amphotericin B deoxycholate (1 mg per kilogram per day) plus flucytosine (100 mg per kilogram per day) for 7 days, followed by fluconazole (1200 mg per day) for 7 days (control). The primary end point was death from any cause at 10 weeks; the trial was powered to show noninferiority at a 10-percentage-point margin. RESULTS: A total of 844 participants underwent randomization; 814 were included in the intention-to-treat population. At 10 weeks, deaths were reported in 101 participants (24.8%; 95% confidence interval [CI], 20.7 to 29.3) in the liposomal amphotericin B group and 117 (28.7%; 95% CI, 24.4 to 33.4) in the control group (difference, -3.9 percentage points); the upper boundary of the one-sided 95% confidence interval was 1.2 percentage points (within the noninferiority margin; P<0.001 for noninferiority). Fungal clearance from cerebrospinal fluid was -0.40 log10 colony-forming units (CFU) per milliliter per day in the liposomal amphotericin B group and -0.42 log10 CFU per milliliter per day in the control group. Fewer participants had grade 3 or 4 adverse events in the liposomal amphotericin B group than in the control group (50.0% vs. 62.3%). CONCLUSIONS: Single-dose liposomal amphotericin B combined with flucytosine and fluconazole was noninferior to the WHO-recommended treatment for HIV-associated cryptococcal meningitis and was associated with fewer adverse events. (Funded by the European and Developing Countries Clinical Trials Partnership and others; Ambition ISRCTN number, ISRCTN72509687.).

Integrating Care for Diabetes and Hypertension with HIV Care in Sub-Saharan Africa: A Scoping Review.

INTRODUCTION: Although HIV continues to have a high prevalence among adults in sub-Saharan Africa (SSA), the burden of noncommunicable diseases (NCD) such as diabetes and hypertension is increasing rapidly. There is an urgent need to expand the capacity of healthcare systems in SSA to provide NCD services and scale up existing chronic care management pathways. A scoping review mapped extant policy and evidence based literature on the feasibility of integrating NCD care with HIV in the region. METHODS: A scoping review methodology was utilised to conduct a systematic search of peer-reviewed and grey literature published in English language and with no date limitation. A systematic search was conducted on PubMed, Embase, CINAHL, and the Cochrane library. The initial search identified 231 records considered for inclusion in this review. Twelve duplicate records were removed. The remaining 219 records were screened by title and abstract of which 165 records were excluded and 54 records were selected for full-text review. A further 16 records were excluded due to a lack of relevance or the unavailability of the full text article. Finally, 38 were charted and analysed thematically. RESULTS: Thirty-eight studies were included. These comprised a range of different models to integrate NCD and HIV care in the region, reflecting differences in health system environments, and disease epidemiology. The studies provide a variety of evidence that integration of HIV and NCD care can be feasible and can improve clinical effectiveness and identify barriers and facilitators to integration and task shifting. The review confirms that integrated HIV and NCD care services is by-and-large feasible, being both clinically effective and cost-effective. CONCLUSION: The review may inform the understanding of how best to develop an integrated model of care service by reducing barriers to uptake, linkage and retention in HIV, diabetes and hypertension treatment in SSA countries.

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.

Prevalence of microvascular and macrovascular complications of diabetes in newly diagnosed type 2 diabetes in low-and-middle-income countries: A systematic review and meta-analysis.

There is an excessive burden of diabetes complications in low-resource settings. We conducted a systematic review to determine the nature and frequency of diabetes complications in newly diagnosed with type 2 diabetes. A systematic search was performed using Medline, CINAHL and Global Health online databases from inception to July 2020. Articles reporting prevalence of microvascular or macrovascular complications within six months of type 2 diabetes diagnosis and published in English or French from low- and middle-income countries (LMICs) were eligible for analysis. Data were extracted using a standardized data extraction tool. Descriptive statistics were used to describe the prevalence of micro and macrovascular complications in newly diagnosed type 2 diabetes. Assessment of heterogeneity was conducted using the inconsistency index (I2) and Cochran-Q chi2 statistical tests. Publication bias was assessed by the Funnel plot and Egger test. A total of 3 292 records underwent title or abstract screening and 95 articles underwent full text review. Thirty-three studies describing 13 283 participants (aged 20 years and older) met the inclusion criteria. The eligible studies were from Asia (n = 24), Africa (n = 4), Oceania (n = 2), South America (n = 2) and the Caribbean (n = 1). For microvascular complications, the median prevalence (interquartile range) of retinopathy, nephropathy and neuropathy were 12% (6%-15%), 15% (7%-35%) and 16% (10%25%) respectively. For macrovascular complications, the median prevalence (interquartile range) was 10% (7%-17%) for ischaemic heart disease, 6% (1%-20%) for peripheral arterial disease and 2% (1%-4%) for stroke. There was evidence of substantial heterogeneity between studies for all outcomes (I2 > 90%. We found a high prevalence of complications in newly diagnosed type 2 diabetes in LMICs. Findings suggest that many people live with diabetes and are only diagnosed when they present with complications in LMICs. Research is needed to guide timely and effective identification of people living with diabetes in these settings.

Integrating diabetes, hypertension and HIV care in sub-Saharan Africa: a Delphi consensus study on international best practice.

BACKGROUND: Although HIV continues to have a high prevalence among adults in sub-Saharan Africa (SSA), the burden of noncommunicable diseases (NCD) such as diabetes and hypertension is increasing rapidly. There is an urgent need to expand the capacity of healthcare systems in SSA to provide NCD services and scale up existing chronic care management pathways. The aim of this study was to identify key components, outcomes, and best practice in integrated service provision for the prevention, identification and treatment of HIV, hypertension and diabetes. METHODS: An international, multi stakeholder e-Delphi consensus study was conducted over two successive rounds. In Round 1, 24 participants were asked to score 27 statements, under the headings 'Service Provision' and 'Benefits of Integration', by importance. In Round 2, the 16 participants who completed Round 1 were shown the distribution of scores from other participants along with the score that they attributed to an outcome and were asked to reflect on the score they gave, based on the scores of the other participants and then to rescore if they wished to. Nine participants completed Round 2. RESULTS: Based on the Round 1 ranking, 19 of the 27 outcomes met the 70% threshold for consensus. Four additional outcomes suggested by participants in Round 1 were added to Round 2, and upon review by participants, 22 of the 31 outcomes met the consensus threshold. The five items participants scored from 7 to 9 in both rounds as essential for effective integrated healthcare delivery of health services for chronic conditions were improved data collection and surveillance of NCDs among people living with HIV to inform integrated NCD/HIV programme management, strengthened drug procurement systems, availability of equipment and access to relevant blood tests, health education for all chronic conditions, and enhanced continuity of care for patients with multimorbidity. CONCLUSIONS: This study highlights the outcomes which may form key components of future complex interventions to define a model of integrated healthcare delivery for diabetes, hypertension and HIV in sub-Saharan Africa.

Patient perspectives on integrated healthcare for HIV, hypertension and type 2 diabetes: a scoping review.

INTRODUCTION: Antiretroviral therapy has reduced mortality and led to longer life expectancy in people living with HIV. These patients are now at an increased risk of non-communicable diseases (NCDs). Integration of care for HIV and NCDs has become a focus of research and policy. In this article, we aim to review patient perspectives on integration of healthcare for HIV, type 2 diabetes and hypertension. METHODS: The framework for scoping reviews developed by Arksey and O'Malley and updated by Peter et al was applied for this review. The databases PubMed, Web of Science and Cochrane library were searched. Broad search terms for HIV, NCDs (specifically type 2 diabetes and hypertension) and healthcare integration were used. As the review aimed to identify definitions of patient perspectives, they were not included as an independent term in the search strategy. References of included publications were searched for relevant articles. Titles and abstracts for these papers were screened by two independent reviewers. The full texts for all the publications appearing to meet the inclusion criteria were then read to make the final literature selection. RESULTS: Of 5502 studies initially identified, 13 articles were included in this review, of which 11 had a geographical origin in sub-Saharan Africa. Nine articles were primarily focused on HIV/diabetes healthcare integration while four articles were focused on HIV/hypertension integration. Patient's experiences with integrated care were reduced HIV-related stigma, reduced travel and treatment costs and a more holistic person-centred care. Prominent concerns were long waiting times at clinics and a lack of continuity of care in some clinics due to a lack of healthcare workers. Non-integrated care was perceived as time-consuming and more expensive. CONCLUSION: Patient perspectives and experiences on integrated care for HIV, diabetes and hypertension were mostly positive. Integrated services can save resources and allow for a more personalised approach to healthcare. There is a paucity of evidence and further longitudinal and interventional evidence from a more diverse range of healthcare systems are needed.

Integrating health services for HIV infection, diabetes and hypertension in sub-Saharan Africa: a cohort study.

BACKGROUND: HIV, diabetes and hypertension have a high disease burden in sub-Saharan Africa. Healthcare is organised in separate clinics, which may be inefficient. In a cohort study, we evaluated integrated management of these conditions from a single chronic care clinic. OBJECTIVES: To determined the feasibility and acceptability of integrated management of chronic conditions in terms of retention in care and clinical indicators. DESIGN AND SETTING: Prospective cohort study comprising patients attending 10 health facilities offering primary care in Dar es Salaam and Kampala. INTERVENTION: Clinics within health facilities were set up to provide integrated care. Patients with either HIV, diabetes or hypertension had the same waiting areas, the same pharmacy, were seen by the same clinical staff, had similar provision of adherence counselling and tracking if they failed to attend appointments. PRIMARY OUTCOME MEASURES: Retention in care, plasma viral load. FINDINGS: Between 5 August 2018 and 21 May 2019, 2640 patients were screened of whom 2273 (86%) were enrolled into integrated care (832 with HIV infection, 313 with diabetes, 546 with hypertension and 582 with multiple conditions). They were followed up to 30 January 2020. Overall, 1615 (71.1%)/2273 were female and 1689 (74.5%)/2266 had been in care for 6 months or more. The proportions of people retained in care were 686/832 (82.5%, 95% CI: 79.9% to 85.1%) among those with HIV infection, 266/313 (85.0%, 95% CI: 81.1% to 89.0%) among those with diabetes, 430/546 (78.8%, 95% CI: 75.4% to 82.3%) among those with hypertension and 529/582 (90.9%, 95% CI: 88.6 to 93.3) among those with multimorbidity. Among those with HIV infection, the proportion with plasma viral load <100 copies/mL was 423(88.5%)/478. CONCLUSION: Integrated management of chronic diseases is a feasible strategy for the control of HIV, diabetes and hypertension in Africa and needs evaluation in a comparative study.