Economic evaluation of integrated services for non-communicable diseases and HIV: costs and client outcomes in rural Malawi.

OBJECTIVE: To evaluate the costs and client outcomes associated with integrating screening and treatment for non-communicable diseases (NCDs) into HIV services in a rural and remote part in southeastern Africa. DESIGN: Prospective cohort study. SETTING: Primary and secondary level health facilities in Neno District, Malawi. PARTICIPANTS: New adult enrollees in Integrated Chronic Care Clinics (IC3) between July 2016 and June 2017. MAIN OUTCOME MEASURES: We quantified the annualised total and per capita economic cost (US$2017) of integrated chronic care, using activity-based costing from a health system perspective. We also measured enrolment, retention and mortality over the same period. Furthermore, we measured clinical outcomes for HIV (viral load), hypertension (controlled blood pressure), diabetes (average blood glucose), asthma (asthma severity) and epilepsy (seizure frequency). RESULTS: The annualised total cost of providing integrated HIV and NCD care was $2 461 901 to provide care to 9471 enrollees, or $260 per capita. This compared with $2 138 907 for standalone HIV services received by 6541 individuals, or $327 per capita. Over the 12-month period, 1970 new clients were enrolled in IC3, with a retention rate of 80%. Among clients with HIV, 81% achieved an undetectable viral load within their first year of enrolment. Significant improvements were observed among clinical outcomes for clients enrolled with hypertension, asthma and epilepsy (p<0.05, in all instances), but not for diabetes (p>0.05). CONCLUSIONS: IC3 is one of the largest examples of fully integrated HIV and NCD care. Integrating screening and treatment for chronic health conditions into Malawi's HIV platform appears to be a financially feasible approach associated with several positive clinical outcomes.

A household-based community health worker programme for non-communicable disease, malnutrition, tuberculosis, HIV and maternal health: a stepped-wedge cluster randomised controlled trial in Neno District, Malawi.

BACKGROUND: Community health worker (CHW) programmes are a valuable component of primary care in resource-poor settings. The evidence supporting their effectiveness generally shows improvements in disease-specific outcomes relative to the absence of a CHW programme. In this study, we evaluated expanding an existing HIV and tuberculosis (TB) disease-specific CHW programme into a polyvalent, household-based model that subsequently included non-communicable diseases (NCDs), malnutrition and TB screening, as well as family planning and antenatal care (ANC). METHODS: We conducted a stepped-wedge cluster randomised controlled trial in Neno District, Malawi. Six clusters of approximately 20 000 residents were formed from the catchment areas of 11 healthcare facilities. The intervention roll-out was staggered every 3 months over 18 months, with CHWs receiving a 5-day foundational training for their new tasks and assigned 20-40 households for monthly (or more frequent) visits. FINDINGS: The intervention resulted in a decrease of approximately 20% in the rate of patients defaulting from chronic NCD care each month (-0.8 percentage points (pp) (95% credible interval: -2.5 to 0.5)) while maintaining the already low default rates for HIV patients (0.0 pp, 95% CI: -0.6 to 0.5). First trimester ANC attendance increased by approximately 30% (6.5pp (-0.3, 15.8)) and paediatric malnutrition case finding declined by 10% (-0.6 per 1000 (95% CI -2.5 to 0.8)). There were no changes in TB programme outcomes, potentially due to data challenges. INTERPRETATION: CHW programmes can be successfully expanded to more comprehensively address health needs in a population, although programmes should be carefully tailored to CHW and health system capacity.

Expanding access to non-communicable disease care in rural Malawi: outcomes from a retrospective cohort in an integrated NCD-HIV model.

OBJECTIVES: Non-communicable diseases (NCDs) account for one-third of disability-adjusted life years in Malawi, and access to care is exceptionally limited. Integrated services with HIV are widely recommended, but few examples exist globally. We report descriptive outcomes from an Integrated Chronic Care Clinic (IC3). DESIGN: This is a retrospective cohort study. SETTING: The study includes an HIV-NCD clinic across 14 primary care facilities in the rural district of Neno, Malawi. PARTICIPANTS: All new patients, including 6233 HIV-NCD diagnoses, enrolled between January 2015 and December 2017 were included. This included 3334 patients with HIV (59.7% women) and 2990 patients with NCD (67.3% women), 10% overall under age 15 years. INTERVENTIONS: Patients were seen at their nearest health centre, with a hospital team visiting routinely to reinforce staffing. Data were collected on paper forms and entered into an electronic medical record. PRIMARY AND SECONDARY OUTCOME MEASURES: Routine clinical measurements are reported at 1-year post-enrolment for patients with more than one visit. One-year retention is reported by diagnosis. RESULTS: NCD diagnoses were 1693 hypertension, 668 asthma, 486 epilepsy, 149 diabetes and 109 severe mental illness. By December 2018, 8.3% of patients with NCD over 15 years were also on HIV treatment. One-year retention was 85% for HIV and 72% for NCDs, with default in 8.4% and 25.5% and deaths in 4.0% and 1.4%, respectively. Clinical outcomes showed statistically significant improvement for hypertension, diabetes, asthma and epilepsy. Of the 1807 (80%) of patients with HIV with viral load results, 85% had undetectable viral load. CONCLUSIONS: The IC3 model, built on an HIV platform, facilitated rapid decentralisation and access to NCD services in rural Malawi. Clinical outcomes and retention in care are favourable, suggesting that integration of chronic disease care at the primary care level poses a way forward for the large dual burden of HIV and chronic NCDs.

Improving uptake of cervical cancer screening services for women living with HIV and attending chronic care services in rural Malawi.

Malawi has the second highest age-standardised incidence rate and the highest mortality rate of cervical cancer in the world. Though the prevalence of HIV is currently 11.7% for Malawian women of reproductive age, cervical cancer screening rates remain low. To address this issue, we integrated cervical cancer screening into a dual HIV and non-communicable disease clinic at a rural district hospital in Neno, Malawi. The project was implemented between January 2017 and March 2018 using the Plan-Do-Study-Act model of quality improvement (QI). At baseline (January to December 2016), only 13 women living with HIV were screened for cervical cancer. One year after implementation of the QI project, 73% (n=547) of women aged 25 to 49 years living with HIV enrolled in HIV care were screened for cervical cancer, with 85.3% of these receiving the screening test for the first time. The number of women living with HIV accessing cervical cancer services increased almost 10 times (from four per month to 39 per month, p<0.001). Key enablers in our QI process included: strong mentorship, regular provision of cervical cancer health talks throughout the hospital, nationally accredited cervical cancer prevention training for all providers, consistent community engagement, continuous monitoring and evaluation, and direct provision of resources to strengthen gaps in the public system. This practical experience integrating cervical cancer screening into routine HIV care may provide valuable lessons for scale-up in rural Malawi.

Increasing utilisation of perinatal services: estimating the impact of community health worker program in Neno, Malawi.

BACKGROUND: By 2015, Malawi had not achieved Millennium Development Goal 4, reducing maternal mortality by about 35% from 675 to 439 deaths per 100,000 livebirths. Hypothesised reasons included low uptake of antenatal care (ANC), intrapartum care, and postnatal care. Involving community health workers (CHWs) in identification of pregnant women and linking them to perinatal services is a key strategy to reinforce uptake of perinatal care in Neno, Malawi. We evaluated changes in uptake after deployment of CHWs between March 2014 and June 2016. METHODS: A CHW intervention was implemented in Neno District, Malawi in a designated catchment area of about 3100 women of childbearing age. The pre-intervention period was March 2014 to February 2015, and the post-intervention period was March 2015 to June 2016. A 5-day maternal health training package was delivered to 211 paid and supervised CHWs. CHWs were deployed to identify pregnant women and escort them to perinatal care visits. A synthetic control method, in which a "counterfactual site" was created from six available control facilities in Neno District, was used to evaluate the intervention. Outcomes of interest included uptake of first-time ANC, ANC within the first trimester, four or more ANC visits, intrapartum care, and postnatal care follow-up. RESULTS: Women enrolled in ANC increased by 18% (95% Credible Interval (CrI): 8, 29%) from an average of 83 to 98 per month, the proportion of pregnant women starting ANC in the first trimester increased by 200% (95% CrI: 162, 234%) from 10 to 29% per month, the proportion of women completing four or more ANC visits increased by 37% (95% CrI: 31, 43%) from 28 to 39%, and monthly utilisation of intrapartum care increased by 20% (95% CrI: 13, 28%) from 85 to 102 women per month. There was little evidence that the CHW intervention changed utilisation of postnatal care (- 37, 95% CrI: - 224, 170%). CONCLUSIONS: In a rural district in Malawi, uptake of ANC and intrapartum care increased considerably following an intervention using CHWs to identify pregnant women and link them to care.

Screening for chronic kidney disease in rural Malawi: results from a diabetic clinic.

OBJECTIVE: Patients with diabetes are at high risk of developing renal insufficiency and chronic kidney disease (CKD). As a result, screening for CKD is essential in diabetic patients as part of their care. This study investigated the prevalence of renal insufficiency, CKD, and correlates of CKD in diabetic patients attending Integrated Chronic Care Clinics in Neno District, Malawi. RESULTS: Of 203 diabetic patients, 148 (73%) were screened for CKD by measurement of serum creatinine and urinary protein between April 2016 and January 2019. 39.2% (n = 58) of the patients had abnormal estimated glomerular filtration rate (eGFR), as estimated by CKD Epidemiology Collaboration formula and/or ≥ 2+ urine protein. 13.5% (95% CI 8.4-20.0%, 20/148) of the patients had renal insufficiency based on eGFR of less than 60 ml/min/1.73 m2. 8.8% (95% CI 4.8-14.6%, 13/148) had CKD based on eGFR of less than 60 ml/min/1.73 m2 measured twice at least 3 months apart. In bivariate analysis, CKD was associated with older age, high systolic blood pressure and lower fasting blood sugar. Despite the low sample size, the study showed a moderately high prevalence of renal insufficiency and CKD in a rural cohort of diabetic patients in Malawi.

Evaluating the impact of a community health worker programme on non-communicable disease, malnutrition, tuberculosis, family planning and antenatal care in Neno, Malawi: protocol for a stepped-wedge, cluster randomised controlled trial.

INTRODUCTION: This protocol concerns the implementation and evaluation of an intervention designed to realign the existing cadre of community health workers (CHWs) in Neno district, Malawi to better support the care needs of the clients they serve. The proposed intervention is a 'Household Model' where CHWs will be reassigned to households, rather than to specific patients with HIV and/or tuberculosis (TB). METHODS AND ANALYSIS: Using a stepped-wedge, cluster-randomised design, this study investigates whether high HIV retention rates can be replicated for non-communicable diseases (NCDs), and the model's impact on TB and paediatric malnutrition case finding, as well as the uptake of family planning and antenatal care. Eleven sites (health centres and hospitals) were arranged into six clusters (average cluster population 21 800). Primary outcomes include retention in care for HIV and chronic NCDs, TB case finding, paediatric malnutrition case finding, and utilisation of early and complete antenatal care. Clinical outcomes are based on routinely collected data from the Ministry of Health's District Health Information System 2 and an OpenMRS electronic medical record supported by Partners In Health. Additionally, semistructured qualitative interviews with various stakeholders will assess community perceptions and context of the Household Model. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the Malawian National Health Science Research Committee (#16/11/1694) in Lilongwe, Malawi; Partners Healthcare Human Research Committee (#2017P000548/PHS) in Somerville, Massachusetts; and the Biomedical and Scientific Research Ethics Sub-Committee (REGO-2017-2060) at the University of Warwick in Coventry, UK. Dissemination will include manuscripts for peer-reviewed publication as well as a full report detailing the findings of the intervention for the Malawian Ministry of Health. TRIAL REGISTRATION NUMBER: NCT03106727. PRIMARY SPONSOR: Partners In Health | Abwenzi Pa Za Umoyo P.O. Box 56, Neno, Malawi. Protocol Version 4, March 2018.

Delivering comprehensive HIV services across the HIV care continuum: a comparative analysis of survival and progress towards 90-90-90 in rural Malawi.

INTRODUCTION: Partners In Health and the Malawi Ministry of Health collaborate on comprehensive HIV services in Neno, Malawi, featuring community health workers, interventions addressing social determinants of health and health systems strengthening. We conducted an observational study to describe the HIV care continuum in Neno and to compare facility-level HIV outcomes against health facilities nationally. METHODS: We compared facility-level outcomes in Neno (n=13) with all other districts (n=682) from 2013 to 2015 using mixed-effects linear regression modelling. We selected four outcomes that are practically useful and roughly mapped on to the 90-90-90 targets: facility-based HIV screenings relative to population, new antiretroviral therapy (ART)enrolments relative to population, 1-year survival rates and per cent retained in care at 1 year. RESULTS: In 2013, the average number of HIV tests performed, as a per cent of the adult population, was 11.75%, while the average newly enrolled patients was 10.03%. Percent receiving testing increased by 4.23% over 3 years (P<0.001, 95% CI 2.98% to 5.49%), while percent enrolled did not change (P=0.28). These results did not differ between Neno and other districts (P=0.52), despite Neno having a higher proportion of expected patients enrolled. In 2013, the average ART 1-year survival was 80.41% nationally and 91.51% in Neno, which is 11.10% higher (P=0.002, 95% CI 4.13% to 18.07%). One-year survival declined by 1.75% from 2013 to 2015 (P<0.001, 95% CI -2.61% to -0.89%); this was similar in Neno (P=0.83). Facility-level 1-year retention was 85.43% nationally in 2013 (P<0.001, 95% CI 84.2% to 86.62%) and 12.07% higher at 97.50% in Neno (P=0.001, 95% CI 5.08% to19.05%). Retention declined by 2.92% (P<0.001, 95% CI -3.69% to -2.14%) between 2013 and 2015, both nationally and in Neno. CONCLUSION: The Neno HIV programme demonstrated significantly higher survival and retention rates compared with all other districts in Malawi. Incorporating community health workers, strengthening health systems and addressing social determinants of health within the HIV programme may help Malawi and other countries accelerate progress towards 90-90-90.

Evaluating the use of pathology in improving diagnosis in rural Malawi.

Introduction: Limited data exists on histologically confirmed cancers and tuberculosis in rural Malawi, despite the high burden of both conditions. One of the main reasons for the limited data is the lack of access to pathology services for diagnosis. We reviewed histopathology results of patients in Neno District, one of the poorest rural districts in Malawi, from May 2011 to July 2017, with an emphasis on cancers and tuberculosis. Methods: This is a retrospective descriptive study reviewing pathology results of samples collected at Neno health facilities and processed at Kamiza Pathology Laboratory. Data was entered into Microsoft Excel and cleaned and analysed using Stata 14. Results: A total of 532 specimens were collected, of which 87% (465) were tissue biopsies (incision or core biopsies), and 13% (67) were cytology samples. Of all specimens, 7% (n=40) of the samples had non-diagnostic results. Among the results that were diagnostic (n=492), 37% (183) were malignancies, 33% (112) were infections and inflammatory conditions other than tuberculosis, 20% (97) were benign tumours, 7% (34) were tuberculosis, 4% (21) were pre-malignant lesions, 5% (23) were normal samples, and 4% (22) were other miscellaneous conditions. Among the malignancies (n=183), 62% (114) were from females and 38% (69) from males. Among females, almost half of the cancers were cervical (43%, n= 49), followed by Kaposi sarcoma (14%, n=16), skin cancers (9%, n=10), and breast cancer (8%, n=9). In males, Kaposi sarcoma was the most common cancer (35%, n=24), followed by skin cancers (17%, n=12). About 75% (n=137) of the cancers occurred in persons aged 15 to 60 years. Conclusion: Histopathology services at a rural hospital in Malawi provides useful diagnostic information on malignancies, tuberculosis and other diagnoses, and can inform management at the district level.

Novel approaches to screening for noncommunicable diseases: Lessons from Neno, Malawi.

BACKGROUND: As Malawi continues to suffer from a large burden of noncommunicable diseases (NCDs), models for NCD screening need to be developed that do not overload a health system that is already heavily burdened by communicable diseases. METHODS: This descriptive study examined 3 screening programmes for NCDs in Neno, Malawi, that were implemented from June 2015 to December 2016. The NCD screening models were integrated into existing platforms, utilising regular mass screening events in the community, patients awaiting to be seen in a combined NCD and HIV clinic, and patients awaiting treatment at outpatient departments (OPDs). Focusing on hypertension and diabetes, we screened all adults 30 years and above for hypertension using a single blood pressure cut-off of 160/110 mmHg, as well as adults 40 years and above for diabetes, measuring either random blood sugar (RBS) or fasting blood sugar (FBS), with referral criteria of FBS > 126 mg/dL and RBS > 200 mg/dL. Data were collected on specifically designed screening registers, then entered and analysed in Excel. RESULTS: Over 14,000 adults (≥ 12 years old) were screened for an array of common conditions at community screening events. Of these adults, 58% (n = 8133) and 29% (n = 4016) were screened for hypertension and diabetes, respectively. Nine percent (n = 716) and 3% ( n = 113) were referred for further hypertension and diabetes assessment respectively. At one OPD, 5818 patients (60%) had their blood pressures measured, and among adults 30 years and above, 168 eligible adults were referred for further hypertension assessment. Since the initiation of the screening programmes, the number of patients ever enrolled for NCD care every 3 months has nearly tripled, from 40 to 114. CONCLUSIONS: The screening models have shown that it is not only feasible to introduce NCD screening into a public system, but screening may have also contributed to increased enrolment in NCD care in Neno, Malawi.

Impact and economic evaluation of a novel HIV service delivery model in rural Malawi.

OBJECTIVE: We performed an impact and cost-effectiveness analysis of a novel HIV service delivery model in a high prevalence, remote district of Malawi with a population of 143 800 people. DESIGN: A population-based retrospective analysis of 1-year survival rates among newly enrolled HIV-positive patients at 682 health facilities throughout Malawi, comparing facilities implementing the service delivery model (n = 13) and those implementing care-as-usual (n = 669). METHODS: Through district-level health surveillance data, we evaluated 1-year survival rates among HIV patients newly enrolled between July 2013 and June 2014 - representing 129 938 patients in care across 682 health facilities - using a multilevel modeling framework. The model, focused on social determinants of health, was implemented throughout Neno District at 13 facilities and compared with facilities in all other districts. Activity-based costing was used to annualize financial and economic costs from a societal perspective. Incremental cost-effectiveness ratios were expressed as quality-adjusted life-years gained. RESULTS: The national average 1-year survival rate for newly enrolled antiretroviral therapy clients was 78.9%: this rate was 87.9% in Neno District, compared with 78.8% across all other districts in Malawi (P < 0.001; 95% confidence interval: 0.079-0.104). The economic cost of receiving care in Neno district (n = 6541 patients) was $317/patient/year, compared with an estimated $219/patient in other districts. This translated to $906 per quality-adjusted life-year gained. CONCLUSION: Neno District's comprehensive model of care, featuring a strong focus on the community, is $98 more expensive per capita per annum but demonstrates superior 1-year survival rates, despite its remote location. Moreover, it should be considered cost-effective by traditional international standards.

Leveraging HIV platforms to work toward comprehensive primary care in rural Malawi: the Integrated Chronic Care Clinic.

This case study describes an integrated chronic care clinic that utilizes a robust HIV program as a platform for NCD screening and treatment. A unique model, the integrated chronic care clinic provides longitudinal care for patients with an array of chronic diseases including HIV and common NCDs, allowing for a single visit for all of a patient's conditions. Set in Malawi's remote Neno District, this clinic structure aims to (1) increase access to care for NCD patients, (2) maximize efficiency given the severe human resource shortages, and (3) replicate strong HIV outcomes for patients with other chronic conditions. The goal is to increase the number of health facilities in Neno capable of fully delivering Malawi's Essential Health Package, the set of cost-effective interventions endorsed by Malawi MOH to reduce burden of disease and leading causes of death. While implementation is ongoing and processes are evolving, this model of healthcare delivery has already improved the accessibility of NCD care by allowing patients to have all of their chronic conditions treated on the same day at their nearest health facility, notably without additional investment of human and financial resources. Currently, 6781 patients on antiretroviral therapy and 721 patients with NCDs are benefitting, including 379 with hypertension, 187 with asthma, 144 with epilepsy, and 76 with diabetes. Among the NCD patient population, 15.1% are HIV-positive. Success hinged largely on several factors, including clear leadership and staff ownership of their specific duties, and a well-defined and uniform patient flow process. Furthermore, deliberate and regular conversations about challenges allowed for constant iteration and improvement of processes. Moving forward, several tasks remain. We are refining the data management process to further consolidate medical records, along with integrating our tracking processes for clients who miss appointments. Additionally, we are exploring opportunities for further integration, including family planning. A follow-up patient satisfaction survey is planned for the coming months to track the impact of the clinic's redesign. Given limited human and financial resources, innovative solutions are required to address the growing burden of chronic disease in Malawi. We have found that an integrated, patient-centered approach maximizes efficiency and reduces barriers to care for the hardest to reach patients.