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.

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.

Revising ethical guidance for the evaluation of programmes and interventions not initiated by researchers.

Public health and service delivery programmes, interventions and policies (collectively, 'programmes') are typically developed and implemented for the primary purpose of effecting change rather than generating knowledge. Nonetheless, evaluations of these programmes may produce valuable learning that helps determine effectiveness and costs as well as informing design and implementation of future programmes. Such studies might be termed 'opportunistic evaluations', since they are responsive to emergent opportunities rather than being studies of interventions that are initiated or designed by researchers. However, current ethical guidance and registration procedures make little allowance for scenarios where researchers have played no role in the development or implementation of a programme, but nevertheless plan to conduct a prospective evaluation. We explore the limitations of the guidance and procedures with respect to opportunistic evaluations, providing a number of examples. We propose that one key missing distinction in current guidance is moral responsibility: researchers can only be held accountable for those aspects of a study over which they have control. We argue that requiring researchers to justify an intervention, programme or policy that would occur regardless of their involvement prevents or hinders research in the public interest without providing any further protections to research participants. We recommend that trial consent and ethics procedures allow for a clear separation of responsibilities for the intervention and the evaluation.

Integrated home-based screening for people living with disabilities: A case study from rural Malawi.

People living with disabilities (PLWDs) have poor access to health services compared to people without disabilities. As a result, PLWDs do not benefit from some of the services provided at health facilities; therefore, new methods need to be developed to deliver these services where PLWDs reside. This case study reports a household-based screening programme targeting PLWDs in a rural district in Malawi. Between March and November 2016, a household-based and integrated screening programme was conducted by community health workers, HIV testing counsellors and a clinic clerk. The programme provided integrated home-based screening for HIV, tuberculosis, hypertension and malnutrition for PLWDs. The programme was designed and implemented for a population of 37 000 people. A total of 449 PLWDs, with a median age of 26 years and about half of them women, were screened. Among the 404 PLWDs eligible for HIV testing, 399 (99%) agreed for HIV testing. Sixty-nine per cent of PLWDs tested for HIV had never previously been tested for HIV. Additionally, 14 patients self-reported to be HIV-positive and all but one were verified to be active in HIV care. A total of 192 of all eligible PLWDs above 18 years old were screened for hypertension, with 9% (n = 17) referred for further follow-up at the nearest facility. In addition, 274 and 371 PLWDs were screened for malnutrition and tuberculosis, respectively, with 6% (n = 18) of PLWDs referred for malnutrition, and 2% (n = 10) of PLWDs referred for tuberculosis testing. We successfully implemented an integrated home-based screening programme in rural 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.

Determining whether Community Health Workers are 'Deployment Ready' Using Standard Setting.

BACKGROUND: Community Health Workers (CHWs) provide basic health screening and advice to members of their own communities. Although CHWs are trained, no CHW programmes have used a formal method to identify the level of achievement on post-training assessments that distinguishes "safe" from "unsafe". Objectives: The aim of this study was to use Ebel method of standard setting for a post-training written knowledge assessment for CHWs in Neno, Malawi. METHODS: 12 participants agreed the definitions of a "just-deployment ready" and an "ideal" CHW. Participants rated the importance and difficulty of each question on a three-point scale and also indicated the proportion of "just-deployment ready" CHWs expected to answer each of the nine question types correctly. Mean scores were used to determine the passing standard, which was reduced by one standard error of measurement (SEM) as this was the first time any passing standard had been employed.The level of agreement across participants' ratings of importance and difficulty was calculated using Krippendorf's alpha. The assessment results from the first cohort of CHW trainees were analysed using classical test theory. FINDINGS: There was poor agreement between participants on item ratings of both importance and difficulty (Krippendorf's alphas of 0.064 and 0.074 respectively). The pass mark applied to the assessment, following adjustment using the SEM, was 53.3%. Based on this pass mark, 68% of 129 CHW trainees were 'clear passes', 11% 'borderline passes', 9% 'borderline fails' and 12% 'clear fails'. CONCLUSIONS: Determining whether a CHW is deployment-ready is an important, but difficult exercise, as evidenced by a lack of agreement regarding question importance and difficulty. Future exercises should allow more time for training, discussion and modification of ratings. Based on the assessment, most CHWs trained could be considered deployment-ready, but following-up their performance in the field will be vital to validate the pass mark set.

A Novel Scenario-Based Interview Tool to Evaluate Nontechnical Skills and Competencies in Global Health Delivery.

BACKGROUND: Despite rapid growth in the number of physicians and academic institutions entering the field of global health, there are few tools that inform global health curricula and assess physician readiness for this field. OBJECTIVE: To address this gap, we describe the development and pilot testing of a new tool to assess nontechnical competencies and values in global health. Competencies assessed include systems-based practice, interpersonal and cross-cultural communication, professionalism and self-care, patient care, mentoring, teaching, management, and personal motivation and experience. METHODS: The Global Health Delivery Competency Assessment Tool presents 15 case vignettes and open-ended questions related to situations a global health practitioner might encounter, and grades the quality of responses on a 6-point ordinal scale. We interviewed 17 of 18 possible global health residents (94%), matched with 17 residents not training in global health, for a total of 34 interviews. A second reviewer independently scored recordings of 13 interviews for reliability. RESULTS: Pilot testing indicated a high degree of discriminant validity, as measured by the instrument's ability to distinguish between residents who were and were not enrolled in a global health program (P < .001). It also demonstrated acceptable consistency, as assessed by interrater reliability (κ = 0.53), with a range of item-level agreement from 84%-96%. CONCLUSIONS: The tool has potential applicability to a variety of academic and programmatic activities, including evaluation of candidates for global health positions and evaluating the success of training programs in equipping practitioners for entry into this field.

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.

Immediate Closures and Violations Identified During Routine Inspections of Public Aquatic Facilities - Network for Aquatic Facility Inspection Surveillance, Five States, 2013.

PROBLEM/CONDITION: Aquatic facility-associated illness and injury in the United States include disease outbreaks of infectious or chemical etiology, drowning, and pool chemical-associated health events (e.g., respiratory distress or burns). These conditions affect persons of all ages, particularly young children, and can lead to disability or even death. A total of 650 aquatic facility-associated outbreaks have been reported to CDC for 1978-2012. During 1999-2010, drownings resulted in approximately 4,000 deaths each year in the United States. Drowning is the leading cause of injury deaths in children aged 1-4 years, and approximately half of fatal drownings in this age group occur in swimming pools. During 2003-2012, pool chemical-associated health events resulted in an estimated 3,000-5,000 visits to U.S. emergency departments each year, and approximately half of the patients were aged <18 years. In August 2014, CDC released the Model Aquatic Health Code (MAHC), national guidance that can be adopted voluntarily by state and local jurisdictions to minimize the risk for illness and injury at public aquatic facilities. REPORTING PERIOD COVERED: 2013. DESCRIPTION OF SYSTEM: The Network for Aquatic Facility Inspection Surveillance (NAFIS) was established by CDC in 2013. NAFIS receives aquatic facility inspection data collected by environmental health practitioners when assessing the operation and maintenance of public aquatic facilities. This report presents inspection data that were reported by 16 public health agencies in five states (Arizona, California, Florida, New York, and Texas) and focuses on 15 MAHC elements deemed critical to minimizing the risk for illness and injury associated with aquatic facilities (e.g., disinfection to prevent transmission of infectious pathogens, safety equipment to rescue distressed bathers, and pool chemical safety). Although these data (the first and most recent that are available) are not nationally representative, 15.7% of the estimated 309,000 U.S. public aquatic venues are located in the 16 reporting jurisdictions. RESULTS: During 2013, environmental health practitioners in the 16 reporting NAFIS jurisdictions conducted 84,187 routine inspections of 48,632 public aquatic venues. Of the 84,187 routine inspection records for individual aquatic venues, 78.5% (66,098) included data on immediate closure; 12.3% (8,118) of routine inspections resulted in immediate closure because of at least one identified violation that represented a serious threat to public health. Disinfectant concentration violations were identified during 11.9% (7,662/64,580) of routine inspections, representing risk for aquatic facility-associated outbreaks of infectious etiology. Safety equipment violations were identified during 12.7% (7,845/61,648) of routine inspections, representing risk for drowning. Pool chemical safety violations were identified during 4.6% (471/10,264) of routine inspections, representing risk for pool chemical-associated health events. INTERPRETATION: Routine inspections frequently resulted in immediate closure and identified violations of inspection items corresponding to 15 MAHC elements critical to protecting public health, highlighting the need to improve operation and maintenance of U.S. public aquatic facilities. These findings also underscore the public health function that code enforcement, conducted by environmental health practitioners, has in preventing illness and injury at public aquatic facilities. PUBLIC HEALTH ACTION: Findings from the routine analyses of aquatic facility inspection data can inform program planning, implementation, and evaluation. At the state and local level, these inspection data can be used to identify aquatic facilities and venues in need of more frequent inspections and to select topics to cover in training for aquatic facility operators. At the national level, these data can be used to evaluate whether the adoption of MAHC elements minimizes the risk for aquatic facility-associated illness and injury. These findings also can be used to prioritize revisions or updates to the MAHC. To optimize the collection and analysis of aquatic facility inspection data and thus application of findings, environmental health practitioners and epidemiologists need to collaborate extensively to identify public aquatic facility code elements deemed critical to protecting public health and determine the best way to assess and document compliance during inspections.