Ethical Considerations for Engaging Children and Adolescents Living with HIV in Research in African Countries: A Systematic Review.

Research engaging children and adolescents living with HIV (CALWH) is critical for youth-friendly services and HIV care, and researchers need to ensure that such engagement is ethical. We conducted a systematic review to identify key ethical considerations for the engagement of CALWH in research. The review focused on primary research articles conducted in African countries that examined ethical issues in CALWH engaged in research. Ten studies met the inclusion criteria; the following seven key domains were extracted: 1) justifications for engaging CALWH in research; 2) community involvement; 3) informed consent/assent; 4) caregiver involvement; 5) perceptions of benefits; 6) perception of the risks of involvement; and 7) confidentiality. These domains can inform the ethical engagement of CALWH in research.

A Type II hybrid effectiveness-implementation study of an integrated CHW intervention to address maternal healthcare in rural Nepal.

Skilled care during pregnancy, childbirth, and postpartum is essential to prevent adverse maternal health outcomes, yet utilization of care remains low in many resource-limited countries, including Nepal. Community health workers (CHWs) can mitigate health system challenges and geographical barriers to achieving universal health coverage. Gaps remain, however, in understanding whether evidence-based interventions delivered by CHWs, closely aligned with WHO recommendations, are effective in Nepal's context. We conducted a type II hybrid effectiveness-implementation, mixed-methods study in two rural districts in Nepal to evaluate the effectiveness and the implementation of an evidence-based integrated maternal and child health intervention delivered by CHWs, using a mobile application. The intervention was implemented stepwise over four years (2014-2018), with 65 CHWs enrolling 30,785 families. We performed a mixed-effects Poisson regression to assess institutional birth rate (IBR) pre-and post-intervention. We used the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework to evaluate the implementation during and after the study completion. There was an average 30% increase in IBR post-intervention, adjusting for confounding variables (p<0.0001). Study enrollment showed 35% of families identified as dalit, janjati, or other castes. About 78-89% of postpartum women received at least one CHW-counseled home visit within 60 days of childbirth. Ten (53% of planned) municipalities adopted the intervention during the study period. Implementation fidelity, measured by median counseled home visits, improved with intervention time. The intervention was institutionalized beyond the study period and expanded to four additional hubs, albeit with adjustments in management and supervision. Mechanisms of intervention impact include increased knowledge, timely referrals, and longitudinal CHW interaction. Full-time, supervised, and trained CHWs delivering evidence-based integrated care appears to be effective in improving maternal healthcare in rural Nepal. This study contributes to the growing body of evidence on the role of community health workers in achieving universal health coverage.

TGFß instructs mTORC2 to activate PKCßII for increased TWIST1 expression in proximal tubular epithelial cell injury.

The plasticity of proximal tubular epithelial cells in response to TGFß contributes to the expression of TWIST1 to drive renal fibrosis. The mechanism of TWIST1 expression is not known. We show that both PI3 kinase and its target mTORC2 increase TGFß-induced TWIST1 expression. TGFß enhances phosphorylation on Ser-660 in the protein kinase C ßII (PKCßII) hydrophobic motif site. Remarkably, phosphorylation-deficient PKCßIIS660A, kinase-dead PKCßII, and PKCßII knockdown blocked TWIST1 expression by TGFß. Inhibition of TWIST1 arrested TGFß-induced tubular cell hypertrophy and the expression of fibronectin, collagen I (α2), and α-smooth muscle actin. By contrast, TWIST1 overexpression induced these pathologies. Interestingly, the inhibition of PKCßII reduced these phenomena, which were countered by the expression of TWIST1. These results provide the first evidence for the involvement of the mTORC2-PKCßII axis in TWIST1 expression to promote tubular cell pathology.

Comparing two data collection methods to track vital events in maternal and child health via community health workers in rural Nepal.

BACKGROUND: Timely tracking of health outcomes is difficult in low- and middle-income countries without comprehensive vital registration systems. Community health workers (CHWs) are increasingly collecting vital events data while delivering routine care in low-resource settings. It is necessary, however, to assess whether routine programmatic data collected by CHWs are sufficiently reliable for timely monitoring and evaluation of health interventions. To study this, we assessed the consistency of vital events data recorded by CHWs using two methodologies-routine data collected while delivering an integrated maternal and child health intervention, and data from a birth history census approach at the same site in rural Nepal. METHODS: We linked individual records from routine programmatic data from June 2017 to May 2018 with those from census data, both collected by CHWs at the same site using a mobile platform. We categorized each vital event over a one-year period as 'recorded by both methods,' 'census alone,' or 'programmatic alone.' We further assessed whether vital events data recorded by both methods were classified consistently. RESULTS: From June 2017 to May 2018, we identified a total of 713 unique births collectively from the census (birth history) and programmatic maternal 'post-delivery' data. Three-fourths of these births (n = 526) were identified by both. There was high consistency in birth location classification among the 526 births identified by both methods. Upon including additional programmatic 'child registry' data, we identified 746 total births, of which 572 births were identified by both census and programmatic methods. Programmatic data (maternal 'post-delivery' and 'child registry' combined) captured more births than census data (723 vs. 595). Both methods consistently classified most infants as 'living,' while infant deaths and stillbirths were largely classified inconsistently or recorded by only one method. Programmatic data identified five infant deaths and five stillbirths not recorded in census data. CONCLUSIONS: Our findings suggest that data collected by CHWs from routinely tracking pregnancies, births, and deaths are promising for timely program monitoring and evaluation. Despite some limitations, programmatic data may be more sensitive in detecting vital events than cross-sectional census surveys asking women to recall these events.

Oncoprotein DJ-1 interacts with mTOR complexes to effect transcription factor Hif1α-dependent expression of collagen I (α2) during renal fibrosis.

Proximal tubular epithelial cells respond to transforming growth factor ß (TGFß) to synthesize collagen I (α2) during renal fibrosis. The oncoprotein DJ-1 has previously been shown to promote tumorigenesis and prevent apoptosis of dopaminergic neurons; however, its role in fibrosis signaling is unclear. Here, we show TGFß-stimulation increased expression of DJ-1, which promoted noncanonical mTORC1 and mTORC2 activities. We show DJ-1 augmented the phosphorylation/activation of PKCßII, a direct substrate of mTORC2. In addition, coimmunoprecipitation experiments revealed association of DJ-1 with Raptor and Rictor, exclusive subunits of mTORC1 and mTORC2, respectively, as well as with mTOR kinase. Interestingly, siRNAs against DJ-1 blocked TGFß-stimulated expression of collagen I (α2), while expression of DJ-1 increased expression of this protein. In addition, expression of dominant negative PKCßII and siRNAs against PKCßII significantly inhibited TGFß-induced collagen I (α2) expression. In fact, constitutively active PKCßII abrogated the effect of siRNAs against DJ-1, suggesting a role of PKCßII downstream of this oncoprotein. Moreover, we demonstrate expression of collagen I (α2) stimulated by DJ-1 and its target PKCßII is dependent on the transcription factor hypoxia-inducible factor 1α (Hif1α). Finally, we show in the renal cortex of diabetic rats that increased TGFß was associated with enhanced expression of DJ-1 and activation of mTOR and PKCßII, concomitant with increased Hif1α and collagen I (α2). Overall, we identified that DJ-1 affects TGFß-induced expression of collagen I (α2) via an mTOR-, PKCßII-, and Hif1α-dependent mechanism to regulate renal fibrosis.

Lessons from an eight-country community health data harmonization collaborative.

BACKGROUND: Community health workers (CHWs) are individuals who are trained and equipped to provide essential health services to their neighbors and have increased access to healthcare in communities worldwide for more than a century. However, the World Health Organization (WHO) Guideline on Health Policy and System Support to Optimize Community Health Worker Programmes reveals important gaps in the evidentiary certainty about which health system design practices lead to quality care. Routine data collection across countries represents an important, yet often untapped, opportunity for exploratory data analysis and comparative implementation science. However, epidemiological indicators must be harmonized and data pooled to better leverage and learn from routine data collection. METHODS: This article describes a data harmonization and pooling Collaborative led by the organizations of the Community Health Impact Coalition, a network of health practitioners delivering community-based healthcare in dozens of countries across four WHO regions. OBJECTIVES: The goals of the Collaborative project are to; (i) enable new opportunities for cross-site learning; (ii) use positive and negative outlier analysis to identify, test, and (if helpful) propagate design practices that lead to quality care; and (iii) create a multi-country 'brain trust' to reinforce data and health information systems across sites. RESULTS: This article outlines the rationale and methods used to establish a data harmonization and pooling Collaborative, early findings, lessons learned, and directions for future research.

Cross-sectional study evaluating the seroprevalence of SARS-CoV-2 antibodies among healthcare workers and factors associated with exposure during the first wave of the COVID-19 pandemic in New York.

OBJECTIVE: Estimate the seroprevalence of SARS-CoV-2 antibodies among New York City Health and Hospitals (NYC H+H) healthcare workers during the first wave of the COVID-19 pandemic, and describe demographic and occupational factors associated with SARS-CoV-2 antibodies among healthcare workers. DESIGN: Descriptive, observational, cross-sectional study using a convenience sample of data from SARS-CoV-2 serological tests accompanied by a demographic and occupational survey administered to healthcare workers. SETTING: A large, urban public healthcare system in NYC. PARTICIPANTS: Participants were employed by NYC H+H and either completed serological testing at NYC H+H between 30 April 2020 and 30 June 2020, or completed SARS-CoV-2 antibody testing outside of NYC H+H and were able to self-report results from the same time period. PRIMARY OUTCOME MEASURE: SARS-CoV-2 serostatus, stratified by key demographic and occupational characteristics reported through the demographic and occupational survey. RESULTS: Seven hundred and twenty-seven survey respondents were included in analysis. Participants had a mean age of 46 years (SD=12.19) and 543 (75%) were women. Two hundred and fourteen (29%) participants tested positive or reported testing positive for the presence of SARS-CoV-2 antibodies (IgG+). Characteristics associated with positive SARS-CoV-2 serostatus were Black race (25% IgG +vs 15% IgG-, p=0.001), having someone in the household with COVID-19 symptoms (49% IgG +vs 21% IgG-, p<0.001), or having a confirmed COVID-19 case in the household (25% IgG +vs 5% IgG-, p<0.001). Characteristics associated with negative SARS-CoV-2 serostatus included working on a COVID-19 patient floor (27% IgG +vs 36% IgG-, p=0.02), working in the intensive care unit (20% IgG +vs 28% IgG-, p=0.03), being employed in a clinical occupation (64% IgG +vs 78% IgG-, p<0.001) or having close contact with a patient with COVID-19 (51% IgG +vs 62% IgG-, p=0.03). CONCLUSIONS: Results underscore the significance that community factors and inequities might have on SARS-CoV-2 exposure for healthcare workers.

Collaborative care model for depression in rural Nepal: a mixed-methods implementation research study.

INTRODUCTION: Despite carrying a disproportionately high burden of depression, patients in low-income countries lack access to effective care. The collaborative care model (CoCM) has robust evidence for clinical effectiveness in improving mental health outcomes. However, evidence from real-world implementation of CoCM is necessary to inform its expansion in low-resource settings. METHODS: We conducted a 2-year mixed-methods study to assess the implementation and clinical impact of CoCM using the WHO Mental Health Gap Action Programme protocols in a primary care clinic in rural Nepal. We used the Capability Opportunity Motivation-Behaviour (COM-B) implementation research framework to adapt and study the intervention. To assess implementation factors, we qualitatively studied the impact on providers' behaviour to screen, diagnose and treat mental illness. To assess clinical impact, we followed a cohort of 201 patients with moderate to severe depression and determined the proportion of patients who had a substantial clinical response (defined as ≥50% decrease from baseline scores of Patient Health Questionnaire (PHQ) to measure depression) by the end of the study period. RESULTS: Providers experienced improved capability (enhanced self-efficacy and knowledge), greater opportunity (via access to counsellors, psychiatrist, medications and diagnostic tests) and increased motivation (developing positive attitudes towards people with mental illness and seeing patients improve) to provide mental healthcare. We observed substantial clinical response in 99 (49%; 95% CI: 42% to 56%) of the 201 cohort patients, with a median seven point (Q1:-9, Q3:-2) decrease in PHQ-9 scores (p<0.0001). CONCLUSION: Using the COM-B framework, we successfully adapted and implemented CoCM in rural Nepal, and found that it enhanced providers' positive perceptions of and engagement in delivering mental healthcare. We observed clinical improvement of depression comparable to controlled trials in high-resource settings. We recommend using implementation research to adapt and evaluate CoCM in other resource-constrained settings to help expand access to high-quality mental healthcare.

High glucose-stimulated enhancer of zeste homolog-2 (EZH2) forces suppression of deptor to cause glomerular mesangial cell pathology.

Function of mTORC1 and mTORC2 has emerged as a driver of mesangial cell pathologies in diabetic nephropathy. The mechanism of mTOR activation is poorly understood in this disease. Deptor is a constitutive subunit and a negative regulator of both mTOR complexes. Mechanistic investigation in mesangial cells revealed that high glucose decreased the expression of deptor concomitant with increased mTORC1 and mTORC2 activities, induction of hypertrophy and, expression of fibronectin and PAI-1. shRNAs against deptor mimicked these pathologic outcomes of high glucose. Conversely, overexpression of deptor significantly inhibited all effects of high glucose. To determine the mechanism of deptor suppression, we found that high glucose significantly increased the expression of EZH2, resulting in lysine-27 tri-methylation of histone H3 (H3K27Me3). Employing approaches including pharmacological inhibition, shRNA-mediated downregulation and overexpression of EZH2, we found that EZH2 regulates high glucose-induced deptor suppression along with activation of mTOR, mesangial cell hypertrophy and fibronectin/PAI-1 expression. Moreover, expression of hyperactive mTORC1 reversed shEZH2-mediated inhibition of hypertrophy and expression of fibronectin and PAI-1 by high glucose. Finally, in renal cortex of diabetic mice, we found that enhanced expression of EZH2 is associated with decreased deptor levels and increased mTOR activity and, expression of fibronectin and PAI-1. Together, our findings provide a novel mechanism for mTOR activation via EZH2 to induce mesangial cell hypertrophy and matrix expansion during early progression of diabetic nephropathy. These results suggest a strategy for leveraging the intrinsic effect of deptor to suppress mTOR activity via reducing EZH2 as a novel therapy for diabetic nephropathy.

Compensation models for community health workers: Comparison of legal frameworks across five countries.

BACKGROUND: Despite the life-saving work they perform, community health workers (CHWs) have long been subject to global debate about their remuneration. There is now, however, an emerging consensus that CHWs should be paid. As the discussion evolves from whether to financially remunerate CHWs to how to do so, there is an urgent need to better understand the types of CHW payment models and their implications. METHODS: This study examines the legal framework on CHW compensation in five countries: Brazil, Ghana, Nigeria, Rwanda, and South Africa. In order to map the characteristics of each approach, a review of the regulatory framework governing CHW compensation in each country was undertaken. Law firms in each of the five countries were engaged to support the identification and interpretation of relevant legal documents. To guide the search and aid in the creation of uniform country profiles, a standardized set of questions was developed, covering: (i) legal requirements for CHW compensation, (ii) CHW compensation mechanisms, and (iii) CHW legal protections and benefits. RESULTS: The five countries profiled represent possible archetypes for CHW compensation: Brazil (public), Ghana (volunteer-based), Nigeria (private), Rwanda (cooperatives with performance based incentives) and South Africa (hybrid public/private). Advantages and disadvantages of each model with respect to (i) CHWs, in terms of financial protection, and (ii) the health system, in terms of ease of implementation, are outlined. CONCLUSIONS: While a strong legal framework does not necessarily translate into high-quality implementation of compensation practices, it is the first necessary step. Certain approaches to CHW compensation - particularly public-sector or models with public sector wage floors - best institutionalize recommended CHW protections. Political will and long-term financing often remain challenges; removing ecosystem barriers - such as multilateral and bilateral restrictions on the payment of salaries - can help governments institutionalize CHW payment.

TGFß acts through PDGFRß to activate mTORC1 via the Akt/PRAS40 axis and causes glomerular mesangial cell hypertrophy and matrix protein expression.

Interaction of transforming growth factor-ß (TGFß)-induced canonical signaling with the noncanonical kinase cascades regulates glomerular hypertrophy and matrix protein deposition, which are early features of glomerulosclerosis. However, the specific target downstream of the TGFß receptor involved in the noncanonical signaling is unknown. Here, we show that TGFß increased the catalytic loop phosphorylation of platelet-derived growth factor receptor ß (PDGFRß), a receptor tyrosine kinase expressed abundantly in glomerular mesangial cells. TGFß increased phosphorylation of the PI 3-kinase-interacting Tyr-751 residue of PDGFRß, thus activating Akt. Inhibition of PDGFRß using a pharmacological inhibitor and siRNAs blocked TGFß-stimulated phosphorylation of proline-rich Akt substrate of 40 kDa (PRAS40), an intrinsic inhibitory component of mTORC1, and prevented activation of mTORC1 in the absence of any effect on Smad 2/3 phosphorylation. Expression of constitutively active myristoylated Akt reversed the siPDGFRß-mediated inhibition of mTORC1 activity; however, co-expression of the phospho-deficient mutant of PRAS40 inhibited the effect of myristoylated Akt, suggesting a definitive role of PRAS40 phosphorylation in mTORC1 activation downstream of PDGFRß in mesangial cells. Additionally, we demonstrate that PDGFRß-initiated phosphorylation of PRAS40 is required for TGFß-induced mesangial cell hypertrophy and fibronectin and collagen I (α2) production. Increased activating phosphorylation of PDGFRß is also associated with enhanced TGFß expression and mTORC1 activation in the kidney cortex and glomeruli of diabetic mice and rats, respectively. Thus, pursuing TGFß noncanonical signaling, we identified how TGFß receptor I achieves mTORC1 activation through PDGFRß-mediated Akt/PRAS40 phosphorylation to spur mesangial cell hypertrophy and matrix protein accumulation. These findings provide support for targeting PDGFRß in TGFß-driven renal fibrosis.

Costing Analysis of a Pilot Community Health Worker Program in Rural Nepal.

Community health workers (CHWs) are essential to primary health care systems and are a cost-effective strategy to achieve the Sustainable Development Goals (SDGs). Nepal is strongly committed to universal health coverage and the SDGs. In 2017, the Nepal Ministry of Health and Population partnered with the nongovernmental organization Nyaya Health Nepal to pilot a program aligned with the 2018 World Health Organization guidelines for CHWs. The program includes CHWs who: (1) receive regular financial compensation; (2) meet a minimum education level; (3) are well supervised; (4) are continuously trained; (5) are integrated into local primary health care systems; (6) use mobile health tools; (7) have consistent supply chain; (8) live in the communities they serve; and (9) provide service without point-of-care user fees. The pilot model has previously demonstrated improved institutional birth rate, antenatal care completion, and postpartum contraception utilization. Here, we performed a retrospective costing analysis from July 16, 2017 to July 15, 2018, in a catchment area population of 60,000. The average per capita annual cost is US$3.05 (range: US$1.94 to US$4.70 across 24 villages) of which 74% is personnel cost. Service delivery and administrative costs and per beneficiary costs for all services are also described. To address the current discourse among Nepali policy makers at the local and federal levels, we also present 3 alternative implementation scenarios that policy makers may consider. Given the Government of Nepal's commitment to increase health care spending (US$51.00 per capita) to 7.0% of the 2030 gross domestic product, paired with recent health care systems decentralization leading to expanded fiscal space in municipalities, this CHW program provides a feasible opportunity to make progress toward achieving universal health coverage and the health-related SDGs. This costing analysis offers insights and practical considerations for policy makers and locally elected officials for deploying a CHW cadre as a mechanism to achieve the SDG targets.

Community-based postpartum contraceptive counselling in rural Nepal: a mixed-methods evaluation.

Unmet need for postpartum contraception in rural Nepal remains high and expanding access to sexual and reproductive healthcare is essential to achieving universal healthcare. We evaluated the impact of an integrated intervention that employed community health workers aided by mobile technology to deliver patient-centred, home-based antenatal and postnatal counselling on postpartum modern contraceptive use. This was a pre-post-intervention study in seven village wards in a single municipality in rural Nepal. The primary outcome was modern contraceptive use among recently postpartum women. We performed a multivariable logistic regression to examine contraceptive use among postpartum women pre- and one-year post-intervention. We conducted qualitative interviews to explore the implementation process. There were 445 postpartum women in the pre-intervention group and 508 in the post-intervention group. Modern contraceptive use increased from 29% pre-intervention to 46% post-intervention (p < 0.0001). Adjusting for age, caste, and household expenditure, time since delivery and sex of child in the index pregnancy, postpartum women one-year post-intervention had twice the odds (OR 2.3; CI 1.7, 3.1; p < 0.0001) of using a modern contraceptive method as compared to pre-intervention. Factors at the individual, family, and systems level influenced women's contraceptive decisions. The intervention contributed to increasing contraceptive use through knowledge transfer, demand generation, referrals to healthcare facilities, and follow-up. A community-based, patient-centred contraceptive counselling intervention supported by mobile technology and integrated into longitudinal care delivered by community health workers appears to be an effective strategy for improving uptake of modern contraception among postpartum women in rural Nepal.

More than a Great Idea: Findings from the Profiles in Public Health Social Work Study.

Progress in refining the definition and basic concepts of public health social work (PHSW) is central to its revitalization. Advancing PHSW further depends on understanding the roles, domains, and daily activities of current PHSW practitioners in the contemporary workforce. The goal of the Profiles in PHSW Study is to explore how public health social workers conceptualize and locate their work. Using snowball sampling, 48 PHSW subjects with four or more years of professional experience were recruited; 34 (70.8%) participated. Qualitative survey responses were compiled and thematically analyzed; six themes emerged related to the nuances of integrating public health and social work, wide-ranging practice across systems and settings, leadership, visibility and viability, and recommendations for how to move PHSW forward. Findings suggest that intentional profession-wide integration of public health approaches into social work education, research, and practice is needed to strengthen the field's impact and role in advancing population health.

Prioritising the role of community health workers in the COVID-19 response.

COVID-19 disproportionately affects the poor and vulnerable. Community health workers are poised to play a pivotal role in fighting the pandemic, especially in countries with less resilient health systems. Drawing from practitioner expertise across four WHO regions, this article outlines the targeted actions needed at different stages of the pandemic to achieve the following goals: (1) PROTECT healthcare workers, (2) INTERRUPT the virus, (3) MAINTAIN existing healthcare services while surging their capacity, and (4) SHIELD the most vulnerable from socioeconomic shocks. While decisive action must be taken now to blunt the impact of the pandemic in countries likely to be hit the hardest, many of the investments in the supply chain, compensation, dedicated supervision, continuous training and performance management necessary for rapid community response in a pandemic are the same as those required to achieve universal healthcare and prevent the next epidemic.

An integrated intervention for chronic care management in rural Nepal: protocol of a type 2 hybrid effectiveness-implementation study.

BACKGROUND: In Nepal, the burden of noncommunicable, chronic diseases is rapidly rising, and disproportionately affecting low and middle-income countries. Integrated interventions are essential in strengthening primary care systems and addressing the burden of multiple comorbidities. A growing body of literature supports the involvement of frontline providers, namely mid-level practitioners and community health workers, in chronic care management. Important operational questions remain, however, around the digital, training, and supervisory structures to support the implementation of effective, affordable, and equitable chronic care management programs. METHODS: A 12-month, population-level, type 2 hybrid effectiveness-implementation study will be conducted in rural Nepal to evaluate an integrated noncommunicable disease care management intervention within Nepal's new municipal governance structure. The intervention will leverage the government's planned roll-out of the World Health Organization's Package of Essential Noncommunicable Disease Interventions (WHO-PEN) program in four municipalities in Nepal, with a study population of 80,000. The intervention will leverage both the WHO-PEN and its cardiovascular disease-specific technical guidelines (HEARTS), and will include three evidence-based components: noncommunicable disease care provision using mid-level practitioners and community health workers; digital clinical decision support tools to ensure delivery of evidence-based care; and training and digitally supported supervision of mid-level practitioners to provide motivational interviewing for modifiable risk factor optimization, with a focus on medication adherence, and tobacco and alcohol use. The study will evaluate effectiveness using a pre-post design with stepped implementation. The primary outcomes will be disease-specific, "at-goal" metrics of chronic care management; secondary outcomes will include alcohol and tobacco consumption levels. DISCUSSION: This is the first population-level, hybrid effectiveness-implementation study of an integrated chronic care management intervention in Nepal. As low and middle-income countries plan for the Sustainable Development Goals and universal health coverage, the results of this pragmatic study will offer insights into policy and programmatic design for noncommunicable disease care management in the future. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04087369. Registered on 12 September 2019.

Measuring fidelity, feasibility, costs: an implementation evaluation of a cluster-controlled trial of group antenatal care in rural Nepal.

BACKGROUND: Access to high-quality antenatal care services has been shown to be beneficial for maternal and child health. In 2016, the WHO published evidence-based recommendations for antenatal care that aim to improve utilization, quality of care, and the patient experience. Prior research in Nepal has shown that a lack of social support, birth planning, and resources are barriers to accessing services in rural communities. The success of CenteringPregnancy and participatory action women's groups suggests that group care models may both improve access to care and the quality of care delivered through women's empowerment and the creation of social networks. We present a group antenatal care model in rural Nepal, designed and implemented by the healthcare delivery organization Nyaya Health Nepal, as well as an assessment of implementation outcomes. METHODS: The study was conducted at Bayalata Hospital in Achham, Nepal, via a public private partnership between the Nepali non-profit, Nyaya Health Nepal, and the Ministry of Health and Population, with financial and technical assistance from the American non-profit, Possible. We implemented group antenatal care as a prospective non-randomized cluster-controlled, type I hybrid effectiveness-implementation study in six village clusters. The implementation approach allows for iterative improvement in design, making changes to improve the quality of the intervention. Assessments of implementation process and model fidelity were undertaken using a mobile checklist completed by nurse supervisors, and observation forms completed by program leadership. We evaluated data quarterly using descriptive statistics to identify trends. Qualitative interviews and team communications were analyzed through immersion crystallization to identify major themes that evolved during the implementation process. RESULTS: A total of 141 group antenatal sessions were run during the study period. This paper reports on implementation results, whereas we analyze and present patient-level effectiveness outcomes in a complementary paper in this journal. There was high process fidelity to the model, with 85.7% (95% CI 77.1-91.5%) of visits completing all process elements, and high content fidelity, with all village clusters meeting the minimum target frequency for 80% of topics. The annual per capita cost for group antenatal care was 0.50 USD. Qualitative analysis revealed the compromise of stable gestation-matched composition of the group members in order to make the intervention feasible. Major adaptations were made in training, documentation, feedback and logistics. CONCLUSION: Group antenatal care provided in collaboration with local government clinics has the potential to provide accessible and high quality antenatal care to women in rural Nepal. The intervention is a feasible and affordable alternative to individual antenatal care. Our experience has shown that adaptation from prior models was important for the program to be successful in the local context within the national healthcare system. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02330887, registered 01/05/2015, retroactively registered.

The power of peers: an effectiveness evaluation of a cluster-controlled trial of group antenatal care in rural Nepal.

BACKGROUND: Reducing the maternal mortality ratio to less than 70 per 100,000 live births globally is one of the Sustainable Development Goals. Approximately 830 women die from pregnancy- or childbirth-related complications every day. Almost 99% of these deaths occur in developing countries. Increasing antenatal care quality and completion, and institutional delivery are key strategies to reduce maternal mortality, however there are many implementation challenges in rural and resource-limited settings. In Nepal, 43% of deliveries do not take place in an institution and 31% of women have insufficient antenatal care. Context-specific and evidence-based strategies are needed to improve antenatal care completion and institutional birth. We present an assessment of effectiveness outcomes for an adaptation of a group antenatal care model delivered by community health workers and midwives in close collaboration with government staff in rural Nepal. METHODS: The study was conducted in Achham, Nepal, via a public private partnership between the Nepali non-profit, Nyaya Health Nepal, and the Ministry of Health and Population, with financial and technical assistance from the American non-profit, Possible. We implemented group antenatal care as a prospective non-randomized, cluster-controlled, type I hybrid effectiveness-implementation study in six village clusters. The implementation approach allowed for iterative improvement in design by making changes to improve the quality of the intervention. We evaluated effectiveness through a difference in difference analysis of institutional birth rates between groups prior to implementation of the intervention and 1 year after implementation. Additionally, we assessed the change in knowledge of key danger signs and the acceptability of the group model compared with individual visits in a nested cohort of women receiving home visit care and home visit care plus group antenatal care. Using a directed content and thematic approach, we analyzed qualitative interviews to identify major themes related to implementation. RESULTS: At baseline, there were 457 recently-delivered women in the six village clusters receiving home visit care and 214 in the seven village clusters receiving home visit care plus group antenatal care. At endline, there were 336 and 201, respectively. The difference in difference analysis did not show a significant change in institutional birth rates nor antenatal care visit completion rates between the groups. There was, however, a significant increase in both institutional birth and antenatal care completion in each group from baseline to endline. We enrolled a nested cohort of 52 participants receiving home visit care and 62 participants receiving home visit care plus group antenatal care. There was high acceptability of the group antenatal care intervention and home visit care, with no significant differences between groups. A significantly higher percentage of women who participated in group antenatal care found their visits to be 'very enjoyable' (83.9% vs 59.6%, p = 0.0056). In the nested cohort, knowledge of key danger signs during pregnancy significantly improved from baseline to endline in the intervention clusters only (2 to 31%, p < 0.001), while knowledge of key danger signs related to labor and childbirth, the postpartum period, and the newborn did not in either intervention or control groups. Qualitative analysis revealed that women found that the groups provided an opportunity for learning and discussion, and the groups were a source of social support and empowerment. They also reported an improvement in services available at their village clinic. Providers noted the importance of the community health workers in identifying pregnant women in the community and linking them to the village clinics. Challenges in birth planning were brought up by both participants and providers. CONCLUSION: While there was no significant change in institutional birth and antenatal care completion at the population level between groups, there was an increase of these outcomes in both groups. This may be secondary to the primary importance of community health worker involvement in both of these groups. Knowledge of key pregnancy danger signs was significantly improved in the home visit plus group antenatal care cohort compared with the home visit care only group. This initial study of Nyaya Health Nepal's adapted group care model demonstrates the potential for impacting women's antenatal care experience and should be studied over a longer period as an intervention embedded within a community health worker program. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02330887 , registered 01/05/2015, retroactively registered.

Implementing a quality improvement initiative for the management of chronic obstructive pulmonary disease in rural Nepal.

Background: Chronic obstructive pulmonary disease accounts for a significant portion of the world's morbidity and mortality, and disproportionately affects low/middle-income countries. Chronic obstructive pulmonary disease management in low-resource settings is suboptimal with diagnostics, medications and high-quality, evidence-based care largely unavailable or unaffordable for most people. In early 2016, we aimed to improve the quality of chronic obstructive pulmonary disease management at Bayalpata Hospital in rural Achham, Nepal. Given that quality improvement infrastructure is limited in our setting, we also aimed to model the use of an electronic health record system for quality improvement, and to build local quality improvement capacity. Design: Using international chronic obstructive pulmonary disease guidelines, the quality improvement team designed a locally adapted chronic obstructive pulmonary disease protocol which was subsequently converted into an electronic health record template. Over several Plan-Do-Study-Act cycles, the team rolled out a multifaceted intervention including educational sessions, reminders, as well as audits and feedback. Results: The rate of oral corticosteroid prescriptions for acute exacerbations of chronic obstructive pulmonary disease increased from 14% at baseline to >60% by month 7, with the mean monthly rate maintained above this level for the remainder of the initiative. The process measure of chronic obstructive pulmonary disease template completion rate increased from 44% at baseline to >60% by month 2 and remained between 50% and 70% for the remainder of the initiative. Conclusion: This case study demonstrates the feasibility of robust quality improvement programmes in rural settings and the essential role of capacity building in ensuring sustainability. It also highlights how individual quality improvement initiatives can catalyse systems-level improvements, which in turn create a stronger foundation for continuous quality improvement and healthcare system strengthening.