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BackgroundThe control of soil-transmitted helminths (STH) is achieved through mass drug administration (MDA) with deworming medications targeting children and other high-risk groups. Recent evidence suggests that it may be possible to interrupt STH transmission by deworming individuals of all ages via community-wide MDA (cMDA). However, a change in delivery platforms will require altering implementation processes.MethodsWe used process mapping, an operational research methodology, to describe the activities required for effective implementation of school-based and cMDA in 18 heterogenous areas and over three years in Benin, India, and Malawi. Planned activities were identified during workshops prior to initiation of a large cMDA trial (the DeWorm3 trial). The process maps were updated annually post-implementation, including adding or removing activities (e.g., adaptations) and determining whether activities occurred according to plan. Descriptive analyses were performed to quantify differences and similarities at baseline and over three implementation years. Comparative analyses were also conducted between study sites and areas implementing school-based vs. cMDA. Digitized process maps were developed to provide a visualization of MDA processes and inspected to identify implementation bottlenecks and inefficient activity flows.ResultsAcross three years and all clusters, implementation of cMDA required an average of 13 additional distinct activities and was adapted more often (5.2 adaptations per year) than school-based MDA. An average of 41% of activities across both MDA platforms did not occur according to planned timelines; however, deviations were often purposeful to improve implementation efficiency or effectiveness. Visualized process maps demonstrated that receipt of drugs at the local level may be an implementation bottleneck. Many activities rely on the effective setting of MDA dates and estimating quantity of drugs, suggesting that the timing of these activities is important to meet planned programmatic outcomes.ConclusionImplementation processes were heterogenous across settings, suggesting that MDA is highly context and resource dependent and that there are many viable ways to implement MDA. Process mapping could be deployed to support a transition from a school-based control program to community-wide STH transmission interruption program and potentially to enable integration with other community-based campaigns.Trial registrationNCT03014167.

BackgroundSoil Transmitted Helminths (STH) infect over 1.5 billion people globally and are associated with anemia and stunting, resulting in an annual toll of 1.9 million Disability-Adjusted Life Years (DALYs). School-based deworming (SBD), via mass drug administration (MDA) campaigns with albendazole or mebendazole, has been recommended by the World Health Organization to reduce levels of morbidity due to STH in endemic areas. DeWorm3 is a cluster-randomized trial, conducted in three study sites in Benin, India, and Malawi, designed to assess the feasibility of interrupting STH transmission with community-wide MDA as a potential strategy to replace SBD. This analysis examines data from the DeWorm3 trial to quantify discrepancies between school-level reporting of SBD and gold standard individual-level survey reporting of SBD.Methodology/principal findingsPopulation-weighted averages of school-level SBD calculated at the cluster level were compared to aggregated individual-level SBD estimates to produce a Mean Squared Error (MSE) estimate for each study site. In order to estimate individual-level SBD coverage, these MSE values were applied to SBD estimates from the control arm of the DeWorm3 trial, where only school-level reporting of SBD coverage had been collected. In each study site, SBD coverage in the school-level datasets was substantially higher than that obtained from individual-level datasets, indicating possible overestimation of school-level SBD coverage. When applying observed MSE to project expected coverages in the control arm, SBD coverage dropped from 89.1% to 70.5% (p-value < 0.001) in Benin, from 97.7% to 84.5% (p-value < 0.001) in India, and from 41.5% to 37.5% (p-value < 0.001) in Malawi.Conclusions/significanceThese estimates indicate that school-level SBD reporting is likely to significantly overestimate program coverage. These findings suggest that current SBD coverage estimates derived from school-based program data may substantially overestimate true pediatric deworming coverage within targeted communities.Trial registrationNCT03014167.

Objectives Use of intrauterine balloon tamponades for refractory postpartum haemorrhage (PPH) management has triggered recent debate since effectiveness studies have yielded conflicting results. Implementation research is needed to identify factors influencing successful integration into maternal healthcare packages. The Ellavi uterine balloon tamponade (UBT) (Ellavi) is a new low-cost, preassembled device for treating refractory PPH.Design A mixed-methods, prospective, implementation research study examining the adoption, sustainability, fidelity, acceptability and feasibility of introducing a newly registered UBT. Cross-sectional surveys were administered post-training and post-use over 10 months.Setting Three Ghanaian (district, regional) and three Kenyan (levels 4–6) healthcare facilities.Participants Obstetric staff (n=451) working within participating facilities.Intervention PPH management training courses were conducted with obstetric staff.Primary and secondary outcome measures Facility measures of adoption, sustainability and fidelity and individual measures of acceptability and feasibility.Results All participating hospitals adopted the device during the study period and the majority (52%–62%) of the employed obstetric staff were trained on the Ellavi; sustainability and fidelity to training content were moderate. The Ellavi was suited for this context due to high delivery and PPH burden. Dynamic training curriculums led by local UBT champions and clear instructions on the packaging yielded positive attitudes and perceptions, and high user confidence, resulting in overall high acceptability. Post-training and post-use, ≥79% of the trainees reported that the Ellavi was easy to use. Potential barriers to use included the lack of adjustable drip stands and difficulties calculating bag height according to blood pressure. Overall, the Ellavi can be feasibly integrated into PPH care and was preferred over condom catheters.Conclusions The training package and time saving Ellavi design facilitated its adoption, acceptability and feasibility. The Ellavi is appropriate and feasible for use among obstetric staff and can be successfully integrated into the Kenyan and Ghanaian maternal healthcare package.Trial registration numbers NCT04502173; NCT05340777.

Abstract Introduction Diabetes and chronic kidney diseases are associated with a large health burden in the USA and globally. Objective To estimate age-standardized mortality rates by county from diabetes mellitus and chronic kidney disease. Design and setting Validated small area estimation models were applied to de-identified death records from the National Center for Health Statistics (NCHS) and population counts from the census bureau, NCHS, and the Human Mortality Database to estimate county-level mortality rates from 1980 to 2014 from diabetes mellitus and chronic kidney disease (CKD). Exposures County of residence. Main outcomes and measures Age-standardized mortality rates by county, year, sex, and cause. Results Between 1980 and 2014, 2,067,805 deaths due to diabetes were recorded in the USA. The mortality rate due to diabetes increased by 33.6% (95% UI: 26.5%–41.3%) between 1980 and 2000 and then declined by 26.4% (95% UI: 22.8%–30.0%) between 2000 and 2014. Counties with very high mortality rates were found along the southern half of the Mississippi river and in parts of South and North Dakota, while very low rates were observed in central Colorado, and select counties in the Midwest, California, and southern Florida. A total of 1,659,045 deaths due to CKD were recorded between 1980 and 2014 (477,332 due to diabetes mellitus, 1,056,150 due to hypertension, 122,795 due to glomerulonephritis, and 2,768 due to other causes). CKD mortality varied among counties with very low mortality rates observed in central Colorado as well as some counties in southern Florida, California, and Great Plains states. High mortality rates from CKD were observed in counties throughout much of the Deep South, and a cluster of counties with particularly high rates was observed around the Mississippi river. Conclusions and relevance This study found large inequalities in diabetes and CKD mortality among US counties. The findings provide insights into the root causes of this variation and call for improvements in risk factors, access to medical care, and quality of medical care.

Self-care reproductive health innovations are increasingly valued as practices that enable women to manage their fertility with greater autonomy. While self-care, by definition, takes place beyond the clinic walls, many self-care practices nonetheless require initial or follow up visits to a health worker. Access to self-care hinges on the extent to which health care workers who serve as gatekeepers find the innovation appropriate and practical. Self-injection of subcutaneous depot medroxyprogesterone acetate (DMPA-SC) is being introduced and scaled in many countries. In late 2018, health workers in Uganda began offering self-injection of DMPA-SC in the public sector, and this study examines health workers' views on the acceptability and feasibility of training women to self-inject. We conducted in-person interviews with 120 health workers active in the self-injection program to better understand provider practices, program satisfaction, and their views on feasibility. A subset of 77 health workers participated in in-depth interviews. Quantitative data was analyzed using Stata (v14) software, and chi square and student t tests used to measure between group differences. Qualitative data was analyzed using Atlas.ti, employing an iterative coding process, to identify key themes that resonated. The majority of health workers were very satisfied with the self-injection program and reported it was moderately easy to integrate self-injection training into routine service delivery. They identified lack of time to train clients in the clinic setting, lack of materials among community health workers, and client fear of self-injection as key challenges. Community health workers were less likely to report time challenges and indicated higher levels of satisfaction and greater ease in offering self-injection services. The relatively high acceptability of the self-injection program among health workers is promising; however, strategies to overcome feasibility challenges, such as workload constraints that limit the ability to offer self-injection training, are needed to expand service delivery to more women interested in this new self-care innovation. As self-injection programs are introduced and scaled across settings, there is a need for evidence regarding how self-care innovations can be designed and implemented in ways that are practical for health workers, while optimizing women's successful adoption and use.

Contraceptive self-injection (SI) is a new self-care practice with potential to transform women's family planning access by putting a popular method, injectable contraception, directly into the hands of users. Research shows that SI is feasible and acceptable; evidence regarding how to design and implement SI programs under real-world conditions is still needed. This evaluation examined women's experiences when self-injection of subcutaneous depot medroxyprogesterone acetate (DMPA-SC) was introduced in Uganda alongside other contraceptive options in the context of informed choice. We conducted structured survey interviews with 958 randomly selected SI clients trained in three districts in 2019. SI clients demonstrated their injection technique on a model to permit an assessment of injection proficiency. A randomly selected subset of 200 were re-interviewed 10–17 months post-training to understand resupply experiences, waste disposal practices and continuation. Finally, we conducted survey interviews with a random sample of 200 clients who participated in training but declined to self-inject. Data were analyzed using Stata IC/14.2. Differences between groups were measured using chi square and t-tests. Multivariate analyses predicting injection proficiency and SI adoption employed mixed effects logistic regression. Nearly three quarters of SI clients (73%) were able to demonstrate injection proficiency without additional instruction from a provider. Years of education, having received a complete training, practicing, and taking home a job aid were associated with higher odds of proficiency. Self-reported satisfaction and continuation were high, with 93% reinjecting independently 3 months post-training. However, a substantial share of those trained opted not to self-inject. Being single, having a partner supportive of family planning use, training with a job aid, practicing, witnessing a demonstration and exposure to a full training were associated with higher odds of becoming an SI client; conversely, those trained in a group had reduced odds of becoming an SI client. The self-care program was successful for the majority of women who became self-injectors, enabling most women to demonstrate SI proficiency. Nearly all those who opted to self-inject reinjected independently, and the majority continued self-injecting for at least 1 year. Additional research should identify strategies to facilitate adoption by women who wish to self-inject but face challenges.

Objectives Current guidelines for the control of soil-transmitted helminths (STH) recommend deworming children and other high-risk groups, primarily using school-based deworming (SBD) programmes. However, targeting individuals of all ages through community-wide mass drug administration (cMDA) may interrupt STH transmission in some settings. We compared the costs of cMDA to SBD to inform decision-making about future updates to STH policy.Design We conducted activity-based microcosting of cMDA and SBD for 2 years in Benin, India and Malawi within an ongoing cMDA trial.Setting Field sites and collaborating research institutions.Primary and secondary outcomes We calculated total financial and opportunity costs and costs per treatment administered (unit costs in 2019 USD ($)) from the service provider perspective, including costs related to community drug distributors and other volunteers.Results On average, cMDA unit costs were more expensive than SBD in India ($1.17 vs $0.72) and Malawi ($2.26 vs $1.69), and comparable in Benin ($2.45 vs $2.47). cMDA was more expensive than SBD in part because most costs (~60%) were ‘supportive costs’ needed to deliver treatment with high coverage, such as additional supervision and electronic data capture. A smaller fraction of cMDA costs (~30%) was routine expenditures (eg, drug distributor allowances). The remaining cMDA costs (~10%) were opportunity costs of staff and volunteer time. A larger percentage of SBD costs was opportunity costs for teachers and other government staff (between ~25% and 75%). Unit costs varied over time and were sensitive to the number of treatments administered.Conclusions cMDA was generally more expensive than SBD. Accounting for local staff time (volunteers, teachers, health workers) in community programmes is important and drives higher cost estimates than commonly recognised in the literature. Costs may be lower outside of a trial setting, given a reduction in supportive costs used to drive higher treatment coverage and economies of scale.Trial registration number NCT03014167.

Objective To present a costing study integrated within the DeWorm3 multi-country field trial of community-wide mass drug administration (cMDA) for elimination of soil-transmitted helminths.Design Tailored data collection instruments covering resource use, expenditure and operational details were developed for each site. These were populated alongside field activities by on-site staff. Data quality control and validation processes were established. Programmed routines were used to clean, standardise and analyse data to derive costs of cMDA and supportive activities.Setting Field site and collaborating research institutions.Primary and secondary outcome measures A strategy for costing interventions in parallel with field activities was discussed. Interim estimates of cMDA costs obtained with the strategy were presented for one of the trial sites.Results The study demonstrated that it was both feasible and advantageous to collect data alongside field activities. Practical decisions on implementing the strategy and the trade-offs involved varied by site; trialists and local partners were key to tailoring data collection to the technical and operational realities in the field. The strategy capitalised on the established processes for routine financial reporting at sites, benefitted from high recall and gathered operational insight that facilitated interpretation of the estimates derived. The methodology produced granular costs that aligned with the literature and allowed exploration of relevant scenarios. In the first year of the trial, net of drugs, the incremental financial cost of extending deworming of school-aged children to the whole community in India site averaged US$1.14 (USD, 2018) per person per round. A hypothesised at-scale routine implementation scenario yielded a much lower estimate of US$0.11 per person treated per round.Conclusions We showed that costing interventions alongside field activities offers unique opportunities for collecting rich data to inform policy toward optimising health interventions and for facilitating transfer of economic evidence from the field to the programme.Trial registration number NCT03014167; Pre-results.

Objectives: To evaluate the cost-effectiveness of self-injected subcutaneous depot medroxyprogesterone acetate (DMPA-SC) compared to health-worker-administered intramuscular DMPA (DMPA-IM) in Senegal and to assess how including practice or demonstration injections in client self-injection training affects estimates. Study design: We developed a decision-tree model with a 12-month time horizon for a hypothetical cohort of 100,000 injectable contraceptive users in Senegal. We used the model to estimate incremental costs per disability-adjusted life year (DALY) averted. The analysis derived model inputs from DMPA-SC self-injection continuation and costing research studies and peer-reviewed literature. We evaluated the cost-effectiveness from societal and health system perspectives and conducted one-way and probabilistic sensitivity analyses to test the robustness of results. Results: Compared to health-worker-administered DMPA-IM, self-injected DMPA-SC could prevent 1402 additional unintended pregnancies and avert 204 maternal DALYs per year for this hypothetical cohort. From a societal perspective, self-injection costs less than health worker administration regardless of the training approach and is therefore dominant. From the health system perspective, self-injection is dominant compared to health worker administration if a one-page instruction sheet is used and one additional DMPA-SC unit is used for training and is cost-effective at $208 per DALY averted when two additional DMPA-SC units are used. Sensitivity analysis showed estimates were robust. Conclusions: Self-injected DMPA-SC averted more pregnancies and DALYs and cost less from the societal perspective compared to health-worker-administered DMPA-IM and hence is dominant. Using fewer DMPA-SC units for practice or demonstration improves cost-effectiveness of self-injection from the health system perspective. Implications: Evidence from Senegal shows that self-injection of DMPA-SC can be dominant or cost-effective from both health system and societal perspectives relative to DMPA-IM from health workers even if women practice injecting or health workers demonstrate with one or two DMPA-SC units. Evidence on whether practice or demonstration is required for client training would be useful. Keywords: Cost-effectiveness, Economic evaluation, DMPA-SC, Injectable contraception, Self-injection, Family planning

Background: Health outcomes are known to vary at both the country and local levels, but trends in mortality across a detailed and comprehensive set of causes have not been previously described at a very local level. Life expectancy in King County, WA, USA, is in the 95th percentile among all counties in the USA. However, little is known about how life expectancy and mortality from different causes of death vary at a local, neighbourhood level within this county. In this analysis, we estimated life expectancy and cause-specific mortality within King County to describe spatial trends, quantify disparities in mortality, and assess the contribution of each cause of death to overall disparities in all-cause mortality. Methods: We applied established so-called garbage code redistribution algorithms and small area estimation methods to death registration data for King County to estimate life expectancy, cause-specific mortality rates, and years of life lost (YLL) rates from 152 causes of death for 397 census tracts from Jan 1, 1990, to Dec 31, 2014. We used the cause list developed for the Global Burden of Disease 2015 study for this analysis. Deaths were tabulated by age group, sex, census tract, and cause of death. We used Bayesian mixed-effects regression models to estimate mortality overall and from each cause. Findings: Between 1990 and 2014, life expectancy in King County increased by 5·4 years (95% uncertainty interval [UI] 5·0–5·7) among men (from 74·0 years [73·7–74·3] to 79·3 years [79·1–79·6]) and by 3·4 years (3·0–3·7) among women (from 80·0 years [79·7–80·2] to 83·3 years [83·1–83·5]). In 2014, life expectancy ranged from 68·4 years (95% UI 66·9–70·1) to 86·7 years (85·0–88·2) for men and from 73·6 years (71·6–75·5) to 88·4 years (86·9–89·9) for women among census tracts within King County. Rates of YLL by cause also varied substantially among census tracts for each cause of death. Geographical areas with relatively high and relatively low YLL rates differed by cause. In general, causes of death responsible for more YLLs overall also contributed more significantly to geographical inequality within King County. However, certain causes contributed more to inequality than to overall YLLs. Interpretation: This census tract-level analysis of life expectancy and cause-specific YLL rates highlights important differences in health among neighbourhoods in King County that are masked by county-level estimates. Efforts to improve population health in King County should focus on reducing geographical inequality, by targeting those health conditions that contribute the most to overall YLLs and to inequality. This analysis should be replicated in other locations to more fully describe fine-grained local-level variation in population health and contribute to efforts to improve health while reducing inequalities. Funding: John W Stanton and Theresa E Gillespie.

As the outbreak of Ebola virus disease (EVD) in West Africa is now contained, attention is turning from control to future outbreak prediction and prevention. Building on a previously published zoonotic niche map (Pigott et al., 2014), this study incorporates new human and animal occurrence data and expands upon the way in which potential bat EVD reservoir species are incorporated. This update demonstrates the potential for incorporating and updating data used to generate the predicted suitability map. A new data portal for sharing such maps is discussed. This output represents the most up-to-date estimate of the extent of EVD zoonotic risk in Africa. These maps can assist in strengthening surveillance and response capacity to contain viral haemorrhagic fevers.