Slaying the Serpent: A Research Agenda to Expand Intervention Development and Accelerate Guinea Worm Eradication Efforts.

Dracunculiasis, also known as Guinea worm disease, is targeted to become the second human disease and first parasitic infection to be eradicated. The global Guinea Worm Eradication Program (GWEP), through community-based interventions, reduced the burden of disease from an estimated 3.5 million cases per year in 1986 to only 13 human cases in 2022. Despite progress, in 2012 Guinea worm disease was detected in domesticated dogs and later in domesticated cats and baboons. Without previous development of any Guinea worm therapeutics, diagnostic tests to detect pre-patent Guinea worm infection, or environmental surveillance tools, the emergence of Guinea worm disease in animal hosts-a threat to eradication-motivated an assessment of evidence gaps and research opportunities. This gap analysis informed the refinement of a robust research agenda intended to generate new evidence and identify additional tools for national GWEPs and to better align the global GWEP with a 2030 Guinea worm eradication certification target. This paper outlines the rationale for the development and expansion of the global GWEP Research Agenda and summarizes the results of the gap analysis that was conducted to identify Guinea worm-related research needs and opportunities. We describe five work streams informed by the research gap analysis that underpin the GWEP Research Agenda and address eradication endgame challenges through the employment of a systems-informed One Health approach. We also discuss the infrastructure in place to disseminate new evidence and monitor research results as well as plans for the continual review of evidence and research priorities.

Factors Influencing Community Engagement during Guinea Worm and Polio Eradication Endgames in Chad: Recommendations for "Last Mile" Programming.

Community engagement is a strategy commonly used in health and development programming. Many disease eradication programs engage with communities through different structures and mechanisms to detect, report, contain, and respond to the diseases they target. Qualitative operational research was conducted in a district of Chad co-endemic for both dracunculiasis (i.e., Guinea worm disease) and circulating vaccine-derived poliovirus to reveal factors influencing community engagement behavior in the context of eradication-related programming. Women and men from six communities and stakeholders from the local, district, and central levels were recruited to participate in focus group discussions and semi-structured in-depth interviews. A thematic analysis was performed to identify barriers and facilitators of community engagement. Barriers to community engagement included mistrust in exogenously established health program initiatives (i.e., initiatives designed by partners external to targeted program communities) resulting from negative past experiences with external entities and community groups and the lure of profit-motivating community engagement. Subgroup and intersectionality analyses revealed that gender and other identities influence whether and to what extent certain members of the community engage in a meaningful way. Facilitators of community engagement included leadership and the influence of authorities and leaders in community participation, perceived benefits of being engaged with community-based initiatives, and use of incentives to enhance community participation. Study findings may be used to inform the refinement of community engagement approaches in Chad and learning agendas for other "last mile" disease eradication programs.

Predicting the Environmental Suitability and Identifying Climate and Sociodemographic Correlates of Guinea Worm (Dracunculus medinensis) in Chad.

A comprehensive understanding of the spatial distribution and correlates of infection are key for the planning of disease control programs and assessing the feasibility of elimination and/or eradication. In this work, we used species distribution modeling to predict the environmental suitability of the Guinea worm (Dracunculus medinensis) and identify important climatic and sociodemographic risk factors. Using Guinea worm surveillance data collected by the Chad Guinea Worm Eradication Program (CGWEP) from 2010 to 2022 in combination with remotely sensed climate and sociodemographic correlates of infection within an ensemble machine learning framework, we mapped the environmental suitability of Guinea worm infection in Chad. The same analytical framework was also used to ascertain the contribution and influence of the identified climatic risk factors. Spatial distribution maps showed predominant clustering around the southern regions and along the Chari River. We also identified areas predicted to be environmentally suitable for infection. Of note are districts near the western border with Cameroon and southeastern border with Central African Republic. Key environmental correlates of infection as identified by the model were proximity to permanent rivers and inland lakes, farmlands, land surface temperature, and precipitation. This work provides a comprehensive model of the spatial distribution of Guinea worm infections in Chad 2010-2022 and sheds light on potential environmental correlates of infection. As the CGWEP moves toward elimination, the methods and results in this study will inform surveillance activities and help optimize the allocation of intervention resources.

Diagnosing norms and norm change in rural Bangladesh: an exploration of gendered social norms and women's empowerment.

BACKGROUND: Gender-transformative public health programs often aim to address power inequities between men and women and promote women's empowerment. However, to achieve transformative change, it is necessary to first identify the underlying norms that perpetuate these power imbalances. The objective of our study was to use Bicchieri's theory of social norms and model of norm change to identify gendered norms and evidence of norm change amongst participants of the Food and Agricultural Approaches to Reducing Malnutrition (FAARM) trial in rural Sylhet Division, Bangladesh. METHODS: We conducted ten life history interviews, 16 key informant interviews, and four focus group discussions with women and men in communities within the FAARM study site in rural, north-eastern Bangladesh. We performed a thematic analysis as well as a relational analysis of the data. RESULTS: We found that social norms dictated the extent and ways in which women participated in household decisions, the locations they could visit, and their autonomy to use household resources. We also found evidence of changes to gendered social norms over time and the desire amongst some men and women to abandon restrictive norms. Certain intersecting factors, such as education and employment, were identified as facilitators and barriers to women's empowerment and the related gendered expectations. CONCLUSIONS: Our findings corroborate existing norms literature, which highlights the strong role social norms play in influencing women's empowerment and behaviour. Our study provides an example of rigorous qualitative methodology that others may follow to assess gendered social norms that can be targeted for transformative change.

Quantifying Factors Associated with Personal Hygiene as Measured by the qPHAT Methodology: Andilaye Trial, Ethiopia.

Many water, sanitation, and hygiene (WASH) interventions target improvements in personal hygiene behaviors. Yet measuring personal hygiene behaviors is a challenge due to a lack of reliable, valid, objective, and simple-to-use approaches. The purpose of this study was to examine differences between two types of hygiene outcome measures and their ability to detect relationships between WASH-related behavioral factors and behaviors. We compared hygiene outcomes generated by the Quantitative Personal Hygiene Assessment Tool (qPHAT), which yields objective measures of cleanliness on an 11-point scale, and those generated by conventional, dichotomous indicators of cleanliness. We used cross-sectional data on hygiene outcomes related to facial and hand cleanliness collected during the Andilaye Trial, an impact evaluation of a community-based WASH intervention implemented in Amhara, Ethiopia. We fit multivariable models to examine associations between measures of children's facial and hand cleanliness, via both qPHAT and dichotomous indicators, and 1) household WASH conditions, 2) psychosocial factors, and 3) reported personal hygiene practices. The qPHAT-generated outcomes were able to detect relationships between intermediate behavioral factors and hygiene outcomes that dichotomous indicators were not, including associations with water insecurity and various psychosocial factors. qPHAT-generated outcomes were negatively associated with reported face washing practices, suggesting a bias in reported behaviors. Our study highlights the limitations of reported practices and dichotomous hygiene indicators and indicates that using more quantitative hygiene outcome measures, such as those generated by qPHAT, may reveal important intermediate factors that influence hygiene behavior and support improved monitoring and evaluation of interventions.

The impact of a demand-side sanitation and hygiene promotion intervention on sustained behavior change and health in Amhara, Ethiopia: A cluster-randomized trial.

Behaviors related to water, sanitation, and hygiene (WASH) are key drivers of infectious disease transmission, and experiences of WASH are potential influencers of mental well-being. Important knowledge gaps exist related to the content and delivery of effective WASH programs and their associated health impacts, particularly within the contexts of government programs implemented at scale. We developed and tested a demand-side intervention called Andilaye, which aimed to change behaviors related to sanitation, personal hygiene, and household environmental sanitation. This theory-informed intervention was delivered through the existing Ethiopian Health Extension Programme (HEP). It was a multilevel intervention with a catalyzing event at the community level and behavior change activities at group and household levels. We randomly selected and assigned 50 kebeles (sub-districts) from three woredas (districts), half to receive the Andilaye intervention, and half the standard of care sanitation and hygiene programming (i.e., community-led total sanitation and hygiene [CLTSH]). We collected data on WASH access, behavioral outcomes, and mental well-being. A total of 1,589 households were enrolled into the study at baseline; 1,472 households (94%) participated in an endline assessment two years after baseline, and approximately 14 months after the initiation of a multi-level intervention. The intervention did not improve construction of latrines (prevalence ratio [PR]: 0.99; 95% CI: 0.82, 1.21) or handwashing stations with water (PR: 0.96; 95% CI: 0.72, 1.26), or the removal of animal feces from the compound (PR: 1.10; 95% CI: 0.95, 1.28). Nor did it impact anxiety (PR: 0.90; 95% CI: 0.72, 1.11), depression (PR: 0.83; 95% CI: 0.64, 1.07), emotional distress (PR: 0.86; 95% CI: 0.67, 1.09) or well-being (PR: 0.90; 95% CI: 0.74, 1.10) scores. We report limited impact of the intervention, as delivered, on changes in behavior and mental well-being. The effectiveness of the intervention was limited by poor intervention fidelity. While sanitation and hygiene improvements have been documented in Ethiopia, behavioral slippage, or regression to unimproved practices, in communities previously declared open defecation free is widespread. Evidence from this trial may help address knowledge gaps related to challenges associated with scalable alternatives to CLTSH and inform sanitation and hygiene programming and policy in Ethiopia and beyond. Trial registration: This trial was registered with clinicaltrials.gov (NCT03075436) on March 9, 2017.

Norms and Social Network-Centric Behavior Change Intervention (Nam Nalavazhvu) for Improved Toilet Usage in Peri-Urban Communities of Tamil Nadu: Protocol for a Cluster-Randomized Controlled Trial.

BACKGROUND: Inconsistent toilet usage is a continuing challenge in India. Despite the impact of social expectations on toilet usage, few programs and studies have developed theoretically grounded norm-centric behavior change interventions to increase toilet use in low-income settings. OBJECTIVE: The objective of this paper is to detail the rationale and design of an ex ante, parallel cluster-randomized trial evaluating the impact of a demand-side, norm-centric behavior change intervention on exclusive toilet use and maintenance in peri-urban Tamil Nadu, India. METHODS: Following formative research, we developed an evidence-based norm-centric behavior change intervention called Nam Nalavazhvu (Tamil for "our well-being"). The multilevel intervention aims to improve toilet usage by shifting empirical expectations or beliefs about other relevant people's sanitation practices. It also provides action-oriented information to aid individuals to set goals and overcome barriers to own, consistently use, and maintain their toilets. This trial includes 76 wards in the Pudukkottai and Karur districts, where half were randomly assigned to receive the intervention and the remaining served as counterfactuals. RESULTS: We enrolled wards and conducted a baseline survey among randomly selected individuals in all 76 wards. The 1-year behavior change intervention is currently ongoing. At the endline, we will collect relevant data and compare results between study arms to determine the impacts of the Nam Nalavazhvu intervention on sanitation-related behavioral, health, and well-being outcomes and potential moderators. This study is powered to detect differences in the prevalence of exclusive toilet use between study arms. We are also conducting a process evaluation to understand the extent to which the intervention was implemented as designed, given the special pandemic context. CONCLUSIONS: Findings from this trial will inform norm-centric behavior change strategies to improve exclusive toilet usage. TRIAL REGISTRATION: ClinicalTrials.gov NCT04269824; https://www.clinicaltrials.gov/ct2/show/NCT04269824. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/24407.

Do descriptive norms messaging interventions backfire? Protocol for a systematic review of the boomerang effect.

BACKGROUND: Descriptive norms messaging interventions are used to motivate people to adopt or maintain desirable behaviors. Such interventions provide people with information that describes an undesirable behavior as uncommon or a desirable behavior as prevalent within a relevant social group. Descriptive norms messaging interventions have shown promise in increasing individual and social benefit for a broad range of health and sustainability programs. However, evidence suggests that people who have adopted desirable behaviors sometimes regress to undesirable behaviors after receiving descriptive norms messages due to the type of information provided in the messages. This phenomenon is called the boomerang effect. We aim to conduct a systematic review of boomerang effects on health and environmental sustainability behaviors resulting from exposure to descriptive norms messaging interventions. METHODS: We will employ our search strategy to identify studies of descriptive norms messaging interventions published prior to December 31, 2020. We will search the Cochrane Library, Campbell Library, PsycINFO, PubMed, Social Science Research Network (SSRN), and Web of Science to retrieve peer-reviewed articles published in English. We will restrict inclusion to studies (e.g., randomized and non-randomized controlled trials, quasi-experimental studies, and observational studies) of health and environmental sustainability interventions that assess behaviors before and after exposure to descriptive norms messaging. Two reviewers will independently extract data about study populations and design, intervention components, and behavioral measures. We will use the revised Cochrane Risk of Bias assessment tool (RoB2) and Risk Of Bias in Non-randomized Studies-of Intervention (ROBINS-I) to assess the risk of bias, and the Liverpool Quality Assessment Tool (LQAT) to assess the quality of evidence. We will conduct thematic analyses to codify interventions, and examine intervention effects across subgroups of individuals based on their behavior prior to intervention exposure (e.g., those practicing desirable behaviors vs. undesirable behaviors). We will also conduct moderator analyses to determine whether boomerang effects are contingent upon other factors including intervention framing and delivery modality. DISCUSSION: This systematic review will provide information about descriptive norms messaging intervention effects across subgroups of individuals and elucidate factors that potentially moderate boomerang effects. The review will yield evidence-based recommendations for the structure and content of descriptive norms messages that can be employed to avoid unintended boomerang effects within the context of health and sustainability programming. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020156989.

Bias in the perceived prevalence of open defecation: Evidence from Bihar, India.

People often form perceptions about how prevalent a behavior is in a social group. However, these perceptions can be inaccurate and biased. While persistent undesirable practices in low-income countries have drawn global attention, evidence regarding people's perception of how prevalent these practices are is scarce. Among those harmful practices, open defecation in India remains a significant public health concern, where it perpetuates the vicious cycle of disease and poverty. In this study, we focus on measuring the perceived prevalence of open defecation among respondents in Bihar, India. We examined the bias in perceived prevalence, which is defined as a pattern of deviation from the actual prevalence of open defecation. Results showed that respondents who defecate in the open overestimate the prevalence of open defecation, whereas those who consistently use toilets underestimate it. This finding suggests a false consensus bias in the perceived prevalence of open defecation. Scholars, policymakers, and program implementers who seek to correct misperceptions about open defecation by broadcasting real prevalence should be aware of biases in the perceived prevalence and address them in behavior change interventions.

Development and reliability of a quantitative personal hygiene assessment tool.

Personal hygiene practices, including facewashing and handwashing, reduce transmission of pathogens, but are difficult to measure. Using color theory principles, we developed and tested a novel metric that generates quantitative measures of facial and hand cleanliness, proxy indicators of personal hygiene practices. In this cross-sectional study, conventional qualitative cleanliness metrics (e.g., presence or absence of nasal and ocular discharge, dirt under nails or on finger pads and palms) were also recorded. We generated Gwet's agreement coefficients to determine the inter-rater reliability of novel and conventional metrics between various rating groups, where appropriate, including two non-blinded raters, non-blinded vs. blinded raters, three blinded raters, and blinded vs. computer raters. Inter-rater reliability of the novel metric was high across all rating groups, ranging from 0.98 (95% CI: 0.97, 0.99) to 0.90 (95% CI: 0.90, 0.91) for facial cleanliness, and 0.97 (95% CI: 0.96, 0.98) to 0.92 (95% CI: 0.91, 0.93) for hand cleanliness. Our novel metric generates more nuanced data than conventional qualitative metrics, and allows for quantifiable assessments of facial and hand cleanliness.

Sanitation and Collective Efficacy in Rural Cambodia: The Value Added of Qualitative Formative Work for the Contextualization of Measurement Tools.

Community-level action may be required to achieve the levels of sanitation uptake necessary for health gains. Evidence suggests that collective action is influenced by collective efficacy (CE)-a group's belief in its abilities to organize and execute action to achieve common goals. The extent to which it is necessary to fully contextualize existing CE measurement tools, in order to conduct meaningful assessments of the factors influencing CE perceptions, is not well understood. This study examines the value added of contextualizing an existing CE measurement tool using qualitative formative research. We employed a modified grounded theory approach to develop a contextualized CE framework based on qualitative data from rural Cambodian villages. The resulting framework included sub-constructs that were pertinent for the rural Cambodian context for which an existing, hypothesized framework did not account: perceived risks/benefits, action knowledge, shared needs/benefits, and external accountability. Complex confirmatory factor analyses indicated that contextualized models fit the data better than hypothesized models for women and men. This study demonstrates that inductive, qualitative research allows community-derived factors to enhance existing tools for context-specific CE measurement. Additional research is needed to determine which CE factors transcend contexts and could, thus, form the foundation of a general CE measurement tool.

Design of a parallel cluster-randomized trial assessing the impact of a demand-side sanitation and hygiene intervention on sustained behavior change and mental well-being in rural and peri-urban Amhara, Ethiopia: Andilaye study protocol.

BACKGROUND: Unimproved water, sanitation, and hygiene (WASH) behaviors are key drivers of infectious disease transmission and influencers of mental well-being. While WASH is seen as a critical enabler of health, important knowledge gaps related to the content and delivery of effective, holistic WASH programming exist. Corresponding impacts of WASH on mental well-being are also underexplored. There is a need for more robust implementation research that yields information regarding whether and how community-based, demand-side interventions facilitate progressive and sustained adoption of improved sanitation and hygiene behaviors and downstream health impacts. The purpose of this protocol is to detail the rationale and design of a cluster-randomized trial evaluating the impact of a demand-side sanitation and hygiene intervention on sustained behavior change and mental well-being in rural and peri-urban Amhara, Ethiopia. METHODS: Together with partners, we developed a theoretically-informed, evidence-based behavioral intervention called Andilaye. We randomly selected and assigned 50 sub-districts (kebeles) from three purposively selected districts (woredas); half to receive the Andilaye intervention, and half the standard of care sanitation and hygiene programming (i.e., community-led total sanitation and hygiene [CLTSH]). During baseline, midline, and endline, we will collect data on an array of behavioral factors, potential moderators (e.g., water and sanitation insecurity, collective efficacy), and our primary study outcomes: sanitation and hygiene behaviors and mental well-being. We will perform a process evaluation to assess intervention fidelity and related attributes. DISCUSSION: While CLTSH has fostered sanitation and hygiene improvements in Ethiopia, evidence of behavioral slippage, or regression to unimproved practices in communities previously declared open defecation free exists. Other limitations of CLTSH, such as its focus on disgust, poor triggering, and over-saturation of Health Extension Workers have been documented. We employed rigorous formative research and practically applied social and behavioral theory to develop Andilaye, a scalable intervention designed to address these issues and complement existing service delivery within Ethiopia's Health Extension Program. Evidence from this trial may help address knowledge gaps related to scalable alternatives to CLTSH and inform sanitation and hygiene programming and policy in Ethiopia and beyond. TRIAL REGISTRATION: This trial was registered with clinicaltrials.gov ( NCT03075436 ) on March 9, 2017.

Collective Efficacy: Development and Validation of a Measurement Scale for Use in Public Health and Development Programmes.

Impact evaluations of water, sanitation, and hygiene interventions have demonstrated lower than expected health gains, in some cases due to low uptake and sustained adoption of interventions at a community level. These findings represent common challenges for public health and development programmes relying on collective action. One possible explanation may be low collective efficacy (CE)-perceptions regarding a group's ability to execute actions related to a common goal. The purpose of this study was to develop and validate a metric to assess factors related to CE. We conducted this research within a cluster-randomised sanitation and hygiene trial in Amhara, Ethiopia. Exploratory and confirmatory factor analyses were carried out to examine underlying structures of CE for men and women in rural Ethiopia. We produced three CE scales: one each for men and women that allow for examinations of gender-specific mechanisms through which CE operates, and one 26-item CE scale that can be used across genders. All scales demonstrated high construct validity. CE factor scores were significantly higher for men than women, even among household-level male-female dyads. These CE scales will allow implementers to better design and target community-level interventions, and examine the role of CE in the effectiveness of community-based programming.

Quantifying user preferences for sanitation construction and use: Application of discrete choice experiments in Amhara, Ethiopia.

OBJECTIVE: To quantify stated preferences for latrine use and construction in Amhara, Ethiopia, using Discrete Choice Experiments (DCEs). METHODS: We conducted image-based DCEs to assess preferences for latrine use (stratified by gender) and construction (among men only) in Amhara, Ethiopia. Preference was quantified using a conditional logistic model to estimate utilities and corresponding odds ratios associated with a set of latrine attributes. RESULTS: For latrine use, tin roof, handwashing stations and clean latrines had the highest relative utility coefficients. Tin roof was preferred to no roof for use (Women: OR: 3.68, 95% CI: 3.18-4.25; Men: OR: 3.75, 95% CI: 3.21-4.39) and new latrine construction (5.92, 5.04-6.95). Concrete slabs, a critical aspect of improved sanitation, was not preferred to dirt floors for use (Women: 0.87, 0.75-1.00; Men: 1.03, 0.88-1.20), but was preferred for new construction (1.52, 1.30-1.78). We did not observe any trends in preference for direct (monetary) or indirect cost (labour days), so we were not able to elicit trade-offs between latrine attributes and these costs for the construction of new latrines. CONCLUSION: Our findings suggest similar latrine use preferences between men and women. We found that tin roofs are the most strongly preferred latrine characteristic, but concrete slabs, commonly promoted in sanitation programmes, were not preferred for use. We demonstrate the utility of DCEs to elicit stated preferences for latrine use and construction among community members who have myriad motivations for using and making improvements to their sanitation facilities, including the ease of cleaning and hygiene, durability, or privacy and comfort.

Interventions to maximize facial cleanliness and achieve environmental improvement for trachoma elimination: A review of the grey literature.

BACKGROUND: Efforts are underway to scale-up the facial cleanliness and environmental improvement (F&E) components of the World Health Organization's SAFE strategy for elimination of trachoma as a public health problem. Improving understanding of the F&E intervention landscape could inform advancements prior to scale-up, and lead to more effective and sustained behavior change. METHODS/FINDINGS: We systematically searched for relevant grey literature published from January 1965 through August 2016. Publications were eligible for review if they described interventions addressing F&E in the context of trachoma elimination programs. Subsequent to screening, we mapped attributes of F&E interventions. We then employed three behavior change frameworks to synthesize mapped data and identify potential intervention gaps. We identified 27 documents meeting inclusion criteria. With the exception of some recent programming, F&E interventions have largely focused on intermediate and distal antecedents of behavior change. Evidence from our analyses suggests many interventions are not designed to address documented determinants of improved F&E practices. No reviewed documents endorsed inclusion of intervention components related to behavioral maintenance or resilience-factors critical for sustaining improved behaviors. CONCLUSIONS: If left unaddressed, identified gaps in intervention content may continue to challenge uptake and sustainability of improved F&E behaviors. Stakeholders designing and implementing trachoma elimination programs should review their F&E intervention content and delivery approaches with an eye toward improvement, including better alignment with established behavior change theories and empirical evidence. Implementation should move beyond information dissemination, and appropriately employ a variety of behavior change techniques to address more proximal influencers of change.

Comparison of respondent-reported and sensor-recorded latrine utilization measures in rural Bangladesh: a cross-sectional study.

Background: Health improvements realized through sanitation are likely achieved through high levels of facilities utilization by all household members. However, measurements of sanitation often rely on either the presence of latrines, which does not guarantee use, or respondent-reported utilization of sanitation facilities, which is prone to response bias. Overstatement of sanitation metrics limits the accuracy of program outcome measures, and has implications for the interpretation of related health impact data. Methods: We conducted a cross-sectional study of 213 households in 14 village water, sanitation and hygiene committee clusters throughout rural Bangladesh and used a combined data- and relationship-scale approach to assess agreement between respondent-reported latrine utilization and sensor-recorded measurement. Results: Four-day household-level respondent-reported defecation averaged 28 events (inter-quartile range [IQR] 20-40), while sensor-recorded defecation averaged 17 events (IQR 11-29). Comparative analyses suggest moderately high accuracy (bias correction factor=0.84), but imprecision in the data (broad scatter of data, Pearson's r=0.35) and thus only weak concordance between measures (ρc=0.29 [95% BCa CI 0.15 to 0.43]). Conclusions: Respondent-reported latrine utilization data should be interpreted with caution, as evidence suggests use is exaggerated. Coupling reported utilization data with objective measures of use may aid in the estimation of latrine use.

Design and rationale of a matched cohort study to assess the effectiveness of a combined household-level piped water and sanitation intervention in rural Odisha, India.

INTRODUCTION: Government efforts to address massive shortfalls in rural water and sanitation in India have centred on construction of community water sources and toilets for selected households. However, deficiencies with water quality and quantity at the household level and community coverage and actual use of toilets have led Gram Vikas, a local non-governmental organization in Odisha, India, to develop an approach that provides household-level piped water connections contingent on full community-level toilet coverage. METHODS: This matched cohort study was designed to assess the effectiveness of a combined piped water and sanitation intervention. Households with children <5 years in 45 randomly selected intervention villages and 45 matched control villages will be followed over 17 months. The primary outcome is prevalence of diarrhoeal diseases; secondary health outcomes include soil-transmitted helminth infection, nutritional status, seroconversion to enteric pathogens, urogenital infections and environmental enteric dysfunction. In addition, intervention effects on sanitation and water coverage, access and use, environmental fecal contamination, women's empowerment, as well as collective efficacy, and intervention cost and cost-effectiveness will be assessed. ETHICS AND DISSEMINATION: The study protocol has been reviewed and approved by the ethics boards of the London School of Hygiene and Tropical Medicine, UK and KIIT University, Bhubaneswar, India. Findings will be disseminated via peer-reviewed literature and presentation to stakeholders, government officials, implementers and researchers. TRIAL REGISTRATION NUMBER: NCT02441699.

Measles outbreak in a highly vaccinated population, San Diego, 2008: role of the intentionally undervaccinated.

OBJECTIVE: In January 2008, an intentionally unvaccinated 7-year-old boy who was unknowingly infected with measles returned from Switzerland, resulting in the largest outbreak in San Diego, California, since 1991. We investigated the outbreak with the objective of understanding the effect of intentional undervaccination on measles transmission and its potential threat to measles elimination. METHODS: We mapped vaccination-refusal rates according to school and school district, analyzed measles-transmission patterns, used discussion groups and network surveys to examine beliefs of parents who decline vaccination, and evaluated containment costs. RESULTS: The importation resulted in 839 exposed persons, 11 additional cases (all in unvaccinated children), and the hospitalization of an infant too young to be vaccinated. Two-dose vaccination coverage of 95%, absence of vaccine failure, and a vigorous outbreak response halted spread beyond the third generation, at a net public-sector cost of $10 376 per case. Although 75% of the cases were of persons who were intentionally unvaccinated, 48 children too young to be vaccinated were quarantined, at an average family cost of $775 per child. Substantial rates of intentional undervaccination occurred in public charter and private schools, as well as public schools in upper-socioeconomic areas. Vaccine refusal clustered geographically and the overall rate seemed to be rising. In discussion groups and survey responses, the majority of parents who declined vaccination for their children were concerned with vaccine adverse events. CONCLUSIONS: Despite high community vaccination coverage, measles outbreaks can occur among clusters of intentionally undervaccinated children, at major cost to public health agencies, medical systems, and families. Rising rates of intentional undervaccination can undermine measles elimination.