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.

Results of a national school-based deworming programme on soil-transmitted helminths infections and schistosomiasis in Kenya: 2012-2017.

BACKGROUND: Soil-transmitted helminth (STH) and schistosome infections are among the most prevalent neglected tropical diseases (NTDs) in the world. School-aged children are particularly vulnerable to these chronic infections that can impair growth, nutritional status and cognitive ability. Mass drug administration (MDA) delivered either once or twice annually is a safe and effective approach recommended by the World Health Organization (WHO) to reduce worm burden. In 2012, Kenya began a national school-based deworming programme (NSBDP) aimed at reducing infection and associated morbidity. The change in prevalence and intensity of these infections was monitored over five years (2012-2017). Here, we present the changes in STH and schistosome infections between baseline and endline assessments, as well as explore the yearly patterns of infection reductions. METHODS: We used series of pre- and post-MDA intervention, repeat cross-sectional surveys in a representative, stratified, two-stage sample of schools in 16 counties of Kenya. The programme consisted of two tiers of monitoring; a national baseline, midterm and endline surveys consisting of 200 schools, and pre- and post-MDA surveys conducted yearly consisting of 60 schools. Stool and urine samples were collected from randomly selected school children and examined for STH and schistosome infections using Kato-Katz and urine filtration techniques respectively. RESULTS: Overall, 32.3%, 16.4% and 13.5% of the children were infected with any STH species during baseline, midterm and endline assessment, respectively, with a relative reduction of 58.2% over the five-year period. The overall prevalence of S. mansoni was 2.1%, 1.5% and 1.7% and of S. haematobium was 14.8%, 6.8% and 2.4%, respectively, for baseline, midterm and endline surveys. We observed inter-region and inter-county heterogeneity variation in the infection levels. CONCLUSIONS: The analysis provided robust assessment of the programme and outlined the current prevalence, mean intensity and re-infection pattern of these infections. Our findings will allow the Government of Kenya to make informed decisions on the strategy to control and eliminate these NTDs. Our results suggest that complimentary interventions may have to be introduced to sustain the chemotherapeutic gains of MDA and accelerate attainment of elimination of these NTDs as a public health problem in Kenya.

Interrupting transmission of soil-transmitted helminths: a study protocol for cluster randomised trials evaluating alternative treatment strategies and delivery systems in Kenya.

INTRODUCTION: In recent years, an unprecedented emphasis has been given to the control of neglected tropical diseases, including soil-transmitted helminths (STHs). The mainstay of STH control is school-based deworming (SBD), but mathematical modelling has shown that in all but very low transmission settings, SBD is unlikely to interrupt transmission, and that new treatment strategies are required. This study seeks to answer the question: is it possible to interrupt the transmission of STH, and, if so, what is the most cost-effective treatment strategy and delivery system to achieve this goal? METHODS AND ANALYSIS: Two cluster randomised trials are being implemented in contrasting settings in Kenya. The interventions are annual mass anthelmintic treatment delivered to preschool- and school-aged children, as part of a national SBD programme, or to entire communities, delivered by community health workers. Allocation to study group is by cluster, using predefined units used in public health provision-termed community units (CUs). CUs are randomised to one of three groups: receiving either (1) annual SBD; (2) annual community-based deworming (CBD); or (3) biannual CBD. The primary outcome measure is the prevalence of hookworm infection, assessed by four cross-sectional surveys. Secondary outcomes are prevalence of Ascaris lumbricoides and Trichuris trichiura, intensity of species infections and treatment coverage. Costs and cost-effectiveness will be evaluated. Among a random subsample of participants, worm burden and proportion of unfertilised eggs will be assessed longitudinally. A nested process evaluation, using semistructured interviews, focus group discussions and a stakeholder analysis, will investigate the community acceptability, feasibility and scale-up of each delivery system. ETHICS AND DISSEMINATION: Study protocols have been reviewed and approved by the ethics committees of the Kenya Medical Research Institute and National Ethics Review Committee, and London School of Hygiene and Tropical Medicine. The study has a dedicated web site. TRIAL REGISTRATION NUMBER: NCT02397772.

The roles of water, sanitation and hygiene in reducing schistosomiasis: a review.

Schistosomiasis is a disease caused by infection with blood flukes of the genus Schistosoma. Transmission of, and exposure to, the parasite result from faecal or urinary contamination of freshwater containing intermediate host snails, and dermal contact with the same water. The World Health Assembly resolution 65.21 from May 2012 urges member states to eliminate schistosomiasis through preventive chemotherapy (i.e. periodic large-scale administration of the antischistosomal drug praziquantel to school-aged children and other high-risk groups), provision of water, sanitation and hygiene (WASH) and snail control. However, control measures focus almost exclusively on preventive chemotherapy, while only few studies made an attempt to determine the impact of upgraded access to safe water, adequate sanitation and good hygiene on schistosome transmission. We recently completed a systematic review and meta-analysis pertaining to WASH and schistosomiasis and found that people with safe water and adequate sanitation have significantly lower odds of a Schistosoma infection. Importantly though, the transmission of schistosomiasis is deeply entrenched in social-ecological systems, and hence is governed by setting-specific cultural and environmental factors that determine human behaviour and snail populations. Here, we provide a comprehensive review of the literature, which explores the transmission routes of schistosomes, particularly focussing on how these might be disrupted with WASH-related technologies and human behaviour. Additionally, future research directions in this area are highlighted.