Diarrhea Clinical Trial
Official title:
Spillover Effects of Water, Sanitation, and Hygiene Interventions on Child Health
The purpose of this study is to measure whether a combined water, sanitation, and hygiene intervention leads to improved health of children who did not receive the intervention themselves and who live within a close vicinity of intervention recipients.
Status | Completed |
Enrollment | 1789 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A to 60 Months |
Eligibility |
Inclusion Criteria: - Children not enrolled in WASH Benefits who live in a compound within 120 steps (2 minutes walking time) of a compound enrolled in WASH Benefits (combined WSH or control arms) and are 0-60 months 24 months after intervention Exclusion Criteria: - Children enrolled in WASH Benefits - Children who live in compounds (baris) that share a courtyard with a compound enrolled in the WASH Benefits study - Children who live in compounds (baris) that share a latrine or handwashing station with a compound enrolled in the WASH Benefits study |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Bangladesh | International Centre for Diarrhoeal Disease Research, Bangladesh | Dhaka |
Lead Sponsor | Collaborator |
---|---|
University of California, Berkeley | Bill and Melinda Gates Foundation, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), International Centre for Diarrhoeal Disease Research, Bangladesh, Stanford University |
Bangladesh,
Arnold BF, Null C, Luby SP, Unicomb L, Stewart CP, Dewey KG, Ahmed T, Ashraf S, Christensen G, Clasen T, Dentz HN, Fernald LC, Haque R, Hubbard AE, Kariger P, Leontsini E, Lin A, Njenga SM, Pickering AJ, Ram PK, Tofail F, Winch PJ, Colford JM Jr. Cluster-randomised controlled trials of individual and combined water, sanitation, hygiene and nutritional interventions in rural Bangladesh and Kenya: the WASH Benefits study design and rationale. BMJ Open. 2013 Aug 30;3(8):e003476. doi: 10.1136/bmjopen-2013-003476. — View Citation
Dreibelbis R, Winch PJ, Leontsini E, Hulland KR, Ram PK, Unicomb L, Luby SP. The Integrated Behavioural Model for Water, Sanitation, and Hygiene: a systematic review of behavioural models and a framework for designing and evaluating behaviour change interventions in infrastructure-restricted settings. BMC Public Health. 2013 Oct 26;13:1015. doi: 10.1186/1471-2458-13-1015. Review. — View Citation
Ercumen A, Naser AM, Unicomb L, Arnold BF, Colford JM Jr, Luby SP. Effects of source- versus household contamination of tubewell water on child diarrhea in rural Bangladesh: a randomized controlled trial. PLoS One. 2015 Mar 27;10(3):e0121907. doi: 10.1371/journal.pone.0121907. eCollection 2015. — View Citation
Hulland KR, Leontsini E, Dreibelbis R, Unicomb L, Afroz A, Dutta NC, Nizame FA, Luby SP, Ram PK, Winch PJ. Designing a handwashing station for infrastructure-restricted communities in Bangladesh using the integrated behavioural model for water, sanitation and hygiene interventions (IBM-WASH). BMC Public Health. 2013 Sep 23;13:877. doi: 10.1186/1471-2458-13-877. — View Citation
Lin A, Arnold BF, Afreen S, Goto R, Huda TM, Haque R, Raqib R, Unicomb L, Ahmed T, Colford JM Jr, Luby SP. Household environmental conditions are associated with enteropathy and impaired growth in rural Bangladesh. Am J Trop Med Hyg. 2013 Jul;89(1):130-7. doi: 10.4269/ajtmh.12-0629. Epub 2013 Apr 29. — View Citation
Sultana R, Mondal UK, Rimi NA, Unicomb L, Winch PJ, Nahar N, Luby SP. An improved tool for household faeces management in rural Bangladeshi communities. Trop Med Int Health. 2013 Jul;18(7):854-60. doi: 10.1111/tmi.12103. Epub 2013 Apr 5. — View Citation
Vujcic J, Ram PK, Hussain F, Unicomb L, Gope PS, Abedin J, Mahmud ZH, Islam MS, Luby SP. Toys and toilets: cross-sectional study using children's toys to evaluate environmental faecal contamination in rural Bangladeshi households with different sanitation facilities and practices. Trop Med Int Health. 2014 May;19(5):528-36. doi: 10.1111/tmi.12292. Epub 2014 Mar 19. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of soil-transmitted helminths (Ascaris, hookworm, Trichuris) | Children's stool will be collected. Kato-Katz will be used to detect Ascaris, hookworm, Trichuris ova in stool. Stool samples with any ova will be considered positive. | Measured approximately 24 months after intervention | No |
Primary | Intensity of soil-transmitted helminth infections (Ascaris, hookworm, Trichuris) | Children's stool will be collected. Kato-Katz will be used to detect Ascaris, hookworm, Trichuris ova in stool. Intensity will be measured using WHO cutoffs based on the number of eggs per gram of stool (>=5,000 eggs/gram for Ascaris, >=1,000 eggs/gram for hookworm, and >=2,000 eggs/gram for Trichuris). | Measured approximately 24 months after intervention | No |
Secondary | Diarrhea prevalence | Diarrhea is defined as 3+ loose or watery stools in 24 hours or 1+ stools with blood in 24 hours. Diarrhea will be measured in interviews using caregiver-reported symptoms with 2-day and 7-day recall, measured 24 months after intervention. | Measured approximately 24 months after intervention | No |
Secondary | Respiratory illness prevalence | Respiratory illness is defined as a persistent cough or difficulty breathing in the 7 days before the interview. Respiratory illness will be measured in interviews using caregiver-reported symptoms with 2-day and 7-day recall, measured 24 months after intervention. | Measured approximately 24 months after intervention | No |
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