Overview

This trial is active, not recruiting.

Condition infant diarrhea
Treatments total sanitation and sanitation marketing, scaling up handwashing behavior change
Sponsor Water and Sanitation Program, World Bank
Start date November 2007
End date December 2010
Trial size 21878 participants
Trial identifier NCT01465204, 1095420

Summary

This study consists of an impact evaluation (IE) of the Scaling up Handwashing with Soap (HWWS) and Total Sanitation and Sanitation Marketing (TSSM) projects of the Water and Sanitation Program (WSP) of the World Bank. The objective of this study is to estimate the causal impact of the HWWS and TSSM interventions on the health and welfare of the rural poor in six developing countries: Peru, Tanzania, Senegal, Vietnam, Indonesia, and India. The IE will assess the impact of exposure to the HWWS and TSSM promotion on individual-level hygiene and sanitation practices, and on the health and welfare of children 0-5 years old. By introducing exogenous variation in handwashing and sanitation practices (through exposure to the HWWS and TSSM promotion), the IE will also answer a number of important questions related to the effect of the intended behavioral change (handwashing and improved sanitation) on health and welfare, thus providing information on the extent to which these behaviors alter intended development outcomes. This study uses a cluster-randomized experimental design, whereby the geographic units called clusters (e.g. village, commune, ward, depending on administrative structure of country) are randomly assigned to receive certain components of the Handwashing and Sanitation interventions in the case of treatment arms, and no Handwashing or Sanitation intervention in the case of control arms. . The final sample for the evaluation will consist of approximately 14,000 households, randomly selected, with at least one child between 0 and 24 months of age at baseline. Data will be collected from these 14,000 households (approximately 54,781 subjects) through household surveys, anthropometric measurements, blood and stool samples, direct observations of behaviors, and community surveys. The data collected will be analyzed using a differences in differences approach, where possible, and the results will be disseminated to country officials and others stakeholders.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(No Intervention)
(Experimental)
scaling up handwashing with soap
scaling up handwashing behavior change
The Handwashing with soap (HWWS) behavior change program expands and improves existing hygiene behavior change efforts with new and innovative promotional approaches in order to generate widespread and sustained improvement in handwashing with soap practices. These approaches include social marketing to deliver handwashing messages; broad and inclusive partnerships with government, private commercial marketing channels, and concerned consumer groups and NGOs.
(Experimental)
total sanitation and sanitation marketing
total sanitation and sanitation marketing
Total Sanitation and Sanitation Marketing (TSSM) program is designed to promote demand for and supply of improved sanitation. On the demand side, it includes "Community-Led Total Sanitation" (CLTS). On the supply side, TSSM incorporates sanitation marketing interventions. Both CLTS and sanitation marketing draw heavily on the behavior-change communication and social marketing approaches that have been well developed in other sectors. The basic TSSM approach also builds sustainability and scalability through the strengthening of the national level sanitation sector enabling environment.
(Experimental)
combined scaling up handwashing with soap and total sanitation and sanitation marketing interventions
total sanitation and sanitation marketing
Total Sanitation and Sanitation Marketing (TSSM) program is designed to promote demand for and supply of improved sanitation. On the demand side, it includes "Community-Led Total Sanitation" (CLTS). On the supply side, TSSM incorporates sanitation marketing interventions. Both CLTS and sanitation marketing draw heavily on the behavior-change communication and social marketing approaches that have been well developed in other sectors. The basic TSSM approach also builds sustainability and scalability through the strengthening of the national level sanitation sector enabling environment.
scaling up handwashing behavior change
The Handwashing with soap (HWWS) behavior change program expands and improves existing hygiene behavior change efforts with new and innovative promotional approaches in order to generate widespread and sustained improvement in handwashing with soap practices. These approaches include social marketing to deliver handwashing messages; broad and inclusive partnerships with government, private commercial marketing channels, and concerned consumer groups and NGOs.

Primary Outcomes

Measure
Diarrhea in Children Under 5
time frame: one year after the intervention

Secondary Outcomes

Measure
ALRI in Children Under 5
time frame: one year after the intervention
Malnutrition in Children Under 5
time frame: one year after the intervention
Anemia in Children Under 5
time frame: one year after the intervention

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - at least one child 0-24 months (at baseline) lives in the household - adult family member (mother of primary caregiver of the selected children for the study) consents to participate in the study and provides consent for the child's participation Exclusion Criteria: - none

Additional Information

Official title Impact Evaluation of Large-Scale Sanitation and Hygiene Interventions in Peru, Tanzania, Senegal, Vietnam, Indonesia, and India
Principal investigator Paul J Gertler, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2011.
Information provided to ClinicalTrials.gov by Water and Sanitation Program, World Bank.