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Impact Evaluation of Large-Scale Sanitation and Hygiene Interventions

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Water and Sanitation Program, World Bank
ClinicalTrials.gov Identifier:
NCT01465204
First received: November 1, 2011
Last updated: November 3, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention
Infant Diarrhea
 Behavioral: Total Sanitation and Sanitation Marketing
Behavioral: Scaling Up Handwashing Behavior Change

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Impact Evaluation of Large-Scale Sanitation and Hygiene Interventions in Peru, Tanzania, Senegal, Vietnam, Indonesia, and India

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Water and Sanitation Program, World Bank:

Primary Outcome Measures:
  • Diarrhea in Children Under 5 [ Time Frame: one year after the intervention ] [ Designated as safety issue: No ]
    incidence and prevalence of diarrhea and highly credible gastrointestinal illness (HCGI) in children under 5 years old (outcome measured in selected countries)


Secondary Outcome Measures:
  • ALRI in Children Under 5 [ Time Frame: one year after the intervention ] [ Designated as safety issue: No ]
    incidence and prevalence of acute lower respiratory infections (ALRI) in children under 5 years old (outcome measured in selected countries)

  • Malnutrition in Children Under 5 [ Time Frame: one year after the intervention ] [ Designated as safety issue: No ]
    prevalence of stunting, wasting and underweight in children under 5 years old by recording key anthropometric measurements (outcome measured in selected countries)

  • Anemia in Children Under 5 [ Time Frame: one year after the intervention ] [ Designated as safety issue: No ]
    prevalence of anemia in children 6 months to 5 years old by measuring hemoglobin levels in the blood (outcome measured in selected countries)


Enrollment: 21878
Study Start Date: November 2007
Estimated Study Completion Date: July 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Experimental: Handwashing Intervention
scaling up handwashing with soap
 Behavioral: 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: Sanitation Intervention
total sanitation and sanitation marketing
 Behavioral: 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
combined scaling up handwashing with soap and total sanitation and sanitation marketing interventions
 Behavioral: 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.
Behavioral: 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01465204

Sponsors and Collaborators
Water and Sanitation Program, World Bank
Investigators
Principal Investigator: Paul J Gertler, PhD UC Berkeley - Haas School of Business
Study Director: Bertha Briceno, MPA/ID World Bank - Water and Sanitation Program
Principal Investigator: Alexandra Orsola-Vidal, MSc World Bank - Water and Sanitation Program
Principal Investigator: Claire Chase, MSc World Bank - Water and Sanitation Program
Principal Investigator: Sebastian F Galiani, PhD Washington University in St. Louis
Principal Investigator: Sebastian W Martinez, PhD Inter-American Development Bank
Principal Investigator: Paul M Wassenich, MPA UC Berkeley
Principal Investigator: Alicia L Salvatore, MPH, PhD Stanford University
Principal Investigator: Sumeet Patil, MA NEERMAN
Principal Investigator: Manisha B Shah, PhD UC Irvine
Principal Investigator: Lisa A Cameron, PhD University of Melbourne
Principal Investigator: Jack M Colford, MD, MPH, PhD UC Berkeley - School of Public Health
Principal Investigator: Ben Arnold, PhD UC Berkeley
Principal Investigator: Lia CH Fernald, MBA, PhD UC Berkeley - School of Public Health
Principal Investigator: Patricia K Kariger, PhD UC Berkeley
Principal Investigator: Christine Stauber, PhD Georgia State University - Institute of Public Health
Principal Investigator: Pavani K Ram, MD University of Buffalo - SUNY
  More Information

No publications provided

Responsible Party: Water and Sanitation Program, World Bank
ClinicalTrials.gov Identifier: NCT01465204     History of Changes
Other Study ID Numbers: 1095420
Study First Received: November 1, 2011
Last Updated: November 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Water and Sanitation Program, World Bank:
Behavior Change
Hygiene & Sanitation Marketing

Additional relevant MeSH terms:
Diarrhea
Diarrhea, Infantile
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013