Impact Evaluation of Large-Scale Sanitation and Hygiene Interventions
Primary Purpose
Infant Diarrhea
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Total Sanitation and Sanitation Marketing
Scaling Up Handwashing Behavior Change
Sponsored by
About this trial
This is an interventional prevention trial for Infant Diarrhea focused on measuring Behavior Change, Hygiene & Sanitation Marketing
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Experimental
Arm Label
Control
Handwashing Intervention
Sanitation Intervention
Combined
Arm Description
scaling up handwashing with soap
total sanitation and sanitation marketing
combined scaling up handwashing with soap and total sanitation and sanitation marketing interventions
Outcomes
Primary Outcome Measures
Diarrhea in Children Under 5
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
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
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
prevalence of anemia in children 6 months to 5 years old by measuring hemoglobin levels in the blood (outcome measured in selected countries)
Full Information
NCT ID
NCT01465204
First Posted
November 1, 2011
Last Updated
November 3, 2011
Sponsor
Water and Sanitation Program, World Bank
1. Study Identification
Unique Protocol Identification Number
NCT01465204
Brief Title
Impact Evaluation of Large-Scale Sanitation and Hygiene Interventions
Official Title
Impact Evaluation of Large-Scale Sanitation and Hygiene Interventions in Peru, Tanzania, Senegal, Vietnam, Indonesia, and India
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
July 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Water and Sanitation Program, World Bank
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Diarrhea
Keywords
Behavior Change, Hygiene & Sanitation Marketing
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21878 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
Handwashing Intervention
Arm Type
Experimental
Arm Description
scaling up handwashing with soap
Arm Title
Sanitation Intervention
Arm Type
Experimental
Arm Description
total sanitation and sanitation marketing
Arm Title
Combined
Arm Type
Experimental
Arm Description
combined scaling up handwashing with soap and total sanitation and sanitation marketing interventions
Intervention Type
Behavioral
Intervention Name(s)
Total Sanitation and Sanitation Marketing
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Scaling Up Handwashing Behavior Change
Intervention Description
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 Outcome Measure Information:
Title
Diarrhea in Children Under 5
Description
incidence and prevalence of diarrhea and highly credible gastrointestinal illness (HCGI) in children under 5 years old (outcome measured in selected countries)
Time Frame
one year after the intervention
Secondary Outcome Measure Information:
Title
ALRI in Children Under 5
Description
incidence and prevalence of acute lower respiratory infections (ALRI) in children under 5 years old (outcome measured in selected countries)
Time Frame
one year after the intervention
Title
Malnutrition in Children Under 5
Description
prevalence of stunting, wasting and underweight in children under 5 years old by recording key anthropometric measurements (outcome measured in selected countries)
Time Frame
one year after the intervention
Title
Anemia in Children Under 5
Description
prevalence of anemia in children 6 months to 5 years old by measuring hemoglobin levels in the blood (outcome measured in selected countries)
Time Frame
one year after the intervention
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul J Gertler, PhD
Organizational Affiliation
UC Berkeley - Haas School of Business
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bertha Briceno, MPA/ID
Organizational Affiliation
World Bank - Water and Sanitation Program
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alexandra Orsola-Vidal, MSc
Organizational Affiliation
World Bank - Water and Sanitation Program
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Claire Chase, MSc
Organizational Affiliation
World Bank - Water and Sanitation Program
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sebastian F Galiani, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sebastian W Martinez, PhD
Organizational Affiliation
Inter-American Development Bank
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul M Wassenich, MPA
Organizational Affiliation
UC Berkeley
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alicia L Salvatore, MPH, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sumeet Patil, MA
Organizational Affiliation
Network for Engineering and Economics Research and Management
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manisha B Shah, PhD
Organizational Affiliation
UC Irvine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa A Cameron, PhD
Organizational Affiliation
University of Melbourne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jack M Colford, MD, MPH, PhD
Organizational Affiliation
UC Berkeley - School of Public Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ben Arnold, PhD
Organizational Affiliation
UC Berkeley
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lia CH Fernald, MBA, PhD
Organizational Affiliation
UC Berkeley - School of Public Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patricia K Kariger, PhD
Organizational Affiliation
UC Berkeley
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christine Stauber, PhD
Organizational Affiliation
Georgia State University - Institute of Public Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pavani K Ram, MD
Organizational Affiliation
University of Buffalo - SUNY
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
29091726
Citation
Briceno B, Coville A, Gertler P, Martinez S. Are there synergies from combining hygiene and sanitation promotion campaigns: Evidence from a large-scale cluster-randomized trial in rural Tanzania. PLoS One. 2017 Nov 1;12(11):e0186228. doi: 10.1371/journal.pone.0186228. eCollection 2017.
Results Reference
derived
PubMed Identifier
25157929
Citation
Patil SR, Arnold BF, Salvatore AL, Briceno B, Ganguly S, Colford JM Jr, Gertler PJ. The effect of India's total sanitation campaign on defecation behaviors and child health in rural Madhya Pradesh: a cluster randomized controlled trial. PLoS Med. 2014 Aug 26;11(8):e1001709. doi: 10.1371/journal.pmed.1001709. eCollection 2014 Aug.
Results Reference
derived
Learn more about this trial
Impact Evaluation of Large-Scale Sanitation and Hygiene Interventions
We'll reach out to this number within 24 hrs