- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01465204
Impact Evaluation of Large-Scale Sanitation and Hygiene Interventions
November 3, 2011 updated by: Water and Sanitation Program, World Bank
Impact Evaluation of Large-Scale Sanitation and Hygiene Interventions in Peru, Tanzania, Senegal, Vietnam, Indonesia, and India
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21878
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
|
|
Experimental: Handwashing Intervention
scaling up handwashing with soap
|
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
|
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
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diarrhea in Children Under 5
Time Frame: one year after the intervention
|
incidence and prevalence of diarrhea and highly credible gastrointestinal illness (HCGI) in children under 5 years old (outcome measured in selected countries)
|
one year after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ALRI in Children Under 5
Time Frame: one year after the intervention
|
incidence and prevalence of acute lower respiratory infections (ALRI) in children under 5 years old (outcome measured in selected countries)
|
one year after the intervention
|
Malnutrition in Children Under 5
Time Frame: one year after the intervention
|
prevalence of stunting, wasting and underweight in children under 5 years old by recording key anthropometric measurements (outcome measured in selected countries)
|
one year after the intervention
|
Anemia in Children Under 5
Time Frame: one year after the intervention
|
prevalence of anemia in children 6 months to 5 years old by measuring hemoglobin levels in the blood (outcome measured in selected countries)
|
one year after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 School of Medicine
- 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, Network for Engineering and Economics Research and Management
- 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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
December 1, 2010
Study Completion (Anticipated)
July 1, 2012
Study Registration Dates
First Submitted
November 1, 2011
First Submitted That Met QC Criteria
November 3, 2011
First Posted (Estimate)
November 4, 2011
Study Record Updates
Last Update Posted (Estimate)
November 4, 2011
Last Update Submitted That Met QC Criteria
November 3, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1095420
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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