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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
Water and Sanitation Program, World Bank
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infant Diarrhea focused on measuring Behavior Change, Hygiene & Sanitation Marketing

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    November 1, 2011
    Last Updated
    November 3, 2011
    Sponsor
    Water and Sanitation Program, World Bank
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    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

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    Impact Evaluation of Large-Scale Sanitation and Hygiene Interventions

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