NCT01465204

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21,878

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2007

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

November 4, 2011

Status Verified

November 1, 2011

Enrollment Period

3.1 years

First QC Date

November 1, 2011

Last Update Submit

November 3, 2011

Conditions

Keywords

Behavior ChangeHygiene & Sanitation Marketing

Outcome Measures

Primary Outcomes (1)

  • 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)

    one year after the intervention

Secondary Outcomes (3)

  • ALRI in Children Under 5

    one year after the intervention

  • Malnutrition in Children Under 5

    one year after the intervention

  • Anemia in Children Under 5

    one year after the intervention

Study Arms (4)

Control

NO INTERVENTION

Handwashing Intervention

EXPERIMENTAL

scaling up handwashing with soap

Behavioral: Scaling Up Handwashing Behavior Change

Sanitation Intervention

EXPERIMENTAL

total sanitation and sanitation marketing

Behavioral: Total Sanitation and Sanitation Marketing

Combined

EXPERIMENTAL

combined scaling up handwashing with soap and total sanitation and sanitation marketing interventions

Behavioral: Total Sanitation and Sanitation MarketingBehavioral: Scaling Up Handwashing Behavior Change

Interventions

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.

CombinedSanitation Intervention

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.

CombinedHandwashing Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Diarrhea, Infantile

Condition Hierarchy (Ancestors)

DiarrheaSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Paul J Gertler, PhD

    UC Berkeley - Haas School of Business

    PRINCIPAL INVESTIGATOR
  • Bertha Briceno, MPA/ID

    World Bank - Water and Sanitation Program

    STUDY DIRECTOR
  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2011

First Posted

November 4, 2011

Study Start

November 1, 2007

Primary Completion

December 1, 2010

Study Completion

July 1, 2012

Last Updated

November 4, 2011

Record last verified: 2011-11