Impact Evaluation of Large-Scale Sanitation and Hygiene Interventions

NCT ID: NCT01465204

Last Updated: 2011-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

21878 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2012-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infant Diarrhea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Handwashing Intervention

scaling up handwashing with soap

Group Type EXPERIMENTAL

Scaling Up Handwashing Behavior Change

Intervention Type BEHAVIORAL

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.

Sanitation Intervention

total sanitation and sanitation marketing

Group Type EXPERIMENTAL

Total Sanitation and Sanitation Marketing

Intervention Type BEHAVIORAL

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.

Combined

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

Group Type EXPERIMENTAL

Total Sanitation and Sanitation Marketing

Intervention Type BEHAVIORAL

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.

Scaling Up Handwashing Behavior Change

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Water and Sanitation Program, World Bank

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Paul J Gertler, PhD

Role: PRINCIPAL_INVESTIGATOR

UC Berkeley - Haas School of Business

Bertha Briceno, MPA/ID

Role: STUDY_DIRECTOR

World Bank - Water and Sanitation Program

Alexandra Orsola-Vidal, MSc

Role: PRINCIPAL_INVESTIGATOR

World Bank - Water and Sanitation Program

Claire Chase, MSc

Role: PRINCIPAL_INVESTIGATOR

World Bank - Water and Sanitation Program

Sebastian F Galiani, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Sebastian W Martinez, PhD

Role: PRINCIPAL_INVESTIGATOR

Inter-American Development Bank

Paul M Wassenich, MPA

Role: PRINCIPAL_INVESTIGATOR

UC Berkeley

Alicia L Salvatore, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Sumeet Patil, MA

Role: PRINCIPAL_INVESTIGATOR

Network for Engineering and Economics Research and Management

Manisha B Shah, PhD

Role: PRINCIPAL_INVESTIGATOR

UC Irvine

Lisa A Cameron, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Melbourne

Jack M Colford, MD, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

UC Berkeley - School of Public Health

Ben Arnold, PhD

Role: PRINCIPAL_INVESTIGATOR

UC Berkeley

Lia CH Fernald, MBA, PhD

Role: PRINCIPAL_INVESTIGATOR

UC Berkeley - School of Public Health

Patricia K Kariger, PhD

Role: PRINCIPAL_INVESTIGATOR

UC Berkeley

Christine Stauber, PhD

Role: PRINCIPAL_INVESTIGATOR

Georgia State University - Institute of Public Health

Pavani K Ram, MD

Role: PRINCIPAL_INVESTIGATOR

University of Buffalo - SUNY

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 29091726 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25157929 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1095420

Identifier Type: -

Identifier Source: org_study_id