Clinical trial NCT01465204: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Infant Diarrhea
Keywords: Behavior Change
Hygiene & Sanitation Marketing
Lead sponsor: Water and Sanitation Program, World Bank
Sponsor class: OTHER
First posted: 2011-11-04
Enrollment: 21878
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Diarrhea in Children Under 5
timeFrame: one year after the intervention
Secondary outcomes:
measure: ALRI in Children Under 5
timeFrame: one year after the intervention
measure: Malnutrition in Children Under 5
timeFrame: one year after the intervention
measure: Anemia in Children Under 5
timeFrame: one year after the intervention
Other outcomes:
Locations:
Study officials:
affiliation: UC Berkeley - Haas School of Business
name: Paul J Gertler, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: World Bank - Water and Sanitation Program
name: Bertha Briceno, MPA/ID
role: STUDY_DIRECTOR
affiliation: World Bank - Water and Sanitation Program
name: Alexandra Orsola-Vidal, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: World Bank - Water and Sanitation Program
name: Claire Chase, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Sebastian F Galiani, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inter-American Development Bank
name: Sebastian W Martinez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UC Berkeley
name: Paul M Wassenich, MPA
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Alicia L Salvatore, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Network for Engineering and Economics Research and Management
name: Sumeet Patil, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: UC Irvine
name: Manisha B Shah, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Melbourne
name: Lisa A Cameron, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UC Berkeley - School of Public Health
name: Jack M Colford, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UC Berkeley
name: Ben Arnold, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UC Berkeley - School of Public Health
name: Lia CH Fernald, MBA, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UC Berkeley
name: Patricia K Kariger, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Georgia State University - Institute of Public Health
name: Christine Stauber, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Buffalo - SUNY
name: Pavani K Ram, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.