Infant DiarrheaNCT01465204
Impact Evaluation of Large-Scale Sanitation and Hygiene Interventions
A study testing Total Sanitation and Sanitation Marketing and Scaling Up Handwashing Behavior Change in people with Infant Diarrhea, run by Water and Sanitation Program, World Bank.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Infant Diarrhea
- What is being tested?
- Total Sanitation and Sanitation Marketing and Scaling Up Handwashing Behavior Change
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21,878 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- none
About this study
Official title: 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.
- Conditions
- Infant Diarrhea
- Being tested
- Total Sanitation and Sanitation Marketing, Scaling Up Handwashing Behavior Change
- Keywords
- Behavior Change, Hygiene & Sanitation Marketing
- Medical subject headings
- Diarrhea, Infantile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Sanitation and Sanitation MarketingBehavioural
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 ChangeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Handwashing Intervention | Experimental | scaling up handwashing with soap Receives: Behavioral: Scaling Up Handwashing Behavior Change |
| Sanitation Intervention | Experimental | total sanitation and sanitation marketing Receives: Behavioral: Total Sanitation and Sanitation Marketing |
| Combined | Experimental | combined scaling up handwashing with soap and total sanitation and sanitation marketing interventions Receives: Behavioral: Total Sanitation and Sanitation Marketing; Behavioral: Scaling Up Handwashing Behavior Change |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: one year after the intervention
Secondary outcomes (3)
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)
Measured: one year after the intervention
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)
Measured: one year after the intervention
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)
Measured: one year after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2011 (estimated)
- Study startNov 2007
- Primary completionDec 2010
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infant DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21,878 participants (actual)
Sponsor and investigators
- Lead sponsor
- Water and Sanitation Program, World Bank
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul J Gertler, PhD, Principal investigator, UC Berkeley - Haas School of BusinessBertha Briceno, MPA/ID, Study director, World Bank - Water and Sanitation ProgramAlexandra Orsola-Vidal, MSc, Principal investigator, World Bank - Water and Sanitation ProgramClaire Chase, MSc, Principal investigator, World Bank - Water and Sanitation ProgramSebastian F Galiani, PhD, Principal investigator, Washington University School of MedicineSebastian W Martinez, PhD, Principal investigator, Inter-American Development BankPaul M Wassenich, MPA, Principal investigator, UC BerkeleyAlicia L Salvatore, MPH, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465204
- Sponsor's protocol ID
- 1095420
- Status last verified
- Nov 2011
- First submitted
- 1 Nov 2011
- Last updated
- 4 Nov 2011
- Results posted
- No
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.
PubMed 29091726Patil 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.
PubMed 25157929
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Evaluation of Large-Scale Sanitation and Hygiene Interventions in Peru, Tanzania, Senegal, Vietnam, Indonesia, and India
- ClinicalTrials.gov ID
- NCT01465204
- Acronym / sponsor ID
- 1095420
- Conditions
- Infant Diarrhea
- Keywords
- Behavior Change, Hygiene & Sanitation Marketing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21,878 participants (actual)
- Lead sponsor
- Water and Sanitation Program, World BankUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jul 2012 (estimated)
- First posted
- 4 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Handwashing Intervention | Experimental | Behavioral: Scaling Up Handwashing Behavior Changescaling up handwashing with soap |
| Sanitation Intervention | Experimental | Behavioral: Total Sanitation and Sanitation Marketingtotal sanitation and sanitation marketing |
| Combined | Experimental | Behavioral: Total Sanitation and Sanitation Marketing, Behavioral: Scaling Up Handwashing Behavior Changecombined scaling up handwashing with soap and total sanitation and sanitation marketing interventions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Sanitation and Sanitation MarketingTotal 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. | Behavioural | Combined, Sanitation Intervention |
| Scaling Up Handwashing Behavior ChangeThe 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. | Behavioural | Combined, Handwashing Intervention |
Primary outcome
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)
3 secondary outcomes
ALRI in Children Under 5
Time frame: one year after the intervention
Malnutrition in Children Under 5
Time frame: one year after the intervention
Anemia in Children Under 5
Time frame: one year after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2011.
- Derived from this study: PubMed 29091726Briceno 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.
- Derived from this study: PubMed 25157929Patil 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul J Gertler, PhD principal investigator
UC Berkeley - Haas School of Business
Bertha Briceno, MPA/ID study director
World Bank - Water and Sanitation Program
Alexandra Orsola-Vidal, MSc principal investigator
World Bank - Water and Sanitation Program
Questions about this trial
What is this clinical trial studying?
A study testing Total Sanitation and Sanitation Marketing and Scaling Up Handwashing Behavior Change in people with Infant Diarrhea, run by Water and Sanitation Program, World Bank.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diarrhea in Children Under 5 (time frame: one year after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01465204, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2011.