NCT01538953

Brief Summary

This study is designed to evaluate the effect of different methods of drinking water treatment on the occurrence of diarrhea among children living in squatter settlements in Karachi, Pakistan, and the marginal benefit of adding handwashing to water treatment. 260 households will receive a new product which combines flocculation with chlorination to produce clearer, less chemically contaminated drinking water. 260 households will receive dilute sodium hypochlorite, i.e. bleach to treat their water. 260 households will receive soap and encouraged to wash their hands regularly. 260 households will receive both soap and the combination flocculation/chlorination water treatment. 260 households will continue their standard water treatment and handwashing practices. The households will be visited each week for 9 months, and the episodes of diarrhea from each child in the household recorded. The rate of diarrhea between the groups will be compared. At the end of 9 months, households who were part of the standard habits and practice group will receive a water storage vessel and disinfectant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8,949

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2003

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2003

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2012

Completed
Last Updated

February 27, 2012

Status Verified

February 1, 2012

Enrollment Period

9 months

First QC Date

February 21, 2012

Last Update Submit

February 24, 2012

Conditions

Keywords

diarrheahandwashingpoint-of-use water treatmentdiarrhea longitudinal prevalence

Outcome Measures

Primary Outcomes (1)

  • diarrhea longitudinal prevalence

Study Arms (5)

Handwashing

EXPERIMENTAL

participants received weekly, in-home handwashing promotion and soap as needed

Other: handwashing

handwashing and water treatment

EXPERIMENTAL
Other: handwashingOther: flocculent-disinfectant for water treatment

Water treatment with sodium hypochlorite

EXPERIMENTAL
Other: water treatment with sodium hypochlorite

Water treatment with flocculent-disinfectant

EXPERIMENTAL

participants received a supply of flocculent-disinfectant product and instruction to use it to treat drinking water

Other: flocculent-disinfectant for water treatment

Control

NO INTERVENTION

Interventions

participants received weekly in-home handwashing promotion and soap as needed

Handwashinghandwashing and water treatment

participants received a supply of flocculent-disinfectant product for water treatment and instruction in how to use it

Water treatment with flocculent-disinfectanthandwashing and water treatment

participants received a supply of dilute sodium hypochlorite and instruction to treat drinking water with it

Water treatment with sodium hypochlorite

Eligibility Criteria

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

You may qualify if:

  • households in study neighborhoods
  • contain a child \< 5 years old
  • have access to water for handwashing

You may not qualify if:

  • participated in handwashing or drinking water treatment programs with HOPE previously

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health-Oriented Preventive Education

Karachi, Pakistan

Location

Related Publications (3)

  • Luby SP, Agboatwalla M, Painter J, Altaf A, Billhimer W, Keswick B, Hoekstra RM. Combining drinking water treatment and hand washing for diarrhoea prevention, a cluster randomised controlled trial. Trop Med Int Health. 2006 Apr;11(4):479-89. doi: 10.1111/j.1365-3156.2006.01592.x.

  • Boudier E, Zurlinden B, Cour A, Rognon M, Devalland-Monnin C, Nirhy-Lanto A, el Khadissi H. [Antenatal diagnosis of achondrogenesis. Two successive cases in the same family]. J Gynecol Obstet Biol Reprod (Paris). 1991;20(5):623-6. French.

  • Bowen A, Agboatwalla M, Luby S, Tobery T, Ayers T, Hoekstra RM. Association between intensive handwashing promotion and child development in Karachi, Pakistan: a cluster randomized controlled trial. Arch Pediatr Adolesc Med. 2012 Nov;166(11):1037-44. doi: 10.1001/archpediatrics.2012.1181.

MeSH Terms

Conditions

Diarrhea

Interventions

Hand DisinfectionWater PurificationSodium Hypochlorite

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hand HygieneHygienePublic HealthEnvironment and Public HealthWaste ManagementSanitary EngineeringSanitationCommunicable Disease ControlPublic Health PracticeHypochlorous AcidChlorine CompoundsInorganic ChemicalsOxidesOxygen CompoundsSodium Compounds

Study Design

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

Study Record Dates

First Submitted

February 21, 2012

First Posted

February 27, 2012

Study Start

March 1, 2003

Primary Completion

December 1, 2003

Study Completion

January 1, 2004

Last Updated

February 27, 2012

Record last verified: 2012-02

Locations