NCT01900912

Brief Summary

Behavioral change is a key ingredient for successful adoption of better sanitation practices in rural Africa. Sanitation programs have, for some time now, incorporated the need to raise awareness and emphasize the benefits of toilet usage. These endeavors, often combined with subsidies linked to toilet construction by households, seek to create a demand for sanitation goods. Yet, progress in securing the desired outcomes from sanitation programs has been slow. Moreover, benefits of sanitation largely take the form of externalities, which individuals do not take into account when making their own decisions about investments. This makes sanitation promotion at the household level particularly challenging. A new approach to sanitation entails a shift away from the provision of subsidies for toilets to individual households and a promotion of behavioral change at individual-level towards emphasizing collective decision-making in order to produce 'open defecation-free' villages. The objective of the intervention is to reduce the incidence of diseases related to poor sanitation and manage public risks posed by the failure to safely confine the excreta of some community members. The way to achieve this objective is by empowering communities motivated to take collective action. Local governments and other agencies perform a facilitating role. There is a growing recognition that this approach, referred to as Community-Led Total Sanitation (CLTS), may help with the reduction of open defecation practices. However, no rigorous impact evaluation of CLTS has been conducted so far. This randomized controlled trial will study the effect of CLTS in rural Mali. As a result, sound evidence will become available to see to what extent CLTS improves health outcomes and what is driving collective action in order to increase sanitation coverage. The direct recipients of the intervention are members of rural communities in Mali who aspire to live in a cleaner environment. The donor community, international organizations, and governments in developing countries will benefit from having simple and clear evidence on the effectiveness of an innovative program for improving sanitation in rural areas. They will learn whether the program has worked or failed to achieve its objective of eradicating open defecation, and about key factors explaining success and failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39,246

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration 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

January 1, 2011

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 17, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 19, 2015

Status Verified

February 1, 2015

Enrollment Period

2.4 years

First QC Date

March 12, 2013

Last Update Submit

February 17, 2015

Conditions

Keywords

sanitationdiarrhea prevalencehealthsocial networkscooperation

Outcome Measures

Primary Outcomes (1)

  • Diarrhea prevalence of children under five years old

    Defined as 3 or more loose or watery defecation events in a 24 hour period. Measured using a 2-day and 2-week recall period.

    Measured 24 months after the baseline survey (12 months after intervention complete)

Secondary Outcomes (4)

  • Length-for-Age Z-scores of children under five years old and children under two years old

    Measured 24 months after baseline

  • Stunting Prevalence of children under five years old and children under two years old

    Measured 24 months after baseline

  • Weight-for-Age Z-scores of children under five years old and children under two years old

    Measured 24 months after baseline

  • Underweight Prevalence of children under five years old and children under two years old

    Measured 24 months after baseline

Other Outcomes (3)

  • Psychological outcomes: knowledge, risk perceptions, safety, privacy

    Measured 24 months after baseline

  • Community outcomes: level of cooperation and trust, social cohesion, wealth disparities, leadership

    Measured 24 months after baseline

  • Symptoms of respiratory illness among children under five years old

    Measured 24 months after intervention

Study Arms (2)

CLTS communities

EXPERIMENTAL

Assigned to a community led total sanitation (CLTS) intervention, carried out by the government with support from Unicef (n=60 communities). The CLTS intervention includes a triggering session facilitated by the government to encourage community members to build their own latrines and stop open defecation. Regular monitoring is conducted by government program staff until the community is declared open defecation free.

Other: CLTS

Rural communities

NO INTERVENTION

No intervention will be delivered (n=61 communities)

Interventions

CLTSOTHER

The goal of CLTS is to obtain Open Defecation Free (ODF) villages. CLTS aims to trigger the community's desire for change, propel them into action and encourage innovation, mutual support and appropriate local solutions, in order to foster greater ownership and sustainability. The phases are: pre-triggering (a group of trained-CLTS people visit the community and request a date to discuss sanitation-related issues for the following days), triggering (people are made to express their views on sanitation issues and their needs), monitoring (involves visits of the community twice a week for a period of 1-3 months) and certification (an external committee evaluates the village for certification as an ODF community).

Also known as: Community Led Total Sanitation
CLTS communities

Eligibility Criteria

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

You may qualify if:

  • Villages located in rural Mali.
  • CLTS targets small villages (less than 4500 inhabitants).
  • Open defecation is present
  • Exclution criteria:
  • Villages where CLTS is already in place

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rural Communities in Mali

Bamako, Koulikoro, Mali

Location

Related Publications (5)

  • Bernheim Douglas and Antonio Rangel. 2007. Behavioural public economics: welfare and policy analysis with non-standard decision-makers. In Behavioural Economics and its applications. Edited by Peter Diamond and Hannu Vartiainen. Princeton University Press.

    BACKGROUND
  • Bloom, H.S. (1995). Minimum Detectable Effects: A Simple Way to Report the Statistical Power of Experimental Designs. Evaluation Review, 19(5), 547-556.

    BACKGROUND
  • Cardenas, Juan-Camilo. 2003. Real wealth and experimental cooperation: experiments in the field lab. Journal of Development Economics, 70: 263-289.

    BACKGROUND
  • Clasen TF, Bostoen K, Schmidt WP, Boisson S, Fung IC, Jenkins MW, Scott B, Sugden S, Cairncross S. Interventions to improve disposal of human excreta for preventing diarrhoea. Cochrane Database Syst Rev. 2010 Jun 16;2010(6):CD007180. doi: 10.1002/14651858.CD007180.pub2.

    PMID: 20556776BACKGROUND
  • Pickering AJ, Djebbari H, Lopez C, Coulibaly M, Alzua ML. Effect of a community-led sanitation intervention on child diarrhoea and child growth in rural Mali: a cluster-randomised controlled trial. Lancet Glob Health. 2015 Nov;3(11):e701-11. doi: 10.1016/S2214-109X(15)00144-8.

MeSH Terms

Conditions

DiarrheaRespiratory Tract Infections

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsInfectionsRespiratory Tract Diseases

Study Officials

  • Maria L. Alzua, Ph.D Econ

    Universidad Nacional de La Plata

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator - Prof

Study Record Dates

First Submitted

March 12, 2013

First Posted

July 17, 2013

Study Start

January 1, 2011

Primary Completion

June 1, 2013

Study Completion

December 1, 2013

Last Updated

February 19, 2015

Record last verified: 2015-02

Locations