NCT01368354

Brief Summary

Summary Diseases due to T. solium and soil transmitted helminths (STHs) are of cosmopolitan distribution and strongly linked with poor sanitation and poverty. These infections are to a great extent perpetuated by open defecation (OD). Community-Led Total Sanitation (CLTS) is an approach in which people in rural communities are facilitated to do their own appraisal and analysis, come to their own conclusions, and take their own actions. To date no rigorous study has been conducted to evaluate the impact of CLTS on the transmission of taeniasis/cysticercosis or STHs, despite the worldwide acclaim which CLTS has received as an approach to improve sanitation. The overall aim of the study is to contribute to the reduction and subsequent control of T. solium and STH infections through the implementation of CLTS approaches in 1 districts in the Eastern Province of Zambia. By using CLTS it is hypothesised that toilet acquisition and usage will be increased with a resultant reduction in OD which will in turn reduce the transmission of T. solium and STH infections in the district. This will be measured by porcine/human cysticercosis prevalence (serological test) and STH infections in humans (quantitative coprological test).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,197

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

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

First Submitted

Initial submission to the registry

June 1, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2011

Completed
10 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

February 11, 2015

Status Verified

February 1, 2015

Enrollment Period

2.8 years

First QC Date

June 1, 2011

Last Update Submit

February 10, 2015

Conditions

CysticercosisHelminthiasis

Keywords

Community Led Total SanitationOpen DefecationCysticercosisSoil transmitted helminthsZambia

Outcome Measures

Primary Outcomes (1)

  • Number of porcine/human cysticercosis cases (serological test)

    Blood samples will be collected from humans and pigs before and after intervention in both study arms. Sera will be tested for presence of circulating cysticercus antigens by a monoclonal antibody based antigen capturing ELISA. Test result above cut-off is positive.

    One Year

Secondary Outcomes (1)

  • Number of STH cases in humans

    1 year

Study Arms (2)

CLTS Arm

ACTIVE COMPARATOR

To induce behavioural changes by confronting the community with their open defecation behaviour. This will lead to voluntary construction and use of latrines and improved hygiene behaviour. CLTS involves facilitating a process to inspire and empower rural communities to stop open defecation and to build and use latrines, without offering external hardware subsidies. Communities are encouraged to appraise and analyse their own sanitation profile, including the extent of open defecation and the spread of faecal-oral contamination.

Behavioral: CLTS

Control arm

NO INTERVENTION

Interventions

CLTSBEHAVIORAL

CLTS (Community Led Total Sanitation) involves facilitating a process to inspire and empower rural communities to stop open defecation and to build and use latrines, without offering external hardware subsidies. Communities are encouraged to appraise and analyse their own sanitation profile, including the extent of open defecation and the spread of faecal-oral contamination. This approach ignites a sense of disgust and share among the community. The community then collectively realises the impact of its unsanitary practices and this realisation mobilises and initiates collective action to improve the existing sanitation profile.

CLTS Arm

Eligibility Criteria

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

You may qualify if:

  • Willingness to collaborate
  • Accessible by road all year round, even during the wet season
  • No current promotion of water, sanitation or hygiene programs
  • Rural setting
  • Minimum of 10 pig-keeping households (HHs)
  • Maximum of 100 HHs

You may not qualify if:

  • Other ongoing sanitation programmes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Katete

Katete District, Eastern Province, Zambia

Location

MeSH Terms

Conditions

CysticercosisHelminthiasis

Condition Hierarchy (Ancestors)

TaeniasisCestode InfectionsParasitic DiseasesInfections

Study Officials

  • Chummy Sikasunge, PhD

    University of Zambia

    PRINCIPAL INVESTIGATOR

  • Evans K. Mwape, MSc

    University of Zambia

    PRINCIPAL INVESTIGATOR

  • Sarah Gabriel, PhD

    Institute of Tropical Medicine, Antwerp, Belgium

    PRINCIPAL INVESTIGATOR

  • Pierre Dorny, PhD

    Institute of Tropical Medicine, Antwerp, Belgium

    STUDY CHAIR

  • Giveson Zulu, PhD

    UNICEF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Chummy Sikalizyo Sikasunge

Study Record Dates

First Submitted

June 1, 2011

First Posted

June 7, 2011

Study Start

April 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

February 11, 2015

Record last verified: 2015-02

Locations

ZA(1)