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Taenia Solium Control Case Study in Zambia (SANTOSOIL)

Primary Purpose

Cysticercosis, Helminthiasis

Status
Completed
Phase
Not Applicable
Locations
Zambia
Study Type
Interventional
Intervention
CLTS
Sponsored by
University of Zambia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cysticercosis focused on measuring Community Led Total Sanitation, Open Defecation, Cysticercosis, Soil transmitted helminths, Zambia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Other ongoing sanitation programmes

Sites / Locations

  • Katete

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

CLTS Arm

Control arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of STH cases in humans
All willing participants will be faecal sampled before and after intervention in both study arm. Samples will be analysed by a quantitative coprological test (Mc Master method) for measuring presence and levels of soil transmitted helminths (ascaris, trichuris and hookworm). An EPG (eggs per gram) count will be determined for each worm species. It is anticipated that CLTS will have an impact (reduction) on faecal contamination of the environment thereby reducing transmission of STH

Full Information

First Posted
June 1, 2011
Last Updated
February 10, 2015
Sponsor
University of Zambia
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1. Study Identification

Unique Protocol Identification Number
NCT01368354
Brief Title
Taenia Solium Control Case Study in Zambia
Acronym
SANTOSOIL
Official Title
Impact of Community-Led Total Sanitation on the Control of Taenia Solium and Soil Transmitted Helminths in the Eastern Province of Zambia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zambia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
The study procedure will consist of conducting a pilot study with census to establish the sample frame, shortly followed by a baseline survey during which baseline data on human cysticercosis, porcine cysticercosis (serological test), STH infection prevalence (quantitative coprological test) and anthropometric data (weight, height, arm circumference) will be obtained from the study communities (infected people will receive treatment). The study communities will be subsequently randomly allocated a status of intervention or control community, and this will determine the point at which CLTS will be administered, but all communities will ultimately receive CLTS. CLTS will be conducted in intervention communities for 12 months by UNICEF. A post-intervention survey will follow the 12 month CLTS campaign, and all factors investigated at baseline will be revisited in both intervention and control communities. The compliance of the CLTS approach will also be measured. CLTS will be administered to control communities after the completion of the post-intervention survey. Baseline data will be used to show that the groups are comparable; in the primary analysis the difference between intervention and control at follow up will be analyzed to evaluate the impact of CLTS. If this intervention can be demonstrated to have an impact on the occurrence and burden of sanitation-linked diseases, then this will provide advocacy for such an approach at policy-maker level.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cysticercosis, Helminthiasis
Keywords
Community Led Total Sanitation, Open Defecation, Cysticercosis, Soil transmitted helminths, Zambia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1197 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CLTS Arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control arm
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
CLTS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of porcine/human cysticercosis cases (serological test)
Description
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.
Time Frame
One Year
Secondary Outcome Measure Information:
Title
Number of STH cases in humans
Description
All willing participants will be faecal sampled before and after intervention in both study arm. Samples will be analysed by a quantitative coprological test (Mc Master method) for measuring presence and levels of soil transmitted helminths (ascaris, trichuris and hookworm). An EPG (eggs per gram) count will be determined for each worm species. It is anticipated that CLTS will have an impact (reduction) on faecal contamination of the environment thereby reducing transmission of STH
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Other ongoing sanitation programmes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chummy Sikasunge, PhD
Organizational Affiliation
University of Zambia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Evans K. Mwape, MSc
Organizational Affiliation
University of Zambia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sarah Gabriel, PhD
Organizational Affiliation
Institute of Tropical Medicine, Antwerp, Belgium
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre Dorny, PhD
Organizational Affiliation
Institute of Tropical Medicine, Antwerp, Belgium
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Giveson Zulu, PhD
Organizational Affiliation
UNICEF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Katete
City
Katete district
State/Province
Eastern
Country
Zambia

12. IPD Sharing Statement

Learn more about this trial

Taenia Solium Control Case Study in Zambia

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