Taenia Solium Control Case Study in Zambia (SANTOSOIL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT01368354

Recruitment Status : Completed

First Posted : June 7, 2011

Last Update Posted : February 11, 2015

Sponsor:

Information provided by (Responsible Party):

Chummy S.Sikasunge, University of Zambia

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).

Condition or disease	Intervention/treatment	Phase
Cysticercosis Helminthiasis	Behavioral: CLTS	Not Applicable

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1197 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
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 Start Date :	April 2012
Actual Primary Completion Date :	January 2015
Actual Study Completion Date :	January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Genetic and Rare Diseases Information Center resources: Helminthiasis Cysticercosis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: CLTS Arm 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 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.
No Intervention: Control arm

Arm

Intervention/treatment

Active Comparator: CLTS Arm

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

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.

No Intervention: Control arm

Outcome Measures

Primary Outcome Measures :

Number of porcine/human cysticercosis cases (serological test) [ Time Frame: One Year ]
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 [ Time Frame: 1 year ]
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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01368354

Locations


Zambia
Katete
Katete district, Eastern, Zambia

Sponsors and Collaborators

University of Zambia

Investigators


Principal Investigator:	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
Study Chair:	Pierre Dorny, PhD	Institute of Tropical Medicine, Antwerp, Belgium
Principal Investigator:	Giveson Zulu, PhD	UNICEF

More Information


Responsible Party:	Chummy S.Sikasunge, Dr. Chummy Sikalizyo Sikasunge, University of Zambia
ClinicalTrials.gov Identifier:	NCT01368354 History of Changes
Other Study ID Numbers:	ICONZ-UNZA
First Posted:	June 7, 2011 Key Record Dates
Last Update Posted:	February 11, 2015
Last Verified:	February 2015

Keywords provided by Chummy S.Sikasunge, University of Zambia:


Community Led Total Sanitation Open Defecation Cysticercosis Soil transmitted helminths Zambia

Additional relevant MeSH terms:


Helminthiasis Cysticercosis Taeniasis Neurocysticercosis Parasitic Diseases Cestode Infections	Central Nervous System Helminthiasis Central Nervous System Parasitic Infections Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases

To Top