Taenia Solium Control Case Study in Zambia (SANTOSOIL)
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|ClinicalTrials.gov Identifier: NCT01368354|
Recruitment Status : Completed
First Posted : June 7, 2011
Last Update Posted : February 11, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cysticercosis Helminthiasis||Behavioral: CLTS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1197 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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|
- 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.
- 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
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
|Katete district, Eastern, Zambia|
|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|