Taenia Solium Control Case Study in Zambia (SANTOSOIL)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Primary Outcome Measures :

1. 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 :

1. 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	Child, Adult, Senior
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
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