Taenia Solium Control Case Study in Zambia

Helminthiasis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01368354
• Other study ID #: ICONZ-UNZA
• Status: Completed
• Phase: N/A
• First received: June 1, 2011
• Last updated: February 10, 2015
• Start date: April 2012
• Est. completion date: January 2015

Study information

• Verified date: February 2015
• Source: University of Zambia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Zambia: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1197
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cysticercosis
• Helminthiasis
• Neurocysticercosis

Intervention

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.

Locations

Country	Name	City	State
Zambia	Katete	Katete district	Eastern

Sponsors (1)

Lead Sponsor	Collaborator
University of Zambia

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	1 year	No