Taenia Solium Control Case Study in Zambia

NCT ID: NCT01368354

Last Updated: 2015-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1197 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2015-01-31

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.

Conditions

Cysticercosis; Helminthiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

CLTS

Intervention Type: BEHAVIORAL

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.

Control arm

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zambia

OTHER

Sponsor Role: lead

Responsible Party

Chummy S.Sikasunge

Dr. Chummy Sikalizyo Sikasunge

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chummy Sikasunge, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Zambia

Evans K. Mwape, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Zambia

Sarah Gabriel, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Tropical Medicine, Antwerp, Belgium

Pierre Dorny, PhD

Role: STUDY_CHAIR

Institute of Tropical Medicine, Antwerp, Belgium

Giveson Zulu, PhD

Role: PRINCIPAL_INVESTIGATOR

UNICEF

Locations

Katete

Katete District, Eastern Province, Zambia

Countries

Zambia

Other Identifiers

ICONZ-UNZA

Identifier Type: -

Identifier Source: org_study_id