Taenia Solium Control Case Study in Zambia (SANTOSOIL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Zambia
Sponsor:
Information provided by (Responsible Party):
Chummy S.Sikasunge, University of Zambia
ClinicalTrials.gov Identifier:
NCT01368354
First received: June 1, 2011
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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 Intervention
Cysticercosis
Helminthiasis
Behavioral: CLTS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Zambia:

Primary Outcome Measures:
  • Number of porcine/human cysticercosis cases (serological test) [ Time Frame: One Year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 2000
Study Start Date: April 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: CLTS
No Intervention: Control arm

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.

  Eligibility

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368354

Contacts
Contact: Chummy Sikasunge, PhD +260211293727 chumsika@yahoo.co.uk
Contact: Isaac Phiri, PhD +260211293727 igphiri@yahoo.co.uk

Locations
Zambia
Katete Recruiting
Katete district, Eastern, Zambia
Contact: Chummy Sikasunge, PhD    +260-979-878 672    chumsika@yahoo.co.uk   
Contact: Evans K Mwape, PhD    +260-977-819236    kemwape@yahoo.com   
Sub-Investigator: Chitwambi Makungu, DVM, MSc         
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

No publications provided

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
Study First Received: June 1, 2011
Last Updated: April 24, 2014
Health Authority: Zambia: Ministry of Health

Keywords provided by University of Zambia:
Community Led Total Sanitation
Open Defecation
Cysticercosis
Soil transmitted helminths
Zambia

Additional relevant MeSH terms:
Cysticercosis
Taeniasis
Neurocysticercosis
Helminthiasis
Cestode Infections
Parasitic Diseases
Central Nervous System Helminthiasis
Central Nervous System Parasitic Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 24, 2014