Clinical trial NCT01368354: Taenia Solium Control Case Study in Zambia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cysticercosis
Helminthiasis
Keywords: Community Led Total Sanitation
Open Defecation
Cysticercosis
Soil transmitted helminths
Zambia
Lead sponsor: University of Zambia
Sponsor class: OTHER
First posted: 2011-06-07
Enrollment: 1197
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of porcine/human cysticercosis cases (serological test)
timeFrame: One Year
Secondary outcomes:
measure: Number of STH cases in humans
timeFrame: 1 year
Other outcomes:
Locations:
city: Katete district
country: Zambia
facility: Katete
state: Eastern
Study officials:
affiliation: University of Zambia
name: Chummy Sikasunge, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Zambia
name: Evans K. Mwape, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Tropical Medicine, Antwerp, Belgium
name: Sarah Gabriel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Tropical Medicine, Antwerp, Belgium
name: Pierre Dorny, PhD
role: STUDY_CHAIR
affiliation: UNICEF
name: Giveson Zulu, PhD
role: PRINCIPAL_INVESTIGATOR
References: