Clinical Trials Logo

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).


Clinical Trial 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

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


Related Conditions & MeSH terms


NCT number NCT01368354
Study type Interventional
Source University of Zambia
Contact
Status Completed
Phase N/A
Start date April 2012
Completion date January 2015

See also
  Status Clinical Trial Phase
Completed NCT04041453 - Albendazole Plus High Dose Ivermectin for Trichuriasis in Pediatric Patients Phase 2
Active, not recruiting NCT03014167 - Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH) Phase 3
Completed NCT02385058 - Study to Evaluate Efficacy and Safety of a Double Treatment Plan Using a Combination of Mebendazole and Quinfamide for Treating Intestinal Helminthiasis and Amebiasis in the Mexican Population Phase 4
Withdrawn NCT02636803 - Study of the Efficacy of Oxfendazole Compared to Albendazole in the Treatment of Trichuris Trichiura Infection in Adults Phase 2
Completed NCT02725255 - Design and Clinical Evaluation of a School Meal With Deworming Properties Phase 2/Phase 3
Active, not recruiting NCT04227834 - Soil-transmitted Helminth Reinfection Rates After Single and Repeated School Hygiene Education N/A
Completed NCT03173742 - Bioavailability and Safety of Two Oral Fixed Dose Preparations Containing 18 mg Ivermectin (IVM 18 MG TABLETS, LICONSA S.A., Spain) Versus Reference Dosing (Weight Based) Containing 6 mg Ivermectin (REVECTINA®, Abbott Laboratórios do Brasil Ltda, Brazil) Phase 1
Completed NCT02397772 - Impact of Alternative Treatment Strategies and Delivery Systems for Soil-transmitted Helminths in Kenya Phase 4
Completed NCT00130910 - Treatment of Helminth co-Infection: Short-Term Effects on HIV-1 Progression Markers and Immune Activation N/A
Completed NCT00004996 - Comparison of Immune Response in Normal Volunteers and Patients With Helminth Infections
Recruiting NCT00001230 - Host Response to Infection and Treatment in Filarial Diseases
Completed NCT04041427 - Urine Albendazole Levels for Coverage Assessment N/A
Completed NCT02396407 - Spillover Effects of Water, Sanitation, and Hygiene Interventions on Child Health N/A
Terminated NCT01271049 - An Evaluation of a Novel Food Product in Adults Residing in an Area Endemic for Helminths N/A
Terminated NCT00817713 - Can Presumptive Anthelminthic Treatment Delay the Progression of HIV in ART-naïve Patients in Rural Africa? N/A
Completed NCT02362932 - The Effect of an Urban Sanitation Intervention on Child Health N/A
Completed NCT02420574 - Assessment of Drug Efficacy of Local Albendazole N/A
Completed NCT00507221 - Empiric Therapy of Helminth Co-infection to Reduce HIV-1 Disease Progression N/A
Completed NCT00469495 - Antihelminthic Therapy Combined With Antimony in the Treatment of Cutaneous Leishmaniasis N/A
Recruiting NCT01459146 - Artemisinin-based Combination Therapy-Intermittent Preventive Treatment (ACT-IPT) Trial Among Schoolchildren in Kassena-Nankana, Ghana Phase 4