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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00463931
Other study ID # SRP-GH-FA-06
Secondary ID
Status Completed
Phase N/A
First received April 19, 2007
Last updated April 19, 2007
Start date September 2006
Est. completion date January 2007

Study information

Verified date April 2007
Source DBL -Institute for Health Research and Development
Contact n/a
Is FDA regulated No
Health authority Ghana: Ministry of Health
Study type Observational

Clinical Trial Summary

Schistosomiasis and soil-transmitted helminhtiasis occur throughout the developing world and are most prevalent in the poorest communitites. These worms have been linked to several nutritional and intellectual deficiencies in many endemic populations worldwide. Helminth control, though crucial has been neglected for varied reasons. Currently, interests towards the control of neglected diseases including schistosomiasis and soil-transmitted helminths has been revived through many interventions including repeated chemotherapy to help improve public health outcomes and prevent long term morbidity. This will contribute to achieving several of the Millennium Development Goals at a favourable cost. A community-directed treatment of human schistosomiasis and STH in school-aged children in rural notrhern Ghana using praziquantel and albendazole is proposed. It is planned to test the hypothesis that community-based volunteers are non-inferior and more cost effective than rural school teachers at reaching school-aged children.


Description:

The primary objectives of the study are:

To compare coverage rate of community based volunteers and rural school teachers in the distribution of praziquantel and albendazole to scholl-aged children To determine the cost effectiveness of using community based volunteers to distribute praziquantel and albendazole to school-aged children in rural Ghana.

Study methods:

A list of all school-aged children (6-15 years) in the study area will be generated from the Navrongo Demographic Surveillance System database and registers produced and given to all school teachers and community based volunteers who will be responsible for the distribution of the antihelminithics. The school teachers and community based volunteers will provide the drugs to both enrolled and non-enrolled school-aged children. Percentage coverage of school-aged children will be the outcome measure and compated between the school teachers and the community based volunteers. Stool and urine samples will be collected from a representative sample (916) of the children for laboratory analysis before the administration of the drugs for baseline data. Sample collection and laboratory analysis will be repeated 6 and 12 months after the first round of chemotherapy.


Recruitment information / eligibility

Status Completed
Enrollment 916
Est. completion date January 2007
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 6 Years to 15 Years
Eligibility Inclusion Criteria:

- Children between 6 and 15 years of age

Study Design

Observational Model: Case Control, Time Perspective: Longitudinal


Locations

Country Name City State
Ghana The Navrongo Health Research Centre Navrongo

Sponsors (1)

Lead Sponsor Collaborator
DBL -Institute for Health Research and Development

Country where clinical trial is conducted

Ghana, 

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