SchistosomiasisNCT00463931
Using Community-Based Volunteers to Reach Non-Enrolled School Aged Children Through Community-Directed Treatment of Schistosomiasis in School-Aged Children in Rural Northern Ghana
An observational study of Schistosomiasis and Soil-Transmitted Helminthiasis, run by DBL -Institute for Health Research and Development at 1 site in Ghana.
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. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Schistosomiasis, Soil-Transmitted Helminthiasis
- How many people
- 916 participants
- Where
- 1 siteGhana
- Study dates
- Sep 2006to Jan 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- Child
Who may be able to join
- Children between 6 and 15 years of age
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Community-Based Volunteers to Reach Non-Enrolled School-Aged Children Through Community-Directed Treatment of Schistosomiasis in School-Aged Children in Rural Northern Ghana
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.
Read the detailed 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.
- Conditions
- Schistosomiasis, Soil-Transmitted Helminthiasis
- Keywords
- Schistosomiasis, Soiltransmitted helminthiasis, Community-based volunteer, School based treatment approach
- Medical subject headings
- Schistosomiasis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
- Study startSep 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchistosomiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 916 participants
Sponsor and investigators
- Lead sponsor
- DBL -Institute for Health Research and Development
- Sponsor type
- University, hospital or other
- Investigators
- Francis Anto, MD, Principal investigator, Navrongo Health Research Centre, Ghana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00463931
- Sponsor's protocol ID
- SRP-GH-FA-06
- Status last verified
- Apr 2007
- First submitted
- 19 Apr 2007
- Last updated
- 20 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Community-Based Volunteers to Reach Non-Enrolled School-Aged Children Through Community-Directed Treatment of Schistosomiasis in School-Aged Children in Rural Northern Ghana
- ClinicalTrials.gov ID
- NCT00463931
- Acronym / sponsor ID
- SRP-GH-FA-06
- Conditions
- Schistosomiasis, Soil-Transmitted Helminthiasis
- Keywords
- Schistosomiasis, Soiltransmitted helminthiasis, Community-based volunteer, School based treatment approach
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 916 participants
- Lead sponsor
- DBL -Institute for Health Research and DevelopmentUniversity, hospital or other
- Study start
- Sep 2006
- Study completion
- Jan 2007 (actual)
- First posted
- 20 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children between 6 and 15 years of age
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis Anto, MD principal investigator
Navrongo Health Research Centre, Ghana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schistosomiasis and Soil-Transmitted Helminthiasis, run by DBL -Institute for Health Research and Development at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2007.