Soil-Transmitted Helminth InfectionNCT00349323
Community Directed Treatment of Soil-Transmitted Helminths Among Young Children in Zambia
An observational study of Soil-Transmitted Helminth Infection and Growth, run by DBL -Institute for Health Research and Development at 1 site in Zambia.
Trial summary
The WHO Special Programme for Research and Training in Tropical Diseases (TDR) developed a Community-Directed Treatment (COMDT) approach, which has been adopted in the control of onchocerciasis and lymphatic filariasis. WHO has recommended the use of COMDT approach in the control of schistosomiasis and STH infections. Read more about this study
- Who is it for?
- Ages 12 to 59 months
- Conditions the study is for
- Soil-Transmitted Helminth Infection, Growth
- What is being tested?
- Community directed treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteZambia
- Study dates
- Aug 2006to Sep 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 12 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 12-59 months
Who cannot join
- Severely ill children
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Community-Directed Treatment in the Control of Soil-Transmitted Helminths Among Children Aged 12-59 Months in Mazabuka District of Zambia
The WHO Special Programme for Research and Training in Tropical Diseases (TDR) developed a Community-Directed Treatment (COMDT) approach, which has been adopted in the control of onchocerciasis and lymphatic filariasis. WHO has recommended the use of COMDT approach in the control of schistosomiasis and STH infections. The COMDT approach has been compared with the school based programmes in certain African countries,but not with the health-facility based approach.
The project will be implemented in Mazabuka district of Zambia where COMDT approach will be implemented in the catchment area of Rural Health Centres (RHC) as a supplement to the health-facility-based approach. After each round of treatmenttreatment coverage and factors responsible for the treatment coverage will be measured in both areas. The health impact of the health facility based approach with and without the COMDT approach will be compared. The effect of the COMDT as a control approach of STH infections will be monitored on infections in the community of children aged 12 to 59 months.
Read the detailed description
Soil-transmitted helminth (STH) infections are of public health importance and widespread in large part of the world, particularly in the poorest sections of the populations residing in the least developed countries. The infections can be controlled by several measures, but currently delivering anthelminthic drugs through schools and health centres is believed to be the most effective as it takes advantage of existing infrastructure. In Zambia, anthelminthic drugs are delivered to children aged 12 to 59 months twice a year through health facilities during the child health promotion week. However, it has been observed that treatment coverage is low in certain areas. Therefore, there is a need to identify the factors associated with the treatment coverage patterns, and to provide evidence of an effective intervention approach that could increase the proportion of children receiving treatment.
The WHO Special Programme for Research and Training in Tropical Diseases (TDR) developed a Community-Directed Treatment (COMDT) approach, which has been adopted in the control of onchocerciasis and lymphatic filariasis. WHO has recommended the use of COMDT approach in the control of schistosomiasis and STH infections. The COMDT approach has been compared with the school based programmes in certain African countries, but has never been used in Zambia and never been compared with the health-facility based approach in the control of these infections in children below school age. It is against this background that this project is being proposed.
The project will be implemented in Mazabuka district of Zambia. Two Rural Health Centres (RHCs) will be selected in the district and mapped for treatment coverage of the health-facility based approach. Focus group discussions (FGDs) and in-depth interviews will be conducted with community members to explore the reasons for existing treatment coverage of the health facility approach. The COMDT approach will then be implemented in the catchment area of one of the RHCs as a supplement to the health-facility-based approach. After each round of treatment, coverage and factors influencing coverage will be measured in both areas. The health impact of the health facility based approach with and without the COMDT approach will be compared. Parameters for health impact will be child growth, prevalence and intensity of STH infections and number of illness episodes requiring treatment. The effect of the COMDT as a control approach of STH infections will be monitored on infections in the community of children aged 12 to 59 months, and the appropriateness of the approach will be evaluated using the African Programme for Onchocerciasis Control grading system. The whole project is expected to take 3 years.
- Conditions
- Soil-Transmitted Helminth Infection, Growth
- Being tested
- Community directed treatment
- Keywords
- Community directed treatment,, soil-transmitted helminth infections,, treatment coverage,, Zambia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community directed treatmentBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2006 (estimated)
- Study startAug 2006
- Primary completionAug 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Soil-Transmitted Helminth InfectionStudies 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
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DBL -Institute for Health Research and Development
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Community Medicine & Department of Biological Sciences, University of Zambia
- Investigators
- Hikabasa Halwindi, M.phil, Principal investigator, Department of Community Medicine, University of Zambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349323
- Sponsor's protocol ID
- 2006-7041-83/hah
- Status last verified
- Feb 2008
- First submitted
- 6 Jul 2006
- Last updated
- 8 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Halwindi H, Magnussen P, Meyrowitsch D, Handema R, Siziya S, Olsen A. Effect on treatment coverage of adding community-directed treatment to the health facility-based approach of delivering anthelminthic drugs to under-five children during child health week in Mazabuka District, Zambia. Int Health. 2010 Dec;2(4):253-61. doi: 10.1016/j.inhe.2010.09.003.
PubMed 24037866
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Directed Treatment in the Control of Soil-Transmitted Helminths Among Children Aged 12-59 Months in Mazabuka District of Zambia
- ClinicalTrials.gov ID
- NCT00349323
- Acronym / sponsor ID
- 2006-7041-83/hah
- Conditions
- Soil-Transmitted Helminth Infection, Growth
- Keywords
- Community directed treatment,, soil-transmitted helminth infections,, treatment coverage,, Zambia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- DBL -Institute for Health Research and DevelopmentUniversity, hospital or other
- Collaborators
- Department of Community Medicine & Department of Biological Sciences, University of Zambia
- Study start
- Aug 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 7 Jul 2006 (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.
The WHO Special Programme for Research and Training in Tropical Diseases (TDR) developed a Community-Directed Treatment (COMDT) approach, which has been adopted in the control of onchocerciasis and lymphatic filariasis. WHO has recommended the use of COMDT approach in the control of schistosomiasis and STH infections. The COMDT approach has been compared with the school based programmes in certain African countries,but not with the health-facility based approach.
The project will be implemented in Mazabuka district of Zambia where COMDT approach will be implemented in the catchment area of Rural Health Centres (RHC) as a supplement to the health-facility-based approach. After each round of treatmenttreatment coverage and factors responsible for the treatment coverage will be measured in both areas. The health impact of the health facility based approach with and without the COMDT approach will be compared. The effect of the COMDT as a control approach of STH infections will be monitored on infections in the community of children aged 12 to 59 months.
Detailed description
Soil-transmitted helminth (STH) infections are of public health importance and widespread in large part of the world, particularly in the poorest sections of the populations residing in the least developed countries. The infections can be controlled by several measures, but currently delivering anthelminthic drugs through schools and health centres is believed to be the most effective as it takes advantage of existing infrastructure. In Zambia, anthelminthic drugs are delivered to children aged 12 to 59 months twice a year through health facilities during the child health promotion week. However, it has been observed that treatment coverage is low in certain areas. Therefore, there is a need to identify the factors associated with the treatment coverage patterns, and to provide evidence of an effective intervention approach that could increase the proportion of children receiving treatment.
The WHO Special Programme for Research and Training in Tropical Diseases (TDR) developed a Community-Directed Treatment (COMDT) approach, which has been adopted in the control of onchocerciasis and lymphatic filariasis. WHO has recommended the use of COMDT approach in the control of schistosomiasis and STH infections. The COMDT approach has been compared with the school based programmes in certain African countries, but has never been used in Zambia and never been compared with the health-facility based approach in the control of these infections in children below school age. It is against this background that this project is being proposed.
The project will be implemented in Mazabuka district of Zambia. Two Rural Health Centres (RHCs) will be selected in the district and mapped for treatment coverage of the health-facility based approach. Focus group discussions (FGDs) and in-depth interviews will be conducted with community members to explore the reasons for existing treatment coverage of the health facility approach. The COMDT approach will then be implemented in the catchment area of one of the RHCs as a supplement to the health-facility-based approach. After each round of treatment, coverage and factors influencing coverage will be measured in both areas. The health impact of the health facility based approach with and without the COMDT approach will be compared. Parameters for health impact will be child growth, prevalence and intensity of STH infections and number of illness episodes requiring treatment. The effect of the COMDT as a control approach of STH infections will be monitored on infections in the community of children aged 12 to 59 months, and the appropriateness of the approach will be evaluated using the African Programme for Onchocerciasis Control grading system. The whole project is expected to take 3 years.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Age 12-59 months
Key exclusion criteria (1 listed)
- Severely ill children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community directed treatment | Behavioural | – |
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 8 May 2008.
- Derived from this study: PubMed 24037866Halwindi H, Magnussen P, Meyrowitsch D, Handema R, Siziya S, Olsen A. Effect on treatment coverage of adding community-directed treatment to the health facility-based approach of delivering anthelminthic drugs to under-five children during child health week in Mazabuka District, Zambia. Int Health. 2010 Dec;2(4):253-61. doi: 10.1016/j.inhe.2010.09.003.
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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.
Hikabasa Halwindi, M.phil principal investigator
Department of Community Medicine, University of Zambia
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 Soil-Transmitted Helminth Infection and Growth, run by DBL -Institute for Health Research and Development at 1 site in Zambia.
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 1 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 8 May 2008. 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 Zambia. 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?
On the ClinicalTrials.gov record for NCT00349323, which also lists 1 linked publication.
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 8 May 2008.