Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00349323
Other study ID # 2006-7041-83/hah
Secondary ID
Status Completed
Phase N/A
First received July 6, 2006
Last updated May 7, 2008
Start date August 2006
Est. completion date September 2007

Study information

Verified date February 2008
Source DBL -Institute for Health Research and Development
Contact n/a
Is FDA regulated No
Health authority Zambia: Ministry of Health
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date September 2007
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender Both
Age group 12 Months to 59 Months
Eligibility Inclusion Criteria:

- Age 12-59 months

Exclusion Criteria:

- Severely ill children

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Behavioral:
Community directed treatment


Locations

Country Name City State
Zambia Mazabuka District Mazabuka

Sponsors (3)

Lead Sponsor Collaborator
DBL -Institute for Health Research and Development Department of Community Medicine & Department of Biological Sciences, University of Zambia

Country where clinical trial is conducted

Zambia, 

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05551975 - Preterm Infants Fed a Human Milk Fortifier N/A
Completed NCT01162798 - Preterm Infant Growth N/A
Completed NCT01721512 - The Growth and Development of Breast and Formula Fed Term Asian Infants N/A
Active, not recruiting NCT00970398 - Effect of an Infant Formula on Infant Growth, Health and Immune Functions N/A
Completed NCT01666457 - Impact of Implementing an Infant Driven Feeding Program on Oral Feeding and Growth Outcomes of Medically Fragile Infants in the Neonatal ICU (NICU)
Completed NCT00808756 - Study on Fermentable Carbohydrates in Healthy Infants N/A
Completed NCT00997971 - Growth, Tolerance in Healthy Infants Fed a Partially Hydrolyzed Rice Protein Phase 3
Completed NCT03276663 - Growth of Healthy Term Infants Fed a Partially Hydrolyzed Follow-up Formula N/A
Recruiting NCT02695784 - Probiotics After Discharge Phase 4
Withdrawn NCT02860026 - Growth and Tolerance of Healthy Term Infants Fed Cow's Milk-Based Infant Formulas N/A
Completed NCT01128517 - Maternal Education on Complementary Feeding and Infant Outcome N/A
Completed NCT00282113 - Effects of Probiotic and Prebiotic Combinations on Premature Infants N/A
Completed NCT03276884 - Growth and Tolerance of Young Infants N/A
Completed NCT04055363 - Human Milk Oligosaccharides (HMOs) Post-market Study on Infants N/A
Completed NCT05302427 - Infant Massage and Infant Growth, Mother-Infant Attachment, and Maternal Self-Confidence N/A
Not yet recruiting NCT05616117 - Next-generation Effects of Vitamin D Supplementation in Pregnancy
Active, not recruiting NCT02410057 - Growth and Metabolism in Infants Fed Protein-reduced, Alpha-lactalbumin Enriched Formula N/A
Completed NCT01210391 - Growth of Infants Fed an Extensively Hydrolyzed Infant Formula N/A
Completed NCT01109849 - Novel Approach to Stimulant Induced Weight Suppression and Its Impact on Growth Phase 4
Completed NCT01158352 - Study to Evaluate the Effect of Short Treatment With Nutritional Supplementation Standardized Innovative Formula, on Growth and Weight Gain in Short and Lean Prepubertal Children N/A

External Links