Schistosomiasis Clinical Trial
— ESIUPTOfficial title:
Evaluation of Strategies for Improved Uptake of Preventive Treatment for Intestinal Schistosomiasis Among School Children in Jinja District, Uganda: a Stratified Cluster Randomized Controlled Trial
Verified date | June 2013 |
Source | Makerere University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Uganda: National Council for Science and Technology |
Study type | Interventional |
Previous research undertaken among adults in high endemic districts of Busia, Adjumani, Moyo
and Nebbi reported unwillingness to take preventive treatment. A particular study conducted
in primary schools of Jinja district showed that only 30% of school children took
praziquantel during the 2011 Mass Drug Administration (MDA). Fear of side effects of
praziquantel, lack of knowledge about schistosomiasis transmission and prevention and lack
of teacher support were some of the major factors associated with the low uptake. Similar
reasons for non-uptake have been reported elsewhere. Thus, measures are needed to increase
uptake of Mass Drug Administration (MDA) in Uganda. There is no doubt that health education
facilitates a better understanding of the obvious risks to health, including the knowledge
of preventing parasitic infections among primary school children. Better compliance to
treatment for schistosomiasis among school children can be achieved through implementing
carefully designed programs involving face to face education methods. Increasing knowledge
about schistosomiasis transmission and prevention and implementing measures to mitigate the
side effects attributable to praziquantel, such as providing a snack prior to drug
administration may improve uptake of the drug among school children.
Hypothesis- Provision of a pre-treatment snack is effective in improving uptake of
preventive treatment for intestinal schistosomiasis among primary school children.
Status | Active, not recruiting |
Enrollment | 1277 |
Est. completion date | June 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 10 Years to 17 Years |
Eligibility |
Inclusion Criteria: - Children in forms 4-6 in the 12 primary schools will be eligible for the study. Children in forms 4-6 are about 10-14 years of age, which is the peak age for schistosomiasis infection in Uganda. Children in form 7 will not be selected to participate in the study because they will not be available to participate in the subsequent evaluation phase of the study. School heads, and class teachers who have been in the schools for more than 6 months will be interviewed. Staffs of the district vector control office, members of the District Health Team (DHT) and parents that have stayed in the Division for more than 6 months will also be interviewed. Exclusion Criteria: - Children and residents who have stayed in the Division or have held their respective offices in the Division for less than 6 months will not be eligible for the study. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Uganda | Primary schools | Jinja |
Lead Sponsor | Collaborator |
---|---|
Makerere University | University of Copenhagen |
Uganda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Occurrence of side effects attributable to praziquantel treatment | It is anticipated that side effects attributable to praziquantel treatment will reduce. | 3 months | No |
Other | Knowledge of schistosomiasis transmission and control | It is anticipated that Knowledge of schistosomiasis transmission and control will increase | 3 months | No |
Primary | Uptake of preventive treatment | It is anticipated that the up-take of preventive treatment will increase from the current 49% to the recommended 75%. | 3 months | No |
Secondary | Prevalence of schistosomiasis infection | It is anticipated that prevalence and intensity of schistosomiasis infection will reduce. | 3 months | No |
Secondary | Intensity of schistosomiasis infection | It is anticipated that the intensity of schistosomiasis infection will reduce | 3 months | No |
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