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Evaluation of Strategies for Improved Uptake of Preventive Treatment for Intestinal Schistosomiasis (ESIUPT)

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ClinicalTrials.gov Identifier: NCT01869465
Recruitment Status : Unknown
Verified June 2013 by Muhumuza Simon, Makerere University.
Recruitment status was:  Active, not recruiting
First Posted : June 5, 2013
Last Update Posted : June 5, 2013
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Muhumuza Simon, Makerere University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Schistosomiasis Other: Pre-treatment snack Behavioral: Education arm Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1277 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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
Study Start Date : October 2012
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Education arm
In the education arm, children will receive specific messages for schistosomiasis transmission and control 1 month prior to Mass Drug Administration. A synopsis of the messages will include the following:What schistosomiasis is and its public health significance among school age children, Schistosomiasis transmission methods, signs and symptoms and its complications, Control methods including the importance of taking preventive treatment annually, Side effects of preventive treatment, why some people suffer serious side-effects and others do not and what to do in order to mitigate the side effects.From each school, the head teacher and the school teacher in-charge of health and sanitation will be trained in the above ,basic principles of health education and in communication skills through a 2 days training workshop. The trained head teachers and heath teachers will in turn, deliver the messages to the children through face to face interactions during school assemblies, twice a week.
Behavioral: Education arm
In the education arm, children will receive specific messages for schistosomiasis transmission and control 1 month prior to Mass Drug Administration (MDA). A synopsis of the messages will include the following:What schistosomiasis is and its public health significance among school age children, Schistosomiasis transmission methods, signs and symptoms and its complications, Control methods including the importance of taking preventive treatment annually, Side effects of preventive treatment, why some people suffer serious side-effects and others do not and what to do in order to mitigate the side effects.From each school, the head teacher and the school teacher in-charge of health and sanitation will be trained in the above aspects of schistosomiasis transmission and control, in basic principles of health education and in communication skills through a 2 days training workshop.

Experimental: Snack arm
The snack will consist of a 300 ml Safi mango juice and a doughnut. Ingredients of the Safi mango juice include vitamin C, fruit flavors from concentrate, sugar, water, citric acid, color E 110 and preservative E 221. The doughnuts will be made of wheat flour, baking powder, sugar and cooking oil. A local manufacturer (House of Eden (U) Limited) will be contracted to make, pre-pack and distribute the snack to the research team at the schools during Mass Drug Administration (MDA). All children in the schools randomized to the snack arm will receive the snack shortly before swallowing the drug. The snack will be distributed by the class teachers who will also distribute record the treatment and snack in separate registers. The snack is estimated to cost about 1 US $ per child.
Other: Pre-treatment snack
The snack will consist of a 300 ml Safi mango juice and a doughnut. Ingredients of the Safi mango juice include vitamin C, fruit flavors from concentrate, sugar, water, citric acid, color E 110 and preservative E 221. The doughnuts will be made of wheat flour, baking powder, sugar and cooking oil. A local manufacturer (House of Eden (U) Limited) will be contracted to make, pre-pack and distribute the snack to the research team at the schools during Mass Drug Administration (MDA). All children in the schools randomized to the snack arm will receive the snack shortly before swallowing the drug. The snack will be distributed by the class teachers who will also distribute record the treatment and snack in separate registers.




Primary Outcome Measures :
  1. Uptake of preventive treatment [ Time Frame: 3 months ]
    It is anticipated that the up-take of preventive treatment will increase from the current 49% to the recommended 75%.


Secondary Outcome Measures :
  1. Prevalence of schistosomiasis infection [ Time Frame: 3 months ]
    It is anticipated that prevalence and intensity of schistosomiasis infection will reduce.

  2. Intensity of schistosomiasis infection [ Time Frame: 3 months ]
    It is anticipated that the intensity of schistosomiasis infection will reduce


Other Outcome Measures:
  1. Occurrence of side effects attributable to praziquantel treatment [ Time Frame: 3 months ]
    It is anticipated that side effects attributable to praziquantel treatment will reduce.

  2. Knowledge of schistosomiasis transmission and control [ Time Frame: 3 months ]
    It is anticipated that Knowledge of schistosomiasis transmission and control will increase



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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869465


Locations
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Uganda
Primary schools
Jinja, Uganda
Sponsors and Collaborators
Makerere University
University of Copenhagen
Investigators
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Principal Investigator: Simon Muhumuza, MBChB, MPH Makerere University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Muhumuza Simon, Doctor, Makerere University
ClinicalTrials.gov Identifier: NCT01869465    
Other Study ID Numbers: ESIUPT2013
First Posted: June 5, 2013    Key Record Dates
Last Update Posted: June 5, 2013
Last Verified: June 2013
Additional relevant MeSH terms:
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Schistosomiasis
Schistosomiasis mansoni
Trematode Infections
Helminthiasis
Parasitic Diseases