Evaluation of Strategies for Improved Uptake of Preventive Treatment for Intestinal Schistosomiasis

NCT01869465 | Unknown

• 1 other identifier: ESIUPT2013
• Study Type: interventional
• Target: 1,277
• Locations: 1 country
• Sites: 1

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.

Conditions

Schistosomiasis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Prevalence of schistosomiasis infection

  3 months

• Intensity of schistosomiasis infection

  3 months

Other Outcomes (2)

• Occurrence of side effects attributable to praziquantel treatment

  3 months

• Knowledge of schistosomiasis transmission and control

  3 months

Study Arms (2)

Education arm

ACTIVE COMPARATOR

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

Snack arm

EXPERIMENTAL

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

Interventions

Pre-treatment snack OTHER

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.

Snack arm

Education arm BEHAVIORAL

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.

Education arm

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Makerere University: lead
• University of Copenhagen: collaborator

Study Sites (1)

Primary schools

Jinja, Uganda

Location

Related Publications (1)

• Muhumuza S, Olsen A, Katahoire A, Kiragga AN, Nuwaha F. Effectiveness of a pre-treatment snack on the uptake of mass treatment for schistosomiasis in Uganda: a cluster randomized trial. PLoS Med. 2014 May 13;11(5):e1001640. doi: 10.1371/journal.pmed.1001640. eCollection 2014 May.

  PMID: 24824051 DERIVED

MeSH Terms

Conditions

Schistosomiasis

Condition Hierarchy (Ancestors)

Trematode Infections; Helminthiasis; Parasitic Diseases; Infections; Vector Borne Diseases

Study Officials

• Simon Muhumuza, MBChB, MPH

  Makerere University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 23, 2013
• First Posted: June 5, 2013
• Study Start: October 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 5, 2013

Record last verified: 2013-06

Locations

UG (1)