Mobilization at the Level of Schools on the Behavioral Change in Favor of the Fight Against Malaria in Mbandjock
Primary Purpose
Malaria
Status
Unknown status
Phase
Not Applicable
Locations
Cameroon
Study Type
Interventional
Intervention
Malaria toolkit
Sponsored by
About this trial
This is an interventional prevention trial for Malaria focused on measuring Malaria, Awareness, Knowledge, Attitudes, Practices
Eligibility Criteria
Inclusion Criteria:
- Children should be of school-going age.
- Children belong to an authorized school.
- Adult belonging to a household.
Exclusion Criteria:
- Children not going to school.
- Children not belonging to an authorized school.
- An adult that cannot be identified with any household.
Sites / Locations
- Mbandjock Health DistrictRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Group A-Malaria toolkit
Group B-No malaria toolkit
Arm Description
School children shall be trained on key malaria messages with a malaria toolkit. From the training received, the pupils will carry out awareness-raising in communities with key messages learnt.
School children shall not be trained on key malaria messages with a malaria toolkit. Pupils will not carry out awareness-raising in communities with key messages. .
Outcomes
Primary Outcome Measures
Number of school children to be trained with the malaria toolkit in order to educate adults on malaria control in different communities in the Mbandjock Health District
The intervention group will include 209 children to be trained with a toolkit on malaria in order to educate 209 adults in their different communities
Secondary Outcome Measures
Full Information
NCT ID
NCT04570241
First Posted
September 14, 2020
Last Updated
September 25, 2020
Sponsor
Cameroon Coalition Against Malaria (CCAM)
1. Study Identification
Unique Protocol Identification Number
NCT04570241
Brief Title
Mobilization at the Level of Schools on the Behavioral Change in Favor of the Fight Against Malaria in Mbandjock
Official Title
Evaluation of the Effect of Mobilization at School Level on Behaviour Change in Favor of Malaria Control in the Health District of Mbandjock in Cameroon
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 20, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cameroon Coalition Against Malaria (CCAM)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main aim of this study is to determine the effect of awareness campaigns by school children targeting their communities on knowledge, attitudes, and practices in malaria control in the Mbandjock health district. A two-arm, open-label, randomized controlled clinical trial will be adopted with the Mbandjock Health District as the test district and Sa'a Health District as control Health District. This will last from January 2017 to December 2020. The Lot Quality Assurance Sampling (LQAS) method was used. The health area was selected in the ratio 2:1. A total of 209 pupils and 209 adults shall be enrolled from households located in Mbandjock. Similarly, 114 pupils and 114 adults will be recruited in Sa'a. In addition, 57 teachers shall be enrolled in the District of Mbandjock only. A total of 703 participants shall be enrolled during the study.
Detailed Description
General objective To determine the effect of awareness campaigns by school children targeting their communities on knowledge, attitudes and practices in malaria control in the Mbandjock health district.
Specific objectives
To describe the socio-demographic characteristics of households in the health districts of Mbandjock and Sa'a at the time of the survey;
To measure the change due the intervention on knowledge of malaria transmission, diagnosis, treatment and prevention in the health district of Mbandjock;
To measure the change due the intervention on attitudes towards malaria diagnosis, treatment and prevention in the Mbandjock health district;
To measure the change due the intervention on practices in the diagnosis, treatment and prevention of malaria in the Mbandjock health district.
Methodology Study design A two-arm, open label, randomized controlled clinical trial will be adopted with Mbandjock health district as the test district and Sa'a Health District a Control Health District.
Study site and study population The study population will be the entire population of the Mbandjock and Sa'a communities.
Sampling method The Lot Quality Assurance Sampling (LQAS) method was used. Since this method requires that the intervention zones be divided into supervision areas, the health areas of each district were considered as supervision areas. The health area was selected in the ratio 2:1. In the test district 11 health areas were used and 6 health district in the control district. 19 households were selected for each health area as required by the LQAS method.
Sample size A total of 209 pupils and 209 adults shall be enrolled from households in Mbandjock. Similarly, 114 pupils and 114 adults will be recruited in Sa'a. In addition, 57 teachers shall be enrolled in the District of Mbandjock only. A total of 703 participants shall be enrolled during the study.
Duration of study The study duration is three years. This will last from January 2017 to December 2020.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
Malaria, Awareness, Knowledge, Attitudes, Practices
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A 2-arm, open-label, randomized controlled clinical trial will be adopted with the Mbandjock health district as the test district and Sa'a Health District a Control Health District.
The Lot Quality Assurance Sampling (LQAS) method was used. Since this method requires that the intervention zones be divided into supervision areas, the health areas of each district were considered as supervision areas. The health area was selected in the ratio 2:1. In the test district 11 health areas were used and 6 health district in the control district. 19 households were selected for each health area as required by the LQAS method.
A total of 209 pupils and 209 adults shall be enrolled from households in Mbandjock. Similarly, 114 pupils and 114 adults will be recruited in Sa'a. In addition, 57 teachers shall be enrolled in the District of Mbandjock only. A total of 703 participants shall be enrolled during the study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
703 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A-Malaria toolkit
Arm Type
Active Comparator
Arm Description
School children shall be trained on key malaria messages with a malaria toolkit. From the training received, the pupils will carry out awareness-raising in communities with key messages learnt.
Arm Title
Group B-No malaria toolkit
Arm Type
No Intervention
Arm Description
School children shall not be trained on key malaria messages with a malaria toolkit. Pupils will not carry out awareness-raising in communities with key messages.
.
Intervention Type
Behavioral
Intervention Name(s)
Malaria toolkit
Intervention Description
Knowledge, attitude, and practice on malaria
Primary Outcome Measure Information:
Title
Number of school children to be trained with the malaria toolkit in order to educate adults on malaria control in different communities in the Mbandjock Health District
Description
The intervention group will include 209 children to be trained with a toolkit on malaria in order to educate 209 adults in their different communities
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children should be of school-going age.
Children belong to an authorized school.
Adult belonging to a household.
Exclusion Criteria:
Children not going to school.
Children not belonging to an authorized school.
An adult that cannot be identified with any household.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wilfred Fon Mbacham, PhD
Phone
(+237) 677579180
Email
wfmbacham@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rose Leke, PhD
Phone
(+237) 699957329
Email
roseleke@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther Talla, MD
Organizational Affiliation
MC-CCAM
Official's Role
Study Director
Facility Information:
Facility Name
Mbandjock Health District
City
Yaoundé
State/Province
Centre
ZIP/Postal Code
+237
Country
Cameroon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fidelia Tarla, MSc
Phone
(+237) 677577706
Email
fideliatarla@gmail.com
First Name & Middle Initial & Last Name & Degree
Line Dongmo, MPH
Phone
(+237) 675420201
Email
dongmoline@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data on knowledge, attitude, and practice of malaria will be shared with the scientific community and policy makers
IPD Sharing Time Frame
December 2020 and for a period of at least 10 years
IPD Sharing Access Criteria
Must be a researcher or policy marker
Learn more about this trial
Mobilization at the Level of Schools on the Behavioral Change in Favor of the Fight Against Malaria in Mbandjock
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