Mobilization at the Level of Schools on the Behavioral Change in Favor of the Fight Against Malaria in Mbandjock
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| ClinicalTrials.gov Identifier: NCT04570241 |
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Recruitment Status :
Recruiting
First Posted : September 30, 2020
Last Update Posted : September 30, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Malaria | Behavioral: Malaria toolkit | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 703 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention 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) |
| Primary Purpose: | Prevention |
| 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 |
| Actual Study Start Date : | January 20, 2017 |
| Estimated Primary Completion Date : | December 31, 2020 |
| Estimated Study Completion Date : | December 31, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Group A-Malaria toolkit
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.
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Behavioral: Malaria toolkit
Knowledge, attitude, and practice on malaria |
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No Intervention: Group B-No malaria toolkit
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. . |
- 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 [ Time Frame: 24 months ]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
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| Ages Eligible for Study: | 9 Years to 65 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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): NCT04570241
| Contact: Wilfred Fon Mbacham, PhD | (+237) 677579180 | wfmbacham@yahoo.com | |
| Contact: Rose Leke, PhD | (+237) 699957329 | roseleke@yahoo.com |
| Cameroon | |
| Mbandjock Health District | Recruiting |
| Yaoundé, Centre, Cameroon, +237 | |
| Contact: Fidelia Tarla, MSc (+237) 677577706 fideliatarla@gmail.com | |
| Contact: Line Dongmo, MPH (+237) 675420201 dongmoline@gmail.com | |
| Study Director: | Esther Talla, MD | MC-CCAM |
| Responsible Party: | Pr Wilfred Fon Mbacham, Principal Investigator, Cameroon Coalition Against Malaria (CCAM) |
| ClinicalTrials.gov Identifier: | NCT04570241 |
| Other Study ID Numbers: |
MCCCAM/10/02/2016 |
| First Posted: | September 30, 2020 Key Record Dates |
| Last Update Posted: | September 30, 2020 |
| Last Verified: | September 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Data on knowledge, attitude, and practice of malaria will be shared with the scientific community and policy makers |
| Supporting Materials: |
Clinical Study Report (CSR) |
| Time Frame: | December 2020 and for a period of at least 10 years |
| Access Criteria: | Must be a researcher or policy marker |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Malaria Awareness Knowledge Attitudes Practices |
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Malaria Protozoan Infections Parasitic Diseases Infections Vector Borne Diseases |