MalariaNCT04570241
Mobilization at the Level of Schools on the Behavioral Change in Favor of the Fight Against Malaria in Mbandjock
A study testing Malaria toolkit in people with Malaria, run by Cameroon Coalition Against Malaria (CCAM) at 1 site in Cameroon.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 65 years
- Conditions the study is for
- Malaria
- What is being tested?
- Malaria toolkit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 703 participants
- Where
- 1 siteCameroon
- Study dates
- 20 Jan 2017to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Children should be of school-going age.
- Children belong to an authorized school.
- Adult belonging to a household.
Who cannot join
- Children not going to school.
- Children not belonging to an authorized school.
- An adult that cannot be identified with any household.
Trial locations and contacts
1 site in 1 country.
Cameroon1 site, 1 recruiting
- Recruiting
Mbandjock Health District
Yaoundé, Centre Region, +237
Fidelia Tarla, MSc, (+237) 677577706, fideliatarla@gmail.com
Line Dongmo, MPH, (+237) 675420201, dongmoline@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Malaria
- Being tested
- Malaria toolkit
- Keywords
- Malaria, Awareness, Knowledge, Attitudes, Practices
- Medical subject headings
- Malaria, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Malaria toolkitBehavioural
Knowledge, attitude, and practice on malaria
| Study group | Role | What they receive |
|---|---|---|
| Group A-Malaria toolkit | Active comparator | 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. Receives: Behavioral: Malaria toolkit |
| Group B-No malaria toolkit | No intervention | 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. . |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start20 Jan 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 703 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cameroon Coalition Against Malaria (CCAM)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr Wilfred Fon Mbacham, Cameroon Coalition Against Malaria (CCAM)
- Investigators
- Esther Talla, MD, Study director, MC-CCAM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570241
- Sponsor's protocol ID
- MCCCAM/10/02/2016
- Status last verified
- Sep 2020
- First submitted
- 14 Sep 2020
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data on knowledge, attitude, and practice of malaria will be shared with the scientific community and policy makers
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04570241
- Acronym / sponsor ID
- MCCCAM/10/02/2016
- Conditions
- Malaria
- Keywords
- Malaria, Awareness, Knowledge, Attitudes, Practices
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 703 participants (estimated)
- Lead sponsor
- Cameroon Coalition Against Malaria (CCAM)University, hospital or other
- Study start
- 20 Jan 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A-Malaria toolkit | Active comparator | Behavioral: Malaria toolkitSchool 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. |
| Group B-No malaria toolkit | No intervention | –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. . |
Who may qualify
- Ages
- 9 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Children should be of school-going age.
- Children belong to an authorized school.
- Adult belonging to a household.
Key exclusion criteria (3 listed)
- Children not going to school.
- Children not belonging to an authorized school.
- An adult that cannot be identified with any household.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Malaria toolkitKnowledge, attitude, and practice on malaria | Behavioural | Group A-Malaria toolkit |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Individual participant dataSharing planned: Yes. Data on knowledge, attitude, and practice of malaria will be shared with the scientific community and policy makers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esther Talla, MD study director
MC-CCAM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Malaria toolkit in people with Malaria, run by Cameroon Coalition Against Malaria (CCAM) at 1 site in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wilfred Fon Mbacham, PhD ((+237) 677579180, wfmbacham@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2020.