NCT04570241

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
703

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2017

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 30, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

September 30, 2020

Status Verified

September 1, 2020

Enrollment Period

3.9 years

First QC Date

September 14, 2020

Last Update Submit

September 25, 2020

Conditions

Keywords

MalariaAwarenessKnowledgeAttitudesPractices

Outcome Measures

Primary Outcomes (1)

  • 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

    24 months

Study Arms (2)

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.

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. .

Interventions

Malaria toolkitBEHAVIORAL

Knowledge, attitude, and practice on malaria

Group A-Malaria toolkit

Eligibility Criteria

Age9 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Children should be of school-going age.
  • Children belong to an authorized school.
  • Adult belonging to a household.

You may not qualify if:

  • Children not going to school.
  • Children not belonging to an authorized school.
  • An adult that cannot be identified with any household.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mbandjock Health District

Yaoundé, Centre Region, +237, Cameroon

RECRUITING

MeSH Terms

Conditions

MalariaBehavior

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Esther Talla, MD

    MC-CCAM

    STUDY DIRECTOR

Central Study Contacts

Wilfred Fon Mbacham, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

September 14, 2020

First Posted

September 30, 2020

Study Start

January 20, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

September 30, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share

Data on knowledge, attitude, and practice of malaria will be shared with the scientific community and policy makers

Shared Documents
CSR
Time Frame
December 2020 and for a period of at least 10 years
Access Criteria
Must be a researcher or policy marker

Locations