Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202408481442659 Date of Approval: 15/08/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Health education intervention on malaria control among caregivers of under-five children in Buea, Cameroon
Official scientific title Text messaging health education intervention on malaria control among caregivers of under-five children of the Buea Health District: A cluster-randomized controlled trial
Brief summary describing the background and objectives of the trial Malaria continues to be a leading cause of morbidity and mortality in many tropical regions of the world, despite global efforts to eradicate the disease. It poses a health threat especially to vulnerable groups such as pregnant women and children under five years in Cameroon including the Buea Health District. We aim to assess the burden of malaria among under-five children, determine caregivers’ knowledge attitudes and practices and care seeking behaviours for suspected episodes of malaria and the effectiveness of text messages health education on malaria prevention and control in selected communities in the Buea Health District.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) HEI4MC
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Prevention
Anticipated trial start date 18/12/2023
Actual trial start date 08/01/2024
Anticipated date of last follow up 02/08/2024
Actual Last follow-up date 30/08/2024
Anticipated target sample size (number of participants) 360
Actual target sample size (number of participants) 394
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Health education delivered via text messages using short message service and WhatsApp Weekly on Mondays 6 months Health education messages on malaria preventive practices and health seeking for suspected episodes of malaria in under-five children shall be sent on weekly basis to the mobile phones of heads of households enrolled into the study. In the single-way SMS interventional arm, the messages will be sent at the beginning of each week without any expectation of response from the caregivers for a duration of six months. SMS will read, “malaria kills, prevent you children from malaria”, also “using mosquito bed nets will prevent malaria in your household”. For a period of 6 months, in the double-way SMS interventional arm, the messages will be sent at the beginning of each week and the caregivers of the children will be encourage and expected to reply back to acknowledge receipt and post any questions (SMSs shall be activated for them monthly). The messages shall be tailored to address the gaps that will be identified at baseline concerning prevention of malaria and health seeking for suspected cases of malaria among under-five children. Follow up community discussions shall be organized 3 months into the trial where participants will be invited to share their experiences, challenges and any attitudes that have been adopted as a result of the study. Determinants of malaria, health seeking and screening for malaria in the children shall be done at baseline and 6 months after the start of the interventions for both control and trial arms. NB. At the end of the study, messages concerning the control and prevention on malaria that had been sent to those in the intervention clusters will be sent to those in the control cluster. This is so that they too will be educated on malaria control and prevention. 268
Control Group Health education delivered via text messages using short message service and WhatsApp weekly on Mondays 6 months for a period of six months, messages on hygienic practices that shall be unrelated to malaria will be sent to caregivers in the control group on weekly bases to keep them involved in the study. This messages shall be sent at the time and period in which intervention messages will be sent to intervention group. 126 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
We shall include caregivers in households with under-five children resident in any of the six communities that will own or have access to mobile phones. RDT for malaria shall be conducted on under-five children in selected households for the study. We shall exclude caregivers in households who are mentally unable to read or respond text messages. Caregivers who would not want to participate in the study shall be excluded from the study. RDT for malaria shall not be conducted on children bellow 2 months of age Adult: 19 Year-44 Year,Infant: 0 Month-23 Month,Infant: 1 Month-23 Month,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 2 Month(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/08/2023 Faculty of Health Sciences Institutional Review board
Ethics Committee Address
Street address City Postal code Country
P.O Box 63, University of Buea Buea 00237 Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Increase in knowledge on malaria prevention, good attitudes and practices towards malaria prevention. Also, good care seeking behaviours in episodes of suspected malaria among under-five children. 6 months after the start of intervention
Secondary Outcome Reduction in the prevalence of malaria among under-five children in the Buea Health District 6 months after start of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Buea Health District Health Areas of Buea Health District Buea 00237 Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
Mildred Nje Laban epse Tanue Faculty of Health Sciences Buea Cameroon
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mildred Nje Laban epse Tanue Faculty of Health Sciences Buea Cameroon Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mildred NJe Laban epse Tanue mildrednje@gmail.com +237675282092 University of Buea
City Postal code Country Position/Affiliation
Buea Cameroon Phd candidate
Role Name Email Phone Street address
Public Enquiries Emmanuel Yenshu socpolub@hotmail.com +237677606664 University of Buea
City Postal code Country Position/Affiliation
Buea PO Box 63 Cameroon Dean of the faculty of Social and management Sciences
Role Name Email Phone Street address
Scientific Enquiries Dickson Shey Nsagha dsnsagha@gmail.com +237677499429 University of Buea
City Postal code Country Position/Affiliation
Buea PO Box 63 Cameroon Vice Dean of the faculty of Health Sciences
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article will be shared, after deidentification (text, tables, figures, and appendices) Statistical Analysis Plan,Study Protocol Immediately following publication, No end date Anyone who which to access the data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information