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.: PACTR202003487018009 Date of Approval: 18/03/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Community Directed Treatment of malaria among children under five in two Health Districts of the West Region of Cameroon
Official scientific title Home-based Prevention and Treatment of Malaria among Under-five children: A Randomised Controlled Trial
Brief summary describing the background and objectives of the trial One child dies of malaria in Africa every two minutes, a preventable and curable disease. Only one-third of febrile children consult a qualified health staff. Most parents go to street vendors rather than to the health system for medication and formal health care is sought only when initial treatment fails. Effective case management of malaria requires prompt diagnosis and treatment within 24 hours. Home-based Management of Malaria reduces the progression to severe malaria by more than 50%. Our research team is developing a randomized control trial to enhance home caregivers’ capacities to prevent, diagnose and treat malaria in the under five children at home. It’s a promising strategy to improve access of under five children to prompt and effective home management of uncomplicated malaria cases. The objective of this trial is to investigate the impact of home-based intervention strategy to prevent and treat malaria in the under-five children.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) HPTM
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Treatment: Drugs
Anticipated trial start date 05/03/2020
Actual trial start date 03/03/2020
Anticipated date of last follow up 31/08/2020
Actual Last follow-up date 15/09/2020
Anticipated target sample size (number of participants) 700
Actual target sample size (number of participants) 700
Recruitment status Not yet recruiting
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Home based Prevention and Treatment of Malaria Train home caregivers, Provide them with malaria kits and replace when there are used 6 months Home caregivers will be selected, trained and educated on malaria case management to recognize uncomplicated malaria, perform malaria Rapid Diagnosis Test and administer artesunate-amodiaquine themselves to their children in case the test is positive, or refer to the health centre in cases of severe malaria or negative test 350
Control Group Community Directed Intervention strategy No 6 months No intervention 350 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Households with at least one child under five; Home caregivers with at least 18 years old and at most 60 years old who take care of children under five and accept to participate in the study after informed assent/consent Home caregivers who refuse to participate in the study will be excluded Households without children under five; Children under 2 months Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 2 Month(s) 59 Month(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 13/09/2019 Faculty of Health Sciences Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Faculty of Health Sciences, Molyko, Buea Buea 00237 Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Improved Caregivers’ Knowledge, Attitude and practice regarding malaria prevention, diagnosis and treatment After six months
Secondary Outcome Improved the management of malaria of children under five at home by home caregivers After six months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Fombap Health Area In the Santchou Health District Fombap 00237 Cameroon
Baneghang Health Area In the Penka-Michel Health District Baneghang 00237 Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
DONGMO KENFACK Esther Kamkop Bafoussam 00237 Cameroon
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor DONGMO KENFACK Esther Kamkop Bafoussam 00237 Cameroon Individual
COLLABORATORS
Name Street address City Postal code Country
Dickson Shey Nsagha Molyko Buea Buea 00237 Cameroon
Tendongfor Nicholas Molyko Buea Buea 00237 Cameroon
TANKEU DONGMO NORBERT Kamkop Bafoussam 00237 Cameroon
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Esther DONGMO KENFACK estherdongmokenfack@gmail.com 00237699835239 Kamkop
City Postal code Country Position/Affiliation
Bafoussam 00237 Cameroon Ph.D. Candidate in Public Health
Role Name Email Phone Street address
Scientific Enquiries Dickson Shey Nsagha dsnsagha@gmail.com 00237677499429 Molyko
City Postal code Country Position/Affiliation
Buea 00237 Cameroon Supervisor
Role Name Email Phone Street address
Public Enquiries Nicholas Tendongfor ntendongfor@gmail.com 00237676927690 Molyko
City Postal code Country Position/Affiliation
Buea 00237 Cameroon Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We plan to share the de-identified individual participant data set to members of the scientific and medical community, to national and international policy makers, including the World Health Organization. Informed Consent Form,Study Protocol March 2020 - March 2030 There will be controlled access to the data/documents with the gatekeepers being the Principal Investigator (PI), who will be responsible for deciding who may have access. Access to the data/documents must include prior ethical approval for secondary data analysis and the statistical methods for secondary data analysis must be vetted by a statistician. If access is requested during the conduct of the trial, it must be directed to all the researcher team via the Principal Investigator
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not yet available 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