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.: PACTR202001837195738 Date of Approval: 21/01/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Malaria Prevention Education on malaria, anemia and cognitive development among school-aged children in two malarious districts in Gamo Gofa Zone: cluster randomized controlled trial with nested process evaluation
Official scientific title Effect of Malaria Prevention Education on malaria, anemia and cognitive development among school-aged children in two malarious districts in Gamo Gofa Zone: cluster randomized controlled trial with nested process evaluation
Brief summary describing the background and objectives of the trial school-aged children become at high risk of malaria due delayed development of protective immunity that is associated with decreased exposure of children for Plasmodium parasite in their early age. However, these children were less benefited from malaria prevention interventions. This study is aiming to assess the effect of malaria prevention education on malaria, anemia and cognitive development of school-aged children in Dara Mallo and Uba Debretsehay primary schools in Southern Ethiopia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Education /Training
Anticipated trial start date 16/10/2019
Actual trial start date 16/10/2019
Anticipated date of last follow up 16/10/2020
Actual Last follow-up date 16/10/2020
Anticipated target sample size (number of participants) 2304
Actual target sample size (number of participants)
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification 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 Malaria preveention education Malaria prevention education will be given twice in the follow-up period Malaria prevention education will be given to children and their parents half a day The intervention is malaria prevention education given to the parents and children by trained science teachers and school headmasters. In this intervention, the discussion on their perceived cause of malaria and miss perceptions are corrected. The consequences of malaria and symptoms of malaria will be discussed. Participants malaria prevention experience will be explored and wrong practices of malaria prevention will be corrected and finally what they do for the 1st time when they suspect their children for malaria is explored and at last they will be communicated only the health facility for the treatment of malaria. 16
Control Group Malaria prevention education malaria prevention education will not be given to the parents and children October 2019 to October 2020 Malaria prevention education that will be given to the children and parents will not be given in the control schools 16 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Aged 5-14 years (age 6-12 for cognitive development Resident in the area at least for the last 20 days Living with parents or guardian to give assent severely ill to respond for questions Has taken antimalarial drug recently Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 5 Year(s) 14 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 05/09/2019 Institutional Research Ethics Review Board
Ethics Committee Address
Street address City Postal code Country
college of Medicine and Health Sciences Arba Minch 0021 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome malaria parasitemia-Difference in the prevalence of malaria parasitemia among school-aged children in intervention and control schools by using rapid diagnostic test or blood film examination at 12 months follow-up 12
Primary Outcome Anemia-Difference in the prevalence of anemia among school-aged children in intervention and control schools by measuring hemoglobin concentration using hemoCue analyzer at 12 months of follow-up 12
Secondary Outcome incidence of clinical malaria-Difference in the incidence of clinical malaria between intervention and control schools at 12 months of follow-up 12
Secondary Outcome hemoglobin concentration-The mean hemoglobin difference between students in the intervention schools and control schools measured by using hemoCue analyzer at 12 months of follow-up 12
Secondary Outcome cognitive performance-Difference in the cognitive development between intervention and control schools measured by using test of everyday attention for children 12
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Arba Minch University College of Medicine and Health Sciences Arba Minch 0021 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Arba Minch University Arba Minch University Arba Minch 0021 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Arba Minch University Arba Minch University, college of Medicine and Health Sciences Arba Minch 0021 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Zerihun Zerdo zedozerihun@gmail.com +251913032073 Arba Minch University, Nech Sar Campus
City Postal code Country Position/Affiliation
Arba Minch 0021 Ethiopia PhD student at university of Antwerp in Belgium
Role Name Email Phone Street address
Scientific Enquiries Jean Pierre Van geertruyden jean-pierre.vangeertruyden@uantwerpen.be +32484618493 Doornstraat 331
City Postal code Country Position/Affiliation
Antwerp Belgium Global Health Institute in Antwerp university in Belgium
Role Name Email Phone Street address
Public Enquiries Zerihun Zerdo zedozerihun@gmail.com +251913032073 Arba Minch University
City Postal code Country Position/Affiliation
Arba Minch 0021 Ethiopia PhD student in Antwerp University
Role Name Email Phone Street address
Principal Investigator Jean Pierre Van geertruyden jean-pierre.vangeertruyden@uantwerpen.be +3248461893 Doornstraat 331
City Postal code Country Position/Affiliation
Antwerp Belgium professor
Role Name Email Phone Street address
Scientific Enquiries Fekadu Massebo fekadu.massebo@amu.edu.et +251911733885 Arba Minch University
City Postal code Country Position/Affiliation
Arba Minch 0021 Ethiopia Associate proffessor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data includes data collected through observation at household, interview with mothers of school-aged children, interview with the children, kato-katz thick smear of stool, malaria diagnosis by RDT, hemoglobin by hemacue and cognitive performance of children Study Protocol within 12 months after completing data collection the data can be accessed after requesting principal investigator
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