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.: PACTR202102614259601 Date of Approval: 25/02/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of Malaria Free Zone Program on the Knowledge and Attitude of Malaria Prevention Among University Students in Conakry, Guinea
Official scientific title Effectiveness of Malaria Free Zone Program on the Knowledge and Attitude of Malaria Prevention Among University Students in Conakry, Guinea
Brief summary describing the background and objectives of the trial The “We control malaria” program will be modified into “Malaria Free Zone” program in this study. About the “We control malaria” program, it was developed by the Catholic Relief Services (CRS) which is an East Africa Regional Office and Ethiopia Country Office. The program sessions were conducted in Addis Ababa which is a city in Ethiopia. According to the Catholic Relief Services (CRS), this program is to empower the community to take ownership and responsibility for their malaria problem. The role of this program is to use six participatory activities around malaria as a whole package of activities as the participants will learn to understand malaria prevention. The objective of the “We control malaria” program is to assist the community in discussing about malaria as well as developing ways to prevent and control the disease. This research will adapt the program and call it “Malaria Free Zone”. Therefore, this study will be adapting the “We control malaria” program and it will be changed into “Malaria Free Zone”. The aim of the “Malaria Free Zone” program is to use the Health Belief Model (HBM) to enhance university students' knowledge and attitude towards malaria prevention in Conakry, Guinea. The HBM has five constructs; including; perceived susceptibility, perceived severity, perceived barriers, perceived benefits and perceived self-efficacy. The conceptual framework for this research will be using the Health Belief Model (HBM) to assess the effectiveness of the health education program in improving the knowledge and attitude on malaria prevention among university students in Conakry, Guinea.
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 01/03/2021
Actual trial start date 01/03/2021
Anticipated date of last follow up 15/05/2021
Actual Last follow-up date 15/05/2021
Anticipated target sample size (number of participants) 226
Actual target sample size (number of participants) 226
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
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 Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Malaria Free Zone 1 day The aim of the Malaria Free Zone program is to use the Health Belief Model (HBM) to enhance university students' knowledge and attitude towards malaria prevention in Conakry, Guinea. The HBM has five constructs; including; perceived susceptibility, perceived severity, perceived barriers, perceived benefits and perceived self-efficacy. 113
Control Group Mosquito borne diseases lecture 1 day Mosquito borne diseases lecture aims to educate university students on the different types of diseases caused by mosquitoes and the ways to prevent these mosquito borne diseases 113 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. University students residing in Conakry 1- University students who reside in a different state other than Conakry 2- University students who are not from Guinea 3- University students who are working 4- University students who are absent from university 5- University students from the Faculty of Medicine and Health Science Adult: 19 Year-44 Year 20 Year(s) 35 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 17/12/2020 Ethics Committee for Research involving Human Subjects
Ethics Committee Address
Street address City Postal code Country
43400 Seri Kembangan, Selangor, Malaysia Selangor 43400 Malaysia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Knowledge and Attitude 8am to 5pm
Secondary Outcome Perceived susceptibility, perceived severity, perceived barriers, perceived benefits and perceived self-efficacy 8am to 5pm
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Gamal Abdel Nasser University of Conakry Dixinn Commune, Conakry, Guinea Conakry Guinea
General Lansana Conte University in Sonfonia Laye laye camara, Conakry, Guinea Conakry Guinea
FUNDING SOURCES
Name of source Street address City Postal code Country
AICHA KOUTOUB SANO Kaloum Manquepas Conakry Guinea
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor AICHA KOUTOUB SANO Kaloum Manquepas Conakry Guinea Individual
COLLABORATORS
Name Street address City Postal code Country
National Program for the Fight Against Malaria Carrefour Central Pharmacy of Guinea, Municipality of Dixinn Conakry Guinea
Guinea Public Health Chair Gamal Abdel Nasser University of Conakry Conakry Guinea
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator AICHA KOUTOUB SANO aishasanosmile@gmai.com 00224628722555 Kaloum Manquepas
City Postal code Country Position/Affiliation
Conakry Guinea Main Researcher
Role Name Email Phone Street address
Public Enquiries Lim Poh Ying pohying_my@upm.edu.my 0060125888713 43400 Serdang, Selangor, Malaysia
City Postal code Country Position/Affiliation
Selangor 43400 Malaysia Supervisor
Role Name Email Phone Street address
Scientific Enquiries Lim Poh Ying pohying_my@upm.edu.my 0060125888713 43400 Serdang, Selangor, Malaysia
City Postal code Country Position/Affiliation
Selangor 43400 Malaysia Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Participant data will be available. The data that will be shared is all of the individual participant data collected during the trial, after deidentification. The documents that will be available is Study Protocol, Statistical Analysis Plan, Informed Consent form, Clinical Study Report, Analytic Code. Data will be available immediately following publication and there will be no end date. Data will be available to anyone who wishes to access the data. Data analysis will be available for any purpose. It is not applicable on the type of mechanism that data will be available on. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date Anyone who wishes 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