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.: PACTR202205830947149 Date of Approval: 06/05/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECTIVENESS OF HEALTH EDUCATION INTERVENTION ON IMPROVING KNOWLEDGE, ATTITUDE AND PERCEIVED PRACTICE OF COVID -19 PREVENTIVE MEASURES AMONG SECONDARY SCHOOL STUDENTS IN DODOMA PERI-URBAN.A QUASI EXPERIMENT STUDY DESIGN.
Official scientific title EFFECTIVENESS OF HEALTH EDUCATION INTERVENTION ON IMPROVING KNOWLEDGE, ATTITUDE AND PERCEIVED PRACTICE OF COVID -19 PREVENTIVE MEASURES AMONG SECONDARY SCHOOL STUDENTS IN DODOMA PERI-URBAN.A QUASI EXPERIMENT STUDY DESIGN.
Brief summary describing the background and objectives of the trial Tanzania is among the country which experiences cases of COVID-19,the most people affected are elderly and people with chronic conditions or illness. Study shows that children are less vulnerable to COVID-19 but can transmit infections to adult. Health education and promotions to secondary school students can help to reduce the burden of COVID-19 if properly implemented. The general objective of this study is to test effectiveness of health education interventions on improving knowledge, attitude and perceived practice of COVID-19 preventives measures among secondary school students in Dodoma peri urban. This study had the following specific objectives -To assess effectiveness of health education intervention on improving knowledge on COVID-19 preventive measures among secondary school students in Dodoma peri-urban. - To determine effectiveness of health education intervention on improving attitude towards COVID-19 preventive measures among secondary school students in Dodoma peri-urban. -To determine effectiveness of health education intervention on improving perceived practice of COVID-19 preventive measures among secondary school students in Dodoma peri-urban.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) A quasi experment study designs
Disease(s) or condition(s) being studied Infections and Infestations,Respiratory
Sub-Disease(s) or condition(s) being studied Respiratory infection
Purpose of the trial Education /Training
Anticipated trial start date 04/04/2022
Actual trial start date 11/04/2022
Anticipated date of last follow up 10/06/2022
Actual Last follow-up date 17/06/2022
Anticipated target sample size (number of participants) 210
Actual target sample size (number of participants) 210
Recruitment status Recruiting
Publication URL Biomedical
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table from a statistics book Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Health education intervention on COVID19 preventive measures Twice a week Two week Intervention The health education materials will be adopted from the ministry of health guideline for prevention of COVID-19(THE UNITED REPUBLIC OF TANZANIA, 2020). The intervention materials will contain the following components: 1. Health education of COVID-19. 2. Attitude and 3. Practice of COVID-19 preventive measures. 1. Health education of COVID-19 The education materials developed by researchers include brochures that will help to raise awareness on causes and ways of spread of COVID-19. Also preventive measures for COVID-19 will be introduced to participants. 2. Attitude and perceived Practice of COVID-19 prevention. The researcher will teach participants proper ways of wearing mask and washing hands by demonstration in order to prevent infection of COVID-19. Brochures will be introduced to participants to raise more awareness. The intervention will be conducted through traditional lecture method twice a week and for two weeks. The session will take 45 minutes to one session. Post test assessment will be done six week after intervention to detect the delay effect of intervention on knowledge, attitude and perceived practice of Covid-19 preventive measures. Post intervention Six weeks after health lecture concerning preventive measures of COVID-19 the same participants will be given post test questionnaires. 105
Control Group No health education on COVID19 preventive measures will be given to control group during the study Not applicable six week Control group will not be given health education on COVID19 preventive measures but baseline information will be collected after initiation of the study and after six week. 105 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All students from form one to form six, who are boarding and day, who will be willing to be part of the study All students from form one to form six, who are boarding and day, who will be sick or out of school for any other reason. Adolescent: 13 Year-18 Year 13 Year(s) 18 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 18/03/2022 THE UNIVERSITY OF DODOMA
Ethics Committee Address
Street address City Postal code Country
P O BOX 259 DODOMA,TANZANIA DODOMA 259 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Increase intention of handwashing with soap and water,use of sanitizer,wearing of mask Six week
Secondary Outcome Poor infrastructure e.g sources of water Six week
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KIKOMBO SECONDARY SCHOOL P O BOX 1249 DODOMA CITY United Republic of Tanzania
ZUZU SECONDARY P.O BOX 1249 DODOMA CITY United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
AMAD CHARLES P. O BOX 395 DODOMA DODOMA 395 United Republic of Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor AMAD CHARLES P.O BOX 395 DODOMA DODOMA 395 United Republic of Tanzania Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator AMAD CHARLES amadjason787@gmail.com +255716632001 P.O BOX 395
City Postal code Country Position/Affiliation
DODOMA 395 United Republic of Tanzania STUDENT
Role Name Email Phone Street address
Public Enquiries ELIA DAUDI eliadaud93@gmail.com +255752917786 P.O BOX 395 DODOMA
City Postal code Country Position/Affiliation
DODOMA 395 United Republic of Tanzania STATISTICIAN
Role Name Email Phone Street address
Scientific Enquiries AMAD CHARLES amadjason787@gmail.com +255716632001 P.O BOX 395 DODOMA
City Postal code Country Position/Affiliation
DODOMA 395 United Republic of Tanzania STUDENT
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes No names of participants will be used for their data in steady code number will be applied.Also legally binding agreement for further data sharing should be adhered,no further sharing of data and no attempt should be made to find identification of participants names. Informed Consent Form,Study Protocol 2years "Open"
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Biomedical research centre 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