COVID-19 VaccinationNCT04930185
Reducing Vaccine Hesitancy (VH) And Vaccine Refusal (VR): Its' Correlation Factors and an Educational Intervention Programme
A study testing Reducing Vaccine Hesitancy (VH) And Vaccine Refusal (VR): An Educational Intervention Programme in people with COVID-19 Vaccination, run by Sunway University at 1 site in Malaysia.
Trial summary
The COVID-19 pandemic has spread to over 200 countries worldwide and is still on the rise in 88 countries. Unfortunately, Malaysia is not the exception and registered 340,642 COVID-19 cases till 29 March 2021 since the outbreak of the pandemic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Vaccination
- What is being tested?
- Reducing Vaccine Hesitancy (VH) And Vaccine Refusal (VR): An Educational Intervention Programme
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Sep 2021to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals aged 18 years and above
- Able to provide informed consent (verbal/written) to participate
- Understand either Bahasa Malaysia
- Participants who have not received their COVID-19 vaccination
- Participants who have access to smart phone and/or mobile phone
- Participants who have access to internet.
Who cannot join
- Those who have had any prior history of psychological or neurological illness
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Sunway University
Petaling Jaya, Selangor, 47500
Pei Boon Ooi, Doctorate, 374918622, researchethics@sunway.edu.my
About this study
The COVID-19 pandemic has spread to over 200 countries worldwide and is still on the rise in 88 countries. Unfortunately, Malaysia is not the exception and registered 340,642 COVID-19 cases till 29 March 2021 since the outbreak of the pandemic.
COVID-19 virus can be transmitted from an infected person to others through droplets when coughing or sneezing as well as by touching objects infected with the virus. Although precautionary measures, which include the regular and mandatory use of face masks, reducing crowds, and physical distancing, have been widely encouraged by WHO and the Malaysian government, getting COVID-19 vaccination remain the way forward to curb the wide spread of the virus and to return to the normal.
Read more
However, the public awareness on the importance of getting vaccinated is still low with high level of vaccination hesitance and refusal. In Malaysia, this challenge is compounded further due to a lack of COVID-19 vaccination educational intervention programme in Bahasa Malaysia to educate the predominantly larger group in the population who are more conversant in ther national language. In order to improve the acceptance rate towards the COVID-19 vaccination in Malaysia, it is imperative to design a comprehensive intervention program that will increase the awareness and knowledge with regards to the efficacy of the COVID-19 vaccine as a solution in overcoming this pandemic.
With this in mind, this study aims to identify the correlational factors of COVID-19 and develop an educational intervention programme on COVID-19 vaccination and thereafter, assess the effectiveness of this educational intervention programme.
Read the detailed description
Research Objectives
- Examine the association among vaccination intention, attitudinal belief, subjective norms, perceived behavioral control, vaccine hesitancy and its reasons among the Malaysian population.
- Develop an educational intervention Programme on COVID-19 vaccination to increase knowledge, positive attitudes, and acceptance toward COVID-19 vaccination
- Assess the effectiveness of the educational intervention programme
Research Hypothesis
The hypotheses are:
- The Ministry of Sciences and Technology (2021) reported that the percentage of Malaysians who voluntarily registered for the COVID-19 vaccine is still low. The researcher, therefore, hypothesize that the level of knowledge, positive attitudes, and acceptance towards the COVID-19 vaccine among Malaysian population to be rather low.
- The researcher hypothesize that there is an association among vaccination intention, attitudinal belief, subjective norms, perceived behavioral control, vaccine hesitancy and its reasons among the Malaysian population
- The researcher hypothesize that the educational intervention programme has a statistically significant effect on reducing vaccination hesitancy and vaccination refusal between the baseline and the assessment soon after the program as well as at 3 months after the programme as compared to the control group)
The Study There are 2 phases in this study. Phase 1 is the cross-sectional study, while Phase 2 will look into the programme development and feasibility and the implementation of a cluster randomised controlled trial (RCT).
Phase 1 Cross-sectional Study
Study design \& procedure:
- This cross-sectional study will utilize both online and paper questionnaire.
- The sample will be recruited through both voluntary response sampling and snowball sampling methods. The survey will be sent out to Malaysian who are more than 18 years old in the online social media platforms.
- To ensure the cross-sectional study to be effective, the researcher decided our sample size based on Krejcie \& Morgan (1970) method that has commonly and widely been used in simple random sampling studies for each sample. Thus, for a wide of 32 million of population in Malaysia, the researcher had targeted for a total of 384 participants are sufficient.
- This cross-sectional study aims to examine the association among vaccination intention, attitudinal belief, subjective norms, perceived behavioural control, vaccine hesitancy and its reasons among the Malaysian population.
Study site and participants
- The cross-sectional study will be taking place in online setting. A few social media platforms are chosen for this purpose such as Facebook, Instagram, WhatsApp, and et-cetera.
- Recruitment materials and survey will be shared on the social medial platforms and advocate public to share among others who are eligible.
Phase 2 (a): Programme Development and Feasibility Study
Study design \& procedure:
- A group of experts consisting of public health experts in health education, health psychology, and other health-care providers (communicable disease background) will hold online meetings (Focus Group Discussions) to develop the modules for the Programme based on literature review, best practices in the field and in consultation with public health experts and other ministerial departments.
- For a focus group discussion (FGD) to be effective, the number of participants shall between 6-8 per group (Krueger \& Casey, 2002). The researcher will target 8 per group and organize up to 5 groups and/or when the researcher reach data saturation points.
- The FGDs will aim to build the content and activities of the Programme. The core members of this research team will finalise the Programme structure, before holding a second online meeting with the experts involved to confirm its validity. This Programme will continue to be refined throughout the study based on the feasibility study results.
Phase 2 (b): Cluster Randomised Controlled Trial (RCT).
Study design \& procedure:
- To evaluate the effectiveness of the Programme, a cluster randomised controlled trial with three assessment points (Baseline, immediate after intervention and 3-month follow-up) will be conducted with the materials and outcome measures listed.
- This will be a study based on pre/post multiple time series study design.
- Students from the School of Medical \& Life Sciences, Sunway University, Faculty of Social Sciences, Quest University International, Ipoh and Centre of Community Health Studies, UKM will be engaged in the design and development of the approved content. By doing so, students from various universities would have a chance to apply what they have learned in the classrooms into the real life.
- Materials will be in the form of pamphlet, webinar content and SMS and in Bahasa Malaysia.
Sample size calculation:
- Non-inferiority designed will be used to show that the new treatment is as effective but need not superior when compared to the standard treatment (Zhong, 2009).
- For non-inferiority design, the formula is:
- Based on the recent published results, non-response rate of standard vaccine rate is reported to be 7% (Khubchandani et al., 2021). Thus, sample size required would be:
- N= 2 x [(1.645+0.845)/0.1]2 x 0.07 x (1-0.07)
- N= 80.7 (approximately 81 participants)
- Assuming a dropout rate of 20%, the researcher will recruit at least 100 participants in each category for each education material used, making a total of 300 for each site (Figure 1).
Study site and participants
- The cluster randomised controlled trial with three parallel arms (i.e., 3 intervention groups ) will be performed in both West and East Coast Malaysia. One major health facility/university will be selected and approached.
- Recruitment materials designed will be shared and distributed both online and offline to the health facilities, schools, churches, mosques, temples, NGOs, recreation malls and societies.
- Conditions
- COVID-19 Vaccination
- Being tested
- Reducing Vaccine Hesitancy (VH) And Vaccine Refusal (VR): An Educational Intervention Programme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reducing Vaccine Hesitancy (VH) And Vaccine Refusal (VR): An Educational Intervention ProgrammeBehavioural
Participants will be receiving the pamphlet about the COVID-19 vaccination information during the intervention.
They will received 3 different sets of questionnaire to measured their level of vaccine hesitancy and vaccine refusal in 3 different time points: (a) before intervention, (b) after the intervention, and (c) 3 months after the intervention.
Data cleansing will be conducted based on the per-protocol analysis. Pre-protocol is a comparison of treatment groups that includes only those patients who completed the treatment originally allocated.
Reducing Vaccine Hesitancy (VH) And Vaccine Refusal (VR): An Educational Intervention ProgrammeBehavioural
Participants will be receiving the webinar last for half an hour about the COVID-19 vaccination information during the intervention.
They will received 3 different sets of questionnaire to measured their level of vaccine hesitancy and vaccine refusal in 3 different time points: (a) before intervention, (b) after the intervention, and (c) 3 months after the intervention.
Data cleansing will be conducted based on the per-protocol analysis. Pre-protocol is a comparison of treatment groups that includes only those patients who completed the treatment originally allocated.
Reducing Vaccine Hesitancy (VH) And Vaccine Refusal (VR): An Educational Intervention ProgrammeBehavioural
Participants will be receiving the SMS about the COVID-19 vaccination information during the intervention.
They will received 3 different sets of questionnaire to measured their level of vaccine hesitancy and vaccine refusal in 3 different time points: (a) before intervention, (b) after the intervention, and (c) 3 months after the intervention.
Data cleansing will be conducted based on the per-protocol analysis. Pre-protocol is a comparison of treatment groups that includes only those patients who completed the treatment originally allocated.
| Study group | Role | What they receive |
|---|---|---|
| Pamphlet | Experimental | Participants will received pamphlet about COVID-19 vaccination Receives: Behavioral: Reducing Vaccine Hesitancy (VH) And Vaccine Refusal (VR): An Educational Intervention Programme |
| Webinar | Experimental | Participants will received webinar about COVID-19 vaccination Receives: Behavioral: Reducing Vaccine Hesitancy (VH) And Vaccine Refusal (VR): An Educational Intervention Programme |
| SMS | Experimental | Participants will received SMS about COVID-19 vaccination Receives: Behavioral: Reducing Vaccine Hesitancy (VH) And Vaccine Refusal (VR): An Educational Intervention Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reducing Vaccine Hesitancy
The vaccine hesitancy scale
Measured: 17 months
Secondary outcomes (1)
Reducing Vaccine Hesitancy
The researcher will build a dichotomous scale from ground up to see the acceptance rate of participants towards each brand of vaccine available in Malaysia
Measured: 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 Sep 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 VaccinationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunway University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ooi Pei Boon, Sunway University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930185
- Sponsor's protocol ID
- SRB/IIR/SMC/F/21/001
- Status last verified
- Jun 2021
- First submitted
- 3 Jun 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Vaccine Hesitancy (VH) And Vaccine Refusal (VR): Its' Correlation Factors and an Educational Intervention Programme
- ClinicalTrials.gov ID
- NCT04930185
- Acronym / sponsor ID
- SRB/IIR/SMC/F/21/001
- Conditions
- COVID-19 Vaccination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Sunway UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The COVID-19 pandemic has spread to over 200 countries worldwide and is still on the rise in 88 countries. Unfortunately, Malaysia is not the exception and registered 340,642 COVID-19 cases till 29 March 2021 since the outbreak of the pandemic.
COVID-19 virus can be transmitted from an infected person to others through droplets when coughing or sneezing as well as by touching objects infected with the virus. Although precautionary measures, which include the regular and mandatory use of face masks, reducing crowds, and physical distancing, have been widely encouraged by WHO and the Malaysian government, getting COVID-19 vaccination remain the way forward to curb the wide spread of the virus and to return to the normal.
However, the public awareness on the importance of getting vaccinated is still low with high level of vaccination hesitance and refusal. In Malaysia, this challenge is compounded further due to a lack of COVID-19 vaccination educational intervention programme in Bahasa Malaysia to educate the predominantly larger group in the population who are more conversant in ther national language. In order to improve the acceptance rate towards the COVID-19 vaccination in Malaysia, it is imperative to design a comprehensive intervention program that will increase the awareness and knowledge with regards to the efficacy of the COVID-19 vaccine as a solution in overcoming this pandemic.
With this in mind, this study aims to identify the correlational factors of COVID-19 and develop an educational intervention programme on COVID-19 vaccination and thereafter, assess the effectiveness of this educational intervention programme.
Detailed description
Research Objectives
- Examine the association among vaccination intention, attitudinal belief, subjective norms, perceived behavioral control, vaccine hesitancy and its reasons among the Malaysian population.
- Develop an educational intervention Programme on COVID-19 vaccination to increase knowledge, positive attitudes, and acceptance toward COVID-19 vaccination
- Assess the effectiveness of the educational intervention programme
Research Hypothesis
The hypotheses are:
- The Ministry of Sciences and Technology (2021) reported that the percentage of Malaysians who voluntarily registered for the COVID-19 vaccine is still low. The researcher, therefore, hypothesize that the level of knowledge, positive attitudes, and acceptance towards the COVID-19 vaccine among Malaysian population to be rather low.
- The researcher hypothesize that there is an association among vaccination intention, attitudinal belief, subjective norms, perceived behavioral control, vaccine hesitancy and its reasons among the Malaysian population
- The researcher hypothesize that the educational intervention programme has a statistically significant effect on reducing vaccination hesitancy and vaccination refusal between the baseline and the assessment soon after the program as well as at 3 months after the programme as compared to the control group)
The Study There are 2 phases in this study. Phase 1 is the cross-sectional study, while Phase 2 will look into the programme development and feasibility and the implementation of a cluster randomised controlled trial (RCT).
Phase 1 Cross-sectional Study
Study design \& procedure:
- This cross-sectional study will utilize both online and paper questionnaire.
- The sample will be recruited through both voluntary response sampling and snowball sampling methods. The survey will be sent out to Malaysian who are more than 18 years old in the online social media platforms.
- To ensure the cross-sectional study to be effective, the researcher decided our sample size based on Krejcie \& Morgan (1970) method that has commonly and widely been used in simple random sampling studies for each sample. Thus, for a wide of 32 million of population in Malaysia, the researcher had targeted for a total of 384 participants are sufficient.
- This cross-sectional study aims to examine the association among vaccination intention, attitudinal belief, subjective norms, perceived behavioural control, vaccine hesitancy and its reasons among the Malaysian population.
Study site and participants
- The cross-sectional study will be taking place in online setting. A few social media platforms are chosen for this purpose such as Facebook, Instagram, WhatsApp, and et-cetera.
- Recruitment materials and survey will be shared on the social medial platforms and advocate public to share among others who are eligible.
Phase 2 (a): Programme Development and Feasibility Study
Study design \& procedure:
- A group of experts consisting of public health experts in health education, health psychology, and other health-care providers (communicable disease background) will hold online meetings (Focus Group Discussions) to develop the modules for the Programme based on literature review, best practices in the field and in consultation with public health experts and other ministerial departments.
- For a focus group discussion (FGD) to be effective, the number of participants shall between 6-8 per group (Krueger \& Casey, 2002). The researcher will target 8 per group and organize up to 5 groups and/or when the researcher reach data saturation points.
- The FGDs will aim to build the content and activities of the Programme. The core members of this research team will finalise the Programme structure, before holding a second online meeting with the experts involved to confirm its validity. This Programme will continue to be refined throughout the study based on the feasibility study results.
Phase 2 (b): Cluster Randomised Controlled Trial (RCT).
Study design \& procedure:
- To evaluate the effectiveness of the Programme, a cluster randomised controlled trial with three assessment points (Baseline, immediate after intervention and 3-month follow-up) will be conducted with the materials and outcome measures listed.
- This will be a study based on pre/post multiple time series study design.
- Students from the School of Medical \& Life Sciences, Sunway University, Faculty of Social Sciences, Quest University International, Ipoh and Centre of Community Health Studies, UKM will be engaged in the design and development of the approved content. By doing so, students from various universities would have a chance to apply what they have learned in the classrooms into the real life.
- Materials will be in the form of pamphlet, webinar content and SMS and in Bahasa Malaysia.
Sample size calculation:
- Non-inferiority designed will be used to show that the new treatment is as effective but need not superior when compared to the standard treatment (Zhong, 2009).
- For non-inferiority design, the formula is:
- Based on the recent published results, non-response rate of standard vaccine rate is reported to be 7% (Khubchandani et al., 2021). Thus, sample size required would be:
- N= 2 x [(1.645+0.845)/0.1]2 x 0.07 x (1-0.07)
- N= 80.7 (approximately 81 participants)
- Assuming a dropout rate of 20%, the researcher will recruit at least 100 participants in each category for each education material used, making a total of 300 for each site (Figure 1).
Study site and participants
- The cluster randomised controlled trial with three parallel arms (i.e., 3 intervention groups ) will be performed in both West and East Coast Malaysia. One major health facility/university will be selected and approached.
- Recruitment materials designed will be shared and distributed both online and offline to the health facilities, schools, churches, mosques, temples, NGOs, recreation malls and societies.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pamphlet | Experimental | Behavioral: Reducing Vaccine Hesitancy (VH) And Vaccine Refusal (VR): An Educational Intervention ProgrammeParticipants will received pamphlet about COVID-19 vaccination |
| Webinar | Experimental | Behavioral: Reducing Vaccine Hesitancy (VH) And Vaccine Refusal (VR): An Educational Intervention ProgrammeParticipants will received webinar about COVID-19 vaccination |
| SMS | Experimental | Behavioral: Reducing Vaccine Hesitancy (VH) And Vaccine Refusal (VR): An Educational Intervention ProgrammeParticipants will received SMS about COVID-19 vaccination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals aged 18 years and above
- Able to provide informed consent (verbal/written) to participate
- Understand either Bahasa Malaysia
- Participants who have not received their COVID-19 vaccination
- Participants who have access to smart phone and/or mobile phone
Key exclusion criteria (1 listed)
- Those who have had any prior history of psychological or neurological illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reducing Vaccine Hesitancy (VH) And Vaccine Refusal (VR): An Educational Intervention ProgrammeParticipants will be receiving the pamphlet about the COVID-19 vaccination information during the intervention. They will received 3 different sets of questionnaire to measured their level of vaccine hesitancy and vaccine refusal in 3 different time points: (a) before intervention, (b) after the intervention, and (c) 3 months after the intervention. Data cleansing will be conducted based on the per-protocol analysis. Pre-protocol is a comparison of treatment groups that includes only those patients who completed the treatment originally allocated. | Behavioural | Pamphlet |
| Reducing Vaccine Hesitancy (VH) And Vaccine Refusal (VR): An Educational Intervention ProgrammeParticipants will be receiving the webinar last for half an hour about the COVID-19 vaccination information during the intervention. They will received 3 different sets of questionnaire to measured their level of vaccine hesitancy and vaccine refusal in 3 different time points: (a) before intervention, (b) after the intervention, and (c) 3 months after the intervention. Data cleansing will be conducted based on the per-protocol analysis. Pre-protocol is a comparison of treatment groups that includes only those patients who completed the treatment originally allocated. | Behavioural | Webinar |
| Reducing Vaccine Hesitancy (VH) And Vaccine Refusal (VR): An Educational Intervention ProgrammeParticipants will be receiving the SMS about the COVID-19 vaccination information during the intervention. They will received 3 different sets of questionnaire to measured their level of vaccine hesitancy and vaccine refusal in 3 different time points: (a) before intervention, (b) after the intervention, and (c) 3 months after the intervention. Data cleansing will be conducted based on the per-protocol analysis. Pre-protocol is a comparison of treatment groups that includes only those patients who completed the treatment originally allocated. | Behavioural | SMS |
Primary outcome
Reducing Vaccine Hesitancy
Time frame: 17 months
The vaccine hesitancy scale
1 secondary outcome
Reducing Vaccine Hesitancy
Time frame: 17 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reducing Vaccine Hesitancy (VH) And Vaccine Refusal (VR): An Educational Intervention Programme in people with COVID-19 Vaccination, run by Sunway University at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pei Boon Ooi, Doctorate (03-74918622, peiboono@sunway.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reducing Vaccine Hesitancy (time frame: 17 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021; AzTrials last refreshed its copy on 6 Nov 2026.