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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Pei Boon Ooi, Doctorate contact

03-74918622

peiboono@sunway.edu.my

Malaysia1 site
  • Sunway University

    Petaling Jaya, Selangor, 47500

    Pei Boon Ooi, Doctorate, 374918622, researchethics@sunway.edu.my

Other trials in Malaysia

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

  1. Examine the association among vaccination intention, attitudinal belief, subjective norms, perceived behavioral control, vaccine hesitancy and its reasons among the Malaysian population.
  2. Develop an educational intervention Programme on COVID-19 vaccination to increase knowledge, positive attitudes, and acceptance toward COVID-19 vaccination
  3. Assess the effectiveness of the educational intervention programme

Research Hypothesis

The hypotheses are:

  1. 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.
  2. 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
  3. 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:

  1. This cross-sectional study will utilize both online and paper questionnaire.
  2. 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.
  3. 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.
  4. 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

  1. 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.
  2. 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:

  1. 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.
  2. 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.
  3. 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:

  1. 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.
  2. This will be a study based on pre/post multiple time series study design.
  3. 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.
  4. Materials will be in the form of pamphlet, webinar content and SMS and in Bahasa Malaysia.

Sample size calculation:

  1. 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).
  2. For non-inferiority design, the formula is:
  3. 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)
  1. 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

  1. 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.
  2. 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.
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 groups in NCT04930185
Study groupRoleWhat they receive
PamphletExperimentalParticipants will received pamphlet about COVID-19 vaccination
Receives: Behavioral: Reducing Vaccine Hesitancy (VH) And Vaccine Refusal (VR): An Educational Intervention Programme
WebinarExperimentalParticipants will received webinar about COVID-19 vaccination
Receives: Behavioral: Reducing Vaccine Hesitancy (VH) And Vaccine Refusal (VR): An Educational Intervention Programme
SMSExperimentalParticipants 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.

  1. Reducing Vaccine Hesitancy

    The vaccine hesitancy scale

    Measured: 17 months

Secondary outcomes (1)
  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.

  1. First posted18 Jun 2021
  2. Study start1 Sep 2021 (estimated)
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Jan 2023 (estimated)

Resources

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)
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

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.

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