COVID-19 Respiratory InfectionNCT05009043
COVID-19 Vaccine Hesitancy and Dental Faculty Staff Members in Egypt
An observational study of COVID-19 Respiratory Infection and Covid19, run by Mariam Ayman Amin Sharaf at 1 site in Egypt.
Trial summary
Healthcare workers (HCWs) play a vital role in determining the success of vaccination programs. Patient acceptance and vaccination rely greatly on the utilization and attitude of HCWs towards the vaccine, their attitude also influences patients' adherence to vaccination schedules and their hesitancy. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Respiratory Infection, Covid19, Vaccine Refusal
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2021to 30 Dec 2021
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Staff members of Faculty of Dentistry, Ain Shams University
Who may be able to join
- Staff members at Faculty of Dentistry, Ain Shams University
- Egyptians.
Who cannot join
- Staff members who refuse to participate in the study.
- Staff members currently living abroad. (As their perception about COVID-19 situation and risk in Egypt will not be accurate)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID-19 Vaccine Hesitancy and Perceptions Among Teaching and Assisting Staff at Faculty of Dentistry, Ain Shams University in Egypt: A Cross-Sectional Study.
Healthcare workers (HCWs) play a vital role in determining the success of vaccination programs. Patient acceptance and vaccination rely greatly on the utilization and attitude of HCWs towards the vaccine, their attitude also influences patients' adherence to vaccination schedules and their hesitancy. HCWs themselves can be hesitant about a certain vaccine and thus can transfer their negative attitudes to their patients, increasing vaccine hesitancy among the general population. Frontline HCWs are at an increased risk of exposure to COVID-19 due to their direct contact with their patients, working hours, psychological stress and job burnout, they also face stigma. Dental health professionals in particular are at an increased risk due to their occupational hazards that include continuous exposure to body fluids and aerosols, this increases their risk of contracting COVID-19. Therefore vaccinating healthcare workers will be beneficial, not only for themselves, but also for their households and patients.
Read the detailed description
To mitigate the rapid spread of COVID-19 and its massive impact on the economy worldwide, efforts have to be made to protect people against the disease, one of the most effective means was found to be vaccination. The range of technology in the development of COVID-19 vaccine is a striking feature where various approaches are being evaluated including, but not limited to: nucleic acid (DNA and RNA), recombinant protein, live-attenuated virus, inactivated virus and virus-like particles approaches. It is the responsibility of governments to ensure equity in the distribution and access to the novel vaccine. Authorized and currently available vaccines in Egypt include: 1) COVID-19 Vaccine AstraZeneca (AZD1222) which is an adenovirus vaccine manufactured in UK, 2) Sputnik V, a recombinant adenovirus vaccine manufactured in Russia and 3) BBIBP-CorV Sinopharm, which is an inactivated vaccine manufactured in China. The total number of vaccine doses administered in Egypt was reported to be 1,315 doses in March 2021.
However, vaccine availability is not enough to ensure large-scale immunization; success of vaccination programs depend greatly on the population's demand and acceptability of the vaccine. Governments should strive to understand determinants of vaccine acceptability and perception of people towards the vaccine. Although vaccination has largely contributed to decreasing the global burden of diseases and mortality, various factors can affect the acceptance of a new vaccine. "Vaccine hesitancy" has been declared by WHO as one of the ten global health threats worldwide, and has been defined as 'delay in acceptance or refusal of vaccination despite availability of vaccination services.' Causes of vaccine hesitancy include concerns about its safety, efficacy, personal beliefs, religious reasons, concerns about its rapid development as the rapid development of swine flu vaccine was previously associated with increased risk of Guillain-Barre syndrome, low benefits perceived and fear of side effects. Moreover, some people have concerns about the manufacturing process of the vaccine, as a defective polio vaccine lead to development of incident cases of polio and paralysis and death in earlier times.
In Egypt, healthcare workers are the first group to have access to COVID-19 vaccine and hence, act as a primary source of knowledge to the public about the vaccine, therefore it is crucial to estimate their level of perception and acceptability of the vaccine and determine factors affecting their acceptability. This will help inform stakeholders to make decisions regarding COVID-19 vaccination programs. To the best of our knowledge, this is the first study in Egypt targeting dental health professionals in particular, owing to their exclusive high exposure level to COVID-19 among healthcare workers
- Conditions
- COVID-19 Respiratory Infection, Covid19, Vaccine Refusal
- Keywords
- COVID-19, Healthcare workers, Dentists, Frontline workers, Vaccine acceptance, Vaccine, Vaccine hesitancy
- Medical subject headings
- COVID-19, Vaccination Refusal, Vaccination Hesitancy
What is being measured
The primary outcome is the main question the study is designed to answer.
Staff members who accept/refuse vaccination against COVID-19
Percentage
Measured: August 2021-October 2021
Secondary outcomes (3)
Perceived barriers and enablers of staff members to get vaccinated against COVID-19
Measured: August 2021-December 2021
Factors associated with acceptance of COVID-19 vaccination among staff members.
Demographics, previous COVID-19 experience, knowledge and attitude
Measured: August 2021-December 2021
Risk perception of COVID-19 among staff members.
Measured: August 2021-December 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start15 Aug 2021
- Primary completion30 Oct 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Respiratory InfectionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mariam Ayman Amin Sharaf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mariam Ayman Amin Sharaf, Ain Shams University
- Investigators
- Mariam Sharaf, Msc, Principal investigator, Ain Shams UniversityAmira Badran, PhD, Study director, Ain Shams UniversityOmar Taqa, Msc, Principal investigator, Ain Shams UniversityHaneen Zahran, Msc, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009043
- Sponsor's protocol ID
- 960
- Status last verified
- Aug 2021
- First submitted
- 16 Aug 2021
- Last updated
- 17 Aug 2021
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Vaccine Hesitancy and Perceptions Among Teaching and Assisting Staff at Faculty of Dentistry, Ain Shams University in Egypt: A Cross-Sectional Study.
- ClinicalTrials.gov ID
- NCT05009043
- Acronym / sponsor ID
- 960
- Conditions
- COVID-19 Respiratory Infection, Covid19, Vaccine Refusal
- Keywords
- COVID-19, Healthcare workers, Dentists, Frontline workers, Vaccine acceptance, Vaccine, Vaccine hesitancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mariam Ayman Amin SharafUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 17 Aug 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.
Healthcare workers (HCWs) play a vital role in determining the success of vaccination programs. Patient acceptance and vaccination rely greatly on the utilization and attitude of HCWs towards the vaccine, their attitude also influences patients' adherence to vaccination schedules and their hesitancy. HCWs themselves can be hesitant about a certain vaccine and thus can transfer their negative attitudes to their patients, increasing vaccine hesitancy among the general population. Frontline HCWs are at an increased risk of exposure to COVID-19 due to their direct contact with their patients, working hours, psychological stress and job burnout, they also face stigma. Dental health professionals in particular are at an increased risk due to their occupational hazards that include continuous exposure to body fluids and aerosols, this increases their risk of contracting COVID-19. Therefore vaccinating healthcare workers will be beneficial, not only for themselves, but also for their households and patients.
Detailed description
To mitigate the rapid spread of COVID-19 and its massive impact on the economy worldwide, efforts have to be made to protect people against the disease, one of the most effective means was found to be vaccination. The range of technology in the development of COVID-19 vaccine is a striking feature where various approaches are being evaluated including, but not limited to: nucleic acid (DNA and RNA), recombinant protein, live-attenuated virus, inactivated virus and virus-like particles approaches. It is the responsibility of governments to ensure equity in the distribution and access to the novel vaccine. Authorized and currently available vaccines in Egypt include: 1) COVID-19 Vaccine AstraZeneca (AZD1222) which is an adenovirus vaccine manufactured in UK, 2) Sputnik V, a recombinant adenovirus vaccine manufactured in Russia and 3) BBIBP-CorV Sinopharm, which is an inactivated vaccine manufactured in China. The total number of vaccine doses administered in Egypt was reported to be 1,315 doses in March 2021.
However, vaccine availability is not enough to ensure large-scale immunization; success of vaccination programs depend greatly on the population's demand and acceptability of the vaccine. Governments should strive to understand determinants of vaccine acceptability and perception of people towards the vaccine. Although vaccination has largely contributed to decreasing the global burden of diseases and mortality, various factors can affect the acceptance of a new vaccine. "Vaccine hesitancy" has been declared by WHO as one of the ten global health threats worldwide, and has been defined as 'delay in acceptance or refusal of vaccination despite availability of vaccination services.' Causes of vaccine hesitancy include concerns about its safety, efficacy, personal beliefs, religious reasons, concerns about its rapid development as the rapid development of swine flu vaccine was previously associated with increased risk of Guillain-Barre syndrome, low benefits perceived and fear of side effects. Moreover, some people have concerns about the manufacturing process of the vaccine, as a defective polio vaccine lead to development of incident cases of polio and paralysis and death in earlier times.
In Egypt, healthcare workers are the first group to have access to COVID-19 vaccine and hence, act as a primary source of knowledge to the public about the vaccine, therefore it is crucial to estimate their level of perception and acceptability of the vaccine and determine factors affecting their acceptability. This will help inform stakeholders to make decisions regarding COVID-19 vaccination programs. To the best of our knowledge, this is the first study in Egypt targeting dental health professionals in particular, owing to their exclusive high exposure level to COVID-19 among healthcare workers
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Staff members of Faculty of Dentistry, Ain Shams University
Key inclusion criteria (2 listed)
- Staff members at Faculty of Dentistry, Ain Shams University
- Egyptians.
Key exclusion criteria (2 listed)
- Staff members who refuse to participate in the study.
- Staff members currently living abroad. (As their perception about COVID-19 situation and risk in Egypt will not be accurate)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Staff members who accept/refuse vaccination against COVID-19
Time frame: August 2021-October 2021
Percentage
3 secondary outcomes
Perceived barriers and enablers of staff members to get vaccinated against COVID-19
Time frame: August 2021-December 2021
Factors associated with acceptance of COVID-19 vaccination among staff members.
Time frame: August 2021-December 2021
Risk perception of COVID-19 among staff members.
Time frame: August 2021-December 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Mariam Sharaf, Msc principal investigator
Ain Shams University
Amira Badran, PhD study director
Ain Shams University
Omar Taqa, Msc principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Respiratory Infection and Covid19, run by Mariam Ayman Amin Sharaf at 1 site in Egypt.
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 2 inclusion and 2 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 17 Aug 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 Egypt. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Staff members who accept/refuse vaccination against COVID-19 (time frame: August 2021-October 2021). 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 17 Aug 2021.