Vaccine HesitancyNCT06675721
A Survey of Acceptance and Factors Associated With Hesitancy Vaccination in Northeast Brazil
An observational study of Vaccine Hesitancy and Vaccine Refusal, run by Centro De Estudos E Pesquisas Em Molestias Infecciosas.
Trial summary
The objective of this study is to investigate vaccination acceptance and identify the reasons why people are not vaccinated. People over 18 years of age who live in neighborhoods with socioeconomic vulnerability and with many cases of infectious diseases, as well as health professionals, will respond to a research… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccine Hesitancy, Vaccine Refusal
- What is being tested?
- Study Questionnaire
- Type of treatment
- Vaccines
- How many people
- 2,500 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Vulnerable populations residing in neighborhoods characterized by socioeconomic vulnerability and high infectious disease incidence. Four neighborhoods in Natal will be the focus, each with their respective population: Lagoa Azul (61,289), Pajuçara (58,021), Felipe Camarão (50,997), and Planalto (31,206). In this project, the inclusion of health professionals as a unified group is essential because of their critical role as trusted source of health information. In Natal, these professionals consist of 5,238 physicians and an estimated 7,066 nurses (derived from a 61.6% prevalence applied to the 11,471 registered nurses in Rio Grande do Norte).
Who may be able to join
- Individuals who are over 18 years old and are residents of the PAJUÇARA, FELIPE CAMARÃO, LAGOA AZUL, or PLANALTO neighborhoods, willing to answer the study questionnaire.
- Healthcare professionals who work in Natal, willing to answer the study questionnaire.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Survey of Acceptance and Factors Associated With Hesitancy Vaccination in a Socioeconomically Disadvantaged Population and Professionals Working in a City Located in Northeast Brazil
The objective of this study is to investigate vaccination acceptance and identify the reasons why people are not vaccinated.
People over 18 years of age who live in neighborhoods with socioeconomic vulnerability and with many cases of infectious diseases, as well as health professionals, will respond to a research questionnaire.
- Conditions
- Vaccine Hesitancy, Vaccine Refusal
- Being tested
- Study Questionnaire
- Medical subject headings
- Vaccination Hesitancy, Vaccination Refusal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study QuestionnaireOther
A survey questionnaire to assess factors related to vaccination adherence, including factors such as vaccine novelty, cost, and prior knowledge among vulnerable populations.
| Study group | Role | What they receive |
|---|---|---|
| Vulnerable group | Individuals who are over 18 years old and are residents of the socioeconomically vulnerable neighborhoods. Receives: Other: Study Questionnaire | |
| Health Professionals | Healthcare professionals who work in Natal. Receives: Other: Study Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resistance to adherence to vaccination
Resistance to adherence to vaccination will be measured using a questionnaire developed for this survey. The questionnaire will be described by mean and standard deviation, and the distribution frequency of each item will be presented, comparing cohorts of health professionals and populations in socioeconomic vulnerability.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study startDec 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine HesitancyStudies 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
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro De Estudos E Pesquisas Em Molestias Infecciosas
- Sponsor type
- University, hospital or other
- Collaborators
- MSD Pharmaceuticals LLC
- Responsible party
- Sponsor
- Investigators
- Kleber G Luz, PhD, Principal investigator, Centro De Estudos E Pesquisas Em Molestias Infecciosas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675721
- Sponsor's protocol ID
- EII1001HEVANO
- Status last verified
- Nov 2024
- First submitted
- 19 Aug 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Survey of Acceptance and Factors Associated With Hesitancy Vaccination in a Socioeconomically Disadvantaged Population and Professionals Working in a City Located in Northeast Brazil
- ClinicalTrials.gov ID
- NCT06675721
- Acronym / sponsor ID
- EII1001HEVANO
- Conditions
- Vaccine Hesitancy, Vaccine Refusal
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Centro De Estudos E Pesquisas Em Molestias InfecciosasUniversity, hospital or other
- Collaborators
- MSD Pharmaceuticals LLC
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 Nov 2024 (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 objective of this study is to investigate vaccination acceptance and identify the reasons why people are not vaccinated.
People over 18 years of age who live in neighborhoods with socioeconomic vulnerability and with many cases of infectious diseases, as well as health professionals, will respond to a research questionnaire.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vulnerable group | – | Other: Study QuestionnaireIndividuals who are over 18 years old and are residents of the socioeconomically vulnerable neighborhoods. |
| Health Professionals | – | Other: Study QuestionnaireHealthcare professionals who work in Natal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Vulnerable populations residing in neighborhoods characterized by socioeconomic vulnerability and high infectious disease incidence. Four neighborhoods in Natal will be the focus, each with their respective population: Lagoa Azul (61,289), Pajuçara (58,021), Felipe Camarão (50,997), and Planalto (31,206). In this project, the inclusion of health professionals as a unified group is essential because of their critical role as trusted source of health information. In Natal, these professionals consist of 5,238 physicians and an estimated 7,066 nurses (derived from a 61.6% prevalence applied to the 11,471 registered nurses in Rio Grande do Norte).
Key inclusion criteria (2 listed)
- Individuals who are over 18 years old and are residents of the PAJUÇARA, FELIPE CAMARÃO, LAGOA AZUL, or PLANALTO neighborhoods, willing to answer the study questionnaire.
- Healthcare professionals who work in Natal, willing to answer the study questionnaire.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Study QuestionnaireA survey questionnaire to assess factors related to vaccination adherence, including factors such as vaccine novelty, cost, and prior knowledge among vulnerable populations. | Other | Health Professionals, Vulnerable group |
Primary outcome
Resistance to adherence to vaccination
Time frame: Baseline
Resistance to adherence to vaccination will be measured using a questionnaire developed for this survey. The questionnaire will be described by mean and standard deviation, and the distribution frequency of each item will be presented, comparing cohorts of health professionals and populations in socioeconomic vulnerability.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- 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.
Kleber G Luz, PhD principal investigator
Centro De Estudos E Pesquisas Em Molestias Infecciosas
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccine Hesitancy and Vaccine Refusal, run by Centro De Estudos E Pesquisas Em Molestias Infecciosas.
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 0 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: opening soon, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kleber G Luz, PhD (+55 84 999824374, klebergluz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resistance to adherence to vaccination (time frame: Baseline). 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 5 Nov 2024.