Vaccine AcceptanceNCT05875779
Peer Education as a Strategy to Promote Vaccine Acceptance
A study testing Peer-led vaccine education intervention in people with Vaccine Acceptance, run by NYU Langone Health at 1 site in United States.
Trial summary
Effective interventions to improve uptake of vaccines among hesitant groups are urgently needed. Peer education is an effective intervention in modifying health behaviors in other conditions and may be effective in promoting vaccine confidence but has not been studied. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Vaccine Acceptance
- What is being tested?
- Peer-led vaccine education intervention
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2022to 1 Aug 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- A parent of a child aged 0 to 18 months born at ≥35 weeks' gestation who is eligible for a dose of PCV-13. Eligibility by age defined as follows:
- Age 0-6 months: never received first dose or is >8 weeks from last dose (3 doses scheduled in this age group at 2, 4, and 6 months)
- Age 7-11 months: never received first dose or is > 8 weeks from last dose (2 doses scheduled in this age group if started at 7 months)
- 12-18 months: never received first dose, is >8 weeks from last dose (2 doses scheduled in this age group if started at 12 months) or is due for booster at 12-18 months having received primary series between age 2-11 months.
- Self-identifies as Orthodox Jewish.
- Is able to provide informed consent.
Who cannot join
- Unable to communicate verbally in English or Yiddish
- Unwilling or unable to utilize a Yiddish in-person or telephone interpreter
- Has already participated in this study as an eligible adult or parent. A parent will only be able to participate in this study once (i.e. for only one child in the family that is eligible)
- Has an appointment at clinic that day to specifically receive vaccines.
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Grossman School of Medicine, Division of Infectious Diseases
New York, New York, 10016
About this study
Official title: Developing Vaccine Educators Within Practices of Community Healthcare Providers: a Pragmatic, Randomized Controlled Trial of Peer Education to Promote Vaccine Acceptance
Effective interventions to improve uptake of vaccines among hesitant groups are urgently needed. Peer education is an effective intervention in modifying health behaviors in other conditions and may be effective in promoting vaccine confidence but has not been studied. To fill this knowledge gap, we will enroll approximately 152 parents of children age 0-18 months who are eligible for pneumococcal conjugate (PCV-13) vaccine and randomize them 1:1 to a peer-led vaccine education intervention or usual care.
- Conditions
- Vaccine Acceptance
- Being tested
- Peer-led vaccine education intervention
- Keywords
- Vaccine confidence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-led vaccine education interventionBehavioural
The intervention will be delivered face-to-face by a trained peer-educator and will consist of one session of 10-20 minutes.
Peer vaccine educators will receive written vaccine materials for distribution. These materials will present content that accurately represents the risks and benefits of vaccination.
Responsibilities of the vaccine educators will be to: provide motivational interviewing with patients, provide vaccine counseling, address questions and concerns regarding available vaccines, brief clinical provider on hesitant patients and areas of their vaccine-related concerns, and provide follow-up with participants at day 30, day 60 and day 90 for additional engagement.
| Study group | Role | What they receive |
|---|---|---|
| Peer-led vaccine education intervention | Experimental | Parents randomized to peer-led vaccine education intervention. Receives: Behavioral: Peer-led vaccine education intervention |
| Usual Care | No intervention | Parents randomized to usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Ages 0 Months to 18 Months at Enrollment who Receive at least One Dose of PCV-13 Vaccine by 3 Months Post-Enrollment
Outcome will be determined via review of patient medical chart.
Measured: Month 3 Post-Enrollment
Secondary outcomes (2)
Number of Participants Ages 1 Month to 18 Months at Enrollment who Receive at least One Dose of PCV-13 Vaccine by 1 Month Post-Enrollment
Outcome will be determined via review of patient medical chart.
Measured: Month 1 Post-Enrollment
Percentage of Days Under-immunized at 3 Months among Participants Ages 0 Months to 18 Months at Enrollment
To obtain the percentage of days underimmunized, investigators will sum the days late across all 4 doses of PCV-13 doses and will divide this by the maximum cumulative number of days a child could be late if they had received no vaccine doses by their age one month post study enrollment. If a dose was never received, the maximum number of days late a child could be for dose will be: age at enrollment in days+31 days minus the latest age in days in which that dose should have been received.
Measured: Month 1 Post-Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start6 Mar 2022
- Primary completion27 May 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaccine AcceptanceStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellie Carmody, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875779
- Sponsor's protocol ID
- 21-01526
- Status last verified
- Aug 2023
- First submitted
- 16 May 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Ellie Carmody, MD, ellie.carmody@nyulangone.org.
Publications
Hoffman E, Kahan T, Auerbach E, Brody H, Abramson NN, Haiken S, Shields D, Elyasi A, Ifrah S, Frenkel-Schick A, Zyskind I, Knoll M, Carmody E. Peer education as a strategy to promote vaccine acceptance: A randomized controlled trial within New York community healthcare practices. Vaccine. 2024 Nov 14;42 Suppl 5:126028. doi: 10.1016/j.vaccine.2024.05.076. Epub 2024 Jun 10.
PubMed 38862308
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Vaccine Educators Within Practices of Community Healthcare Providers: a Pragmatic, Randomized Controlled Trial of Peer Education to Promote Vaccine Acceptance
- ClinicalTrials.gov ID
- NCT05875779
- Acronym / sponsor ID
- 21-01526
- Conditions
- Vaccine Acceptance
- Keywords
- Vaccine confidence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 6 Mar 2022 (actual)
- Primary completion
- 27 May 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 25 May 2023 (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.
Effective interventions to improve uptake of vaccines among hesitant groups are urgently needed. Peer education is an effective intervention in modifying health behaviors in other conditions and may be effective in promoting vaccine confidence but has not been studied. To fill this knowledge gap, we will enroll approximately 152 parents of children age 0-18 months who are eligible for pneumococcal conjugate (PCV-13) vaccine and randomize them 1:1 to a peer-led vaccine education intervention or usual care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer-led vaccine education intervention | Experimental | Behavioral: Peer-led vaccine education interventionParents randomized to peer-led vaccine education intervention. |
| Usual Care | No intervention | –Parents randomized to usual care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- A parent of a child aged 0 to 18 months born at ≥35 weeks' gestation who is eligible for a dose of PCV-13. Eligibility by age defined as follows:
- Self-identifies as Orthodox Jewish.
- Is able to provide informed consent.
Key exclusion criteria (4 listed)
- Unable to communicate verbally in English or Yiddish
- Unwilling or unable to utilize a Yiddish in-person or telephone interpreter
- Has already participated in this study as an eligible adult or parent. A parent will only be able to participate in this study once (i.e. for only one child in the family that is eligible)
- Has an appointment at clinic that day to specifically receive vaccines.
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 |
|---|---|---|
| Peer-led vaccine education interventionThe intervention will be delivered face-to-face by a trained peer-educator and will consist of one session of 10-20 minutes. Peer vaccine educators will receive written vaccine materials for distribution. These materials will present content that accurately represents the risks and benefits of vaccination. Responsibilities of the vaccine educators will be to: provide motivational interviewing with patients, provide vaccine counseling, address questions and concerns regarding available vaccines, brief clinical provider on hesitant patients and areas of their vaccine-related concerns, and provide follow-up with participants at day 30, day 60 and day 90 for additional engagement. | Behavioural | Peer-led vaccine education intervention |
Primary outcome
Number of Participants Ages 0 Months to 18 Months at Enrollment who Receive at least One Dose of PCV-13 Vaccine by 3 Months Post-Enrollment
Time frame: Month 3 Post-Enrollment
Outcome will be determined via review of patient medical chart.
2 secondary outcomes
Number of Participants Ages 1 Month to 18 Months at Enrollment who Receive at least One Dose of PCV-13 Vaccine by 1 Month Post-Enrollment
Time frame: Month 1 Post-Enrollment
Percentage of Days Under-immunized at 3 Months among Participants Ages 0 Months to 18 Months at Enrollment
Time frame: Month 1 Post-Enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Derived from this study: PubMed 38862308Hoffman E, Kahan T, Auerbach E, Brody H, Abramson NN, Haiken S, Shields D, Elyasi A, Ifrah S, Frenkel-Schick A, Zyskind I, Knoll M, Carmody E. Peer education as a strategy to promote vaccine acceptance: A randomized controlled trial within New York community healthcare practices. Vaccine. 2024 Nov 14;42 Suppl 5:126028. doi: 10.1016/j.vaccine.2024.05.076. Epub 2024 Jun 10.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Ellie Carmody, MD, ellie.carmody@nyulangone.org.
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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.
Ellie Carmody, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer-led vaccine education intervention in people with Vaccine Acceptance, run by NYU Langone Health at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 7 Aug 2023. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants Ages 0 Months to 18 Months at Enrollment who Receive at least One Dose of PCV-13 Vaccine by 3 Months Post-Enrollment (time frame: Month 3 Post-Enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05875779, which also lists 1 linked publication.
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 7 Aug 2023.