Vaccine HesitancyNCT06297876
COVIDVaxStories: Randomized Trial to Reduce COVID-19 Vaccine Hesitancy in Populations of Color
A study testing Storytelling and Learn More (Active Comparator) in people with Vaccine Hesitancy, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
Pilot randomized controlled trial testing the investigator's previously developed storytelling method to create an interactive, multi-media storytelling intervention to address community-identified reasons for vaccine hesitancy among Black and Hispanic individuals in Central Massachusetts Read more about this study
- Who is it for?
- Ages 18 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccine Hesitancy
- What is being tested?
- Storytelling and Learn More (Active Comparator)
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2023to 9 Aug 2024
- 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 to 105 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >= 18 years of age
- identifies as Black and/or Hispanic
- lives in Massachusetts
- vaccinated for COVID-19.
Who cannot join
- Unable to provide consent in English or Spanish
- Has not completed the primary series of COVID-19 vaccinations (2 shots for Moderna or Pfizer, one shot for Johnson \& Johnson).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01605
About this study
Official title: COVIDVaxStories: A Pilot Double-blind Randomized, Parallel Design Trial of Storytelling to Reduce COVID-19 Vaccine Hesitation in Populations of Color Using a Respondent-driven Sampling Design
Pilot randomized controlled trial testing the investigator's previously developed storytelling method to create an interactive, multi-media storytelling intervention to address community-identified reasons for vaccine hesitancy among Black and Hispanic individuals in Central Massachusetts
Read the detailed description
Intervention Development The investigators will recruit 64-80 Black and Hispanic community members for storytelling development groups (described below) through our already established COVID community advisory board (C-CAB). The C-CAB represents ten community organizations throughout the Greater Worcester area including churches and community centers. Further information on procedures for intervention development can be found in the "study procedures" section.
Pilot Randomized Controlled Trial (RCT) The investigators will conduct a pilot feasibility randomized controlled trial. The investigators will enroll approximately 50 Black persons who identify as Black and/or Hispanic in Central Massachusetts. The investigators will use a Respondent-Driven Sampling (RDS) Design, a quantitative form of the "snowballing" approach that has been proven effective in under-represented groups19-22 to pilot our recruitment strategy. In RDS a preset number of "seeds" are selected with the assistance of community partners. The seeds are community members with large social networks. Each seed recruits a preset number of participants utilizing their social networks and this process continues in waves until the predetermined sample size is met. Each seed is linked to their recruits to enable social network analysis.
Study procedures from consent to intervention will be delivered through Qualtrics, an online service that allows researchers to design and deliver online research instruments with minimal time and effort, and without extensive programming experience (Qualtrics.com). A short screening survey, e-informed-consent form, surveys, and videos (both English and Spanish versions) will be uploaded into Qualtrics. Qualtrics is available on both mobile devices and desktops,14 through mobile app or internet. The University of Massachusetts Chan Medical School (UMMS) has a university license to use Qualtrics, which provide robust data safety and privacy and is approved by our Institutional Review Board (IRB). The investigators will utilize the Quantitative Methods Core (QMC), a service core that has been formed under the auspices of the Division of Biostatistics and Health Services Research within the Department of Population and Health Sciences as well as our current research coordinator who have partnered to create a Qualtrics interface that delivers pre-intervention surveys, randomization, intervention delivery, and post intervention surveys, for our completed Enhancing racial and ethnic diversity in COVID-19 research participation through storytelling (COVIDstory)study. Qualtrics has also previously been used for the aforementioned features for an intervention aimed at increasing uptake of the Human Papillomavirus (HPV) vaccine among young Asian women.14 The investigators will build on this infrastructure to tailor the randomization, surveys, and intervention delivery for this intervention in this population.
Participants will be randomly assigned to either the storytelling arm or the comparison arm through a randomization algorithm embedded within Qualtrics. A stratified approach will be used, with equal enrollment by racial/ethnic category: Black or Hispanic. Each person recruited will be directed to Qualtrics which will be set to proceed in a systematic and sequential manner until the full sample size of 25 participants in the intervention group and 25 participants in the comparison group, stratified by race/ethnicity, are attained. Study subjects and investigators will be blinded as to group assignment. As with our current NCI funded project, all participant-facing aspects of Qualtrics (screening, consent, randomization, surveys, intervention videos) will be available in both English and Spanish. .
- Conditions
- Vaccine Hesitancy
- Being tested
- Storytelling, Learn More (Active Comparator)
- Medical subject headings
- Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StorytellingBehavioural
Also called Narrative
Narrative stories will be videos that are 2-3 minutes long and will show community members speaking based on community identified themes.
Learn More (Active Comparator)Behavioural
Informational videos that are of similar length and on the same topic as the storytelling videos.
| Study group | Role | What they receive |
|---|---|---|
| Storytelling | Experimental | Participants will view short video narratives of community members speaking about why they chose to get vaccinated against Coronavirus Disease of 2019 (COVID-19) and how they overcame hesitancy. Participants will also view the informational videos described below. Receives: Behavioral: Storytelling |
| Learn More | Other | Participants will view short informational videos that provide factual information on the COVID-19 vaccines. Receives: Behavioral: Learn More (Active Comparator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vaccine Hesitancy
Validated vaccine hesitancy questionnaire
Measured: From beginning of survey to end of survey typically, 30 minutes
Secondary outcomes (1)
Vaccine Uptake
Percent in each study arm whose vaccination status changed post intervention by querying the participant. The investigators will also pilot test their willingness to provide the investigators with proof of vaccination (e.g., documentation from vaccinating entity or excerpt from electronic health record, if a change is reported
Measured: 6 months after participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start19 May 2023
- Primary completion9 Aug 2024
- Study completion9 Aug 2024
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.
- More trials run by University of Massachusetts, WorcesterThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Jeroan Allison, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297876
- Sponsor's protocol ID
- H00023815
- Status last verified
- Dec 2024
- First submitted
- 1 May 2023
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- 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 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVIDVaxStories: A Pilot Double-blind Randomized, Parallel Design Trial of Storytelling to Reduce COVID-19 Vaccine Hesitation in Populations of Color Using a Respondent-driven Sampling Design
- ClinicalTrials.gov ID
- NCT06297876
- Acronym / sponsor ID
- H00023815
- Conditions
- Vaccine Hesitancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 19 May 2023 (actual)
- Primary completion
- 9 Aug 2024 (actual)
- Study completion
- 9 Aug 2024 (actual)
- First posted
- 7 Mar 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.
Pilot randomized controlled trial testing the investigator's previously developed storytelling method to create an interactive, multi-media storytelling intervention to address community-identified reasons for vaccine hesitancy among Black and Hispanic individuals in Central Massachusetts
Detailed description
Intervention Development The investigators will recruit 64-80 Black and Hispanic community members for storytelling development groups (described below) through our already established COVID community advisory board (C-CAB). The C-CAB represents ten community organizations throughout the Greater Worcester area including churches and community centers. Further information on procedures for intervention development can be found in the "study procedures" section.
Pilot Randomized Controlled Trial (RCT) The investigators will conduct a pilot feasibility randomized controlled trial. The investigators will enroll approximately 50 Black persons who identify as Black and/or Hispanic in Central Massachusetts. The investigators will use a Respondent-Driven Sampling (RDS) Design, a quantitative form of the "snowballing" approach that has been proven effective in under-represented groups19-22 to pilot our recruitment strategy. In RDS a preset number of "seeds" are selected with the assistance of community partners. The seeds are community members with large social networks. Each seed recruits a preset number of participants utilizing their social networks and this process continues in waves until the predetermined sample size is met. Each seed is linked to their recruits to enable social network analysis.
Study procedures from consent to intervention will be delivered through Qualtrics, an online service that allows researchers to design and deliver online research instruments with minimal time and effort, and without extensive programming experience (Qualtrics.com). A short screening survey, e-informed-consent form, surveys, and videos (both English and Spanish versions) will be uploaded into Qualtrics. Qualtrics is available on both mobile devices and desktops,14 through mobile app or internet. The University of Massachusetts Chan Medical School (UMMS) has a university license to use Qualtrics, which provide robust data safety and privacy and is approved by our Institutional Review Board (IRB). The investigators will utilize the Quantitative Methods Core (QMC), a service core that has been formed under the auspices of the Division of Biostatistics and Health Services Research within the Department of Population and Health Sciences as well as our current research coordinator who have partnered to create a Qualtrics interface that delivers pre-intervention surveys, randomization, intervention delivery, and post intervention surveys, for our completed Enhancing racial and ethnic diversity in COVID-19 research participation through storytelling (COVIDstory)study. Qualtrics has also previously been used for the aforementioned features for an intervention aimed at increasing uptake of the Human Papillomavirus (HPV) vaccine among young Asian women.14 The investigators will build on this infrastructure to tailor the randomization, surveys, and intervention delivery for this intervention in this population.
Participants will be randomly assigned to either the storytelling arm or the comparison arm through a randomization algorithm embedded within Qualtrics. A stratified approach will be used, with equal enrollment by racial/ethnic category: Black or Hispanic. Each person recruited will be directed to Qualtrics which will be set to proceed in a systematic and sequential manner until the full sample size of 25 participants in the intervention group and 25 participants in the comparison group, stratified by race/ethnicity, are attained. Study subjects and investigators will be blinded as to group assignment. As with our current NCI funded project, all participant-facing aspects of Qualtrics (screening, consent, randomization, surveys, intervention videos) will be available in both English and Spanish. .
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Storytelling | Experimental | Behavioral: StorytellingParticipants will view short video narratives of community members speaking about why they chose to get vaccinated against Coronavirus Disease of 2019 (COVID-19) and how they overcame hesitancy. Participants will also view the informational videos described below. |
| Learn More | Other | Behavioral: Learn More (Active Comparator)Participants will view short informational videos that provide factual information on the COVID-19 vaccines. |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >= 18 years of age
- identifies as Black and/or Hispanic
- lives in Massachusetts
- vaccinated for COVID-19.
Key exclusion criteria (2 listed)
- Unable to provide consent in English or Spanish
- Has not completed the primary series of COVID-19 vaccinations (2 shots for Moderna or Pfizer, one shot for Johnson \& Johnson).
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 |
|---|---|---|
| StorytellingAlso: NarrativeNarrative stories will be videos that are 2-3 minutes long and will show community members speaking based on community identified themes. | Behavioural | Storytelling |
| Learn More (Active Comparator)Informational videos that are of similar length and on the same topic as the storytelling videos. | Behavioural | Learn More |
Primary outcome
Change in Vaccine Hesitancy
Time frame: From beginning of survey to end of survey typically, 30 minutes
Validated vaccine hesitancy questionnaire
1 secondary outcome
Vaccine Uptake
Time frame: 6 months after participation
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 4 Dec 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Storytelling and Learn More (Active Comparator) in people with Vaccine Hesitancy, run by University of Massachusetts, Worcester 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 4 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: finished, as of the sponsor's last update on 4 Dec 2024. 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?
Change in Vaccine Hesitancy (time frame: From beginning of survey to end of survey typically, 30 minutes). 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 4 Dec 2024.