Vaccination RefusalDIAMOND-RNCT05764174
Digital Applications to Monitor Novel Coronavirus Disease and Response in Colombia - Syndromic and Vaccination Surveillance
A study testing Factual messages, Narrative message and Mixed message in people with Vaccination Refusal and COVID-19, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
Brief Summary: The main objective of this activity is to assess the effectiveness of different messaging strategies (factual, narrative, mixed and a control) to promote COVID-19 adult vaccination. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccination Refusal, COVID-19
- What is being tested?
- Factual messages, Narrative message and Mixed message
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,409 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2022to 17 Dec 2022
- 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
- Willingness to participate in the trial
- Being older than 18
- Have not been fully vaccinated against COVID-19 (those who did not get any vaccine, did not get the complete vaccination scheme or did not get one booster if less than 50 or two boosters if older than 50).
Who cannot join
- Willingness to stop their participation in the trial
- Being younger than 18
- Have been fully vaccinated against COVID-19
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
About this study
Brief Summary: The main objective of this activity is to assess the effectiveness of different messaging strategies (factual, narrative, mixed and a control) to promote COVID-19 adult vaccination.
Read the detailed description
The investigators deploy mobile phone surveys using Interactive Voice Response (IVR) in a random sample of mobile phone numbers (random digit dialing or RDD) in Colombia.
Adult individuals who have not been fully vaccinated against COVID-19 (defined as those who 1) did not get any vaccine; 2) did not get the complete vaccination scheme 3) did not get one booster when less than 50 years old; 4) did not get two boosters when older than 50 years old), and who consent to be recontacted are invited to participate in the messaging trial. After consent, participants are randomized in three different treatment arms or one control arm. Participants in each treatment arm are presented with different messages to improve COVID-19 vaccination. Participants in the arm with factual messages listen to actual data and scientifical information on COVID-19 vaccination. Those in the narrative arm listen to messages appealing to emotions drawing on the COVID-19 vaccination experiences that were explored in a qualitative study conducted earlier. The mixed arm combines both factual and narrative messages. Finally, the control arm does not deliver any message and will only ask for whether the participant got vaccinated in the last two weeks. Individuals in each of the three treatment arms receive seven different types of messages. Each message is delivered twice every week for seven weeks and their vaccination status is inquired in the same calls to assess whether the participants received their vaccine after the last call. IN all arms, respondents are asked a simple question to test the attention they pay to the information provided in the message. The three treatment arms are compared against the control to assess the probability that any of the arms is significantly better than the control. With this aim, the minimum target sample size for each messaging group is N=173 which allows for the detection of a difference between groups of at least 15% with a double-tailed distribution at alpha=0.05 and power =0.8.
The investigators launched a first cohort on September 21, 2022 over sampling both the treatment and control arms to reduce the risk of attrition and aiming at obtaining 250 recruited participants that agree to participate. Due to high attrition, a second cohort was deployed on October 25, 2022 following the same procedure as for the first cohort, this time with a target of 400 recruited respondents with the aim of achieving the required sample size.
The investigators assess the differential likelihood of vaccinating during the trial for individuals participating in the different arms, including the control.
- Conditions
- Vaccination Refusal, COVID-19
- Being tested
- Factual messages, Narrative message, Mixed message
- Medical subject headings
- Vaccination Refusal, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Factual messagesBehavioural
Messages with descriptive data on COVID-19 vaccines
Narrative messageBehavioural
Messages with emotional descriptions on COVID-19 vaccines
Mixed messageBehavioural
Messages with both descriptive data and emotional descriptions on COVID-19 vaccines
| Study group | Role | What they receive |
|---|---|---|
| Factual messages | Active comparator | Participants in the arm with factual messages will listen to actual data on vaccination. Receives: Behavioral: Factual messages |
| Narrative message | Active comparator | Participants the narrative messages will listen to messages appealing to emotions that were explored in a qualitative study conducted earlier. Receives: Behavioral: Narrative message |
| Mixed messages | Active comparator | The mixed arm will combine both factual and narrative messages. Receives: Behavioral: Mixed message |
| Control arm | No intervention | Participants in the control arm will not be provided with a message and will only be asked for whether they participant got vaccinated in the last two weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage point change on the probability of new vaccination for treatment arms vs. control
The participant reports to have been vaccinated against COVID-19 in the last two weeks
Measured: 7 weeks
Secondary outcomes (3)
Percentage point change on the probability of new vaccination conditional on correct answer to the test
The participant reports to have been vaccinated against COVID-19 in the last two weeks and also has a high score on the response to the tests after the message
Measured: 7 weeks
Percentage point change on the probability of new vaccination conditional on demographic, socioeconomic and health characteristics
The participant reports to have been vaccinated against COVID-19 in the last two weeks and that likelihood is related to specific demographic, health and socioeconomic variables captured
Measured: 7 weeks
Percentage of attrition between each of the different waves of messages.
Participants enrolling in the trial, decide to stop participating at any time. The likelihood of participation is assessed in correlation with sociodemographic variables.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start21 Sep 2022
- Primary completion17 Dec 2022
- Study completion17 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccination RefusalStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three treatment arms and one control will be deployed.
- Masking
- None (open label)
- Enrolment
- 2,409 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Pontificia Universidad Javeriana
- Responsible party
- Sponsor
- Investigators
- Andres Vecino, MD PhD, Principal investigator, Johns Hopkins Bloomberg School of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764174
- Sponsor's protocol ID
- 00017868
- Acronym
- DIAMOND-R
- Status last verified
- Mar 2023
- First submitted
- 12 Jan 2023
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will only be analyzed by the Johns Hopkins team in an anonymized manner. Other researchers will have access only to aggregated information. No attempts to obtain identifiable information will be done and the numbers will be deleted from the main database once completed the data collection
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Applications to Monitor Novel Coronavirus Disease and Response in Colombia - Syndromic and Vaccination Surveillance
- ClinicalTrials.gov ID
- NCT05764174
- Acronym / sponsor ID
- DIAMOND-R / 00017868
- Conditions
- Vaccination Refusal, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,409 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Pontificia Universidad Javeriana
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 17 Dec 2022 (actual)
- Study completion
- 17 Dec 2022 (actual)
- First posted
- 10 Mar 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.
Brief Summary: The main objective of this activity is to assess the effectiveness of different messaging strategies (factual, narrative, mixed and a control) to promote COVID-19 adult vaccination.
Detailed description
The investigators deploy mobile phone surveys using Interactive Voice Response (IVR) in a random sample of mobile phone numbers (random digit dialing or RDD) in Colombia.
Adult individuals who have not been fully vaccinated against COVID-19 (defined as those who 1) did not get any vaccine; 2) did not get the complete vaccination scheme 3) did not get one booster when less than 50 years old; 4) did not get two boosters when older than 50 years old), and who consent to be recontacted are invited to participate in the messaging trial. After consent, participants are randomized in three different treatment arms or one control arm. Participants in each treatment arm are presented with different messages to improve COVID-19 vaccination. Participants in the arm with factual messages listen to actual data and scientifical information on COVID-19 vaccination. Those in the narrative arm listen to messages appealing to emotions drawing on the COVID-19 vaccination experiences that were explored in a qualitative study conducted earlier. The mixed arm combines both factual and narrative messages. Finally, the control arm does not deliver any message and will only ask for whether the participant got vaccinated in the last two weeks. Individuals in each of the three treatment arms receive seven different types of messages. Each message is delivered twice every week for seven weeks and their vaccination status is inquired in the same calls to assess whether the participants received their vaccine after the last call. IN all arms, respondents are asked a simple question to test the attention they pay to the information provided in the message. The three treatment arms are compared against the control to assess the probability that any of the arms is significantly better than the control. With this aim, the minimum target sample size for each messaging group is N=173 which allows for the detection of a difference between groups of at least 15% with a double-tailed distribution at alpha=0.05 and power =0.8.
The investigators launched a first cohort on September 21, 2022 over sampling both the treatment and control arms to reduce the risk of attrition and aiming at obtaining 250 recruited participants that agree to participate. Due to high attrition, a second cohort was deployed on October 25, 2022 following the same procedure as for the first cohort, this time with a target of 400 recruited respondents with the aim of achieving the required sample size.
The investigators assess the differential likelihood of vaccinating during the trial for individuals participating in the different arms, including the control.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Three treatment arms and one control will be deployed.
| Arm | Type | Receives |
|---|---|---|
| Factual messages | Active comparator | Behavioral: Factual messagesParticipants in the arm with factual messages will listen to actual data on vaccination. |
| Narrative message | Active comparator | Behavioral: Narrative messageParticipants the narrative messages will listen to messages appealing to emotions that were explored in a qualitative study conducted earlier. |
| Mixed messages | Active comparator | Behavioral: Mixed messageThe mixed arm will combine both factual and narrative messages. |
| Control arm | No intervention | –Participants in the control arm will not be provided with a message and will only be asked for whether they participant got vaccinated in the last two weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willingness to participate in the trial
- Being older than 18
- Have not been fully vaccinated against COVID-19 (those who did not get any vaccine, did not get the complete vaccination scheme or did not get one booster if less than 50 or two boosters if older than 50).
Key exclusion criteria (3 listed)
- Willingness to stop their participation in the trial
- Being younger than 18
- Have been fully vaccinated against COVID-19
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 |
|---|---|---|
| Factual messagesMessages with descriptive data on COVID-19 vaccines | Behavioural | Factual messages |
| Narrative messageMessages with emotional descriptions on COVID-19 vaccines | Behavioural | Narrative message |
| Mixed messageMessages with both descriptive data and emotional descriptions on COVID-19 vaccines | Behavioural | Mixed messages |
Primary outcome
Percentage point change on the probability of new vaccination for treatment arms vs. control
Time frame: 7 weeks
The participant reports to have been vaccinated against COVID-19 in the last two weeks
3 secondary outcomes
Percentage point change on the probability of new vaccination conditional on correct answer to the test
Time frame: 7 weeks
Percentage point change on the probability of new vaccination conditional on demographic, socioeconomic and health characteristics
Time frame: 7 weeks
Percentage of attrition between each of the different waves of messages.
Time frame: 7 weeks
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 10 Mar 2023.
- Individual participant dataSharing planned: No. IPD will only be analyzed by the Johns Hopkins team in an anonymized manner. Other researchers will have access only to aggregated information. No attempts to obtain identifiable information will be done and the numbers will be deleted from the main database once completed the data collection
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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.
Andres Vecino, MD PhD principal investigator
Johns Hopkins Bloomberg School of 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 Factual messages, Narrative message and Mixed message in people with Vaccination Refusal and COVID-19, run by Johns Hopkins Bloomberg School of Public 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 3 inclusion and 3 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 10 Mar 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?
Percentage point change on the probability of new vaccination for treatment arms vs. control (time frame: 7 weeks). 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 10 Mar 2023.