CClinicalTrials.gg
CompletedNCT05764174DIAMOND-RUpdated Mar 10, 2023

Digital Applications to Monitor Novel Coronavirus Disease and Response in Colombia - Syndromic and Vaccination Surveillance

An interventional study of Factual messages and Narrative message in Vaccination Refusal and COVID-19, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-10.

Sponsored by Johns Hopkins Bloomberg School of Public Health · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Sep 2022, registered Jan 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
2,409
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Vaccination Refusal
  • COVID-19
03

In context

Coronavirus Infections

928 studies on the registry are indexed under Coronavirus Infections; 49 are open to participants now.

This study's enrollment of 2,409 is above the median of 105 across 540 interventional studies indexed under Coronavirus Infections.

Browse Coronavirus Infections studies →

Lead sponsor

Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 364 studies on the registry; 41 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • Willingness to stop their participation in the trial
  • Being younger than 18
  • Have been fully vaccinated against COVID-19
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,409 participants (actual)

Study arms

  • Active comparator
    Factual messages

    Participants in the arm with factual messages will listen to actual data on vaccination.

    Behavioral: Factual messages

  • Active comparator
    Narrative message

    Participants the narrative messages will listen to messages appealing to emotions that were explored in a qualitative study conducted earlier.

    Behavioral: Narrative message

  • Active comparator
    Mixed messages

    The mixed arm will combine both factual and narrative messages.

    Behavioral: Mixed message

  • No intervention
    Control arm

    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.

Interventions

  • BehavioralFactual messages

    Messages with descriptive data on COVID-19 vaccines

  • BehavioralNarrative message

    Messages with emotional descriptions on COVID-19 vaccines

  • BehavioralMixed message

    Messages with both descriptive data and emotional descriptions on COVID-19 vaccines

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 7 weeks

Secondary outcomes

  1. 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

    Time frame: 7 weeks

  2. 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

    Time frame: 7 weeks

  3. 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.

    Time frame: 7 weeks

07

Study locations

1 site
  • Johns Hopkins Bloomberg School of Public Health
    Baltimore, Maryland 21205, United States
08

References and documents

Individual participant data

Plan to share: 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

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05764174
Lead sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Pontificia Universidad Javeriana
Responsible party
Sponsor
First posted
Mar 10, 2023
Start date
Sep 21, 2022
Primary completion
Dec 17, 2022
Completion
Dec 17, 2022
Last update
Mar 10, 2023

Study contacts

Andres Vecino, MD PhD
principal investigator · Johns Hopkins Bloomberg School of Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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