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

Sponsor
Johns Hopkins Bloomberg School of Public Health (Other)
Overall Status
Completed
CT.gov ID
NCT05764174
Collaborator
Pontificia Universidad Javeriana (Other)
2,409
1
4
2.9
842.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Factual messages
  • Behavioral: Narrative message
  • Behavioral: Mixed message
N/A

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

Study Type:
Interventional
Actual Enrollment :
2409 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Three treatment arms and one control will be deployed.Three treatment arms and one control will be deployed.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Digital Applications to Monitor Novel Coronavirus Disease and Response in Colombia - Syndromic and Vaccination Surveillance
Actual Study Start Date :
Sep 21, 2022
Actual Primary Completion Date :
Dec 17, 2022
Actual Study Completion Date :
Dec 17, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Factual messages

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

Behavioral: Factual messages
Messages with descriptive data on COVID-19 vaccines

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
Messages with emotional descriptions on COVID-19 vaccines

Active Comparator: Mixed messages

The mixed arm will combine both factual and narrative messages.

Behavioral: Mixed message
Messages with both descriptive data and emotional descriptions on COVID-19 vaccines

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.

Outcome Measures

Primary Outcome Measures

  1. Percentage point change on the probability of new vaccination for treatment arms vs. control [7 weeks]

    The participant reports to have been vaccinated against COVID-19 in the last two weeks

Secondary Outcome Measures

  1. Percentage point change on the probability of new vaccination conditional on correct answer to the test [7 weeks]

    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

  2. Percentage point change on the probability of new vaccination conditional on demographic, socioeconomic and health characteristics [7 weeks]

    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

  3. Percentage of attrition between each of the different waves of messages. [7 weeks]

    Participants enrolling in the trial, decide to stop participating at any time. The likelihood of participation is assessed in correlation with sociodemographic variables.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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:
  • Willingness to stop their participation in the trial

  • Being younger than 18

  • Have been fully vaccinated against COVID-19

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins Bloomberg School of Public Health Baltimore Maryland United States 21205

Sponsors and Collaborators

  • Johns Hopkins Bloomberg School of Public Health
  • Pontificia Universidad Javeriana

Investigators

  • Principal Investigator: Andres Vecino, MD PhD, Johns Hopkins Bloomberg School of Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT05764174
Other Study ID Numbers:
  • 00017868
First Posted:
Mar 10, 2023
Last Update Posted:
Mar 10, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2023