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

Primary Purpose

Vaccination Refusal, COVID-19

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Factual messages
Narrative message
Mixed message
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Vaccination Refusal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Johns Hopkins Bloomberg School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

Factual messages

Narrative message

Mixed messages

Control arm

Arm Description

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

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

The mixed arm will combine both factual and narrative messages.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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.

Full Information

First Posted
January 12, 2023
Last Updated
March 1, 2023
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Pontificia Universidad Javeriana
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1. Study Identification

Unique Protocol Identification Number
NCT05764174
Brief Title
Digital Applications to Monitor Novel Coronavirus Disease and Response in Colombia - Syndromic and Vaccination Surveillance
Acronym
DIAMOND-R
Official Title
Digital Applications to Monitor Novel Coronavirus Disease and Response in Colombia - Syndromic and Vaccination Surveillance
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 21, 2022 (Actual)
Primary Completion Date
December 17, 2022 (Actual)
Study Completion Date
December 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Pontificia Universidad Javeriana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaccination Refusal, COVID-19

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three treatment arms and one control will be deployed.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2409 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Factual messages
Arm Type
Active Comparator
Arm Description
Participants in the arm with factual messages will listen to actual data on vaccination.
Arm Title
Narrative message
Arm Type
Active Comparator
Arm Description
Participants the narrative messages will listen to messages appealing to emotions that were explored in a qualitative study conducted earlier.
Arm Title
Mixed messages
Arm Type
Active Comparator
Arm Description
The mixed arm will combine both factual and narrative messages.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Factual messages
Intervention Description
Messages with descriptive data on COVID-19 vaccines
Intervention Type
Behavioral
Intervention Name(s)
Narrative message
Intervention Description
Messages with emotional descriptions on COVID-19 vaccines
Intervention Type
Behavioral
Intervention Name(s)
Mixed message
Intervention Description
Messages with both descriptive data and emotional descriptions on COVID-19 vaccines
Primary Outcome Measure Information:
Title
Percentage point change on the probability of new vaccination for treatment arms vs. control
Description
The participant reports to have been vaccinated against COVID-19 in the last two weeks
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Percentage point change on the probability of new vaccination conditional on correct answer to the test
Description
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
Title
Percentage point change on the probability of new vaccination conditional on demographic, socioeconomic and health characteristics
Description
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
Title
Percentage of attrition between each of the different waves of messages.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andres Vecino, MD PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bloomberg School of Public Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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

Learn more about this trial

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

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