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

NCT ID: NCT05764174

Last Updated: 2023-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2409 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-21

Study Completion Date

2022-12-17

Brief Summary

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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

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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

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Vaccination Refusal COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three treatment arms and one control will be deployed.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Factual messages

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

Group Type ACTIVE_COMPARATOR

Factual messages

Intervention Type BEHAVIORAL

Messages with descriptive data on COVID-19 vaccines

Narrative message

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

Group Type ACTIVE_COMPARATOR

Narrative message

Intervention Type BEHAVIORAL

Messages with emotional descriptions on COVID-19 vaccines

Mixed messages

The mixed arm will combine both factual and narrative messages.

Group Type ACTIVE_COMPARATOR

Mixed message

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Factual messages

Messages with descriptive data on COVID-19 vaccines

Intervention Type BEHAVIORAL

Narrative message

Messages with emotional descriptions on COVID-19 vaccines

Intervention Type BEHAVIORAL

Mixed message

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pontificia Universidad Javeriana

OTHER

Sponsor Role collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andres Vecino, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Health

Locations

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Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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00017868

Identifier Type: -

Identifier Source: org_study_id

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