What Works to Get the Elderly Vaccinated Against COVID-19? Experimental Evidence From India

March 27, 2023 updated by: Esther Duflo, National Bureau of Economic Research, Inc.
COVID-19 poses a substantial risk to elderly populations; understanding how to get elders vaccinated against the virus is therefore a policy priority. An experiment with elders in Tamil Nadu, India will be used to evaluate interventions policymakers might use to raise vaccination rates amongst the elderly. The particular interventions being tested are: calling elders to inform them about vaccination; encouragement of a "buddy system," whereby elders are accompanied to the vaccination site by another adult who could also get the vaccine; and seeding vaccination information with "gossips," individuals who elders identify as being good at spreading information in the elders' communities. The interventions are phone-based, and can be implemented quickly and at low cost. This makes them promising strategies the Tamil Nadu government and other governments could use to vaccinate elderly populations against COVID-19.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3006

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Tamil Nadu
      • Chennai, Tamil Nadu, India
        • JPAL SA at IFMR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 55 years of age
  • Has phone number

Exclusion Criteria:

- Not part of the experiments registered under protocol IDs 223749 or 172020

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Community receives buddy and gossip treatment, individual informed directly (arm (1))

(i) Individual elder given vaccination information.

(ii) Individual elder encouraged to get vaccinated using "buddy system," whereby he/she is accompanied to the vaccination site by another adult who could also get the vaccine. A potential buddy also given vaccination information and encouraged to help the elder get to the vaccination site so they could both be vaccinated.

(iii) Members of elder's community asked who in the community is good at spreading information. These "gossips" then asked to spread information about vaccination of elders and to encourage their communities to use the buddy system to get elders vaccinated.
Behavioral: Information
Elder informed about vaccination.
Behavioral: Buddy
Elder encouraged to get vaccinated using "buddy system," whereby he/she is accompanied to the vaccination site by another adult who could also get the vaccine. A potential buddy also given vaccination information and encouraged to help the elder get to the vaccination site so they could both be vaccinated.
Behavioral: Gossip intervention
Members of elder's community asked who in the community is good at spreading information. These "gossips" then asked to spread information about vaccination of elders. If buddy intervention assigned in community, gossips also asked to encourage their communities to use the buddy system to get elders vaccinated.
Behavioral: Information assigned in community
Information intervention assigned for other elders in community.
Behavioral: Buddy assigned in community
Buddy intervention assigned for other elders in community.
Experimental: Community receives buddy and gossip treatment, individual not informed directly (arm (2))
Individual elder lives in community with elders in arm (1).
Behavioral: Gossip intervention
Members of elder's community asked who in the community is good at spreading information. These "gossips" then asked to spread information about vaccination of elders. If buddy intervention assigned in community, gossips also asked to encourage their communities to use the buddy system to get elders vaccinated.
Behavioral: Information assigned in community
Information intervention assigned for other elders in community.
Behavioral: Buddy assigned in community
Buddy intervention assigned for other elders in community.
Experimental: Community receives gossip treatment, individual informed directly (arm (3))

(i) Individual elder given vaccination information.

(ii) Members of elder's community asked who in the community is good at spreading information. These "gossips" then asked to spread information about vaccination of elders.
Behavioral: Information
Elder informed about vaccination.
Behavioral: Gossip intervention
Members of elder's community asked who in the community is good at spreading information. These "gossips" then asked to spread information about vaccination of elders. If buddy intervention assigned in community, gossips also asked to encourage their communities to use the buddy system to get elders vaccinated.
Behavioral: Information assigned in community
Information intervention assigned for other elders in community.
Experimental: Community receives gossip treatment, individual not informed directly (arm (4))
Individual elder lives in community with elders in arm (3).
Behavioral: Gossip intervention
Members of elder's community asked who in the community is good at spreading information. These "gossips" then asked to spread information about vaccination of elders. If buddy intervention assigned in community, gossips also asked to encourage their communities to use the buddy system to get elders vaccinated.
Behavioral: Information assigned in community
Information intervention assigned for other elders in community.
Experimental: Community receives buddy treatment, individual informed directly (arm (5))

(i) Individual elder given vaccination information.

(ii) Individual elder encouraged to get vaccinated using "buddy system," whereby he/she is accompanied to the vaccination site by another adult who could also get the vaccine. A potential buddy also given vaccination information and encouraged to help the elder get to the vaccination site so they could both be vaccinated.
Behavioral: Information
Elder informed about vaccination.
Behavioral: Buddy
Elder encouraged to get vaccinated using "buddy system," whereby he/she is accompanied to the vaccination site by another adult who could also get the vaccine. A potential buddy also given vaccination information and encouraged to help the elder get to the vaccination site so they could both be vaccinated.
Behavioral: Information assigned in community
Information intervention assigned for other elders in community.
Behavioral: Buddy assigned in community
Buddy intervention assigned for other elders in community.
Experimental: Community receives buddy treatment, individual not informed directly (arm (6))
Individual elder lives in community with elders in arm (5).
Behavioral: Information assigned in community
Information intervention assigned for other elders in community.
Behavioral: Buddy assigned in community
Buddy intervention assigned for other elders in community.
Experimental: Community receives information, individual informed directly (arm (7))
Individual elder given vaccination information.
Behavioral: Information
Elder informed about vaccination.
Behavioral: Information assigned in community
Information intervention assigned for other elders in community.
Experimental: Community receives information, individual not informed directly (arm (8))
Individual elder lives in community with elders in arm (7).
Behavioral: Information assigned in community
Information intervention assigned for other elders in community.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Received at least one shot
Time Frame: 8 weeks after intervention
Elders asked on phone call if they have received zero, one, or two doses of COVID-19 vaccine. Outcome takes the value of 1 if they received at least one shot, and 0 otherwise.
8 weeks after intervention
Received two shots
Time Frame: 8 weeks after intervention
Elders asked on phone call if they have received zero, one, or two doses of COVID-19 vaccine. Outcome takes the value of 1 if they received two shots, and 0 otherwise.
8 weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Bureau of Economic Research, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 17, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1702861995A021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Dietary Supplements

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