NCT04870593

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,006

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

1.5 years

First QC Date

April 28, 2021

Last Update Submit

March 27, 2023

Conditions

AgingCovid19

Outcome Measures

Primary Outcomes (2)

  • Received at least one shot

    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

    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

Study Arms (8)

Community receives buddy and gossip treatment, individual informed directly (arm (1))

EXPERIMENTAL

(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: InformationBehavioral: BuddyBehavioral: Gossip interventionBehavioral: Information assigned in communityBehavioral: Buddy assigned in community

Community receives buddy and gossip treatment, individual not informed directly (arm (2))

EXPERIMENTAL

Individual elder lives in community with elders in arm (1).

Behavioral: Gossip interventionBehavioral: Information assigned in communityBehavioral: Buddy assigned in community

Community receives gossip treatment, individual informed directly (arm (3))

EXPERIMENTAL

(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: InformationBehavioral: Gossip interventionBehavioral: Information assigned in community

Community receives gossip treatment, individual not informed directly (arm (4))

EXPERIMENTAL

Individual elder lives in community with elders in arm (3).

Behavioral: Gossip interventionBehavioral: Information assigned in community

Community receives buddy treatment, individual informed directly (arm (5))

EXPERIMENTAL

(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: InformationBehavioral: BuddyBehavioral: Information assigned in communityBehavioral: Buddy assigned in community

Community receives buddy treatment, individual not informed directly (arm (6))

EXPERIMENTAL

Individual elder lives in community with elders in arm (5).

Behavioral: Information assigned in communityBehavioral: Buddy assigned in community

Community receives information, individual informed directly (arm (7))

EXPERIMENTAL

Individual elder given vaccination information.

Behavioral: InformationBehavioral: Information assigned in community

Community receives information, individual not informed directly (arm (8))

EXPERIMENTAL

Individual elder lives in community with elders in arm (7).

Behavioral: Information assigned in community

Interventions

InformationBEHAVIORAL

Elder informed about vaccination.

Community receives buddy and gossip treatment, individual informed directly (arm (1))Community receives buddy treatment, individual informed directly (arm (5))Community receives gossip treatment, individual informed directly (arm (3))Community receives information, individual informed directly (arm (7))
BuddyBEHAVIORAL

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.

Community receives buddy and gossip treatment, individual informed directly (arm (1))Community receives buddy treatment, individual informed directly (arm (5))
Gossip interventionBEHAVIORAL

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.

Community receives buddy and gossip treatment, individual informed directly (arm (1))Community receives buddy and gossip treatment, individual not informed directly (arm (2))Community receives gossip treatment, individual informed directly (arm (3))Community receives gossip treatment, individual not informed directly (arm (4))
Information assigned in communityBEHAVIORAL

Information intervention assigned for other elders in community.

Community receives buddy and gossip treatment, individual informed directly (arm (1))Community receives buddy and gossip treatment, individual not informed directly (arm (2))Community receives buddy treatment, individual informed directly (arm (5))Community receives buddy treatment, individual not informed directly (arm (6))Community receives gossip treatment, individual informed directly (arm (3))Community receives gossip treatment, individual not informed directly (arm (4))Community receives information, individual informed directly (arm (7))Community receives information, individual not informed directly (arm (8))
Buddy assigned in communityBEHAVIORAL

Buddy intervention assigned for other elders in community.

Community receives buddy and gossip treatment, individual informed directly (arm (1))Community receives buddy and gossip treatment, individual not informed directly (arm (2))Community receives buddy treatment, individual informed directly (arm (5))Community receives buddy treatment, individual not informed directly (arm (6))

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 55 years of age
  • Has phone number

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

JPAL SA at IFMR

Chennai, Tamil Nadu, India

Location

MeSH Terms

Conditions

COVID-19

Interventions

Residence Characteristics

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

DemographyPopulation CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 28, 2021

First Posted

May 3, 2021

Study Start

April 17, 2021

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

March 29, 2023

Record last verified: 2023-03

Locations

IN(1)