Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000164796
Ethics application status
Approved
Date submitted
25/01/2022
Date registered
31/01/2022
Date last updated
23/06/2022
Date data sharing statement initially provided
31/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Promoting large scale COVID-19 vaccination in India
Scientific title
Identifying the most cost-effective way to enable large scale vaccination for COVID-19 in India
Secondary ID [1] 306151 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 324989 0
vaccine promotion 324990 0
Condition category
Condition code
Infection 322432 322432 0 0
Other infectious diseases
Public Health 322433 322433 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The objective of the proposed study is to identify the most effective strategy to promote large scale vaccination among adults in India. Towards this end, the eligible sample of unvaccinated individuals will be randomly assigned to a control group or one of the five treatment arms.

There will be five treatment groups: Information will be disseminated about the available vaccines, benefits, and costs associated with getting vaccinated via awareness campaign from a reliable source to all the five treatment groups. While the first treatment group will receive only the information treatment, the other four treatment groups will receive another additional intervention each. Thus, in addition to the information campaign, the other four treatment groups will receive one of the four different interventions (sure gift vis-à-vis lucky draw vis-à-vis accessibility vis-à-vis campaign to address misconception via an ambassador) to isolate the effect of each of the different treatments.

The five different treatments that we will focus on in the proposed project are as follows:

Treatment 1 (T1): Information campaign only. In this treatment, participants will receive basic information about the available Covid19 vaccines and the benefits of having it to protect from Covid19 for themselves and for their loves ones. The information will be delivered verbally by the field workers on behalf of the researchers to each participant based on a 1-page information sheet (maximum time will be about 10-15 minutes) and the information will be designed specifically for this study based on the information provided from reliable sources such as WHO as well as national health ministries.

Treatment 2 (T2): Information + sure gift worth INR 400 (i.e., $6 approx) conditional upon vaccination in order to compensate them for lost daily wages due to travel and forgone earnings for additional day's work in case of any side effects that may arise. Our enumerators will give respondents the gift within two weeks upon confirmation of vaccination (e.g., physical or digital vaccination certificate).

Treatment 3 (T3): Information + participation in a lucky draw with a 5% chance of winning a gift worth INR 8,000 ($120 approx), conditional upon vaccination. The expected value from this lucky draw will be the same as the sure payment treatment (Treatment 2). Our research team, including enumerators and field coordinators, will be involved in drawing the lucky draw each month, determine eligible participants (i.e., respondents confirmed to have received vaccine), and deliver the gifts to the winner. Thus, as part of the lucky draw one out of 20 individuals (who participated in the study, got the information from us and got vaccinated) will be randomly selected by the research team to receive a gift worth INR 8,000. The gift will be made available to the winner within two weeks of the lucky draw results being declared.

Treatment 4 (T4): Information + Accessibility (helping them with registration/enrolment, travelling to get vaccinated, and reminding/encouraging them to get vaccinated at the right time via brief telephone reminders). In addition, a gentle and brief reminder will be provided both through a phone call as well as a SMS about two weeks after the intervention is delivered. We will help the target group with the registration procedure and will track their progress from registration to vaccination, reminding them to get vaccinated (all free of cost). They will also be provided help with identifying the nearest vaccination center and travelling to the same, and any transport cost using the most convenient travel mode as well as any other logistics needed to travel to get vaccinated, as locally available.

Treatment 5 (T5): Information + campaign/motivation by eminent figures in the community (e.g., village leaders, teachers, doctors, etc). We will approach village leaders, elders, shopkeepers, teachers, doctors to identify the most respected and trusted eminent figure in their community (e.g., religious leaders, teachers, doctors) and ask him/her to campaign and propagate information to address misconceptions related to the available vaccines. The selected individuals (leaders) should already be vaccinated. Campaigning by eminent figures will start as soon as he/she is selected, as around the same time with other treatments.

Specifically, the selected eminent figures (we call them 'Ambassadors') will be asked to campaign and propagate specific information (in addition to basic information being provided to all) to address misconceptions related to the available vaccines. Ambassadors will speak with the unvaccinated selected individuals one-to-one by visiting them while following strict health protocols (e.g., every respondent and ambassador will wear mask, maintain 1.5 meters between individuals, open air space), and try to convince them to get vaccinated. The meeting will occur once during the campaign period (1 month) and each meeting will last for a maximum 1 hour. The campaign will be based on context-specific information and guidelines provided by the central and local government bodies and will dispel misperceptions about the disease, the available vaccines, distribution of infection and fatality rates and improve knowledge about COVID-19 prevention and transmission etc. In addition, to enhance information retention about the information session, the ambassadors will deliver a pamphlet that summarizes key information about COVID-19 vaccines.

The control group on the other hand will receive no such information campaign about the vaccines or any specific incentives.

The research team will visit the participants about one month after the intervention to verify their vaccination status. They will be visited again one month after the first verification to update the vaccination status and conduct the endline and spillover surveys (which will ask randomly selected individuals from the villages about their vaccination status- to understand if the intervention also influenced other people to get vaccinated).

The vaccination status will be verified using the registration information and text messages sent by the govt's department of public health confirming the dose of the vaccine and the date being vaccinated.

We will select a total of 884 locations (villages) and on average about 9 individuals from each of these locations. From each household, we will focus on adult individuals who are eligible for COVID19 vaccine free of cost and are unvaccinated. Only one participant will be recruited for the purpose of the survey and the intervention from each household. Randomization into treatment and control groups will be done next at the village level. About 8,000 selected individuals identified from the 884 locations will be randomized (using a computer program), with 295 locations in the pure control (T0), 103 in information campaign only (T1) arm, 124 locations in T2, 133 locations in T3, 118 locations in T4 and 111 locations in the T5 arm.

All these changes were made prior to enrolment commencement
Intervention code [1] 322662 0
Behaviour
Comparator / control treatment
The "pure control" arm (T0) will receive no intervention. On the other hand, there will be another treatment arm (information campaign only-T1) which will receive basic information about the available vaccines and the benefits associated with the same. The information will be delivered verbally by the field workers on behalf of the researchers to each participant based on a 1-page information sheet (maximum time will be about 10-15 minutes) and the information will be designed specifically for this study based on the information provided from reliable sources such as WHO as well as national health ministries. The changes were made prior to enrolment commencement.
Control group
Active

Outcomes
Primary outcome [1] 330196 0
Knowledge about COVID-19 and vaccines (Health Belief Model)
(e.g., knowledge about COVID-19 and its prevention, severity of COVID-19, benefits of COVID-19 vaccines)
Timepoint [1] 330196 0
These information will be collected: Before the intervention at baseline (April-June 2022) and during the endline survey post-intervention (August-October 2022). This information will be collected via one-to-one survey specifically designed for this study.
Primary outcome [2] 330197 0
Beliefs about COVID-19 and vaccines (Health Belief Model)
(e.g., vulnerability to catching COVID-19, barriers to COVID-19 vaccines)
Timepoint [2] 330197 0
These information will be collected: Before the intervention at baseline (April-June 2022) and during the endline survey post-intervention (August-October 2022). This information will be collected via one-to-one survey specifically designed for this study.
Primary outcome [3] 330198 0
Vaccination intention (self-reported) and uptake (verified by physical or digital proof)
Timepoint [3] 330198 0
These information will be collected: Before the intervention at baseline (April-June 2022) and during the endline survey post-intervention (August-October 2022). This information will be collected via one-to-one survey specifically designed for this study.
Secondary outcome [1] 405271 0
Fear of COVID-19 infection.
Timepoint [1] 405271 0
These information will be collected: Before the intervention at baseline (April-June 2022) and during the endline survey post-intervention (August-October 2022). This information will be collected via one-to-one survey specifically designed for this study.
Secondary outcome [2] 405272 0
Compliance behaviors related to COVID-19 such as mask wearing.
Timepoint [2] 405272 0
These information will be collected: Before the intervention at baseline (April-June 2022) and during the endline survey post-intervention (August-October 2022). This information will be collected via one-to-one survey specifically designed for this study.
Secondary outcome [3] 405273 0
Susceptibility to post-intervention COVID-19 infection.
Timepoint [3] 405273 0
These information will be collected: Before the intervention at baseline (April-June 2022) and during the endline survey post-intervention (August-October 2022). This information will be collected via one-to-one survey specifically designed for this study.

Eligibility
Key inclusion criteria
About 8,000 unvaccinated individuals aged 18-65 years (one from each household) randomly selected from 884 different locations (both rural and urban) across several districts in India.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals aged below 18 years
Individuals aged above 65 years
Those not able to give informed consent
Those not visiting relatives in the study area and not living there for the next 9 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster level randomisation using a randomisation table created
by computer software. Within cluster eligible population will be randomly selected.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
15/02/2022
Actual
1/04/2022
Date of last participant enrolment
Anticipated
31/03/2022
Actual
31/05/2022
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
12000
Accrual to date
Final
8000
Recruitment outside Australia
Country [1] 24516 0
India
State/province [1] 24516 0
Several districts of Uttar Pradesh

Funding & Sponsors
Funding source category [1] 310492 0
Other
Name [1] 310492 0
Asian Development Bank
Country [1] 310492 0
Philippines
Primary sponsor type
University
Name
Indian Institute of Technology Kanpur
Address
Indian Institute of Technology Kanpur
Kalyanpur, Kanpur, India 208016.
Country
India
Secondary sponsor category [1] 311658 0
Individual
Name [1] 311658 0
Asadul Islam
Address [1] 311658 0
Monash University
Wellington Rd,
Clayton
VIC 3800
&
Caulfield Campus
900 Dandenong Rd
Caulfield East
VIC 3145
Country [1] 311658 0
Australia
Secondary sponsor category [2] 311800 0
Individual
Name [2] 311800 0
Sonalini Khetrapal
Address [2] 311800 0
Asian Development Bank Headquarters (HQ)
6 ADB Avenue, Mandaluyong City 1550, Metro Manila, Philippines
Country [2] 311800 0
Philippines
Secondary sponsor category [3] 311801 0
Individual
Name [3] 311801 0
Hyuncheol Bryant Kim,
Address [3] 311801 0
Economics Department and Division of Public Policy,
Hong Kong University of Science and Technology
Clear Water Bay, Kowloon, Hong Kong
Country [3] 311801 0
Hong Kong
Secondary sponsor category [4] 311803 0
Individual
Name [4] 311803 0
Armand Sim
Address [4] 311803 0
Monash University
Wellington Rd,
Clayton
VIC 3800
&
Caulfield Campus
900 Dandenong Rd
Caulfield East
VIC 3145
Country [4] 311803 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310122 0
Institutional Ethics Committee, Indian Institute of Technology Kanpur.
Ethics committee address [1] 310122 0
Ethics committee country [1] 310122 0
India
Date submitted for ethics approval [1] 310122 0
20/08/2021
Approval date [1] 310122 0
02/09/2021
Ethics approval number [1] 310122 0
IITK/IEC/2021-22/I/14

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116550 0
Prof Debayan Pakrashi
Address 116550 0
Department of Economic Sciences
Indian Institute of Technology Kanpur
Kalyanpur, Kanpur, India 208016
Country 116550 0
India
Phone 116550 0
+91 0512 259 6107
Fax 116550 0
Email 116550 0
[email protected]
Contact person for public queries
Name 116551 0
Asadul Islam
Address 116551 0
Caulfield Campus Building H, Room 4.37, Sir John Monash Drive Monash University Caulfield East Vic 3145, Australia
Country 116551 0
Australia
Phone 116551 0
+61 3 9903 2783
Fax 116551 0
+61 3 9903 1128
Email 116551 0
[email protected]
Contact person for scientific queries
Name 116552 0
Asadul Islam
Address 116552 0
Caulfield Campus Building H, Room 4.37, Sir John Monash Drive Monash University Caulfield East Vic 3145, Australia
Country 116552 0
Australia
Phone 116552 0
+61 3 9903 2783
Fax 116552 0
+61 3 9903 1128
Email 116552 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data of published results only.
When will data be available (start and end dates)?
Immediately after publication, no specific start and end date to be decided.
Available to whom?
Only researchers who provide a methodologically sound proposal, and case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected]).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.