Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000068763
Ethics application status
Approved
Date submitted
13/01/2022
Date registered
20/01/2022
Date last updated
10/05/2023
Date data sharing statement initially provided
20/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Promoting COVID-19 vaccination in rural Bangladesh
Scientific title
Identifying the most cost-effective way to large scale vaccination for COVID-19 in rural Bangladesh
Secondary ID [1] 306130 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Covid-19 324814 0
vaccine promotion 324815 0
Condition category
Condition code
Public Health 322261 322261 0 0
Health service research
Infection 322360 322360 0 0
Other infectious diseases

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 Bangladesh. Towards this end, the eligible sample of unvaccinated individuals will be randomly assigned to a control group and one of the three treatment arms.

There will be three 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 three treatment groups. While the first treatment group will receive only the information treatment, the other two treatment groups will receive additional interventions. Thus, in addition to the information campaign, the other two treatment groups will receive one of the two different interventions (accessibility vis-à-vis campaign to address misconception via an ambassador) to isolate the effect of each of the different treatments.

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

Treatment 1 (T1): Information campaign only.

Treatment 2 (T2): Information campaign + 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). The 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 travelling cost using the most convenient travel mode as locally available. This intervention will be provided by the staff of the NGO partner, GDRI (Global Development Research Institute), who will work closely under the supervision of the research team.

Treatment 3 (T3): Information + campaign/motivation by eminent figures in the community (e.g., village leaders, teachers, doctors, etc). We will approach village leaders 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. To be more convincing and credible, the selected individuals should already be vaccinated or at least have registered to get vaccinated. Campaigning by eminent figures will start as soon as he/she is selected.

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.

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 685 locations (villages), with 10-20 unvaccinated people (average 13 participants per village) 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. Randomization into treatment and control groups will be done next at the village level. About 9,000 selected individuals identified from the 685 locations will be randomised (using a computer program), with 137 locations in the pure control (T0) and information campaign only (T1) arms, 205 locations in T2 and 206 locations in the T3 arm.

All these changes were happened prior to enrolment commencement
Intervention code [1] 322534 0
Treatment: Other
Intervention code [2] 322535 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 and costs 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] 330021 0
Knowledge about COVID-19 and vaccines.
Timepoint [1] 330021 0
These information will be collected: Before the intervention at baseline (February-May 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] 330128 0
Beliefs about COVID-19 and vaccines
Timepoint [2] 330128 0
These information will be collected: Before the intervention at baseline (February-May 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] 330129 0
Vaccination intention and uptake.
Timepoint [3] 330129 0
These information will be collected: Before the intervention at baseline (February-May 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] 404629 0
Fear of COVID infection.
Timepoint [1] 404629 0
These information will be collected: Before the intervention at baseline (February-May 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] 404968 0
Compliance behaviors related to covid-19 such as mask wearing
Timepoint [2] 404968 0
These information will be collected: Before the intervention at baseline (February-May 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] 404969 0
Susceptibility to post-intervention Covid infection.
Timepoint [3] 404969 0
These information will be collected: Before the intervention at baseline (February-May 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 9,000 unvaccinated individuals (as of May 15, 2022) aged 18-65 years (one from each household) randomly selected from 685 different locations (both rural and urban) across several districts in Bangladesh.
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
Completed
Date of first participant enrolment
Anticipated
24/01/2022
Actual
24/01/2022
Date of last participant enrolment
Anticipated
28/02/2022
Actual
30/04/2022
Date of last data collection
Anticipated
30/04/2023
Actual
6/05/2023
Sample size
Target
12000
Accrual to date
Final
12000
Recruitment outside Australia
Country [1] 24468 0
Bangladesh
State/province [1] 24468 0
Several districts

Funding & Sponsors
Funding source category [1] 310477 0
Other
Name [1] 310477 0
Asian Development Bank
Country [1] 310477 0
Philippines
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd,
Clayton
VIC 3800
&
Caulfield Campus
900 Dandenong Rd
Caulfield East
VIC 3145
Country
Australia
Secondary sponsor category [1] 311629 0
Individual
Name [1] 311629 0
Debayan Pakrashi
Address [1] 311629 0
Debayan Pakrashi
Department of Economic Sciences
Indian Institute of Technology Kanpur
Kanpur, India 208016
Country [1] 311629 0
India
Secondary sponsor category [2] 311647 0
Individual
Name [2] 311647 0
Dinesh Arora
Address [2] 311647 0
Asian Development Bank Headquarters (HQ)
6 ADB Avenue, Mandaluyong City 1550, Metro Manila, Philippines
Country [2] 311647 0
Philippines
Secondary sponsor category [3] 311648 0
Individual
Name [3] 311648 0
Dai-Ling Chen
Address [3] 311648 0
Asian Development Bank Headquarters (HQ)
6 ADB Avenue, Mandaluyong City 1550, Metro Manila, Philippines
Country [3] 311648 0
Philippines
Other collaborator category [1] 282116 0
Individual
Name [1] 282116 0
Shafiun Nahin Shimul
Address [1] 282116 0
Institute of Health Economics,
University of Dhaka
Nilkhet Rd, Dhaka 1000
Country [1] 282116 0
Bangladesh
Other collaborator category [2] 282117 0
Individual
Name [2] 282117 0
Hyuncheol Bryant Kim,
Address [2] 282117 0
Economics Department and Division of Public Policy,
Hong Kong University of Science and Technology
Clear Water Bay, Kowloon, Hong Kong
Country [2] 282117 0
Hong Kong
Other collaborator category [3] 282118 0
Individual
Name [3] 282118 0
Armand Sim
Address [3] 282118 0
Monash University
Wellington Rd,
Clayton
VIC 3800
&
Caulfield Campus
900 Dandenong Rd
Caulfield East
VIC 3145
Country [3] 282118 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310107 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 310107 0
Ethics committee country [1] 310107 0
Australia
Date submitted for ethics approval [1] 310107 0
Approval date [1] 310107 0
09/12/2021
Ethics approval number [1] 310107 0
31121
Ethics committee name [2] 310121 0
Institutional Review Board
Ethics committee address [2] 310121 0
Ethics committee country [2] 310121 0
Bangladesh
Date submitted for ethics approval [2] 310121 0
23/09/2021
Approval date [2] 310121 0
04/12/2021
Ethics approval number [2] 310121 0
IHE/IRB/DU/32/2021/Final

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

Contacts
Principal investigator
Name 116498 0
Prof Asadul Islam
Address 116498 0
Caulfield Campus Building H, Room 4.37, Sir John Monash Drive Monash University Caulfield East Vic 3145, Australia
Country 116498 0
Australia
Phone 116498 0
+61 3 9903 2783
Fax 116498 0
+61 3 9903 1128
Email 116498 0
[email protected]
Contact person for public queries
Name 116499 0
Asadul Islam
Address 116499 0
Caulfield Campus Building H, Room 4.37, Sir John Monash Drive Monash University Caulfield East Vic 3145, Australia
Country 116499 0
Australia
Phone 116499 0
+61 3 9903 2783
Fax 116499 0
+61 3 9903 1128
Email 116499 0
[email protected]
Contact person for scientific queries
Name 116500 0
Asadul Islam
Address 116500 0
Caulfield Campus Building H, Room 4.37, Sir John Monash Drive Monash University Caulfield East Vic 3145, Australia
Country 116500 0
Australia
Phone 116500 0
+61 3 9903 2783
Fax 116500 0
+61 3 9903 1128
Email 116500 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 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.