Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000055707
Ethics application status
Approved
Date submitted
22/12/2021
Date registered
18/01/2022
Date last updated
11/01/2023
Date data sharing statement initially provided
18/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Role of Vaccine Ambassadors on COVID-19 vaccine take-up in Indonesia
Scientific title
The Role of Vaccine Ambassadors on COVID-19 vaccine take-up in Indonesia
Secondary ID [1] 306050 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 vaccination uptake 324694 0
COVID-19 324798 0
Condition category
Condition code
Public Health 322144 322144 0 0
Health promotion/education
Respiratory 322249 322249 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment Group 1 --
In villages assigned to this treatment, we will approach local health cadres to serve as ambassadors for the COVID-19 vaccination program. We will recruit an effective science communicator to train ambassadors to deliver information in a consistent, compassionate, empathetic, and honest manner since communication is a key to convince people to get vaccinated. Training for the ambassadors will commence two weeks prior to the intervention delivery to ensure knowledge retention and effectiveness of the training.

The training will be provided in both online and offline sessions. Online sessions will take 3 hours to complete, consisting of interactive lecture, discussion, and quiz. Offline sessions will consist of role-play sessions that will last 45 minutes to complete.

The ambassador will be tasked with doing personal visits to respondents’ house. During the meeting, the ambassador will talk about scripted messages containing:

General information about COVID-19, the private and social benefits of COVID-19 vaccine (e.g., higher vaccination rate translates to more freedom in movement and better economy), how to access the vaccine (such as location of vaccination site and registration help if needed), mortality and take-up rates in their district.
Moral messages regarding responsibility of taking COVID-19 vaccine during emergency situations to protect others.

The meetings will take place twice during the intervention period and take at most 30 minutes every time. The second meeting will take place a week after the first meeting. The second meeting will focus on clarifying respondents' understanding of the messages delivered by the ambassador in the first meeting. In addition to meetings, we will deliver leaflet containing information on private and social benefits of as well as reminder for getting Covid-19 vaccine. The leaflets will be designed specifically for this study. The leaflets will be delivered during the second meeting.

Treatment Group 2
In the second intervention group, we will recruit an ambassador who has the same tasks as the ambassador in Treatment Group 1. The second group only differs in the selection mechanism. We will leverage social networks in the village to choose an ambassador in Treatment 2. We will ask a random subset of our sample in each village to nominate 3 individuals who in their view are respected, trusted, and good at spreading news and information in their village. To get a rather more complete picture of the situation in the village, we will also ask random vaccinated people—that we identified during screening—the same question. Afterwards, we will approach the individual who receives the most nominations and ask them to serve as the ambassador. The selected individuals should already be vaccinated or at least have registered to get vaccinated.

All ambassadors in the treatment group 2 will receive the same training provided to the ambassadors in the treatment group 1.

The duration of the intervention in all treatment groups (including control) will be two weeks : first home visit in the first week of intervention and second (and last) home visit in the following week.

Quality control strategies :
We will require all ambassadors to maintain participant logs, where we will check when the home visits will take place. The study team will do random check to the participants house during the planned visiting time. Additionally, we will do random spot check where we will call the participants and ask confirmatory questions to check whether ambassadors did delivered the intervention.
Intervention code [1] 322467 0
Behaviour
Comparator / control treatment
In this intervention, we will approach and recruit any layperson to become an ambassador in a randomly assigned village. Selection of the ambassadors (both in treatment and control groups) will commence 1-2 weeks prior to the training. They will have the same tasks as ambassadors in Treatment groups 1 and 2. and will receive the same training provided to the treatment groups.

Following several current studies in COVID-19-related literature, we decided not to have a pure control group—one that does not receive COVID-19 ambassador intervention—in this project for two reasons. First, we want to combat misinformation about COVID-19 vaccine and COVID-19 in general because misinformation can have non-negligible consequences on health outcomes. Thus, we consider excluding villages from receiving information about COVID-19 vaccine as unethical. Second, having no pure control group allows us to test and compare the effectiveness of three actors as ambassadors to combat misinformation. Thus, if successful, this project can help decision makers formulate or scale-up a similar program.

Control group
Active

Outcomes
Primary outcome [1] 329922 0
Changes in the Covid-19 Vaccination status as shown by official record (vaccine certificate)
Timepoint [1] 329922 0
6-8 weeks after intervention commencement (the first home visit).
Primary outcome [2] 329957 0
Changes in the intention to receive Covid-19 vaccine (using questionnaire developed specific for this study)
Timepoint [2] 329957 0
6-8 weeks after intervention commencement (the first home visit).
Secondary outcome [1] 404425 0
Nil
Timepoint [1] 404425 0
Nil

Eligibility
Key inclusion criteria
We will recruit participants who are :
1. Have not received full Covid-19 vaccine (2 doses)
2. Minimum of 18 years of age to maximum of 65 years of age
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Medically exempt from Covid-19 vaccination

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will randomly select 300 villages with ten individuals (one individual per household) per village out of three regencies in West Java. We will randomize intervention at the village level. In total, we will have 3600 respondents across 3 treatment groups. Our randomisation strategy is the following :

1. We will pick 3 regencies in West Java province with the lowest vaccination rates
2. We will randomly select villages within these 3 regencies into 3 treatment groups
3. In each village we will conduct a screening survey prior to recruitment to ensure balance in baseline characteristics, such as gender, education background, and socioeconomic background.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We estimate the number of cluster and participants needed via power calculation with the following assumptions :
1. Minimum detectable effect : 0.10 (10 percent)
2. Intra-cluster correlation (ICC) between villages : 0.2

Which resulted in 300 clusters (villages)/3600 participants

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/01/2022
Actual
14/02/2022
Date of last participant enrolment
Anticipated
13/02/2022
Actual
14/04/2022
Date of last data collection
Anticipated
30/04/2022
Actual
8/09/2022
Sample size
Target
3600
Accrual to date
Final
2877
Recruitment outside Australia
Country [1] 24450 0
Indonesia
State/province [1] 24450 0
West Java

Funding & Sponsors
Funding source category [1] 310387 0
University
Name [1] 310387 0
Monash University
Country [1] 310387 0
Australia
Funding source category [2] 310426 0
Other Collaborative groups
Name [2] 310426 0
The Abdul Latif Jameel Poverty Action Lab (JPAL) Southeast Asia
Country [2] 310426 0
Indonesia
Primary sponsor type
Individual
Name
Asad Islam
Address
Centre for Development Economics and Sustainability (CDES)
Monash University

Building H, Level 4
900 Dandenong Road
Caulfield East 3145
VICTORIA
Country
Australia
Secondary sponsor category [1] 311532 0
Individual
Name [1] 311532 0
Armand Sim
Address [1] 311532 0
Centre for Development Economics and Sustainability (CDES)
Monash University

Building H, Level 4
900 Dandenong Road
Caulfield East 3145
VICTORIA
Country [1] 311532 0
Australia
Secondary sponsor category [2] 311550 0
Individual
Name [2] 311550 0
Giovanni Empel
Address [2] 311550 0
Centre for Health Economics (CHE)
Monash University

Building H, Level 5
900 Dandenong Road
Caulfield East 3145
VICTORIA
Country [2] 311550 0
Australia
Secondary sponsor category [3] 311551 0
Individual
Name [3] 311551 0
Jahen Rezki
Address [3] 311551 0
Lembaga Penyelidikan Ekonomi dan Masyarakat (LPEM)/Institute for Economic and Social Research
Faculty of Economics and Business
University of Indonesia

Jl. Salemba Raya IV Gedung Ali Wardhana, RW.5, Kenari, Kec. Senen, Kota Jakarta Pusat, Daerah Khusus Ibukota Jakarta 10430
Country [3] 311551 0
Indonesia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310037 0
Lembaga Penyelidikan Ekonomi & Masyarakat Fakultas Ekonomi dan Bisnis Universitas Indonesia
Ethics committee address [1] 310037 0
Ethics committee country [1] 310037 0
Indonesia
Date submitted for ethics approval [1] 310037 0
Approval date [1] 310037 0
06/12/2021
Ethics approval number [1] 310037 0
012/ UN2.F6.D2.LPM/PPM.KEP/2021
Ethics committee name [2] 310047 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [2] 310047 0
Ethics committee country [2] 310047 0
Australia
Date submitted for ethics approval [2] 310047 0
Approval date [2] 310047 0
04/11/2021
Ethics approval number [2] 310047 0
30699

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

Contacts
Principal investigator
Name 116270 0
Prof Asad Islam
Address 116270 0
Centre for Development Economics and Sustainability (CDES)
Monash University

Building H, Level 4
900 Dandenong Road
Caulfield East 3145
VICTORIA
Country 116270 0
Australia
Phone 116270 0
+61399032783
Fax 116270 0
Email 116270 0
[email protected]
Contact person for public queries
Name 116271 0
Giovanni Empel
Address 116271 0
Centre for Health Economics (CHE)
Monash University

Building H, Level 5
900 Dandenong Road
Caulfield East 3145
VICTORIA
Country 116271 0
Australia
Phone 116271 0
+61426558932
Fax 116271 0
Email 116271 0
[email protected]
Contact person for scientific queries
Name 116272 0
Asad Islam
Address 116272 0
Centre for Development Economics and Sustainability (CDES)
Monash University

Building H, Level 4
900 Dandenong Road
Caulfield East 3145
VICTORIA
Country 116272 0
Australia
Phone 116272 0
+61399032783
Fax 116272 0
Email 116272 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?
Individual data after de-identification process
When will data be available (start and end dates)?
Data will be made available to interested researchers after we have publish the main results. This will be approximately within 1 year after the endline survey finished (around June 2022 - May 2023). The data will be available at least 5 (years) following the publication of main results (2027-2028).
Available to whom?
Interested researchers will have to submit formal request of access to the data along with a short proposal to the Primary Investigator.
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Application should be directed to the Primary Investigator
Professor Asad Islam ([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.