Vaccination RefusalNCT05225064
Increasing COVID-19 Vaccine Uptake in Developing Countries (Bihar)
A study testing Incentives to be vaccinated, Mask and Encouragement to wear a mask in people with Vaccination Refusal, run by Yale University at 1 site in India.
Trial summary
Working with governments in Bihar, India, we will evaluate a number of mechanisms to increase vaccine uptake. These include household vaccination visits instead of community vaccination clinic.monetary and non-monetary incentives, and concurrent mask promotion. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccination Refusal
- What is being tested?
- Incentives to be vaccinated, Mask and Encouragement to wear a mask
- Type of treatment
- Vaccines, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114,512 participants
- Where
- 1 siteIndia
- Study dates
- 19 Jan 2022to 27 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Lives in study village
Who cannot join
- Does not live in study village
Trial locations and contacts
1 site in 1 country.
About this study
Working with governments in Bihar, India, we will evaluate a number of mechanisms to increase vaccine uptake. These include household vaccination visits instead of community vaccination clinic.monetary and non-monetary incentives, and concurrent mask promotion. This ClinicalTrials entry contains results only for the study in Bihar.
Read the detailed description
The goal of the study is to identify strategies that best promote and support COVID vaccine uptake in developing countries, we propose to test a range of scalable social and behavioural interventions. This could help policy makers design and employ interventions that are effective. This is especially valuable in resource constrained contexts where funds and institutional resources can be diverted towards interventions that have proven to work.
In Bihar the intervention will be village-level social mobilization involving community promotion, including in-person vaccine reinforcement, and household-level social mobilization. Some treatment villages will receive household- level interventions with varying intensity (different proportion of households will be visited). There will also an accompanying mask distribution campaign during household visits where the importance of mask-wearing as a complement to vaccine use will be explained.
This ClinicalTrials entry contains results only for the study in Bihar.
- Conditions
- Vaccination Refusal
- Being tested
- Incentives to be vaccinated, Mask, Encouragement to wear a mask, Vaccination made more convenient, Social mobilization campaign to be vaccinated
- Keywords
- COVID-19, vaccination, masks, incentives
- Medical subject headings
- Vaccination Refusal, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incentives to be vaccinatedBehavioural
Individuals will be provided with a guaranteed cash payment, entry into a cash lottery, or guaranteed gift of food if they are vaccinated
MaskDevice
Individuals are given cloth masks
Encouragement to wear a maskBehavioural
Individuals who are not wearing masks over their mouth and nose are stopped in public places and encouraged to wear a mask
Vaccination made more convenientBehavioural
Vaccines are conducted at the household-level rather than the village-level
Social mobilization campaign to be vaccinatedBehavioural
Village-level social mobilization campaign to be vaccinated
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No vaccine or mask promotion, but access to vaccines increased to match access in intervention villages |
| Village-level vaccine clinics with monetary, non-monetary, or no incentive | Experimental | Village-level vaccine clinics with monetary, non-monetary, or no incentive. Villages are cross-randomized to grocery coupon, food ration, no incentive, or grocery coupon to both community member and community health worker after the community member has received a vaccination. Receives: Behavioral: Incentives to be vaccinated; Behavioral: Vaccination made more convenient; Behavioral: Social mobilization campaign to be vaccinated |
| Household-level vaccination with monetary or no incentive | Experimental | Household-level vaccination with monetary incentive or no incentive. Villages are cross-randomized to grocery coupon or no incentive upon receiving vaccination Receives: Behavioral: Incentives to be vaccinated; Behavioral: Vaccination made more convenient; Behavioral: Social mobilization campaign to be vaccinated |
| Village-level vaccination without incentive, plus mask promotion | Experimental | Individuals are encourage to attend village-level vaccine clinics but not given any incentive. Mask distribution and reinforcement activities are conducted in villages at a similar time as vaccine promotion. Receives: Device: Mask; Behavioral: Encouragement to wear a mask; Behavioral: Vaccination made more convenient; Behavioral: Social mobilization campaign to be vaccinated |
| Village-level vaccination without incentive | Experimental | Individuals are encourage to attend village-level vaccine clinics but not given any incentive. Receives: Behavioral: Vaccination made more convenient; Behavioral: Social mobilization campaign to be vaccinated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of individuals who receive the first, second, or third dose of covid vaccine
Prevalence of vaccination with difference doses
Measured: up to 4 weeks (endline may vary depending on estimated uptake rates)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start19 Jan 2022
- Primary completion27 Apr 2022
- Study completion27 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccination RefusalStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are five arms. Arm 1: Control; Arm 2: Village-level vaccine clinics with monetary, non-monetary, or no incentive; Arm 3: Household-level vaccination with monetary, non-monetary, or no incentive; Arm 4: Mask promotion; Arm 5: Village-level vaccine clinics and mask promotion
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 114,512 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Connecticut, Lahore University of Management Sciences, University of California, Berkeley, Innovations for Poverty Action
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225064
- Sponsor's protocol ID
- 2000031541
- Status last verified
- Jun 2022
- First submitted
- 2 Feb 2022
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing COVID-19 Vaccine Uptake in Developing Countries (Bihar)
- ClinicalTrials.gov ID
- NCT05225064
- Acronym / sponsor ID
- 2000031541
- Conditions
- Vaccination Refusal
- Keywords
- COVID-19, vaccination, masks, incentives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114,512 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- University of Connecticut, Lahore University of Management Sciences, University of California, Berkeley, Innovations for Poverty Action
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 27 Apr 2022 (actual)
- Study completion
- 27 Apr 2022 (actual)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Working with governments in Bihar, India, we will evaluate a number of mechanisms to increase vaccine uptake. These include household vaccination visits instead of community vaccination clinic.monetary and non-monetary incentives, and concurrent mask promotion. This ClinicalTrials entry contains results only for the study in Bihar.
Detailed description
The goal of the study is to identify strategies that best promote and support COVID vaccine uptake in developing countries, we propose to test a range of scalable social and behavioural interventions. This could help policy makers design and employ interventions that are effective. This is especially valuable in resource constrained contexts where funds and institutional resources can be diverted towards interventions that have proven to work.
In Bihar the intervention will be village-level social mobilization involving community promotion, including in-person vaccine reinforcement, and household-level social mobilization. Some treatment villages will receive household- level interventions with varying intensity (different proportion of households will be visited). There will also an accompanying mask distribution campaign during household visits where the importance of mask-wearing as a complement to vaccine use will be explained.
This ClinicalTrials entry contains results only for the study in Bihar.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- There are five arms. Arm 1: Control; Arm 2: Village-level vaccine clinics with monetary, non-monetary, or no incentive; Arm 3: Household-level vaccination with monetary, non-monetary, or no incentive; Arm 4: Mask promotion; Arm 5: Village-level vaccine clinics and mask promotion
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No vaccine or mask promotion, but access to vaccines increased to match access in intervention villages |
| Village-level vaccine clinics with monetary, non-monetary, or no incentive | Experimental | Behavioral: Incentives to be vaccinated, Behavioral: Vaccination made more convenient, Behavioral: Social mobilization campaign to be vaccinatedVillage-level vaccine clinics with monetary, non-monetary, or no incentive. Villages are cross-randomized to grocery coupon, food ration, no incentive, or grocery coupon to both community member and community health worker after the community member has received a vaccination. |
| Household-level vaccination with monetary or no incentive | Experimental | Behavioral: Incentives to be vaccinated, Behavioral: Vaccination made more convenient, Behavioral: Social mobilization campaign to be vaccinatedHousehold-level vaccination with monetary incentive or no incentive. Villages are cross-randomized to grocery coupon or no incentive upon receiving vaccination |
| Village-level vaccination without incentive, plus mask promotion | Experimental | Device: Mask, Behavioral: Encouragement to wear a mask, Behavioral: Vaccination made more convenient, Behavioral: Social mobilization campaign to be vaccinatedIndividuals are encourage to attend village-level vaccine clinics but not given any incentive. Mask distribution and reinforcement activities are conducted in villages at a similar time as vaccine promotion. |
| Village-level vaccination without incentive | Experimental | Behavioral: Vaccination made more convenient, Behavioral: Social mobilization campaign to be vaccinatedIndividuals are encourage to attend village-level vaccine clinics but not given any incentive. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Lives in study village
Key exclusion criteria (1 listed)
- Does not live in study village
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incentives to be vaccinatedIndividuals will be provided with a guaranteed cash payment, entry into a cash lottery, or guaranteed gift of food if they are vaccinated | Behavioural | Household-level vaccination with monetary or no incentive, Village-level vaccine clinics with monetary, non-monetary, or no incentive |
| MaskIndividuals are given cloth masks | Device | Village-level vaccination without incentive, plus mask promotion |
| Encouragement to wear a maskIndividuals who are not wearing masks over their mouth and nose are stopped in public places and encouraged to wear a mask | Behavioural | Village-level vaccination without incentive, plus mask promotion |
| Vaccination made more convenientVaccines are conducted at the household-level rather than the village-level | Behavioural | Household-level vaccination with monetary or no incentive, Village-level vaccination without incentive, Village-level vaccination without incentive, plus mask promotion, Village-level vaccine clinics with monetary, non-monetary, or no incentive |
| Social mobilization campaign to be vaccinatedVillage-level social mobilization campaign to be vaccinated | Behavioural | Household-level vaccination with monetary or no incentive, Village-level vaccination without incentive, Village-level vaccination without incentive, plus mask promotion, Village-level vaccine clinics with monetary, non-monetary, or no incentive |
Primary outcome
Percent of individuals who receive the first, second, or third dose of covid vaccine
Time frame: up to 4 weeks (endline may vary depending on estimated uptake rates)
Prevalence of vaccination with difference doses
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incentives to be vaccinated, Mask and Encouragement to wear a mask in people with Vaccination Refusal, run by Yale University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of individuals who receive the first, second, or third dose of covid vaccine (time frame: up to 4 weeks (endline may vary depending on estimated uptake rates)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.