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Increasing COVID-19 Vaccine Uptake in Developing Countries (Bihar)

Primary Purpose

Vaccination Refusal

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Incentives to be vaccinated
Mask
Encouragement to wear a mask
Vaccination made more convenient
Social mobilization campaign to be vaccinated
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vaccination Refusal focused on measuring COVID-19, vaccination, masks, incentives

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Lives in study village

Exclusion Criteria:

  • Does not live in study village

Sites / Locations

  • Project Concern International

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Arm Label

Control

Village-level vaccine clinics with monetary, non-monetary, or no incentive

Household-level vaccination with monetary or no incentive

Village-level vaccination without incentive, plus mask promotion

Village-level vaccination without incentive

Arm Description

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. 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 incentive or no incentive. Villages are cross-randomized to grocery coupon or no incentive upon receiving vaccination

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.

Individuals are encourage to attend village-level vaccine clinics but not given any incentive.

Outcomes

Primary Outcome Measures

Percent of individuals who receive the first, second, or third dose of covid vaccine
Prevalence of vaccination with difference doses

Secondary Outcome Measures

Full Information

First Posted
February 2, 2022
Last Updated
June 20, 2022
Sponsor
Yale University
Collaborators
University of Connecticut, Lahore University of Management Sciences, University of California, Berkeley, Innovations for Poverty Action
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1. Study Identification

Unique Protocol Identification Number
NCT05225064
Brief Title
Increasing COVID-19 Vaccine Uptake in Developing Countries (Bihar)
Official Title
Increasing COVID-19 Vaccine Uptake in Developing Countries (Bihar)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 19, 2022 (Actual)
Primary Completion Date
April 27, 2022 (Actual)
Study Completion Date
April 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
University of Connecticut, Lahore University of Management Sciences, University of California, Berkeley, Innovations for Poverty Action

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaccination Refusal
Keywords
COVID-19, vaccination, masks, incentives

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Masking Description
The investigator and outcome assessor will be blind to study arm assignment. Due to the nature of the intervention, participants and care providers will not be blind to intervention assignment; however they are likely to be unaware of intervention components because they are not expect to communicate with those who are assigned to a different intervention arm
Allocation
Randomized
Enrollment
114512 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
No vaccine or mask promotion, but access to vaccines increased to match access in intervention villages
Arm Title
Village-level vaccine clinics with monetary, non-monetary, or no incentive
Arm Type
Experimental
Arm Description
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.
Arm Title
Household-level vaccination with monetary or no incentive
Arm Type
Experimental
Arm Description
Household-level vaccination with monetary incentive or no incentive. Villages are cross-randomized to grocery coupon or no incentive upon receiving vaccination
Arm Title
Village-level vaccination without incentive, plus mask promotion
Arm Type
Experimental
Arm Description
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.
Arm Title
Village-level vaccination without incentive
Arm Type
Experimental
Arm Description
Individuals are encourage to attend village-level vaccine clinics but not given any incentive.
Intervention Type
Behavioral
Intervention Name(s)
Incentives to be vaccinated
Intervention Description
Individuals will be provided with a guaranteed cash payment, entry into a cash lottery, or guaranteed gift of food if they are vaccinated
Intervention Type
Device
Intervention Name(s)
Mask
Intervention Description
Individuals are given cloth masks
Intervention Type
Behavioral
Intervention Name(s)
Encouragement to wear a mask
Intervention Description
Individuals who are not wearing masks over their mouth and nose are stopped in public places and encouraged to wear a mask
Intervention Type
Behavioral
Intervention Name(s)
Vaccination made more convenient
Intervention Description
Vaccines are conducted at the household-level rather than the village-level
Intervention Type
Behavioral
Intervention Name(s)
Social mobilization campaign to be vaccinated
Intervention Description
Village-level social mobilization campaign to be vaccinated
Primary Outcome Measure Information:
Title
Percent of individuals who receive the first, second, or third dose of covid vaccine
Description
Prevalence of vaccination with difference doses
Time Frame
up to 4 weeks (endline may vary depending on estimated uptake rates)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Lives in study village Exclusion Criteria: Does not live in study village
Facility Information:
Facility Name
Project Concern International
City
Patna
State/Province
Bihar
ZIP/Postal Code
800001
Country
India

12. IPD Sharing Statement

Learn more about this trial

Increasing COVID-19 Vaccine Uptake in Developing Countries (Bihar)

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