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

June 20, 2022 updated by: Yale University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

114512

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Bihar
      • Patna, Bihar, India, 800001
        • Project Concern International

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Lives in study village

Exclusion Criteria:

  • Does not live in study village

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No vaccine or mask promotion, but access to vaccines increased to match access in intervention villages
Experimental: Village-level vaccine clinics with monetary, non-monetary, or no incentive
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.
Behavioral: Incentives to be vaccinated
Individuals will be provided with a guaranteed cash payment, entry into a cash lottery, or guaranteed gift of food if they are vaccinated
Behavioral: Vaccination made more convenient
Vaccines are conducted at the household-level rather than the village-level
Behavioral: Social mobilization campaign to be vaccinated
Village-level social mobilization campaign to be vaccinated
Experimental: Household-level vaccination with monetary or no incentive
Household-level vaccination with monetary incentive or no incentive. Villages are cross-randomized to grocery coupon or no incentive upon receiving vaccination
Behavioral: Incentives to be vaccinated
Individuals will be provided with a guaranteed cash payment, entry into a cash lottery, or guaranteed gift of food if they are vaccinated
Behavioral: Vaccination made more convenient
Vaccines are conducted at the household-level rather than the village-level
Behavioral: Social mobilization campaign to be vaccinated
Village-level social mobilization campaign to be vaccinated
Experimental: Village-level vaccination without incentive, plus mask promotion
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.
Behavioral: Vaccination made more convenient
Vaccines are conducted at the household-level rather than the village-level
Behavioral: Social mobilization campaign to be vaccinated
Village-level social mobilization campaign to be vaccinated
Device: Mask
Individuals are given cloth masks
Behavioral: Encouragement to wear a mask
Individuals who are not wearing masks over their mouth and nose are stopped in public places and encouraged to wear a mask
Experimental: Village-level vaccination without incentive
Individuals are encourage to attend village-level vaccine clinics but not given any incentive.
Behavioral: Vaccination made more convenient
Vaccines are conducted at the household-level rather than the village-level
Behavioral: Social mobilization campaign to be vaccinated
Village-level social mobilization campaign to be vaccinated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 4 weeks (endline may vary depending on estimated uptake rates)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

University of California, Berkeley
University of Connecticut
Innovations for Poverty Action
Lahore University of Management Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2022

Primary Completion (Actual)

April 27, 2022

Study Completion (Actual)

April 27, 2022

Study Registration Dates

First Submitted

February 2, 2022

First Submitted That Met QC Criteria

February 2, 2022

First Posted (Actual)

February 4, 2022

Study Record Updates

Last Update Posted (Actual)

June 22, 2022

Last Update Submitted That Met QC Criteria

June 20, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000031541

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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