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

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05225064
• Collaborator: University of Connecticut (Other), Lahore University of Management Sciences (Other), University of California, Berkeley (Other), Innovations for Poverty Action (Other)
• Enrollment: 114,512
• Location: 1
• Arms: 5
• Actual Duration (Months): 3.2
• Patients Per Site Per Month: 35565.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vaccination Refusal	Behavioral: Incentives to be vaccinated; Device: Mask; Behavioral: Encouragement to wear a mask; Behavioral: Vaccination made more convenient; Behavioral: Social mobilization campaign to be vaccinated	N/A

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

• Study Type: Interventional
• Actual Enrollment: 114512 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 promotionThere 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 (Investigator, Outcomes 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
• Primary Purpose: Prevention
• Official Title: Increasing COVID-19 Vaccine Uptake in Developing Countries (Bihar)
• Actual Study Start Date: Jan 19, 2022
• Actual Primary Completion Date: Apr 27, 2022
• Actual Study Completion Date: Apr 27, 2022

Arms and Interventions

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.	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; 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 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

Outcome Measures

Primary Outcome Measures

1. Percent of individuals who receive the first, second, or third dose of covid vaccine [up to 4 weeks (endline may vary depending on estimated uptake rates)]

   Prevalence of vaccination with difference doses

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Lives in study village

Exclusion Criteria:

• Does not live in study village

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Project Concern International	Patna	Bihar	India	800001

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT05225064
• Other Study ID Numbers: 2000031541
• First Posted: Feb 4, 2022
• Last Update Posted: Jun 22, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yale University: COVID-19; vaccination; masks; incentives
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Jun 22, 2022