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

NCT05225064 | Completed

• 1 other identifier: 2000031541
• Study Type: interventional
• Target: 114,512
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaccination Refusal

Keywords

COVID-19; vaccination; masks; incentives

Outcome Measures

Primary Outcomes (1)

• Percent of individuals who receive the first, second, or third dose of covid vaccine

  Prevalence of vaccination with difference doses

  up to 4 weeks (endline may vary depending on estimated uptake rates)

Study Arms (5)

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.

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

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.

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.

Behavioral: Vaccination made more convenient; Behavioral: Social mobilization campaign to be vaccinated

Interventions

Incentives to be vaccinated BEHAVIORAL

Individuals will be provided with a guaranteed cash payment, entry into a cash lottery, or guaranteed gift of food if they are vaccinated

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

Mask DEVICE

Individuals are given cloth masks

Village-level vaccination without incentive, plus mask promotion

Encouragement to wear a mask BEHAVIORAL

Individuals who are not wearing masks over their mouth and nose are stopped in public places and encouraged to wear a mask

Village-level vaccination without incentive, plus mask promotion

Vaccination made more convenient BEHAVIORAL

Vaccines are conducted at the household-level rather than the village-level

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 vaccinated BEHAVIORAL

Village-level social mobilization campaign to be vaccinated

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

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Lives in study village

You may not qualify if:

• Does not live in study village

Sponsors & Collaborators

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

Study Sites (1)

Project Concern International

Patna, Bihar, 800001, India

Location

MeSH Terms

Conditions

Vaccination Refusal; COVID-19

Interventions

Masks

Condition Hierarchy (Ancestors)

Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 4, 2022
• Study Start: January 19, 2022
• Primary Completion: April 27, 2022
• Study Completion: April 27, 2022
• Last Updated: June 22, 2022

Record last verified: 2022-06

Locations

IN (1)