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

NCT05225064 — Not applicable, Completed, 114512 participants, Yale University

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Registry	NCT05225064
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, prevention
Enrollment	114512 (Actual)
Sponsor	Yale University (Other); collaborators: University of Connecticut, Lahore University of Management Sciences, University of California, Berkeley, Innovations for Poverty Action
Conditions	Vaccination Refusal
Interventions	Incentives to be vaccinated, Mask, Encouragement to wear a mask, Vaccination made more convenient, Social mobilization campaign to be vaccinated (Behavioral, device)
Dates	start 2022-01-19, primary completion 2022-04-27, completion 2022-04-27, first posted 2022-02-04, last updated 2022-06-22
Locations	1 site in India

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
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 vaccinated	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 or no incentive	Experimental	Behavioral: Incentives to be vaccinated; Behavioral: Vaccination made more convenient; Behavioral: Social mobilization campaign to be vaccinated	Household-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 vaccinated	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.
Village-level vaccination without incentive	Experimental	Behavioral: Vaccination made more convenient; Behavioral: Social mobilization campaign to be vaccinated	Individuals are encourage to attend village-level vaccine clinics but not given any incentive.

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
Mask (Device): Individuals are given cloth masks
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
Vaccination made more convenient (Behavioral): Vaccines are conducted at the household-level rather than the village-level
Social mobilization campaign to be vaccinated (Behavioral): Village-level social mobilization campaign to be vaccinated

+Outcome measures

Primary outcomes

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

Sex: All, ages: 15 Years to any, accepts healthy volunteers

Inclusion Criteria:

* Lives in study village

Exclusion Criteria:

* Does not live in study village

+Locations (1)

Facility	City	Country	Status
Project Concern International	Patna, Bihar	India