Chatbot-based Intervention to Promote Vaccine Acceptance in Varansi, India

NCT05994820 | Completed

• 1 other identifier: IRB00023512
• Study Type: interventional
• Target: 2,058
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn compare the efficacy Chatbot messaging directed to parents of infants and children living in unstable urban housing (UUH) in Varansi, India. The main questions it aims to answer are: 1) Can a Chatbot intervention be used to improve attitudes towards childhood vaccines? 2) Does an intervention in which vaccination is presented in the larger context of well-being improve attitudes towards vaccination?

Conditions

Vaccine Hesitancy

Keywords

Health Communication; Chatbot; Social Networks

Outcome Measures

Primary Outcomes (3)

• Post Intervention Vaccine Intentions

  Vaccine intentions will be assessed through 3-Likert type questions that ask participants to respond on a five-point scale (from strongly disagree to strongly agree, where higher scores mean more higher intentions). Responses will be averaged into an index (spanning from 0 = lowest intention to 5 = highest intention to vaccinate) to signify vaccine intentions. We will assess changes in these intentions from baseline to post-intervention.

  4 months

• Post Intervention Vaccine Attitudes

  Vaccine attitudes will be assessed through an 8-item scale using Likert-style questions that ask participants to respond on a five-point scale (from strongly disagree to strongly agree, where higher scores mean more positive agreement). Responses will be averaged into an index (spanning from 0 = lowest intention to 5 = highest intention to vaccinate) to signify vaccine attitudes. We will assess changes in these attitudes from baseline to post-intervention. Please note that, in this methodology, there is no need to create a binary "negative attitude" versus "positive attitude."

  4 months

• Post Intervention Vaccine Hesitancy

  Vaccine Hesitancy will be assessed through a validated 10-item scale from Shapiro et al. 2017. All items utilize a Likert-type response format. that ask participants to respond on a five-point scale (from strongly disagree to strongly agree, where higher scores mean more positive agreement) answers. Responses will be averaged into an index (spanning from 0 = most hesitancy, to 5 = least least hesitancy) to signify vaccine hesitancy. We will assess changes in hesitancy from baseline to post-intervention. Please note that, in this methodology, there is no need to create a binary "hesitant" versus "not hesitant."

  4 months

Secondary Outcomes (1)

• Parental Awareness of Vaccine Services

  4 months

Study Arms (3)

Control

NO INTERVENTION

These participants receive no intervention. No chatbot messaging. Usual care.

Vaccine Campaign

EXPERIMENTAL

These participants will receive the Happy Baby Programme messages through a WhatsApp Chatbot. All messages will be narrowly focused on vaccine promotion.

Behavioral: Happy Baby Programme -Vaccine Campaign

Vaccine++ Campaign

EXPERIMENTAL

These participants will receive the Happy Baby Programme messages through a WhatsApp Chatbot. All messages will promote vaccines in conjunction with other health-promotion activities (e.g. nutrition, breastfeeding, etc.).

Behavioral: Happy Baby Programme- Vaccine ++ Campaign

Interventions

Happy Baby Programme- Vaccine ++ Campaign BEHAVIORAL

The Happy Baby Programme is a WhatsApp based Chatbot designed to promote childhood vaccination in Hindi as part of a holistic healthy baby approach that includes nutrition and sanitation.

Vaccine++ Campaign

Eligibility Criteria

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

You may qualify if:

• Speak Hindi;
• Reside in selected UUH neighborhood of Varanasi, India;
• Identify as a caregiver of a young child (\<2) OR be at least 5 months pregnant and due to giver birth during the study period;
• Child is registered with local community health workers and included on patient rosters for vaccination clinics (also known as Village Health Sanitation and Nutrition Days (VHSNDs));
• Have regular access to a phone with WhatsApp.

You may not qualify if:

• Only one caregiver is eligible per household

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead

Study Sites (1)

D-COR (Development Corner) Consulting

Dwārka, New Delhi, 110077, India

Location

MeSH Terms

Conditions

Vaccination Hesitancy

Condition Hierarchy (Ancestors)

Vaccination Refusal; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Rajiv N Rimal, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: All parties are aware of assignment
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 16, 2023
• Study Start: September 26, 2023
• Primary Completion: February 10, 2024
• Study Completion: February 10, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)