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

Vaccine Hesitancy Clinical Trial

Official title:

Implementing and Evaluating a Chatbot-based Intervention to Promote Vaccine Acceptance in Varansi, India

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05994820
• Other study ID #: IRB00023512
• Secondary ID: IRB00023512
• Status: Completed
• Phase: N/A
• Start date: September 26, 2023
• Est. completion date: February 10, 2024

Study information

• Verified date: February 2024
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Description:

Only 2/3 of Indian infants and children are fully immunized. In communities facing unstable urban housing (UUH) vaccination rates are even lower. COVID-19 introduced new challenges for community health workers in these areas, and many do not have the capacity to promote vaccination. At the same time, the pandemic also prompted more parents and caregivers to engage with smartphones to manage the child's health. The investigators believe that a WhatsApp-based Chatbot intervention may be an effective way to promote routine childhood vaccination among caregivers without creating additional burdens on community health workers. To test this, the investigators are developing the Happy Baby Programme. This programme will be disseminated as a Chatbot through WhatsApp to parents of infants and young children living in Varanasi, in the Indian state of Uttar Pradesh. In addition to testing the overall efficacy of a Chatbot messaging platform, the investigators will compare two different Chatbot messaging designs, one featuring vaccine-only messaging and a second that positions vaccines as part of a broader set of well-being practices.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2058
• Est. completion date: February 10, 2024
• Est. primary completion date: February 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Only one caregiver is eligible per household
• Not meeting inclusion criteria.

Related Conditions & MeSH terms

• Vaccine Hesitancy

Intervention

Behavioral:
• Happy Baby Programme -Vaccine Campaign
The Happy Baby Programme is a WhatsApp based Chatbot designed to promote childhood vaccination in Hindi.
• Happy Baby Programme- Vaccine ++ Campaign
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.

Locations

Country	Name	City	State
India	D-COR (Development Corner) Consulting	Dwarka	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Parental Awareness of Vaccine Services	Awareness will be assessed through 2 knowledge based questions on a questionnaire administered after the intervention. Responses will scored on a three-point scale: 0 = not aware; 1 = aware but does not know the date; and 2= aware and knows the date. Higher scores correspond to greater awareness.	4 months