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

• ClinicalTrials.gov Identifier: NCT05994820
• Recruitment Status: Completed
• First Posted: August 16, 2023
• Last Update Posted: March 1, 2024
• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Information provided by (Responsible Party): Johns Hopkins Bloomberg School of Public Health

Tracking Information

• First Submitted Date: August 9, 2023
• First Posted Date: August 16, 2023
• Last Update Posted Date: March 1, 2024
• Actual Study Start Date: September 26, 2023
• Actual Primary Completion Date: February 10, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 9, 2023)

• Post Intervention Vaccine Intentions [ Time Frame: 4 months ]
  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.
• Post Intervention Vaccine Attitudes [ Time Frame: 4 months ]
  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."
• Post Intervention Vaccine Hesitancy [ Time Frame: 4 months ]
  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."

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 9, 2023)

Parental Awareness of Vaccine Services [ Time Frame: 4 months ]

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Chatbot-based Intervention to Promote Vaccine Acceptance in Varansi, India
• Official Title: Implementing and Evaluating a Chatbot-based Intervention to Promote Vaccine Acceptance in Varansi, India
• 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?
• Detailed 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:

All parties are aware of assignment

Primary Purpose: Other

• Condition: 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.
• Behavioral: 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.

Study Arms

• No Intervention: Control
  These participants receive no intervention. No chatbot messaging. Usual care.
• Experimental: Vaccine Campaign
  These participants will receive the Happy Baby Programme messages through a WhatsApp Chatbot. All messages will be narrowly focused on vaccine promotion.
  Intervention: Behavioral: Happy Baby Programme -Vaccine Campaign
• Experimental: Vaccine++ Campaign
  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.).
  Intervention: Behavioral: Happy Baby Programme- Vaccine ++ Campaign

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 29, 2024): 2058
• Original Estimated Enrollment (submitted: August 9, 2023): 1950
• Actual Study Completion Date: February 10, 2024
• Actual Primary Completion Date: February 10, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT05994820
• Other Study ID Numbers: IRB00023512; IRB00023512 ( Other Identifier: JHSPH IRB )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: All participant data will be deidentified and stored on local servers (in India). American researchers will only access deidentified data for evaluation purposes.

• Current Responsible Party: Johns Hopkins Bloomberg School of Public Health
• Original Responsible Party: Same as current
• Current Study Sponsor: Johns Hopkins Bloomberg School of Public Health
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Rajiv N Rimal, PhD; Johns Hopkins University

• PRS Account: Johns Hopkins Bloomberg School of Public Health
• Verification Date: February 2024