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Completed

NCT Number: NCT05994820

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

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?

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Key information

Conditions

Vaccine Hesitancy Behavior Health Behavior Treatment Adherence and Compliance Treatment Refusal Vaccination Hesitancy Vaccination Refusal

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

D-COR (Development Corner) Consulting

Dwārka, New Delhi, 110077, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Happy Baby Programme -Vaccine Campaign

Behavioral

The Happy Baby Programme is a WhatsApp based Chatbot designed to promote childhood vaccination in Hindi.

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.

Primary outcomes

  1. 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.

  2. 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."

  3. 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."

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 16, 2023
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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