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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05994820
Other study ID # IRB00023512
Secondary ID IRB00023512
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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