Chatbot-based Intervention to Promote Vaccine Acceptance in Varansi, India
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ClinicalTrials.gov Identifier: NCT05994820 |
Recruitment Status :
Completed
First Posted : August 16, 2023
Last Update Posted : March 1, 2024
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Condition or disease | Intervention/treatment | Phase |
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Vaccine Hesitancy | Behavioral: Happy Baby Programme -Vaccine Campaign Behavioral: Happy Baby Programme- Vaccine ++ Campaign | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2058 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Masking Description: | All parties are aware of assignment |
Primary Purpose: | Other |
Official Title: | Implementing and Evaluating a Chatbot-based Intervention to Promote Vaccine Acceptance in Varansi, India |
Actual Study Start Date : | September 26, 2023 |
Actual Primary Completion Date : | February 10, 2024 |
Actual Study Completion Date : | February 10, 2024 |
Arm | Intervention/treatment |
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No Intervention: Control
These participants receive no intervention. No chatbot messaging. Usual care.
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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.
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Behavioral: Happy Baby Programme -Vaccine Campaign
The Happy Baby Programme is a WhatsApp based Chatbot designed to promote childhood vaccination in Hindi. |
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.).
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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. |
- 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."
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05994820
India | |
D-COR (Development Corner) Consulting | |
Dwārka, New Delhi, India, 110077 |
Principal Investigator: | Rajiv N Rimal, PhD | Johns Hopkins University |
Responsible Party: | Johns Hopkins Bloomberg School of Public Health |
ClinicalTrials.gov Identifier: | NCT05994820 |
Other Study ID Numbers: |
IRB00023512 IRB00023512 ( Other Identifier: JHSPH IRB ) |
First Posted: | August 16, 2023 Key Record Dates |
Last Update Posted: | March 1, 2024 |
Last Verified: | February 2024 |
Individual Participant Data (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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Health Communication Chatbot Social Networks |
Vaccines Immunologic Factors Physiological Effects of Drugs |