Timeliness of Immunization and Compliance Assessment Study (TICA)
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ClinicalTrials.gov Identifier: NCT03428776 |
Recruitment Status :
Completed
First Posted : February 12, 2018
Last Update Posted : September 27, 2019
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Condition or disease | Intervention/treatment | Phase |
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Vaccinations | Behavioral: Standard Compliance-linked incentives Behavioral: Intelligent Compliance-linked incentives Other: Record keeping | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2065 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Single blinded prospective study |
Masking: | Double (Investigator, Outcomes Assessor) |
Primary Purpose: | Health Services Research |
Official Title: | Timeliness of Immunization and Compliance Assessment Study |
Actual Study Start Date : | April 25, 2018 |
Actual Primary Completion Date : | September 25, 2019 |
Actual Study Completion Date : | September 25, 2019 |
Arm | Intervention/treatment |
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Sham Comparator: Controls
Self returns
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Other: Record keeping
Electronic immunization records on cloud-based software platform and use of biometric identification |
Active Comparator: Standard Compliance-linked incentives
Standard mobile-phone reminders and compliance-linked incentives
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Behavioral: Standard Compliance-linked incentives
Standard mobile-phone reminders and compliance-linked incentives Electronic immunization records on cloud-based software platform and use of biometric identification |
Active Comparator: Intelligent Compliance-linked incentives
Intelligent mobile-phone reminders and compliance-linked incentives
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Behavioral: Intelligent Compliance-linked incentives
Intelligent mobile-phone reminders and compliance-linked incentives Electronic immunization records on cloud-based software platform and use of biometric identification |
- Timeliness of immunization [ Time Frame: 12-15 months ]Defined as the proportion of immunizations administered before the scheduled date or within 14 days of the after scheduled date.
- Immunization rate [ Time Frame: 12-15 months ]Calculated for each individual child and defined as the proportion of the total number of immunizations received divided by the total number of immunizations required at the time of measurement (e.g. at enrollment, end of study, etc.).

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: | up to 24 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Mother (or caregiver) with one or more children ≤24 months in their family will be enrolled
- There will be no exclusion criteria based on race, ethnicity or gender.
Exclusion Criteria:
- Participants unable or unwilling to comply with the protocol or with any other condition that would impede compliance or hinder completion of the study (e.g. no mobile-phone in the family), or failure to give informed consent would be the only exclusion 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): NCT03428776
India | |
BUDS | |
Haryana, India, 21287 |
Principal Investigator: | Sanjay K Jain, MD | Johns Hopkins University |
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT03428776 |
Other Study ID Numbers: |
IRB00161339 |
First Posted: | February 12, 2018 Key Record Dates |
Last Update Posted: | September 27, 2019 |
Last Verified: | September 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |