Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 95 for:    vaccination | India
Previous Study | Return to List | Next Study

Timeliness of Immunization and Compliance Assessment Study (TICA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03428776
Recruitment Status : Active, not recruiting
First Posted : February 12, 2018
Last Update Posted : July 8, 2019
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Bal Umang Drishya Sanstha (BUDS), India
Royal Datamatics Pvt. Ltd. (RDPL), India
St. Louis University
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
Although coverage for primary childhood immunizations has improved, a significant proportion of young children and pregnant women living in low-resource settings remain inadequately immunized. While young children receive some primary vaccines, many are never fully vaccinated. Progressive decline in immunizations are in large part attributable to poor follow-up and compliance. Major challenges include maintaining immunization records linked to positive identification of the individual child, incentivizing follow-up and return immunizations and efficiently identifying and targeting non-compliant subjects. Mobile-phone costs have decreased dramatically in the developing world with rapid proliferation of web and mobile-phone connectivity. Novel approaches that integrate these modern technologies with existing resources in low and middle income countries can cost-effectively address these challenges. In this proposal, investigators will evaluate a novel software platform, utilizing biometric identification and of subjects, paired with intelligent and subject-aware, mobile-phone reminders and compliance-linked incentives to improve uptake and coverage of primary vaccinations in young children.

Condition or disease Intervention/treatment Phase
Vaccinations Behavioral: Standard Compliance-linked incentives Behavioral: Intelligent Compliance-linked incentives Other: Record keeping Not Applicable

Detailed Description:
A cloud-based, biometric-linked vaccination record, mobile-phone reminder and compliance-linked incentive software platform to provide robust and universal access of vaccinations. The investigators will implement this platform in a low-resource settings with the following features: a) Cloud-based for robust and universal access. b) Biometric-linked for positive identification. c) Digital storage and reporting for transparent view of program operations. d) Global Positioning System (GPS)-linked, allowing rapid assessment of vaccination status of communities. e) Increasing vaccination uptake and coverage by intelligent and subject-aware automated reminders and compliance-linked incentives.

Layout table for study information
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
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : April 2020

Arm Intervention/treatment
Sham Comparator: Controls
Self returns
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
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
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.).



Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

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


Locations
Layout table for location information
India
BUDS
Haryana, India, 21287
Sponsors and Collaborators
Johns Hopkins University
Bill and Melinda Gates Foundation
Bal Umang Drishya Sanstha (BUDS), India
Royal Datamatics Pvt. Ltd. (RDPL), India
St. Louis University
Investigators
Layout table for investigator information
Principal Investigator: Sanjay K Jain, MD Johns Hopkins University

Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03428776     History of Changes
Other Study ID Numbers: IRB00161339
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Vaccines
Immunologic Factors
Physiological Effects of Drugs