Timeliness of Immunization and Compliance Assessment Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Timeliness of Immunization and Compliance Assessment Study

Conditions
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Vaccinations

Intervention / Treatment
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* Behavioral: Standard Compliance-linked incentives
* Behavioral: Intelligent Compliance-linked incentives
* Other: Record keeping


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single blinded prospective study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Controls<br>Self returns | Other: Record keeping<br>* Electronic immunization records on cloud-based software platform and use of biometric identification<br>|
| Active Comparator: Standard Compliance-linked incentives<br>Standard mobile-phone reminders and compliance-linked incentives | Behavioral: Standard Compliance-linked incentives<br>* Standard mobile-phone reminders and compliance-linked incentives Electronic immunization records on cloud-based software platform and use of biometric identification<br>|
| Active Comparator: Intelligent Compliance-linked incentives<br>Intelligent mobile-phone reminders and compliance-linked incentives | Behavioral: Intelligent Compliance-linked incentives<br>* Intelligent mobile-phone reminders and compliance-linked incentives Electronic immunization records on cloud-based software platform and use of biometric identification<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timeliness of immunization | Defined as the proportion of immunizations administered before the scheduled date or within 14 days of the after scheduled date. | 12-15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunization rate | 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.). | 12-15 months |