Enhancing Health Care Access With Cellular Technology

Vaccination Clinical Trial

Official title:

Enhancing Health Care Access With Cellular Technology: Networked and Mobile Technologies to Improve Uptake and Coverage of Vaccinations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03180138
• Other study ID #: IRB00086292
• Secondary ID: R03EB015955
• Status: Completed
• Phase: N/A
• Start date: July 11, 2016
• Est. completion date: July 20, 2017

Study information

• Verified date: June 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Despite the impressive economic progress in developing countries, significant proportion of young children and pregnant women living in low-resource settings remain inadequately immunized. Progressive decline in immunizations are in large part attributable to poor follow-up and compliance. National and international pediatric bodies, recommend a time sensitive schedule for childhood immunizations, boosting immunity with each subsequent cycle, leading to adequate levels of immune protection. Due to inadequate protective immunity, resulting from poor vaccination compliance, outbreaks of vaccine-preventable diseases are rampant, making childhood mortality in this group among the highest in the world. Major challenges of vaccination programs include maintaining / tracking records, linked to positive identification of individual children, and strategies to improve follow-up and compliance. Novel cellular technology based approaches targeting behavior modifications can therefore significantly impact health outcomes in these communities. In this proposal, the investigators will evaluate a novel software platform, utilizing biometric identification of subjects, paired with cell-phone reminders and compliance-linked incentives to improve uptake and coverage of primary vaccinations in young children and pregnant women.

Description:

A web-based, biometric-linked vaccination record, cell-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) Web-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 automated text message reminders and compliance-linked incentives.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 608
• Est. completion date: July 20, 2017
• Est. primary completion date: July 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 24 Months

Eligibility

Inclusion Criteria:

Mother-child (or caregiver-child) units with child <2 years of age OR Pregnant women

Exclusion Criteria:

Family does not have cell-phone OR cannot provide informed consent

Related Conditions & MeSH terms

• Vaccination

Intervention

Behavioral:
• Reminders alone
Automated reminders (text and /or voice in local language) for upcoming vaccination visit(s) will be provided via cell-phone to the subject (mother / caregiver) or pregnant woman.
• Compliance-linked incentives
Automated compliance-linked incentives (as cell-phone minutes) will be provided via cell-phone to the subject (mother / caregiver) or pregnant woman.

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Johns Hopkins University	Bal Umang Drishya Sanstha (BUDS), India, Ministry of Science and Technology, India, National Institute for Biomedical Imaging and Bioengineering (NIBIB), Royal Datamatics Pvt. Ltd. (RDPL), India, St. Louis University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunization Rate	Percent of the total number of immunizations received divided by the total number of immunizations required at the time of measurement for each child. Calculated for each child and in each cohort.	12 months
Secondary	Timeliness of Vaccinations	The percent of immunizations administered before or within 14 days after the scheduled date for the immunization. Calculated for each cohort.	12 months