Clinical trial NCT03180138: Enhancing Health Care Access With Cellular Technology
Official title: Enhancing Health Care Access With Cellular Technology: Networked and Mobile Technologies to Improve Uptake and Coverage of Vaccinations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccination
Keywords: mobile phone
Children's Health
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
name: Ministry of Science and Technology, India
name: Bal Umang Drishya Sanstha (BUDS), India
name: Royal Datamatics Pvt. Ltd. (RDPL), India
name: St. Louis University
First posted: 2017-06-08
Enrollment: 608
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blinded prospective study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Immunization Rate
timeFrame: 12 months
Secondary outcomes:
measure: Timeliness of Vaccinations
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Sanjay K Jain, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.
citation: Seth R, Akinboyo I, Chhabra A, Qaiyum Y, Shet A, Gupte N, Jain AK, Jain SK. Mobile Phone Incentives for Childhood Immunizations in Rural India. Pediatrics. 2018 Apr;141(4):e20173455. doi: 10.1542/peds.2017-3455. Epub 2018 Mar 14.