Improving Childhood Immunization
"Improving Childhood Immunizations with Cellular Technology"(Under Dr Rajeev Seth, Pediatrician & Indian Principal Investigator (PI), for execution through the non-profit organization, Bal Umang Drishya Sanstha (BUDS), from April 2018).
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 (NFHS, 2016). 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.
The study proposes an intelligent and subject-aware, cloud-based, GPS- and biometrically-linked immunization record, reminder and alert platform which leverages the existing mobile-phone connectivity and community resources in the developing world. This platform will be evaluated to improve immunization coverage and timeliness of routine immunizations in young children in low-resource settings. The group will build on an ongoing Indo-US collaboration with Non-Governmental Organization (NGO) – Bal Umang Drishya Sanstha (BUDS) and a private software company – Royal Datamatics Pvt. Ltd. (RDPL), both operating locally in Delhi, India with Johns Hopkins University, USA.
The central hypothesis is that an intelligent and subject-aware, cloud-based, GPS- and biometrically-linked platform to: a) electronically record immunizations for each subject; b) promote group immunizations for children within the same “family” units; c) alert and trigger home-visits for non-compliant subjects and; d) verify home-visits by GPS-tracking, will significantly improve the immunization coverage and timeliness of routine immunizations in low-resource settings
The study proposes to generate essential data on whether an intelligent, subject-aware, cloud-based platform can improve timeliness of routine immunizations.
The project proposal is implementing a cloud-based, biometric-linked immunization record and reminder platform in a low-resource, rural community of Mewat, Haryana, India. A target enrollment of 1,500 children was proposed in villages Shikarpur, Malaka, Buraka, Guraka, Rehari, Salaka, Padheni, Dhulawat, Kharkhadi, Ghusbethi, Kiruri, Bhutlaka, Patluka, Pipaka in Block Tauru & Village Ghasera Mewat, Haryana. Children aged ≤24 months from these rural communities are randomly assigned to a control and two study groups (a) self-returns (control); (b) standard reminders + compliance-linked incentives and (c) intelligent reminders + compliance-linked incentives. The ethical committee has assessed that the study started recruitment on April 25, 2018 and as of Dec 28, 2018, 1,353 children were consented and randomized. Preliminary data suggests that during the course of the study, there was an increase in the vaccination rates from a median of ~40% at enrollment to ~68.5% at the interim analysis (December 28, 2018). Since the investigators remain blinded, they do not know whether all or specific groups are contributing to this effect. However, this allows them to re-calculate our power for the outcomes of the study. Based on these data, they will increase the sample size to 2,064. Power calculations are based upon 2,064 children randomly allocated in a 1:1:1 fashion to each of the three study arms. They further assumed a 10% drop out or loss to follow-up in this study population resulting in a total of 1,875 (625 per arm). With this sample size, they will be able to detect: For timeliness of immunizations: < 10% increase in the experimental groups combined (b and c) compared with the control group (a). For immunization rate: < 12% increase the experimental groups combined (b and c) compared with the control group (a). Both are at a 0.05 alpha level and 80% power.
The PI anticipates that they shall need to continue the study until July 25, 2019 to enroll 2064 children. Given the need to follow the subjects for more time, the PI requested and has received permission from IRB to continue till December31, 2019. The study can always stop early based on PI achieving the study parameters.