Effect of vaccine reminder and tracker bracelets on routine childhood immunization coverage and timeliness in urban Pakistan: protocol for a randomized controlled trial

Inability to track children’s vaccination history coupled with parents’ lack of awareness of vaccination due dates compounds the problem of low immunization coverage and timeliness in developing countries. Traditional Reminder/Recall (RR) interventions such as paper-based immunization cards or mHealth based platforms do not yield optimal results in resource-constrained settings. There is thus a need for a low-cost intervention that can simultaneously stimulate demand and track immunization history to help reduce drop-outs and improve immunization coverage and timeliness. The objective of this study is to evaluate the impact of low-cost vaccine reminder and tracker bracelets for improving routine childhood immunization coverage and timeliness in Pakistani children under 2 years of age. The study is an individually randomized, three-arm parallel Randomized Controlled Trial with two intervention groups and one control group. Infants in the two intervention groups will be given two different types of silicone bracelets at the time of recruitment, while infants in the control group will not receive any intervention. The two types of bracelets consist of symbols and/or numbers to denote the EPI vaccination schedule and each time the child will come for vaccination, the study staff will perforate a hole in the appropriate symbol to denote vaccine administration. Therefore, by looking at the bracelet, caregivers will be able to see how many vaccines have been received. Our primary outcome measure is the increase in coverage and timeliness of Pentavalent-3/PCV-3/Polio-3 and Measles-1 vaccine in the intervention versus control groups. A total of 1446 participants will be recruited from 4 Expanded Program on Immunization (EPI) centers in Landhi Town, Karachi. Each enrolled child will be followed up till the Measles-1 vaccine is administered, or till eleven months have elapsed since enrolment. Participant recruitment commenced on July 19, 2017, and was completed on October 10, 2017. Proposed duration of the study is 18 months and expected end date is December 1, 2018. This study constitutes one of the first attempts to rigorously evaluate an innovative, low-cost vaccine reminder bracelet. ClinicalTrials.gov NCT03310762 . Retrospectively Registered on October 16, 2017.