疫苗提醒和追踪手环对巴基斯坦城市儿童常规免疫接种覆盖率和及时性的影响:一项随机对照试验方案。
Effect of vaccine reminder and tracker bracelets on routine childhood immunization coverage and timeliness in urban Pakistan: protocol for a randomized controlled trial.
机构信息
IRD Pakistan, 4th Floor, Woodcraft Building, Plot 3 & 3-A, Sector 47, Korangi Creek Road, Karachi, Pakistan.
IRD Global, 583 Orchard Road, #06-01 Forum, 238884, Singapore.
出版信息
BMC Public Health. 2019 Oct 30;19(1):1421. doi: 10.1186/s12889-019-7667-3.
BACKGROUND
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.
METHODS
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.
DISCUSSION
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.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03310762 . Retrospectively Registered on October 16, 2017.
背景
发展中国家儿童疫苗接种记录难以追踪,加之家长对疫苗接种时间缺乏认识,导致免疫接种覆盖率和及时性低的问题更加严重。传统的提醒/召回(RR)干预措施,如纸质免疫卡或基于移动医疗的平台,在资源有限的情况下并不能取得最佳效果。因此,需要一种低成本的干预措施,既能刺激需求,又能跟踪免疫接种记录,以帮助减少流失,提高免疫接种覆盖率和及时性。本研究旨在评估低成本疫苗提醒和跟踪手环对提高巴基斯坦 2 岁以下儿童常规儿童免疫接种覆盖率和及时性的影响。
方法
本研究为一项个体随机、三臂平行随机对照试验,有两组干预组和一组对照组。在招募时,两组干预组的婴儿将分别戴上两种不同类型的硅树脂手环,而对照组的婴儿将不接受任何干预。两种类型的手环上都有符号和/或数字来表示 EPI 疫苗接种时间表,每次孩子来接种疫苗时,研究人员都会在适当的符号上打一个孔,表示疫苗接种。因此,通过查看手环,照顾者就能看到已经接种了多少疫苗。我们的主要观察指标是干预组与对照组之间五联疫苗/PCV-3/脊髓灰质炎-3 和麻疹-1 疫苗覆盖率和及时性的提高。总共将从卡拉奇兰迪镇的 4 个扩大免疫规划(EPI)中心招募 1446 名参与者。每个入组的儿童将被随访至麻疹-1 疫苗接种完成,或自入组后 11 个月。
讨论
参与者招募于 2017 年 7 月 19 日开始,于 2017 年 10 月 10 日完成。研究预计持续 18 个月,预计结束日期为 2018 年 12 月 1 日。本研究是首次尝试严格评估一种创新的、低成本的疫苗提醒手环。
试验注册
ClinicalTrials.gov NCT03310762。2017 年 10 月 16 日回顾性注册。