The Effect of Using Vaccine Reminder and Tracker Bracelets to Improve Routine Childhood Immunization Coverage and Timeliness in Pakistan: a Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,445
- 试验地点
- 4
- 主要终点
- Increase in immunization coverage in intervention versus control
研究概览
简要总结
Pakistan has one of the highest infant mortality rates in the world in part, due to the low coverage (54%) for all basic vaccinations. Low uptake, lack of awareness among parents to complete the recommended immunization schedule and inability to remember vaccine appointments are some of the key factors hindering improvement in uptake of immunization services. On the supply side, ineffective methods to track children's' vaccine doses means that there is no reliable mechanism to verify vaccine administration and estimate accurate immunization coverage.
This study proposes to develop and test two types of silicon bracelets for children to stimulate immunization demand and simultaneously address supply side verification issues. These bracelets use a combination of numbers and symbols to denote the age of the child and due vaccines and are designed for illiterate or uneducated mothers; are low-cost and adaptable to most local settings. At the time of vaccine administration, the appropriate symbol denoting the vaccine on the bracelets is punched and therefore the bracelets can serve as effective reminders for mothers for timely immunization of their child and as a tool for vaccinators to verify vaccine administration and coverage.
An individually randomized, three-arm parallel group design randomized control trial will be conducted with equal allocation in the two treatment groups and control group. Children in intervention group A will receive the simple silicon bracelets, children in intervention group B will receive the bracelets developed by Alma Sana Inc. and children in the Control group will not receive any intervention. The impact of these immunization reminder bracelets on immunization coverage and timeliness will be evaluated through a randomized control trial (RCT) across 4 immunization centers in Karachi. To evaluate the bracelets' impact, variables of interest-coverage and timeliness rates of pentavalent-3/PCV-3/polio-3 and Measles 1 vaccine will be compared between Group A and the Control Group and Group B and the Control Group.
Proposed results include increase in immunization coverage and timeliness of Pentavalent-3/Pneumococcal Conjugate Vaccine (PCV-3)/Polio-3 and Measles-1 in the intervention versus control group.
The study will provide evidence of the bracelet's effectiveness for the global health community and provide a simple tool for strengthening routine immunization efforts in Pakistan.
详细描述
The overall goal of the intervention is improvement in both immunization coverage rates and timeliness among the study participants through introducing simple silicon bracelets as childhood vaccination reminders and trackers.
An individually randomized, three-arm parallel group design randomized control trial will be conducted with equal allocation to evaluate the impact of the Alma Sana bracelet and simple silicon bracelet by comparing the variables of interest (coverage and timeliness rates of (pentavalent-3/PCV-3/polio-3 and Measles 1) between treatment groups and the Control Group.
Study Procedures:
A consent form will be used to seek consent from caregivers accompanying the child to screen the child for the study. Among those who provide consent, a screening form will be used to identify the eligible participants. After screening, seeking consent from primary caregivers (mother and/or father) they will be randomized into the treatment groups (to receive the bracelet) or to serve as a control. The randomization sequence will be created using Stata version 13 with a 1:1:1 allocation using random block sizes of 3, 6, 9 and 12. The allocation sequence will be concealed from the study staff responsible for screening and enrolling participants in serially numbered, opaque, sealed envelopes. After randomization, each child will be assigned a unique study ID (a sticker containing the study ID will be pasted on the child's government issued EPI card).
Details of the procedures in the intervention and control groups are outlined below:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
The allocation sequence will be concealed from the study staff responsible for screening and enrolling participants in serially numbered, opaque, sealed envelopes.
入排标准
- 年龄范围
- — 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child is visiting the center for BCG or Pentavalent-1/Polio-1/PCV-1 vaccination.
- •Child is healthy
- •Child's caregiver has been a resident of study area for more than 6 months
- •Child is accompanied by a primary caregiver (mother and/or father)
排除标准
- •Child's age is more than 3 months. The average age of children for Penta-1 vaccine visit in Pakistan is 2.2 months (approximately 10 weeks). Children older than 3 weeks will be excluded on account of exceeding the average age for Penta-1 administration.
- •Parents plan to go to a different center for completing the vaccination course
研究组 & 干预措施
Alma Sana Bracelet Arm
Subjects in this arm will receive a vaccine reminder and tracker bracelet developed by Alma Sana Inc. This bracelet uses a combination of symbols and numbers to denote the entire vaccine schedule a child is supposed to receive before the age of 2 years. Shapes indicate vaccines, and numbers signify the child's age.
干预措施: Alma Sana Bracelet (Other)
Simple Silicon Bracelet Arm
Subjects in this arm will receive a simple silicon bracelet. This bracelet has six symbols to remind parents that their child needs to get at least six vaccination visits before he reaches 2 years of age. The first five symbols are represented by a crescent shape and the sixth symbol is represented by a star shape to denote that the child is fully immunized.
干预措施: Simple Silicon Bracelet (Other)
Control Arm
Subjects in this arm will not receive any bracelet/intervention.
结局指标
主要结局
Increase in immunization coverage in intervention versus control
时间窗: The outcome will be measured after at least 9 months of follow up of the last participant enrolled
The primary outcome measure is the increase in coverage (i.e. the proportion of children getting vaccinated for) Pentavalent-3/PCV-3/polio-3 and Measles 1 vaccine in intervention versus control arm.
Increase in timeliness of immunization in intervention versus control
时间窗: The outcome will be measured after at least 9 months of follow up of the last participant enrolled
The primary outcome measure is the increase in timeliness of Pentavalent-3/PCV-3/polio-3 and Measles 1 vaccine in intervention versus control arm. Timeliness is defined as the proportion of children getting vaccinated for a particular antigen within the specified time duration i.e. a timely dose of Pentavalent-3/PCV-3/polio-3 is administered when the child is between 14 weeks and 22 weeks of age.
次要结局
- Comparison of timely immunization coverage rates between treatment groups(The outcome will be measured after at least 9 months of follow up of the last participant enrolled)
研究者
Danya Arif
Program Manager
Interactive Research and Development