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临床试验/NCT04177485
NCT04177485已完成不适用

Evaluating a Caregiver SMS Reminder Intervention to Reduce Immunization Drop-out in Arua, Uganda-a Randomized Controlled Trial

Centers for Disease Control and Prevention0 个研究点目标入组 1,962 人开始时间: 2016年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,962
主要终点
Number of participants who received MCV by 12 months of age as assessed by data abstraction of home-based records at endline survey.

研究概览

简要总结

Faced with high rates of immunization drop-out, Uganda's immunization program requires innovative approaches to address this weakness. Building upon Uganda's growing mHealth infrastructure to pilot a scalable short message service (SMS) system to remind caregivers of their children's upcoming vaccination visits, it was hypothesized that the SMS intervention will increase immunization coverage in a cost-effective and affordable manner that would make it scalable. The study design was an investigator-blinded, multi-center, parallel groups randomized controlled trial with randomization occurring at the caregiver level in select health facilities of Arua District in Uganda. Enrollment took place at the time of Pentavalent 1 vaccination, and both arms included standard of care provided by the health worker. However, in the intervention arm, caregivers also received SMS text messages reminding them to return for their children's second and third doses of Pentavalent vaccine (four and eight weeks after the first dose of Pentavalent vaccine) and measles-containing vaccine (9 months of age). The primary outcome of interest is vaccination coverage at 12 months of age among children enrolled in the study and will be measured by comparing Penta3 and MCV coverage between arms. The study will also examine the SMS impact on timeliness of vaccine receipt, as it is hypothesized that those children receiving the SMS intervention will be more likely to have timely vaccination than those in the control group. The study will also assess caregiver acceptability and cost-effectiveness of the SMS intervention. In addition to assessing its impact on strengthening the immunization program, this intervention has implications for strengthening other programs of the health system through similar health messaging directed toward caregivers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Care Provider, Investigator)

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Is a caregiver of a child between the ages of 6 weeks and 6 months of age and presents at one of the study sites for child's Penta1 vaccination
  • Access to a personal or household cell phone that can receive text messages
  • Lives in Arua district

排除标准

  • Does not have access to the cell phone number at time of registration
  • Does not agree or is unable to consent to participate in the study
  • Does not anticipate being the caregiver through the child's first birthday
  • Plans to move out of Arua district in the upcoming year
  • Prior enrollment of the caregiver with a different child

结局指标

主要结局

Number of participants who received MCV by 12 months of age as assessed by data abstraction of home-based records at endline survey.

时间窗: through study completion, an average of 12 months in the study

次要结局

  • Cost per additional child that is up-to-date with vaccination(through study completion, an average of 12 months in the study)
  • Number of participants who received all eligible vaccines (Penta2, PCV2, Polio2, Penta3, PCV3, Polio3, MCV) as assessed by data abstraction of home-based records and caregiver recall at endline survey.(through study completion, an average of 12 months in the study)
  • Number of participants who would be interested in receiving SMS immunization reminders for their next child, as assessed with a yes/no question at the endline survey.(through study completion, an average of 12 months in the study)
  • Number of participants who received Penta3 by 12 months of age as assessed by data abstraction of home-based records at endline survey.(through study completion, an average of 12 months in the study)
  • Number of participants who received Penta3 within 12 weeks of Penta1 as assessed by data abstraction of home-based records at endline survey.(through study completion, an average of 12 months in the study)
  • Number of participants who received MCV by 10 months of age as assessed by data abstraction of home-based records at endline survey.(through study completion, an average of 12 months in the study)

研究者

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Daniel Ehlman

Principal Investigator

Centers for Disease Control and Prevention

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