Mobile Health Solutions Combined With Behavior Change Approaches to Improve Vaccination Coverage and Timeliness in Bangladesh: a Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 7,800
- 主要终点
- Full vaccination
研究概览
简要总结
Noncompliance and delay in vaccination have caused millions of preventable deaths worldwide particularly in low-and middle-income countries (LMICs). The main reasons for delay in vaccinations or dropout from vaccination programs are vaccine hesitancy, lack of knowledge, forgetting due date, lack of trust, and religious and social barriers. Recently, various mobile health (mHealth) interventions such as voice call, text message reminders have been implemented in LMICs to improve awareness of vaccine availability and provide timely reminders. However, the implication and impact assessment of mHealth interventions with behavior change message for improving vaccination coverage and timeliness is limited. In this project, a three-armed cluster randomized controlled trial (cRCT) will be conducted to assess the impact and cost-effectiveness of mHealth interventions with behavioral change approach on vaccination coverage and timeliness in Bangladesh. A total of 7800 caregivers of children aged less than 4 weeks will be recruited and randomly allocated equally to each arm: control, voice call, and short message service (SMS) reminders with behavioral change message. The primary outcomes will include coverage of full immunization among children in first year of life, and secondary outcomes will be coverage for each vaccine, timeliness, and infant mortality.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •You are the infant's caregiver (mother, father, or legal guardian).
- •The infant is less than 4 weeks (28 days) old at the time of enrollment.
- •You reside within the jurisdiction of the designated community health center and have no plans to move within the next 12 months.
- •Depending on your assigned group, you can do one of the following:
- •You can read Bengali SMS messages yourself.
- •You can receive support from a family member living with you who reads Bengali aloud.
- •(Note: For the voice call group, literacy is not an issue.)
- •You understand the content of this study and have completed the required informed consent form.
排除标准
- •Caregivers of children aged 4 weeks or older at the time of enrollment
- •Children who have received any vaccine other than BCG or polio at birth
- •The caregiver plans to move out of the study area within the next six months.
- •The caregiver does not want to receive the vaccination at the intervention health center.
- •The caregiver (father, mother, or other family member) does not have a phone.
研究组 & 干预措施
Automatic voice call
An automatic voice call will be sent on 3 days and one day before the scheduled visit at 6 weeks, 10 weeks, and 14 weeks for the three doses of DPT vaccine and age 9 months for MCV1 vaccine.
干预措施: Automated voice reminders with behavior change messages (Behavioral)
Text with behavior change messages
The study participant will receive the text message 3 and 1 days before the vaccination schedule
干预措施: Text with behavior change message (Behavioral)
Control
The participant of the control group will receive only standard care.
干预措施: Control (Other)
结局指标
主要结局
Full vaccination
时间窗: 1 year
Full vaccination coverage by 12 months of age is defined as receiving all scheduled vaccines (BCG, 3 doses of DPT, 3 doses of polio, and 1 dose of MCV1).
Vaccine Timeliness
时间窗: 1 year
Timeliness of vaccination: measured by whether each vaccine was administered within 2 weeks of the recommended schedule (at ages 6 weeks, 10 weeks, 14 weeks, and 9 months)
次要结局
- Vaccination coverage(1 year)
- Cost-effectiveness of the intervention(1 year after)
研究者
ISLAM MD RASHEDUL
Principal Investigator
Japan Institute for Health Secutiry