Testing a Biometric Identification System to Improve Malaria Vaccine Completion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4,715
- 试验地点
- 1
- 主要终点
- Completion of full malaria sequence (Index children)
研究概览
简要总结
Receiving all four doses of the malaria vaccine can significantly protect children against malaria illness, hospitalization, and death. However, in Ghana, only 46% of children complete the full vaccination sequence. More broadly, many children in Ghana do not receive the full set of recommended pediatric vaccinations. To address this, Simprints, in collaboration with Ghana Health Services, will implement a digital vaccination record system linked to biometrics. This system will automatically identify children who are behind on their vaccination schedule, providing health workers with information to prioritize community outreach. Additionally, it will send voice message reminders to caregivers to improve compliance. A cluster-randomized controlled trial (c-RCT) will be conducted in the Oti region to measure the impact of this innovation on the proportion of children completing malaria and routine vaccination schedules.
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
入排标准
- 年龄范围
- 15 Years 至 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women (in the last two trimesters), aged 15-49 years old, who do not plan to permanently move in the next 12 months.
- •Women with children under 6 months old, aged 15-49 years old, who do not plan to permanently move in the next 12 months.
排除标准
- •Non-age-eligible women.
- •Men and non-emancipated minors.
- •Women who do not consent.
研究组 & 干预措施
Treatment
Health facilities randomized in treatment clusters will be provided with a digital vaccination record system (e-tracker) linked to biometrics (facial recognition) of caregivers (if child is below 6 months) or of children (if child is above 6 months) [HEALTH FACILITY INTERVENTION]. Caregivers (if child is below 6 months) or children (if child is above 6 months) living in communities in the catchment areas of health facilities randomized in treatment clusters [INDIVIDUAL INTERVENTION] will be registered at the community level into the e-tracker and biometrics (facial recognition), and caregivers of children who are due for or missed vaccination will receive voice message appointment reminders if they provided a phone number during the registration in biometrics.
干预措施: HEALTH FACILITY INTERVENTION (Behavioral)
Treatment
Health facilities randomized in treatment clusters will be provided with a digital vaccination record system (e-tracker) linked to biometrics (facial recognition) of caregivers (if child is below 6 months) or of children (if child is above 6 months) [HEALTH FACILITY INTERVENTION]. Caregivers (if child is below 6 months) or children (if child is above 6 months) living in communities in the catchment areas of health facilities randomized in treatment clusters [INDIVIDUAL INTERVENTION] will be registered at the community level into the e-tracker and biometrics (facial recognition), and caregivers of children who are due for or missed vaccination will receive voice message appointment reminders if they provided a phone number during the registration in biometrics.
干预措施: INDIVIDUAL INTERVENTION (Behavioral)
Control
Health facilities randomized in control clusters, and caregivers (if child is below 6 months) or children (if child is above 6 months) living in communities in the catchment areas of health facilities randomized in control clusters will not receive any intervention during the study period.
结局指标
主要结局
Completion of full malaria sequence (Index children)
时间窗: Measured at endline, 24-26 months after baseline
Record of 4 doses of malaria vaccines for the index child recorded by the individual child's booklet (or self-reported by the mother if the booklet is not available)
Timely full malaria vaccination (Index children)
时间窗: Measured at endline, 24-26 months after baseline
Record of 4 doses of malaria vaccines for the index child recorded by the individual child's booklet (or self-reported by the mother if the booklet is not available) taken within the appropriate time frame.
Completion of full routine vaccination sequence (basic antigens) (Index children)
时间窗: Measured at endline, 24-26 months after baseline
Records of doses of routine vaccines (basic antigens) for the index child recorded in the individual child's booklet (or self-reported by the mother if the booklet is not available). Defined as receipt of all of the following: One dose of BCG vaccine; Three doses of polio vaccine given as oral polio vaccine (OPV); Inactivated polio vaccine (IPV); Three doses of Pentavalent vaccine (Penta); One dose of measles-rubella vaccine (MR).
Completion of full routine vaccination sequence (national schedule) (Index children)
时间窗: Measured at endline, 24-26 months after baseline
Records of doses of routine vaccines (national schedule) for the index child recorded in the individual child's booklet (or self-reported by the mother if the booklet is not available). Full vaccination coverage based on the national schedule is defined as the index child having received all the following: BCG; Three doses of Pentavalent (Penta); Four doses of OPV (including OPV given at birth); One dose of IPV; One dose of yellow fever vaccine; Three doses of pneumococcal vaccine (PCV); Three doses of rotavirus vaccine; Two doses of measles-rubella vaccine (MR); One dose of meningitis A vaccine (MenA).
次要结局
- Early, Late or Very Late malaria vaccination (Index children)(Measured at endline, 24-26 months after baseline)
- Timely full routine vaccination sequence (basic antigens) (Index children)(Measured at endline, 24-26 months after baseline)
- Timely full routine vaccination sequence (national schedule) (Index children)(Measured at endline, 24-26 months after baseline)
- Early, Late or Very Late full routine vaccination sequence (basic antigens) (Index children)(Measured at endline, 24-26 months after baseline)
- Early, Late or Very Late full routine vaccination sequence (national schedule) (Index children)(Measured at endline, 24-26 months after baseline)
- Number of malaria vaccines taken (Index children)(Measured at endline, 24-26 months after baseline)
- Number of routine vaccines taken (basic antigens) (Index children)(Measured at endline, 24-26 months after baseline)
- Number of routine vaccines taken (full national schedule) (Index children)(Measured at endline, 24-26 months after baseline)
- Number of timely malaria vaccines taken (Index children)(Measured at endline, 24-26 months after baseline)
- Number of timely routine vaccines taken (basic antigens) (Index children)(Measured at endline, 24-26 months after baseline)
- Number of timely routine vaccines taken (full national schedule) (Index children)(Measured at endline, 24-26 months after baseline)
- Received each vaccine on time (full national schedule) (Index child), analyzed individually(Measured at endline, 24-26 months after baseline)
- Up to date on malaria vaccine (children under 3 years old in study households)(Measured at endline, 24-26 months after baseline)
- Up to date on routine vaccines (basic antigens) (Children under 3 years old in study households)(Measured at endline, 24-26 months after baseline)
- Up to date on routine vaccines (full schedule) (Children under 3 years old in study households)(Measured at endline, 24-26 months after baseline)
- Cumulative number of late days in receipt of malaria vaccination (index children)(Measured at endline, 24-26 months after baseline)
- Cumulative number of late days in receipt of basic antigens (index children)(Measured at endline, 24-26 months after baseline)
- Cumulative number of late days in receipt of routine vaccines according to national schedule (index children)(Measured at endline, 24-26 months after baseline)
- Mother knows when to bring the child to the clinic for the first vaccination(Measured at endline, 24-26 months after baseline)
- Facility Vaccine Data Accuracy(Measured around endline, 24-26 months after baseline)
研究者
Elisa Maria Maffioli
Assistant Professor
University of Michigan