Testing a Biometric Identification System to Improve Malaria Vaccine Completion

University of Michigan

Status: Enrolling

Conditions: Vaccination

Treatments: Behavioral: INDIVIDUAL INTERVENTION; Behavioral: HEALTH FACILITY INTERVENTION

Study type: Interventional

Funder types: Other

Identifiers

NCT07261280

HUM00270320

Details and patient eligibility

About

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.

Enrollment: 4,715 estimated patients

Sex: Female

Ages: 15 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Non-age-eligible women.
• Men and non-emancipated minors.
• Women who do not consent.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,715 participants in 2 patient groups

Treatment

Experimental group

Description:

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.

Treatment:

Behavioral: HEALTH FACILITY INTERVENTION

Behavioral: INDIVIDUAL INTERVENTION

Control

No Intervention group

Description:

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.