Testing a Biometric Identification System to Improve Malaria Vaccine Completion

NCT ID: NCT07261280

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 4715 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-15
• Study Completion Date: 2027-12-31

Brief Summary

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.

Conditions

Vaccination

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

HEALTH FACILITY INTERVENTION

Intervention Type: BEHAVIORAL

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). With the support of Ghana Health Services, Simprints will train CHWs on digital vaccination record system (e-tracker) and biometrics. Simprints will also provide Technical Assistance to CHWs for the duration of the study.

INDIVIDUAL INTERVENTION

Intervention Type: BEHAVIORAL

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 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. Reminders will be sent before a child is due a visit to receive vaccination, as well as after a child missed his due visit.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

HEALTH FACILITY INTERVENTION

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). With the support of Ghana Health Services, Simprints will train CHWs on digital vaccination record system (e-tracker) and biometrics. Simprints will also provide Technical Assistance to CHWs for the duration of the study.

Intervention Type: BEHAVIORAL

INDIVIDUAL 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 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. Reminders will be sent before a child is due a visit to receive vaccination, as well as after a child missed his due visit.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Ghana

OTHER

Sponsor Role: collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Elisa Maria Maffioli

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elisa Maria Maffioli, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Jessica Cohen, PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard University

Chris Guure

Role: PRINCIPAL_INVESTIGATOR

University of Ghana

Locations

Communities in Oti Region

Oti Region, , Ghana

Site Status: RECRUITING

Countries

Ghana

Central Contacts

Elisa Maria Maffioli, PhD

Role: CONTACT

elisamaf@umich.edu

443-875-4930

Jessica Cohen, PhD

Role: CONTACT

cohenj@hsph.harvard.edu

Facility Contacts

Chris Guure

Role: primary

cbguure@ug.edu.gh

+233242928284

Other Identifiers

HUM00270320

Identifier Type: -

Identifier Source: org_study_id