Testing a Biometric Identification System to Improve Malaria Vaccine Completion

NCT07261280 | Recruiting

• 1 other identifier: HUM00270320
• Study Type: interventional
• Target: 4,715
• Locations: 1 country
• Sites: 1

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

Keywords

Vaccine; Malaria; Adherence; Biometrics; Health Systems

Outcome Measures

Primary Outcomes (4)

• Completion of full malaria sequence (Index children)

  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)

  Measured at endline, 24-26 months after baseline

• Timely full malaria vaccination (Index children)

  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.

  Measured at endline, 24-26 months after baseline

• Completion of full routine vaccination sequence (basic antigens) (Index children)

  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).

  Measured at endline, 24-26 months after baseline

• Completion of full routine vaccination sequence (national schedule) (Index children)

  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).

  Measured at endline, 24-26 months after baseline

Secondary Outcomes (20)

• 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 malaria vaccination (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

Study Arms (2)

Treatment

EXPERIMENTAL

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.

Behavioral: HEALTH FACILITY INTERVENTION; Behavioral: INDIVIDUAL INTERVENTION

Control

NO INTERVENTION

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.

Interventions

HEALTH FACILITY INTERVENTION 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.

Treatment

INDIVIDUAL INTERVENTION 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.

Treatment

Eligibility Criteria

• Age: 15 Years - 49 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead
• University of Ghana: collaborator
• Harvard School of Public Health (HSPH): collaborator

Study Sites (1)

Communities in Oti Region

Oti Region, Ghana

RECRUITING

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Elisa Maria Maffioli, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Jessica Cohen, PhD

  Harvard University

  PRINCIPAL INVESTIGATOR

• Chris Guure

  University of Ghana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa Maria Maffioli, PhD

CONTACT

443-875-4930; elisamaf@umich.edu

Jessica Cohen, PhD

CONTACT

cohenj@hsph.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 3, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GH (1)