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NCT Number: NCT07261280

Testing a Biometric Identification System to Improve Malaria Vaccine Completion

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.

Recruiting

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Key information

Age range

15 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Completion of full malaria sequence (Index children)

    Time frame: 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)

  2. Timely full malaria vaccination (Index children)

    Time frame: 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.

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

    Time frame: 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).

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

    Time frame: 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).

Secondary outcomes

  1. Timely full routine vaccination sequence (basic antigens) (Index children)

    Time frame: 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). Taken within the appropriate time frame.

  2. Timely full routine vaccination sequence (national schedule) (Index children)

    Time frame: 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, taken within the appropriate time frame.

  3. Early, Late or Very Late malaria vaccination (Index children)

    Time frame: 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 outside the appropriate time frame.

  4. Early, Late or Very Late full routine vaccination sequence (basic antigens) (Index children)

    Time frame: 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). Taken outside the appropriate time frame

  5. Early, Late or Very Late full routine vaccination sequence (national schedule) (Index children)

    Time frame: 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). Taken outside the appropriate time frame.

  6. Number of malaria vaccines taken (Index children)

    Time frame: Measured at endline, 24-26 months after baseline

    Number of recorded malaria vaccines taken (from 0 to 4) by the index child recorded by the individual child's booklet (or self-reported by the mother if the booklet is not available).

  7. Number of routine vaccines taken (basic antigens) (Index children)

    Time frame: Measured at endline, 24-26 months after baseline

    Number of recorded basic antigens taken (0 to 9) by the index child recorded by the individual child's booklet (or self-reported by the mother if the booklet is not available).

  8. Number of routine vaccines taken (full national schedule) (Index children)

    Time frame: Measured at endline, 24-26 months after baseline

    Number of recorded vaccinations taken (0 to 19) from the national schedule by the index child recorded by the individual child's booklet (or self-reported by the mother if the booklet is not available)

  9. Number of timely malaria vaccines taken (Index children)

    Time frame: Measured at endline, 24-26 months after baseline

    Number of recorded malaria vaccines taken (from 0 to 4) within the appropriate time frame by the index child recorded by the individual child's booklet (or self-reported by the mother if the booklet is not available).

  10. Number of timely routine vaccines taken (basic antigens) (Index children)

    Time frame: Measured at endline, 24-26 months after baseline

    Number of recorded basic antigens taken (0 to 9) within the appropriate time frame by the index child recorded by the individual child's booklet (or self-reported by the mother if the booklet is not available)

  11. Number of timely routine vaccines taken (full national schedule) (Index children)

    Time frame: Measured at endline, 24-26 months after baseline

    Number of recorded vaccinations taken (0 to 19) from the national schedule within the appropriate time frame by the index child recorded by the individual child's booklet (or self-reported by the mother if the booklet is not available)

  12. Received each vaccine on time (full national schedule) (Index child), analyzed individually

    Time frame: Measured at endline, 24-26 months after baseline

    Among each of the following, analyzed individually, index child received the vaccine within the appropriate time frame according to the national schedule (as recorded in the individual child's booklet or as self-reported by the mother)

  13. Up to date on malaria vaccine (children under 3 years old in study households)

    Time frame: Measured at endline, 24-26 months after baseline

    Record of having taken all doses of malaria vaccine as appropriate for child's age as recorded by the children's booklets (or self-reported by the mother if the booklet is not available)

  14. Up to date on routine vaccines (basic antigens) (Children under 3 years old in study households)

    Time frame: Measured at endline, 24-26 months after baseline

    Record of having taken all doses of basic antigens as appropriate for child's age as recorded by the children' s booklets (or self-reported by the mother if the booklet is not available)

  15. Up to date on routine vaccines (full schedule) (Children under 3 years old in study households)

    Time frame: Measured at endline, 24-26 months after baseline

    Record of having taken all doses of national vaccine schedule as appropriate for child's age as recorded by the children' s booklets (or self-reported by the mother if the booklet is not available)

  16. Cumulative number of late days in receipt of malaria vaccination (index children)

    Time frame: Measured at endline, 24-26 months after baseline

    Among those who received at least a dose of the malaria vaccine, the number of days late the vaccine(s) were relative to what the national schedule considers "on time" for each dose. Late days are equal to zero for those who received the vaccine on time or early.

  17. Cumulative number of late days in receipt of basic antigens (index children)

    Time frame: Measured at endline, 24-26 months after baseline

    Among those who received at least one dose of basic antigens, the number of days late the vaccine(s) were relative to what the national schedule considers "on time" for each dose. Late days are equal to zero for those who received the vaccine on time or early.

  18. Cumulative number of late days in receipt of routine vaccines according to national schedule (index children)

    Time frame: Measured at endline, 24-26 months after baseline

    Among those who received at least one dose of routine vaccines according to the national schedule, the number of days late the vaccine(s) were relative to what the national schedule considers "on time" for each dose. Late days are equal to zero for those who received the vaccine on time or early.

  19. Mother knows when to bring the child to the clinic for the first vaccination

    Time frame: Measured at endline, 24-26 months after baseline

    Mother self-reports being sure or very sure about when to bring the child to the clinic for the first vaccination

  20. Facility Vaccine Data Accuracy

    Time frame: Measured around endline, 24-26 months after baseline

    Discrepancy in the total number of children vaccinated based on paper-based records at the facility vs digital records in DHMIS 2. Measured as the vaccine "verification factor" for BCG, Penta 3 and MR-2 over a three month period, comparing the total number of children vaccinated with each of the three vaccines over this period reported in DHIMS 2 with the paper-based record.

Study contacts

Contact information is provided by the study sponsor or research team.

Elisa Maria Maffioli, PhD

CONTACT

[email protected]

443-875-4930

Jessica Cohen, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Harvard School of Public Health (HSPH)
  • University of Ghana

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 3, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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