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Recruiting NCT07261280

Testing a Biometric Identification System to Improve Malaria Vaccine Completion

No phase Interventional Vaccination

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HEALTH FACILITY INTERVENTION, INDIVIDUAL INTERVENTION.
Who it may be relevant to
Registry conditions: Vaccination. Basic parameters: 15 years — 49 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Ghana
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Behavioral 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.
  • 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

Primary outcome measures

  • Completion of full malaria sequence (Index children) [Time frame: Measured at endline, 24-26 months after baseline]
  • Timely full malaria vaccination (Index children) [Time frame: Measured at endline, 24-26 months after baseline]
  • Completion of full routine vaccination sequence (basic antigens) (Index children) [Time frame: Measured at endline, 24-26 months after baseline]
  • Completion of full routine vaccination sequence (national schedule) (Index children) [Time frame: Measured at endline, 24-26 months after baseline]
Secondary outcome measures (12)
  • Timely full routine vaccination sequence (basic antigens) (Index children) [Time frame: Measured at endline, 24-26 months after baseline]
  • Timely full routine vaccination sequence (national schedule) (Index children) [Time frame: Measured at endline, 24-26 months after baseline]
  • Early, Late or Very Late malaria vaccination (Index children) [Time frame: Measured at endline, 24-26 months after baseline]
  • Early, Late or Very Late full routine vaccination sequence (basic antigens) (Index children) [Time frame: Measured at endline, 24-26 months after baseline]
  • Early, Late or Very Late full routine vaccination sequence (national schedule) (Index children) [Time frame: Measured at endline, 24-26 months after baseline]
  • Number of malaria vaccines taken (Index children) [Time frame: Measured at endline, 24-26 months after baseline]
  • Number of routine vaccines taken (basic antigens) (Index children) [Time frame: Measured at endline, 24-26 months after baseline]
  • Number of routine vaccines taken (full national schedule) (Index children) [Time frame: Measured at endline, 24-26 months after baseline]
  • Number of timely malaria vaccines taken (Index children) [Time frame: Measured at endline, 24-26 months after baseline]
  • Number of timely routine vaccines taken (basic antigens) (Index children) [Time frame: Measured at endline, 24-26 months after baseline]
  • Number of timely routine vaccines taken (full national schedule) (Index children) [Time frame: Measured at endline, 24-26 months after baseline]
  • Received each vaccine on time (full national schedule) (Index child), analyzed individually [Time frame: Measured at endline, 24-26 months after baseline]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

Ghana · 1 center
  • Communities in Oti Region — Oti Region

Identifiers

NCT: NCT07261280 · HUM00270320

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗