Health Trialsby

Testing a Biometric Identification System to Improve Malaria Vaccine Completion

ConditionVaccination

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age15-49

SponsorUniversity of Michigan

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Non-age-eligible women.

Men and non-emancipated minors.

Women who do not consent.

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

4,715 Participants

are divided into 2 treatment groups

Group A: TreatmentExperimental treatment 2 interventions

Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame

Measured at endline, 24-26 months after baseline

2

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.

Time frame

Measured at endline, 24-26 months after baseline

3

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).

Time frame

Measured at endline, 24-26 months after baseline

4

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).

Time frame

Measured at endline, 24-26 months after baseline

Secondary outcomes

1

Timely 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). Taken within the appropriate time frame.

Time frame

Measured at endline, 24-26 months after baseline

2

Timely 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, taken within the appropriate time frame.

Time frame

Measured at endline, 24-26 months after baseline

3

Early, Late or Very Late 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 outside the appropriate time frame.

Time frame

Measured at endline, 24-26 months after baseline

4

Early, Late or Very Late 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). Taken outside the appropriate time frame

Time frame

Measured at endline, 24-26 months after baseline

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Communities in Oti RegionRecruiting Oti Region Ghana

Ghana

Ghana

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

University of Ghana

Collaborator

Harvard School of Public Health (HSPH)

Collaborator

Source ClinicalTrials.gov