VaccinationNCT07261280
Testing a Biometric Identification System to Improve Malaria Vaccine Completion
A study testing HEALTH FACILITY INTERVENTION and INDIVIDUAL INTERVENTION in people with Vaccination, run by University of Michigan at 1 site in Ghana.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaccination
- What is being tested?
- HEALTH FACILITY INTERVENTION and INDIVIDUAL INTERVENTION
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,715 participants
- Where
- 1 siteGhana
- Study dates
- 15 Oct 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Non-age-eligible women.
- Men and non-emancipated minors.
- Women who do not consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jessica Cohen, PhD contact
Ghana1 site, 1 recruiting
- Recruiting
Communities in Oti Region
Oti Region
Chris Guure, +233242928284, cbguure@ug.edu.gh
About this study
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
- Being tested
- HEALTH FACILITY INTERVENTION, INDIVIDUAL INTERVENTION
- Keywords
- Vaccine, Malaria, Adherence, Biometrics, Health Systems
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEALTH FACILITY INTERVENTIONBehavioural
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 INTERVENTIONBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: 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: Measured at endline, 24-26 months after baseline
Secondary outcomes (20)
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.
Measured: Measured at endline, 24-26 months after baseline
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.
Measured: Measured at endline, 24-26 months after baseline
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.
Measured: Measured at endline, 24-26 months after baseline
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
Measured: Measured at endline, 24-26 months after baseline
Early, Late or Very Late 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). Taken outside the appropriate time frame.
Measured: Measured at endline, 24-26 months after baseline
Number of malaria vaccines taken (Index children)
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).
Measured: Measured at endline, 24-26 months after baseline
Number of routine vaccines taken (basic antigens) (Index children)
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).
Measured: Measured at endline, 24-26 months after baseline
Number of routine vaccines taken (full national schedule) (Index children)
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)
Measured: Measured at endline, 24-26 months after baseline
Number of timely malaria vaccines taken (Index children)
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).
Measured: Measured at endline, 24-26 months after baseline
Number of timely routine vaccines taken (basic antigens) (Index children)
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)
Measured: Measured at endline, 24-26 months after baseline
Number of timely routine vaccines taken (full national schedule) (Index children)
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)
Measured: Measured at endline, 24-26 months after baseline
Received each vaccine on time (full national schedule) (Index child), analyzed individually
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)
Measured: Measured at endline, 24-26 months after baseline
Up to date on malaria vaccine (children under 3 years old in study households)
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)
Measured: Measured at endline, 24-26 months after baseline
Up to date on routine vaccines (basic antigens) (Children under 3 years old in study households)
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)
Measured: Measured at endline, 24-26 months after baseline
Up to date on routine vaccines (full schedule) (Children under 3 years old in study households)
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)
Measured: Measured at endline, 24-26 months after baseline
Cumulative number of late days in receipt of malaria vaccination (index children)
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.
Measured: Measured at endline, 24-26 months after baseline
Cumulative number of late days in receipt of basic antigens (index children)
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.
Measured: Measured at endline, 24-26 months after baseline
Cumulative number of late days in receipt of routine vaccines according to national schedule (index children)
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.
Measured: Measured at endline, 24-26 months after baseline
Mother knows when to bring the child to the clinic for the first vaccination
Mother self-reports being sure or very sure about when to bring the child to the clinic for the first vaccination
Measured: Measured at endline, 24-26 months after baseline
Facility Vaccine Data Accuracy
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.
Measured: Measured around endline, 24-26 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start15 Oct 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaccinationStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,715 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ghana, Harvard School of Public Health (HSPH)
- Responsible party
- Principal investigator, Elisa Maria Maffioli, University of Michigan
- Investigators
- Elisa Maria Maffioli, PhD, Principal investigator, University of MichiganJessica Cohen, PhD, Principal investigator, Harvard UniversityChris Guure, Principal investigator, University of Ghana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261280
- Sponsor's protocol ID
- HUM00270320
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Biometric Identification System to Improve Malaria Vaccine Completion
- ClinicalTrials.gov ID
- NCT07261280
- Acronym / sponsor ID
- HUM00270320
- Conditions
- Vaccination
- Keywords
- Vaccine, Malaria, Adherence, Biometrics, Health Systems
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,715 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- University of Ghana, Harvard School of Public Health (HSPH)
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: HEALTH FACILITY INTERVENTION, Behavioral: INDIVIDUAL INTERVENTIONHealth 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. |
| 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. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Non-age-eligible women.
- Men and non-emancipated minors.
- Women who do not consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEALTH FACILITY INTERVENTIONHealth 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. | Behavioural | Treatment |
| INDIVIDUAL INTERVENTIONCaregivers (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. | Behavioural | Treatment |
Primary outcome
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)
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.
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).
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).
20 secondary outcomes
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
Up to date on malaria vaccine (children under 3 years old in study households)
Time frame: Measured at endline, 24-26 months after baseline
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
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
Cumulative number of late days in receipt of malaria vaccination (index children)
Time frame: Measured at endline, 24-26 months after baseline
Cumulative number of late days in receipt of basic antigens (index children)
Time frame: Measured at endline, 24-26 months after baseline
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
Mother knows when to bring the child to the clinic for the first vaccination
Time frame: Measured at endline, 24-26 months after baseline
Facility Vaccine Data Accuracy
Time frame: Measured around endline, 24-26 months after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica Cohen, PhD contact
Elisa Maria Maffioli, PhD principal investigator
University of Michigan
Jessica Cohen, PhD principal investigator
Harvard University
Chris Guure principal investigator
University of Ghana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEALTH FACILITY INTERVENTION and INDIVIDUAL INTERVENTION in people with Vaccination, run by University of Michigan at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elisa Maria Maffioli, PhD (443-875-4930, elisamaf@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of full malaria sequence (Index children) (time frame: Measured at endline, 24-26 months after baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.