An interventional study of HEALTH FACILITY INTERVENTION and INDIVIDUAL INTERVENTION in Vaccination, sponsored by University of Michigan. Recruiting at 1 site in Ghana. Open to female participants aged 15 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-03.
Sponsored by University of Michigan · Not applicable, Interventional, and Health services research
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.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's planned enrollment of 4,715 is above the median of 252 across 937 interventional studies indexed under Malaria.
Browse Malaria studies →University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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.
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.
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.
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
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
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
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
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
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
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
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
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.
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
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)
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)
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)
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)
Time frame: 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.
Time frame: 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.
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)
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.
Time frame: 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
Time frame: 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.
Time frame: Measured around endline, 24-26 months after baseline
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Dec 2027, 26 months after the start.
Of 95 non-industry interventional studies with no phase under Malaria, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's planned 26 months is above that.
Counting every sponsor, half of 101 studies reached it within 23 months; a quarter within 8 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
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