Communities in Oti Region
Oti Region, Ghana
Location status: Recruiting
NCT Number: NCT07261280
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.
Interested in participating?
Request Info15 year–49 year
Female
Interventional
Not applicable
Oti Region, Ghana
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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). 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.
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)
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.
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).
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).
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.
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.
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.
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
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.
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).
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).
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)
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).
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)
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)
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)
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)
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)
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)
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.
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.
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.
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
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.
Contact information is provided by the study sponsor or research team.
Elisa Maria Maffioli, PhD
CONTACT
Jessica Cohen, PhD
CONTACT
University of Michigan
Other
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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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