An interventional study of SMS reminder and Travel subsidy in Diphtheria, Tetanus and Pertussis, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 1 site in Kenya. Open to participants aged 0 Weeks to 5 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-27.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Not applicable, Interventional, and Other
The project goal is to conduct a randomized controlled trial (RCT) to test whether mobile phone short message system (SMS) reminders, either with or without mobile-phone based travel subsidies will improve timeliness, coverage, and drop-out rates of routine EPI vaccines in rural western Kenya.
267 studies on the registry are indexed under Diphtheria; 17 are open to participants now.
This study's enrollment of 2,018 is above the median of 448 across 241 interventional studies indexed under Diphtheria.
Browse Diphtheria studies →Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 371 studies on the registry; 42 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: SMS reminder
Other: SMS reminder · Other: Travel subsidy
Other: SMS reminder · Other: Travel subsidy 2
Percent of children immunized
Time frame: Up to 12 months of age
Percent of fully immunized children (FIC) by study arm
FIC = One dose bacille Calmette-Guerin (BCG) vaccine, three doses pentavalent (diphtheria, pertussis, tetanus, hepatitis B, haemophilus influenzae type b) vaccine, three doses polio vaccine and one dose measles vaccine. The proportion of FIC infants by 10 months of age in each of the intervention arms (SMS only and SMS + subsidy) will be separately compared to the control arm using statistical analyses that adjust for the cluster design and any socio-demographic variables that may be unequally distributed across study arms
Time frame: 10 months of age
Proportion of children vaccinated by study arm
The proportion of intervention arm infants that receive vaccination within 2 weeks of the scheduled date will be calculated for each dose of vaccine and compared to the control arm using statistical analyses that adjust for our cluster design and any socio-demographic variables that may be unequally distributed across study arms
Time frame: Within 2 weeks of each scheduled vaccine date
Proportion of children dropping out between doses
Comparison of the differences in percentages of children vaccinated with pentavalent1 and pentavalent3 in the interventions arms compared to this difference in the control arm using statistical analyses that adjust for our cluster design and any socio-demographic variables that may be unequally distributed across study arms
Time frame: Age 24 weeks
Proportion of children receiving measles and pentavalent vaccines by study arm
Comparison of vaccine coverage (pentavalent3 and measles, separately) between intervention and control arms
Time frame: Age 24 weeks (pentavalent only), 10 months and age 12 months
Proportion in each arm vaccinated by mobile phone ownership and by residential distance from a health facility
Vaccine coverage analysis stratified by mobile phone ownership and residential distance
Time frame: Age 12 months
Height-for-age,to evaluate if the interventions had impact on other health status indicators
Using regression, average height for age in each group will be compared across study groups
Time frame: Age 12 months
Direct costs for each intervention arm
Costs include SMS messages, the amount of travel subsidy transferred, and the tariffs and fees that are associated with using mobile-money. For each arm, these costs will be divided by the number of children vaccinated and comparisons will be made across study arms
Time frame: 25 months, approximate time period for deploying interventions
Bed-net usage, to evaluate if the interventions had impact on other indicators of health status
Proportion of children using bed-nets will be compared across study groups
Time frame: Age 12 months
Vitamin A coverage, o evaluate if the interventions had impact on other indicators of health status
Proportion of children who have received vitamin A supplementation will be compared across study groups
Time frame: Age 12 months
The record gives a start of Oct 2013, a primary completion of Feb 2016 and a completion of Feb 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Johns Hopkins Bloomberg School of Public Health →