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SMS Mobile Technology for Vaccine Coverage and Acceptance (Vaxtech)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01663636
Recruitment Status : Completed
First Posted : August 13, 2012
Results First Posted : December 31, 2018
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Adherence to Vaccination Schedules
Intervention Behavioral: SMS message reminding mothers to come for their scheduled vaccines
Enrollment 321
Recruitment Details Parents of infants between the ages of 8 and 14 weeks presenting for the first dose of the 3-dose infant primary immunization series were eligible if they owned a mobile phone with SMS text messaging capability and were recruited in 2 pubic health clinics in Guatemala City from April to May of 2013.
Pre-assignment Details At least one parent had to be literate and able to use SMS technology. Parents were excluded if they were under 18 years of age or if their child had a contraindication to vaccination. Allocation to SMS vaccine (intervention) or usual care (control) was done using a computer generated randomization.
Arm/Group Title SMS Vaccine Usual Care
Hide Arm/Group Description Parent or guardian will be sent an SMS message reminding them to bring in their infant(s) for the infant(s) scheduled vaccines 1 week prior to the date of 2nd and 3rd doses. Parent or guardian and their infants who are under usual care (no SMS) will serve as a control group.
Period Title: Infant SMS Reminder Feasibility Study
Started 160 161
Completed 135 130
Not Completed 25 31
Reason Not Completed
Lost to Follow-up             25             31
Period Title: Parent SMS Acceptability Assessment
Started 135 130
Completed 135 130
Not Completed 0 0
Arm/Group Title SMS Vaccine Usual Care Total
Hide Arm/Group Description Mothers will be sent an SMS message reminding them to come for their scheduled vaccines 1 week prior to the date of 2nd and 3rd doses Mothers under usual care will serve as a control Total of all reporting groups
Overall Number of Baseline Participants 160 161 321
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 160 participants 161 participants 321 participants
9.7  (1.4) 9.4  (1.2) 9.5  (1.3)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 160 participants 161 participants 321 participants
Male 76 89 165
Female 84 71 155
Missing value 0 1 1
Number of Participants who live <16 km from the Clinic  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 160 participants 161 participants 321 participants
Live <16 km from the Clinic 157 160 317
Live =>16 km from the Clinic 3 1 4
1.Primary Outcome
Title Completion of 3 Doses of Pentavalent Vaccine
Hide Description Number of children vaccinated with the recommended dose of Pentavalent vaccines according to the age schedule of the National Immunization Program in Guatemala
Time Frame 8 months of age
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SMS Vaccine Usual Care
Hide Arm/Group Description:
Mothers will be sent an SMS message reminding them to come for their scheduled vaccines 1 week prior to the date of 2nd and 3rd doses
Mothers under usual care will serve as a control
Overall Number of Participants Analyzed 160 161
Measure Type: Number
Unit of Measure: participants
135 130
Time Frame 1 year
Adverse Event Reporting Description Breaches in confidentiality or inadvertent information releases were monitored.
 
Arm/Group Title SMS Vaccine Usual Care
Hide Arm/Group Description Mothers will be sent an SMS message reminding them to come for their scheduled vaccines 1 week prior to the date of 2nd and 3rd doses Mothers under usual care will serve as a control
All-Cause Mortality
SMS Vaccine Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
SMS Vaccine Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/160 (0.00%)   0/161 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SMS Vaccine Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/160 (0.00%)   0/161 (0.00%) 
Study was not powered to assess efficacy. SMS texts platform did not have a reporting feature, limiting our ability to confirm message reception. High vaccine visit completion rates made evaluation of an effect challenging.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Edwin J. Asturias
Organization: Center for Global Health, University of Colorado
Phone: 3037246282
EMail: edwin.asturias@ucdenver.edu
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01663636     History of Changes
Other Study ID Numbers: 12-1144
OPP1061430 ( Other Identifier )
First Submitted: August 8, 2012
First Posted: August 13, 2012
Results First Submitted: February 18, 2016
Results First Posted: December 31, 2018
Last Update Posted: December 31, 2018