Trial Outcomes & Findings for SMS Mobile Technology for Vaccine Coverage and Acceptance (NCT NCT01663636)

Results Overview

Number of children vaccinated with the recommended dose of Pentavalent vaccines according to the age schedule of the National Immunization Program in Guatemala

Recruitment status

COMPLETED

Target enrollment

321 participants

Primary outcome timeframe

8 months of age

Results posted on

2018-12-31

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	SMS Vaccine 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.	Usual Care Parent or guardian and their infants who are under usual care (no SMS) will serve as a control group.
Infant SMS Reminder Feasibility Study STARTED	160	161
Infant SMS Reminder Feasibility Study COMPLETED	135	130
Infant SMS Reminder Feasibility Study NOT COMPLETED	25	31
Parent SMS Acceptability Assessment STARTED	135	130
Parent SMS Acceptability Assessment COMPLETED	135	130
Parent SMS Acceptability Assessment NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	SMS Vaccine 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.	Usual Care Parent or guardian and their infants who are under usual care (no SMS) will serve as a control group.
Infant SMS Reminder Feasibility Study Lost to Follow-up	25	31

Baseline Characteristics

SMS Mobile Technology for Vaccine Coverage and Acceptance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SMS Vaccine n=160 Participants 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	Usual Care n=161 Participants Mothers under usual care will serve as a control	Total n=321 Participants Total of all reporting groups
Age, Continuous	9.7 weeks STANDARD_DEVIATION 1.4 • n=5 Participants	9.4 weeks STANDARD_DEVIATION 1.2 • n=7 Participants	9.5 weeks STANDARD_DEVIATION 1.3 • n=5 Participants
Sex/Gender, Customized Male	76 participants n=5 Participants	89 participants n=7 Participants	165 participants n=5 Participants
Sex/Gender, Customized Female	84 participants n=5 Participants	71 participants n=7 Participants	155 participants n=5 Participants
Sex/Gender, Customized Missing value	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Number of Participants who live <16 km from the Clinic Live <16 km from the Clinic	157 participants n=5 Participants	160 participants n=7 Participants	317 participants n=5 Participants
Number of Participants who live <16 km from the Clinic Live =>16 km from the Clinic	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 months of age

Number of children vaccinated with the recommended dose of Pentavalent vaccines according to the age schedule of the National Immunization Program in Guatemala

Outcome measures

Outcome measures
Measure	SMS Vaccine n=160 Participants 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	Usual Care n=161 Participants Mothers under usual care will serve as a control
Completion of 3 Doses of Pentavalent Vaccine	135 participants	130 participants

Adverse Events

SMS Vaccine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Edwin J. Asturias

Center for Global Health, University of Colorado

Phone: 3037246282

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place