SMS Mobile Technology for Vaccine Coverage and Acceptance (Vaxtech)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by University of Colorado, Denver.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01663636
First received: August 8, 2012
Last updated: February 4, 2013
Last verified: August 2012
  Purpose

To pilot test a mobile phone SMS system that will provide periodical messaging texts to mothers or custodians of infants who come for their first dose vaccines within the first 3 months of life to improve timely immunization coverage, vaccine acceptance and ensure vaccine safety monitoring. The intervention will include a "cloud-based" information system alimented by mobile phone data entry at the health post nurse level, that links child vaccination status and is able to remind parents and nurses of the need for next vaccination appointment and provide a system for reporting of adverse events following immunization in the immediate post-vaccination period.


Condition Phase
Adverse Event Following Immunization
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: SMS Mobile Technology for Vaccine Coverage and Acceptance in Guatemalan Infants

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Number of days unvaccinated [ Time Frame: 9 months of age ] [ Designated as safety issue: No ]
    Number of days that a child is not vaccinated with the recommended dose of vaccines according to the age schedule of the National Immunization Program in Guatemala


Secondary Outcome Measures:
  • AEFI reports [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    Number of perceived serious adverse events following immunization (AEFI) in infants receiving their routine vaccines in the first 3 days after vaccination.


Estimated Enrollment: 300
Study Start Date: September 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
SMS Vaccine
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
SMS BF
Mothers will serve as a control, and will be sent a message to remind them to continue breastfeeding

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Month to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Infants under 12 months of age from Ministry of Health Clinics in Guatemala City

Criteria

Inclusion Criteria:

  • Infants 1-3 months of age coming for their 1 dose of primary vaccines

Exclusion Criteria:

  • Received 1 dose of vaccines, excluding BCG
  • No mobile phone
  • Intent to move from the clinic area in the next 6 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01663636

Contacts
Contact: Edwin J Asturias, MD (303)7246282 edwin.asturias@ucdenver.edu
Contact: Sean O'Leary, MD Sean.O'Leary@childrenscolorado.org

Locations
Guatemala
University del Valle Recruiting
Guatemala, Guatemala, 01001
Contact: Ingrid L Contreras, MS    (502)23640492 ext 478      
Contact: Mirsa Ariano    (502)23640492 ext 478      
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Edwin J Asturias, MD University of Colorado School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01663636     History of Changes
Other Study ID Numbers: 12-1144, OPP1061430
Study First Received: August 8, 2012
Last Updated: February 4, 2013
Health Authority: Guatemala: Ministry of Public Health and Social Assistance
United Nations: World Health Organization
United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
vaccines
SMS
mobile phones

ClinicalTrials.gov processed this record on October 19, 2014