NCT01663636

Brief Summary

To pilot test a mobile phone SMS (Short Message Service) 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2012

Completed
19 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

December 31, 2018

Completed
Last Updated

December 31, 2018

Status Verified

June 1, 2018

Enrollment Period

1.7 years

First QC Date

August 8, 2012

Results QC Date

February 18, 2016

Last Update Submit

June 28, 2018

Conditions

Keywords

vaccinesSMSmobile phones

Outcome Measures

Primary Outcomes (1)

  • Completion of 3 Doses of Pentavalent Vaccine

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

    8 months of age

Study Arms (2)

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

Behavioral: SMS message reminding mothers to come for their scheduled vaccines

Usual care

Mothers under usual care will serve as a control

Interventions

Eligibility Criteria

Age1 Month - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Received 1 dose of vaccines, excluding BCG
  • No mobile phone with SMS or unable to use SMS at home
  • Intent to move from the clinic area in the next 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University del Valle

Guatemala City, 01001, Guatemala

Location

Related Publications (1)

  • Domek GJ, Contreras-Roldan IL, O'Leary ST, Bull S, Furniss A, Kempe A, Asturias EJ. SMS text message reminders to improve infant vaccination coverage in Guatemala: A pilot randomized controlled trial. Vaccine. 2016 May 5;34(21):2437-2443. doi: 10.1016/j.vaccine.2016.03.065. Epub 2016 Mar 26.

Limitations and Caveats

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.

Results Point of Contact

Title
Dr. Edwin J. Asturias
Organization
Center for Global Health, University of Colorado

Study Officials

  • Edwin J Asturias, MD

    University of Colorado School of Medicine

    PRINCIPAL INVESTIGATOR
  • Ingrid L Contreras-Roldan, MD

    University del Valle, Guatemala

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2012

First Posted

August 13, 2012

Study Start

September 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2015

Last Updated

December 31, 2018

Results First Posted

December 31, 2018

Record last verified: 2018-06

Locations