NCT02567006

Brief Summary

This project plans to learn more about whether sending text messages to parents on their mobile phones to remind them when their child is due for his or her next vaccination will improve children getting vaccinated on time.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
720

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

2 active sites

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

September 30, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2017

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2017

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

1.4 years

First QC Date

September 30, 2015

Last Update Submit

September 24, 2019

Conditions

Adherence to Vaccination SchedulesTimeliness of VaccinationAcceptability of SMS Reminder Program

Keywords

vaccinesremindersimmunization timelinessvaccine coverage

Outcome Measures

Primary Outcomes (1)

  • Completion of vaccine primary series

    Completion of 2nd and 3rd dose of vaccines by 1 year of age

    12 months of age

Secondary Outcomes (3)

  • Factors associated with immunization delays

    12 months

  • Acceptability of SMS vaccine reminders

    12 months

  • Timeliness of immunization

    12 months

Study Arms (2)

Short Message Service (SMS) group

ACTIVE COMPARATOR

Receiving SMS message reminders 1 week before scheduled vaccination

Behavioral: SMS message

Usual care

PLACEBO COMPARATOR

Not receiving SMS messages

Other: Usual care

Interventions

SMS messageBEHAVIORAL

SMS messages will be delivered at 6, 4, and 2 days before the next scheduled date of the primary vaccines for the intervention group

Also known as: text messages
Short Message Service (SMS) group
Usual careOTHER

Health clinic nurse provides regular appointment in the vaccination card with no active reminders

Usual care

Eligibility Criteria

Age6 Weeks - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • First dose of primary vaccination series
  • Parents owning a mobile phone and able to decipher SMS messages
  • Consent form signed

You may not qualify if:

  • Moving away from the study site in the next 12 months
  • Ineligible for primary vaccination series by the MOH

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fundacion para la Salud Integral de los Guatemaltecos CU

Coatepeque, Departamento de Quetzaltenango, Guatemala

Location

University del Valle, Guatemala

Guatemala City, 01015, Guatemala

Location

Related Publications (5)

  • Gurman TA, Rubin SE, Roess AA. Effectiveness of mHealth behavior change communication interventions in developing countries: a systematic review of the literature. J Health Commun. 2012;17 Suppl 1:82-104. doi: 10.1080/10810730.2011.649160.

    PMID: 22548603BACKGROUND

  • Head KJ, Noar SM, Iannarino NT, Grant Harrington N. Efficacy of text messaging-based interventions for health promotion: a meta-analysis. Soc Sci Med. 2013 Nov;97:41-8. doi: 10.1016/j.socscimed.2013.08.003. Epub 2013 Aug 13.

    PMID: 24161087BACKGROUND

  • Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.

    PMID: 32813276DERIVED

  • Domek GJ, Contreras-Roldan IL, Bull S, O'Leary ST, Bolanos Ventura GA, Bronsert M, Kempe A, Asturias EJ. Text message reminders to improve infant immunization in Guatemala: A randomized clinical trial. Vaccine. 2019 Sep 30;37(42):6192-6200. doi: 10.1016/j.vaccine.2019.08.046. Epub 2019 Sep 3.

    PMID: 31492475DERIVED

  • Domek GJ, O'Leary ST, Bull S, Bronsert M, Contreras-Roldan IL, Bolanos Ventura GA, Kempe A, Asturias EJ. Measuring vaccine hesitancy: Field testing the WHO SAGE Working Group on Vaccine Hesitancy survey tool in Guatemala. Vaccine. 2018 Aug 23;36(35):5273-5281. doi: 10.1016/j.vaccine.2018.07.046. Epub 2018 Jul 27.

    PMID: 30061026DERIVED

Study Officials

  • Edwin J Asturias, MD

    University of Colorado, Denver

    STUDY CHAIR

  • Gretchen Domek, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

  • Ingrid L Contreras, MD

    University del Valle, Guatemala

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 2, 2015

Study Start

March 1, 2016

Primary Completion

July 7, 2017

Study Completion

July 10, 2017

Last Updated

September 26, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

GU(2)