SMS Mobile Technology to Improve Early Childhood Vaccine Coverage in Guatemala (SMSVaxGuate)

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.

Study Overview

• Status: Completed
• Conditions: Adherence to Vaccination Schedules; Timeliness of Vaccination; Acceptability of SMS Reminder Program
• Intervention / Treatment: Behavioral: SMS message; Other: Usual care

Detailed Description

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. The vaccines that will be given are the same routine vaccinations registered in Guatemala and used by the Ministry of Health regardless of enrollment in the study.

• Study Type: Interventional
• Enrollment (Actual): 720
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Guatemala
  • Guatemala, Guatemala, 01015
    • University del Valle, Guatemala
  • Quetzaltenango
    • Coatepeque, Quetzaltenango, Guatemala
      • Fundacion para la Salud Integral de los Guatemaltecos CU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Short Message Service (SMS) group; Receiving SMS message reminders 1 week before scheduled vaccination	Behavioral: SMS message; SMS messages will be delivered at 6, 4, and 2 days before the next scheduled date of the primary vaccines for the intervention group; Other Names: text messages
Placebo Comparator: Usual care; Not receiving SMS messages	Other: Usual care; Health clinic nurse provides regular appointment in the vaccination card with no active reminders

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion of vaccine primary series	Completion of 2nd and 3rd dose of vaccines by 1 year of age	12 months of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors associated with immunization delays	Demographic, education and behavioral factors associated with days late for vaccination	12 months
Acceptability of SMS vaccine reminders	Qualitative data from focus groups to evaluate acceptability of SMS program	12 months
Timeliness of immunization	Days delayed from date for 2nd and 3rd dose of vaccination	12 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Universidad del Valle, Guatemala; Fundacion para la Salud Integral de los Guatemaltecos CU; Ministry of Health, Guatemala
• Investigators: Study Chair: Edwin J Asturias, MD, University of Colorado, Denver; Principal Investigator: Gretchen Domek, MD, University of Colorado, Denver; Study Director: Ingrid L Contreras, MD, University del Valle, Guatemala

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): July 7, 2017
• Study Completion (Actual): July 10, 2017

Study Registration Dates

• First Submitted: September 30, 2015
• First Submitted That Met QC Criteria: September 30, 2015
• First Posted (Estimate): October 2, 2015

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: reminders; vaccines; immunization timeliness; vaccine coverage
• Other Study ID Numbers: 14-2170; 1R21HD084115-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No