Adherence to Vaccination SchedulesSMSVaxGuateNCT02567006
SMS Mobile Technology to Improve Early Childhood Vaccine Coverage in Guatemala
A study testing SMS message in people with Adherence to Vaccination Schedules and Timeliness of Vaccination, run by University of Colorado, Denver at 2 sites in Guatemala.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 weeks to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Adherence to Vaccination Schedules, Timeliness of Vaccination, Acceptability of SMS Reminder Program
- What is being tested?
- SMS message
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 720 participants
- Where
- 2 sitesGuatemala
- Study dates
- 1 Mar 2016to 10 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 weeks to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- First dose of primary vaccination series
- Parents owning a mobile phone and able to decipher SMS messages
- Consent form signed
Who cannot join
- Moving away from the study site in the next 12 months
- Ineligible for primary vaccination series by the MOH
Trial locations and contacts
2 sites in 1 country.
Guatemala2 sites
Fundacion para la Salud Integral de los Guatemaltecos CU
Coatepeque, Departamento de Quetzaltenango
University del Valle, Guatemala
Guatemala City, 01015
About this study
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.
Read the 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.
- Conditions
- Adherence to Vaccination Schedules, Timeliness of Vaccination, Acceptability of SMS Reminder Program
- Being tested
- SMS message, Usual care
- Keywords
- vaccines, reminders, immunization timeliness, vaccine coverage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS messageBehavioural
Also called text messages
SMS messages will be delivered at 6, 4, and 2 days before the next scheduled date of the primary vaccines for the intervention group
Usual careOther
Health clinic nurse provides regular appointment in the vaccination card with no active reminders
| Study group | Role | What they receive |
|---|---|---|
| Short Message Service (SMS) group | Active comparator | Receiving SMS message reminders 1 week before scheduled vaccination Receives: Behavioral: SMS message |
| Usual care | Placebo comparator | Not receiving SMS messages Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of vaccine primary series
Completion of 2nd and 3rd dose of vaccines by 1 year of age
Measured: 12 months of age
Secondary outcomes (3)
Factors associated with immunization delays
Demographic, education and behavioral factors associated with days late for vaccination
Measured: 12 months
Acceptability of SMS vaccine reminders
Qualitative data from focus groups to evaluate acceptability of SMS program
Measured: 12 months
Timeliness of immunization
Days delayed from date for 2nd and 3rd dose of vaccination
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study start1 Mar 2016
- Primary completion7 Jul 2017
- Study completion10 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Adherence to Vaccination SchedulesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 720 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad del Valle, Guatemala, Fundacion para la Salud Integral de los Guatemaltecos CU, Ministry of Health, Guatemala, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Edwin J Asturias, MD, Study chair, University of Colorado, DenverGretchen Domek, MD, Principal investigator, University of Colorado, DenverIngrid L Contreras, MD, Study director, University del Valle, Guatemala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567006
- Sponsor's protocol ID
- 14-2170
- Other IDs
- 1R21HD084115-01
- Acronym
- SMSVaxGuate
- Status last verified
- Sep 2019
- First submitted
- 30 Sep 2015
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22548603Head 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.
PubMed 24161087Palmer 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.
PubMed 32813276Domek 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.
PubMed 31492475Domek 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.
PubMed 30061026
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMS Mobile Technology to Improve Early Childhood Vaccine Coverage in Guatemala
- ClinicalTrials.gov ID
- NCT02567006
- Acronym / sponsor ID
- SMSVaxGuate / 14-2170
- Conditions
- Adherence to Vaccination Schedules, Timeliness of Vaccination, Acceptability of SMS Reminder Program
- Keywords
- vaccines, reminders, immunization timeliness, vaccine coverage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Universidad del Valle, Guatemala, Fundacion para la Salud Integral de los Guatemaltecos CU, Ministry of Health, Guatemala, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 7 Jul 2017 (actual)
- Study completion
- 10 Jul 2017 (actual)
- First posted
- 2 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short Message Service (SMS) group | Active comparator | Behavioral: SMS messageReceiving SMS message reminders 1 week before scheduled vaccination |
| Usual care | Placebo comparator | Other: Usual careNot receiving SMS messages |
Who may qualify
- Ages
- 6 weeks to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- First dose of primary vaccination series
- Parents owning a mobile phone and able to decipher SMS messages
- Consent form signed
Key exclusion criteria (2 listed)
- Moving away from the study site in the next 12 months
- Ineligible for primary vaccination series by the MOH
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMS messageAlso: text messagesSMS messages will be delivered at 6, 4, and 2 days before the next scheduled date of the primary vaccines for the intervention group | Behavioural | Short Message Service (SMS) group |
| Usual careHealth clinic nurse provides regular appointment in the vaccination card with no active reminders | Other | Usual care |
Primary outcome
Completion of vaccine primary series
Time frame: 12 months of age
Completion of 2nd and 3rd dose of vaccines by 1 year of age
3 secondary outcomes
Factors associated with immunization delays
Time frame: 12 months
Acceptability of SMS vaccine reminders
Time frame: 12 months
Timeliness of immunization
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Background: PubMed 22548603Gurman 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.
- Background: PubMed 24161087Head 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.
- Derived from this study: PubMed 32813276Palmer 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.
- Derived from this study: PubMed 31492475Domek 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.
- Derived from this study: PubMed 30061026Domek 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edwin J Asturias, MD study chair
University of Colorado, Denver
Gretchen Domek, MD principal investigator
University of Colorado, Denver
Ingrid L Contreras, MD study director
University del Valle, Guatemala
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS message in people with Adherence to Vaccination Schedules and Timeliness of Vaccination, run by University of Colorado, Denver at 2 sites in Guatemala.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Guatemala. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of vaccine primary series (time frame: 12 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02567006, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.