Adherence to Vaccination SchedulesVaxtechNCT01663636
SMS Mobile Technology for Vaccine Coverage and Acceptance
An observational study of Adherence to Vaccination Schedules, run by University of Colorado, Denver at 1 site in Guatemala.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Adherence to Vaccination Schedules
- What is being tested?
- SMS message reminding mothers to come for their scheduled vaccines
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- How many people
- 321 participants
- Where
- 1 siteGuatemala
- Study dates
- Sep 2012to Jun 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 month to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants under 12 months of age from Ministry of Health Clinics in Guatemala City
Who may be able to join
- Infants 1-3 months of age coming for their 1 dose of primary vaccines
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SMS Mobile Technology for Vaccine Coverage and Acceptance in Guatemalan Infants
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.
Read the detailed description
Significance: Vaccine coverage and acceptance in many municipal districts of Guatemala and other low- and middle-income countries are below the acceptable 80% reported at the national level for DPT3 (diphtheria, pertussis, tetanus) and measles vaccines. Despite the considerable effort to introduce new vaccines like Hib (Haemophilus influenzae type B) and rotavirus, in many countries like Guatemala infants do not get immunized on time. Completion of the recommended primary series does not reach beyond 70% of eligible infants by 12 months of age, placing them at risk of disease due to incomplete protection and missing the opportunity to get vaccinated appropriately. Reasons for not getting vaccinated on time include the lack of a system of reminders for the target population, missed opportunities to get vaccinated at the health services due to the lack of vaccine inventories and timely supply of vaccines (including the need for "group sessions for vaccinations" in order to secure the cold chain and vaccine availability).
In addition, monitoring of adverse events following immunization is lacking in most low and middle-income countries. Public acceptance for immunization is based not only on the effectiveness of the vaccine to reduce illness and death, but in the perception of vaccine safety at the population level. To maintain the confidence and acceptance in immunization programs, the reporting and proper response to events following immunization is critical. Allowing parents to notify possible adverse events following immunization provides them with direct access to the health care system to obtain a rapid response for their concerns, but also feedback about the safety of the vaccines and maintain vaccine trust and acceptance. Mobile phone reminders have been used in some populations in high-income countries to recall patients for influenza vaccinations, collect data on asthma dairies, and ensure adherence to antiretroviral therapy. In Guatemala, a country with an estimated population of 14 million inhabitants, there are at least 15 million mobile phones reported in use. At least 4 out of 5 families own and use a mobile phone, and a recent rapid needs assessment from the area of Quetzaltenango showed that at least 48% of mothers from very poor families own and use a mobile phone. The availability of this technology provides with an opportunity to use it as a method to collect information regarding vaccine coverage, use, supply and even monitoring of vaccine safety concerns.
Specific Aims:
- To pilot test the SMS immunization system that allows immunization reminders to parents and health care workers in order to improve the vaccine timeliness completion rate and overall immunization coverage
Study: 320 infants younger than 3 months of age from municipal districts in Guatemala known to have vaccine coverage rates for DPT3 below 80% and who are coming to the health services for their first dose of vaccine will be recruited for the study. After obtaining consent for participation in the study, the parents will be provided with a mobile phone with SMS capability and instructed on its use. The health care worker will use her mobile device to enter the data on the child including date of birth, mother´s mobile phone number, date of vaccination and vaccines given, and these data will be uploaded into a remote database linked to the mobile phone system.
After the child has been vaccinated the mother or custodian will receive the following SMS notifications:
- Within 3 days of vaccination an SMS will be send inquiring for any serious or medically relevant adverse events following immunization that the parent will like to report. The response will be uploaded automatically after the parent provides a reply, and will prompt a call from the health care worker if an AEFI (Adverse events following immunization) has been reported into the system.
- One week before the next scheduled date for 2nd and 3rd dose of vaccines, the parents will automatically receive daily SMS message for 3 consecutive days, instructing them to visit the health care center to vaccinate their children. If the child fails to attend the immunization appointment, the nurse will receive an automatic message one week later reminding her/him to physically recall the child for immunization.
Section II. How will you test it? The intervention will be tested in Guatemala City an area known to have attained vaccine coverage for Pentavalent/DTP3 of only 78% for all its districts in the latest Maternal Infant Health Survey conducted in 2008-2009. The development of the remote data base system as well as the mobile phone base platform will be done in conjunction with local phone companies. Those funds will provide the investment for the development of the software platform, and for the mobile phones and airtime to be given to parents and health care workers.
Essential Data and Outcomes for Phase 1:
- Rates of completion of primary immunization series in the intervention group including age at completion for 2nd and 3rd doses and rates of missed opportunities for vaccination
- Satisfaction and feedback about intervention from mother at study completion
- Conditions
- Adherence to Vaccination Schedules
- Being tested
- SMS message reminding mothers to come for their scheduled vaccines
- Keywords
- vaccines, SMS, mobile phones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS message reminding mothers to come for their scheduled vaccinesBehavioural
Reminder
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: SMS message reminding mothers to come for their scheduled vaccines | |
| Usual care | Mothers under usual care will serve as a control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edwin J Asturias, MD, Principal investigator, University of Colorado School of MedicineIngrid L Contreras-Roldan, MD, Study director, University del Valle, Guatemala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663636
- Sponsor's protocol ID
- 12-1144
- Other IDs
- OPP1061430
- Acronym
- Vaxtech
- Status last verified
- Jun 2018
- First submitted
- 8 Aug 2012
- Last updated
- 31 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 27026145
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMS Mobile Technology for Vaccine Coverage and Acceptance in Guatemalan Infants
- ClinicalTrials.gov ID
- NCT01663636
- Acronym / sponsor ID
- Vaxtech / 12-1144
- Conditions
- Adherence to Vaccination Schedules
- Keywords
- vaccines, SMS, mobile phones
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 13 Aug 2012 (estimated)
- Results
- Posted 31 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Significance: Vaccine coverage and acceptance in many municipal districts of Guatemala and other low- and middle-income countries are below the acceptable 80% reported at the national level for DPT3 (diphtheria, pertussis, tetanus) and measles vaccines. Despite the considerable effort to introduce new vaccines like Hib (Haemophilus influenzae type B) and rotavirus, in many countries like Guatemala infants do not get immunized on time. Completion of the recommended primary series does not reach beyond 70% of eligible infants by 12 months of age, placing them at risk of disease due to incomplete protection and missing the opportunity to get vaccinated appropriately. Reasons for not getting vaccinated on time include the lack of a system of reminders for the target population, missed opportunities to get vaccinated at the health services due to the lack of vaccine inventories and timely supply of vaccines (including the need for "group sessions for vaccinations" in order to secure the cold chain and vaccine availability).
In addition, monitoring of adverse events following immunization is lacking in most low and middle-income countries. Public acceptance for immunization is based not only on the effectiveness of the vaccine to reduce illness and death, but in the perception of vaccine safety at the population level. To maintain the confidence and acceptance in immunization programs, the reporting and proper response to events following immunization is critical. Allowing parents to notify possible adverse events following immunization provides them with direct access to the health care system to obtain a rapid response for their concerns, but also feedback about the safety of the vaccines and maintain vaccine trust and acceptance. Mobile phone reminders have been used in some populations in high-income countries to recall patients for influenza vaccinations, collect data on asthma dairies, and ensure adherence to antiretroviral therapy. In Guatemala, a country with an estimated population of 14 million inhabitants, there are at least 15 million mobile phones reported in use. At least 4 out of 5 families own and use a mobile phone, and a recent rapid needs assessment from the area of Quetzaltenango showed that at least 48% of mothers from very poor families own and use a mobile phone. The availability of this technology provides with an opportunity to use it as a method to collect information regarding vaccine coverage, use, supply and even monitoring of vaccine safety concerns.
Specific Aims:
- To pilot test the SMS immunization system that allows immunization reminders to parents and health care workers in order to improve the vaccine timeliness completion rate and overall immunization coverage
Study: 320 infants younger than 3 months of age from municipal districts in Guatemala known to have vaccine coverage rates for DPT3 below 80% and who are coming to the health services for their first dose of vaccine will be recruited for the study. After obtaining consent for participation in the study, the parents will be provided with a mobile phone with SMS capability and instructed on its use. The health care worker will use her mobile device to enter the data on the child including date of birth, mother´s mobile phone number, date of vaccination and vaccines given, and these data will be uploaded into a remote database linked to the mobile phone system.
After the child has been vaccinated the mother or custodian will receive the following SMS notifications:
- Within 3 days of vaccination an SMS will be send inquiring for any serious or medically relevant adverse events following immunization that the parent will like to report. The response will be uploaded automatically after the parent provides a reply, and will prompt a call from the health care worker if an AEFI (Adverse events following immunization) has been reported into the system.
- One week before the next scheduled date for 2nd and 3rd dose of vaccines, the parents will automatically receive daily SMS message for 3 consecutive days, instructing them to visit the health care center to vaccinate their children. If the child fails to attend the immunization appointment, the nurse will receive an automatic message one week later reminding her/him to physically recall the child for immunization.
Section II. How will you test it? The intervention will be tested in Guatemala City an area known to have attained vaccine coverage for Pentavalent/DTP3 of only 78% for all its districts in the latest Maternal Infant Health Survey conducted in 2008-2009. The development of the remote data base system as well as the mobile phone base platform will be done in conjunction with local phone companies. Those funds will provide the investment for the development of the software platform, and for the mobile phones and airtime to be given to parents and health care workers.
Essential Data and Outcomes for Phase 1:
- Rates of completion of primary immunization series in the intervention group including age at completion for 2nd and 3rd doses and rates of missed opportunities for vaccination
- Satisfaction and feedback about intervention from mother at study completion
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMS Vaccine | – | Behavioral: SMS message reminding mothers to come for their scheduled vaccinesMothers 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 |
| Usual care | – | –Mothers under usual care will serve as a control |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants under 12 months of age from Ministry of Health Clinics in Guatemala City
Key inclusion criteria (1 listed)
- Infants 1-3 months of age coming for their 1 dose of primary vaccines
Key exclusion criteria (3 listed)
- 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
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 message reminding mothers to come for their scheduled vaccinesReminder | Behavioural | SMS Vaccine |
Primary outcome
Completion of 3 Doses of Pentavalent Vaccine
Time frame: 8 months of age
Number of children vaccinated with the recommended dose of Pentavalent vaccines according to the age schedule of the National Immunization Program in Guatemala
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27026145Domek 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.
- Center for Global Health GrantsLink provided by the sponsor.
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 principal investigator
University of Colorado School of Medicine
Ingrid L Contreras-Roldan, MD study director
University del Valle, Guatemala
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adherence to Vaccination Schedules, run by University of Colorado, Denver at 1 site 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 1 inclusion and 3 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 31 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Yes. Results are posted in the registry (first posted 31 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 3 Doses of Pentavalent Vaccine (time frame: 8 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 NCT01663636, which also lists 1 linked publication.
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 31 Dec 2018.