Adherence to Vaccination Schedules Clinical Trial
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.
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:
1) 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:
1. 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.
2. 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:
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
2. Satisfaction and feedback about intervention from mother at study completion
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02567006 -
SMS Mobile Technology to Improve Early Childhood Vaccine Coverage in Guatemala
|
N/A |