<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01663636</url>
  </required_header>
  <id_info>
    <org_study_id>12-1144</org_study_id>
    <secondary_id>OPP1061430</secondary_id>
    <nct_id>NCT01663636</nct_id>
  </id_info>
  <brief_title>SMS Mobile Technology for Vaccine Coverage and Acceptance</brief_title>
  <acronym>Vaxtech</acronym>
  <official_title>SMS Mobile Technology for Vaccine Coverage and Acceptance in Guatemalan Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To pilot test a mobile phone SMS (Short Message Service) system that will provide periodical&#xD;
      messaging texts to mothers or custodians of infants who come for their first dose vaccines&#xD;
      within the first 3 months of life to improve timely immunization coverage, vaccine acceptance&#xD;
      and ensure vaccine safety monitoring. The intervention will include a &quot;cloud-based&quot;&#xD;
      information system alimented by mobile phone data entry at the health post nurse level, that&#xD;
      links child vaccination status and is able to remind parents and nurses of the need for next&#xD;
      vaccination appointment and provide a system for reporting of adverse events following&#xD;
      immunization in the immediate post-vaccination period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Significance: Vaccine coverage and acceptance in many municipal districts of Guatemala and&#xD;
      other low- and middle-income countries are below the acceptable 80% reported at the national&#xD;
      level for DPT3 (diphtheria, pertussis, tetanus) and measles vaccines. Despite the&#xD;
      considerable effort to introduce new vaccines like Hib (Haemophilus influenzae type B) and&#xD;
      rotavirus, in many countries like Guatemala infants do not get immunized on time. Completion&#xD;
      of the recommended primary series does not reach beyond 70% of eligible infants by 12 months&#xD;
      of age, placing them at risk of disease due to incomplete protection and missing the&#xD;
      opportunity to get vaccinated appropriately. Reasons for not getting vaccinated on time&#xD;
      include the lack of a system of reminders for the target population, missed opportunities to&#xD;
      get vaccinated at the health services due to the lack of vaccine inventories and timely&#xD;
      supply of vaccines (including the need for &quot;group sessions for vaccinations&quot; in order to&#xD;
      secure the cold chain and vaccine availability).&#xD;
&#xD;
      In addition, monitoring of adverse events following immunization is lacking in most low and&#xD;
      middle-income countries. Public acceptance for immunization is based not only on the&#xD;
      effectiveness of the vaccine to reduce illness and death, but in the perception of vaccine&#xD;
      safety at the population level. To maintain the confidence and acceptance in immunization&#xD;
      programs, the reporting and proper response to events following immunization is critical.&#xD;
      Allowing parents to notify possible adverse events following immunization provides them with&#xD;
      direct access to the health care system to obtain a rapid response for their concerns, but&#xD;
      also feedback about the safety of the vaccines and maintain vaccine trust and acceptance.&#xD;
      Mobile phone reminders have been used in some populations in high-income countries to recall&#xD;
      patients for influenza vaccinations, collect data on asthma dairies, and ensure adherence to&#xD;
      antiretroviral therapy. In Guatemala, a country with an estimated population of 14 million&#xD;
      inhabitants, there are at least 15 million mobile phones reported in use. At least 4 out of 5&#xD;
      families own and use a mobile phone, and a recent rapid needs assessment from the area of&#xD;
      Quetzaltenango showed that at least 48% of mothers from very poor families own and use a&#xD;
      mobile phone. The availability of this technology provides with an opportunity to use it as a&#xD;
      method to collect information regarding vaccine coverage, use, supply and even monitoring of&#xD;
      vaccine safety concerns.&#xD;
&#xD;
      Specific Aims:&#xD;
&#xD;
      1) To pilot test the SMS immunization system that allows immunization reminders to parents&#xD;
      and health care workers in order to improve the vaccine timeliness completion rate and&#xD;
      overall immunization coverage&#xD;
&#xD;
      Study: 320 infants younger than 3 months of age from municipal districts in Guatemala known&#xD;
      to have vaccine coverage rates for DPT3 below 80% and who are coming to the health services&#xD;
      for their first dose of vaccine will be recruited for the study. After obtaining consent for&#xD;
      participation in the study, the parents will be provided with a mobile phone with SMS&#xD;
      capability and instructed on its use. The health care worker will use her mobile device to&#xD;
      enter the data on the child including date of birth, mother´s mobile phone number, date of&#xD;
      vaccination and vaccines given, and these data will be uploaded into a remote database linked&#xD;
      to the mobile phone system.&#xD;
&#xD;
      After the child has been vaccinated the mother or custodian will receive the following SMS&#xD;
      notifications:&#xD;
&#xD;
        1. Within 3 days of vaccination an SMS will be send inquiring for any serious or medically&#xD;
           relevant adverse events following immunization that the parent will like to report. The&#xD;
           response will be uploaded automatically after the parent provides a reply, and will&#xD;
           prompt a call from the health care worker if an AEFI (Adverse events following&#xD;
           immunization) has been reported into the system.&#xD;
&#xD;
        2. One week before the next scheduled date for 2nd and 3rd dose of vaccines, the parents&#xD;
           will automatically receive daily SMS message for 3 consecutive days, instructing them to&#xD;
           visit the health care center to vaccinate their children. If the child fails to attend&#xD;
           the immunization appointment, the nurse will receive an automatic message one week later&#xD;
           reminding her/him to physically recall the child for immunization.&#xD;
&#xD;
      Section II. How will you test it? The intervention will be tested in Guatemala City an area&#xD;
      known to have attained vaccine coverage for Pentavalent/DTP3 of only 78% for all its&#xD;
      districts in the latest Maternal Infant Health Survey conducted in 2008-2009. The development&#xD;
      of the remote data base system as well as the mobile phone base platform will be done in&#xD;
      conjunction with local phone companies. Those funds will provide the investment for the&#xD;
      development of the software platform, and for the mobile phones and airtime to be given to&#xD;
      parents and health care workers.&#xD;
&#xD;
      Essential Data and Outcomes for Phase 1:&#xD;
&#xD;
        1. Rates of completion of primary immunization series in the intervention group including&#xD;
           age at completion for 2nd and 3rd doses and rates of missed opportunities for&#xD;
           vaccination&#xD;
&#xD;
        2. Satisfaction and feedback about intervention from mother at study completion&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Completion of 3 Doses of Pentavalent Vaccine</measure>
    <time_frame>8 months of age</time_frame>
    <description>Number of children vaccinated with the recommended dose of Pentavalent vaccines according to the age schedule of the National Immunization Program in Guatemala</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">321</enrollment>
  <condition>Adherence to Vaccination Schedules</condition>
  <arm_group>
    <arm_group_label>SMS Vaccine</arm_group_label>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <description>Mothers under usual care will serve as a control</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SMS message reminding mothers to come for their scheduled vaccines</intervention_name>
    <description>Reminder</description>
    <arm_group_label>SMS Vaccine</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Infants under 12 months of age from Ministry of Health Clinics in Guatemala City&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants 1-3 months of age coming for their 1 dose of primary vaccines&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Received 1 dose of vaccines, excluding BCG&#xD;
&#xD;
          -  No mobile phone with SMS or unable to use SMS at home&#xD;
&#xD;
          -  Intent to move from the clinic area in the next 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>12 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Edwin J Asturias, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ingrid L Contreras-Roldan, MD</last_name>
    <role>Study Director</role>
    <affiliation>University del Valle, Guatemala</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University del Valle</name>
      <address>
        <city>Guatemala</city>
        <zip>01001</zip>
        <country>Guatemala</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Guatemala</country>
  </location_countries>
  <link>
    <url>http://www.ucdenver.edu/academics/colleges/PublicHealth/research/centers/globalhealth/Pages/welcome.aspx</url>
    <description>Center for Global Health Grants</description>
  </link>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <results_first_submitted>February 18, 2016</results_first_submitted>
  <results_first_submitted_qc>June 28, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">December 31, 2018</results_first_posted>
  <last_update_submitted>June 28, 2018</last_update_submitted>
  <last_update_submitted_qc>June 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vaccines</keyword>
  <keyword>SMS</keyword>
  <keyword>mobile phones</keyword>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Parents of infants between the ages of 8 and 14 weeks presenting for the first dose of the 3-dose infant primary immunization series were eligible if they owned a mobile phone with SMS text messaging capability and were recruited in 2 pubic health clinics in Guatemala City from April to May of 2013.</recruitment_details>
      <pre_assignment_details>At least one parent had to be literate and able to use SMS technology. Parents were excluded if they were under 18 years of age or if their child had a contraindication to vaccination. Allocation to SMS vaccine (intervention) or usual care (control) was done using a computer generated randomization.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>SMS Vaccine</title>
          <description>Parent or guardian will be sent an SMS message reminding them to bring in their infant(s) for the infant(s) scheduled vaccines 1 week prior to the date of 2nd and 3rd doses.</description>
        </group>
        <group group_id="P2">
          <title>Usual Care</title>
          <description>Parent or guardian and their infants who are under usual care (no SMS) will serve as a control group.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Infant SMS Reminder Feasibility Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="160"/>
                <participants group_id="P2" count="161"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="135"/>
                <participants group_id="P2" count="130"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Parent SMS Acceptability Assessment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="135"/>
                <participants group_id="P2" count="130"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="135"/>
                <participants group_id="P2" count="130"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>SMS Vaccine</title>
          <description>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</description>
        </group>
        <group group_id="B2">
          <title>Usual Care</title>
          <description>Mothers under usual care will serve as a control</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="160"/>
            <count group_id="B2" value="161"/>
            <count group_id="B3" value="321"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.7" spread="1.4"/>
                    <measurement group_id="B2" value="9.4" spread="1.2"/>
                    <measurement group_id="B3" value="9.5" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                    <measurement group_id="B2" value="89"/>
                    <measurement group_id="B3" value="165"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="84"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="155"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing value</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants who live &lt;16 km from the Clinic</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Live &lt;16 km from the Clinic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="157"/>
                    <measurement group_id="B2" value="160"/>
                    <measurement group_id="B3" value="317"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Live =&gt;16 km from the Clinic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Completion of 3 Doses of Pentavalent Vaccine</title>
        <description>Number of children vaccinated with the recommended dose of Pentavalent vaccines according to the age schedule of the National Immunization Program in Guatemala</description>
        <time_frame>8 months of age</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SMS Vaccine</title>
            <description>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</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Mothers under usual care will serve as a control</description>
          </group>
        </group_list>
        <measure>
          <title>Completion of 3 Doses of Pentavalent Vaccine</title>
          <description>Number of children vaccinated with the recommended dose of Pentavalent vaccines according to the age schedule of the National Immunization Program in Guatemala</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="160"/>
                <count group_id="O2" value="161"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="135"/>
                    <measurement group_id="O2" value="130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <desc>Breaches in confidentiality or inadvertent information releases were monitored.</desc>
      <group_list>
        <group group_id="E1">
          <title>SMS Vaccine</title>
          <description>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</description>
        </group>
        <group group_id="E2">
          <title>Usual Care</title>
          <description>Mothers under usual care will serve as a control</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="160"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="160"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Study was not powered to assess efficacy. SMS texts platform did not have a reporting feature, limiting our ability to confirm message reception. High vaccine visit completion rates made evaluation of an effect challenging.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Edwin J. Asturias</name_or_title>
      <organization>Center for Global Health, University of Colorado</organization>
      <phone>3037246282</phone>
      <email>edwin.asturias@ucdenver.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01663636
org study id: 12-1144
secondary id: OPP1061430
nct id: NCT01663636
lead sponsor: 
has dmc: No
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
observational model: Cohort
time perspective: Prospective
measure: Completion of 3 Doses of Pentavalent Vaccine
time frame: 8 months of age
description: Number of children vaccinated with the recommended dose of Pentavalent vaccines according to the age schedule of the National Immunization Program in Guatemala
arm group label: SMS Vaccine
description: 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
arm group label: Usual care
description: Mothers under usual care will serve as a control
intervention type: Behavioral
intervention name: SMS message reminding mothers to come for their scheduled vaccines
description: Reminder
arm group label: SMS Vaccine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 12 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Edwin J Asturias, MD
role: Principal Investigator
affiliation: University of Colorado School of Medicine
last name: Ingrid L Contreras-Roldan, MD
role: Study Director
affiliation: University del Valle, Guatemala
facility: 
country: Guatemala
url: http://www.ucdenver.edu/academics/colleges/PublicHealth/research/centers/globalhealth/Pages/welcome.aspx
description: Center for Global Health Grants
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Study was not powered to assess efficacy. SMS texts platform did not have a reporting feature, limiting our ability to confirm message reception. High vaccine visit completion rates made evaluation of an effect challenging.
point of contact: 