<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/NCT01722734</url>
  </required_header>
  <id_info>
    <org_study_id>19850-101</org_study_id>
    <nct_id>NCT01722734</nct_id>
  </id_info>
  <brief_title>Preserving ACTs - Text Reminders to Increase Adherence to ACT Treatment</brief_title>
  <acronym>PACT</acronym>
  <official_title>Preserving ACTs - Text Reminders to Increase Adherence to ACT Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Harvard School of Public Health (HSPH)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Harvard School of Public Health (HSPH)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized controlled trial was conducted to assess the effectiveness of text reminders&#xD;
      sent to ACT users through an automated text messaging system short-message-system.&#xD;
&#xD;
      Study hypothesis: text message reminders increase adherence&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized controlled trial was conducted to assess the effectiveness of text reminders&#xD;
      sent to ACT users through an automated text messaging system short-message-system. Patients&#xD;
      were enrolled at clinics and pharmacies upon receipt of ACTs and enrolled in the automated&#xD;
      system for 3 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">December 2011</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-reported Adherence to Artemisinin-combination Therapy (ACT) Treatment</measure>
    <time_frame>70 hours</time_frame>
    <description>Percentage of participants completing full ACT treatment regimen 70 hours after treatment initiation. Subjects were visited at home, and asked to report when each of the prescribed six doses were taken. Adherence was defined as the (self-reported) completion of all six doses.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">1140</enrollment>
  <condition>Malaria</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in the control arm only got a generic health message at the end of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Short Message</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Long message</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Text message reminders</intervention_name>
    <description>Patients in the two treatment arms receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals to remind them to take their malaria medication as prescribed.</description>
    <arm_group_label>Long message</arm_group_label>
    <arm_group_label>Short Message</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -subjects acquiring ACTs in Tamale, Ghana&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects acquiring ACTs for non household members&#xD;
&#xD;
          -  subjects under the age of 18&#xD;
&#xD;
          -  subjects without access to cell phones&#xD;
&#xD;
          -  subjects living more than 30 minutes from pickup location&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gunther Fink, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Harvard School of Public Health (HSPH)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Study site</name>
      <address>
        <city>Tamale</city>
        <state>Northern Region</state>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ghana</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <results_first_submitted>October 23, 2013</results_first_submitted>
  <results_first_submitted_qc>February 3, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 21, 2014</results_first_posted>
  <last_update_submitted>February 3, 2014</last_update_submitted>
  <last_update_submitted_qc>February 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Harvard School of Public Health (HSPH)</investigator_affiliation>
    <investigator_full_name>Günther Fink</investigator_full_name>
    <investigator_title>Assistant Professor of International Health Economics</investigator_title>
  </responsible_party>
  <keyword>Malaria</keyword>
  <keyword>ACTs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malaria</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were recruited at all private and public facilities distributing Artemisinin-combination Therapies (ACTs).</recruitment_details>
      <pre_assignment_details>Only subjects from the Tamale area with cell phones were included.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Control</title>
          <description>Control group participants received only a message after five days informing them about the importance of using bed nets for malaria. No reminders to take ACTs were sent.</description>
        </group>
        <group group_id="P2">
          <title>Short Message</title>
          <description>Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.</description>
        </group>
        <group group_id="P3">
          <title>Long Message</title>
          <description>Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="554"/>
                <participants group_id="P2" count="277"/>
                <participants group_id="P3" count="309"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="552"/>
                <participants group_id="P2" count="276"/>
                <participants group_id="P3" count="307"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Control</title>
          <description>Patients in this group received only a generic malaria information message (use bed nets) at the end of the study.</description>
        </group>
        <group group_id="B2">
          <title>Short Message</title>
          <description>Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.</description>
        </group>
        <group group_id="B3">
          <title>Long Message</title>
          <description>Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.</description>
        </group>
        <group group_id="B4">
          <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="554"/>
            <count group_id="B2" value="277"/>
            <count group_id="B3" value="309"/>
            <count group_id="B4" value="1140"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Age is reported for the sick person in the household, which includes children in the care of adults, who were enrolled in the study and who received the message treatments.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="166"/>
                    <measurement group_id="B2" value="105"/>
                    <measurement group_id="B3" value="111"/>
                    <measurement group_id="B4" value="382"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="342"/>
                    <measurement group_id="B2" value="158"/>
                    <measurement group_id="B3" value="166"/>
                    <measurement group_id="B4" value="666"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="32"/>
                    <measurement group_id="B4" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <description>Age reflects age of the patient. For patients of age 18 and younger, caregivers were enrolled and interviewed and thus primary study subjects.</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.3" spread="17.7"/>
                    <measurement group_id="B2" value="23" spread="17.1"/>
                    <measurement group_id="B3" value="23.8" spread="17.8"/>
                    <measurement group_id="B4" value="24.3" spread="17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="302"/>
                    <measurement group_id="B2" value="152"/>
                    <measurement group_id="B3" value="180"/>
                    <measurement group_id="B4" value="634"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="252"/>
                    <measurement group_id="B2" value="125"/>
                    <measurement group_id="B3" value="129"/>
                    <measurement group_id="B4" value="506"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Ghana</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="554"/>
                    <measurement group_id="B2" value="277"/>
                    <measurement group_id="B3" value="309"/>
                    <measurement group_id="B4" value="1140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Self-reported Adherence to Artemisinin-combination Therapy (ACT) Treatment</title>
        <description>Percentage of participants completing full ACT treatment regimen 70 hours after treatment initiation. Subjects were visited at home, and asked to report when each of the prescribed six doses were taken. Adherence was defined as the (self-reported) completion of all six doses.</description>
        <time_frame>70 hours</time_frame>
        <population>The number of subjects analyzed is smaller than the number of subjects enrolled due to missing data on adherence. A total of 30 observations were lost due to missing information on adherence - 16 in the control group, 9 in the short message group, and 5 in the long message group.</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Subjects in this group received only one generic malaria message (use bed nets) at the end of the study.</description>
          </group>
          <group group_id="O2">
            <title>Short Message</title>
            <description>Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.</description>
          </group>
          <group group_id="O3">
            <title>Long Message</title>
            <description>Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-reported Adherence to Artemisinin-combination Therapy (ACT) Treatment</title>
          <description>Percentage of participants completing full ACT treatment regimen 70 hours after treatment initiation. Subjects were visited at home, and asked to report when each of the prescribed six doses were taken. Adherence was defined as the (self-reported) completion of all six doses.</description>
          <population>The number of subjects analyzed is smaller than the number of subjects enrolled due to missing data on adherence. A total of 30 observations were lost due to missing information on adherence - 16 in the control group, 9 in the short message group, and 5 in the long message group.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="538"/>
                <count group_id="O2" value="268"/>
                <count group_id="O3" value="304"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.5" lower_limit="57.39" upper_limit="65.648"/>
                    <measurement group_id="O2" value="69.0" lower_limit="63.45" upper_limit="74.60"/>
                    <measurement group_id="O3" value="64.1" lower_limit="58.72" upper_limit="69.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse effects were restricted to the 3 days monitoring period.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Control</title>
          <description>Patients in this group received only a generic malaria message at the end of the study.</description>
        </group>
        <group group_id="E2">
          <title>Short Message</title>
          <description>Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.</description>
        </group>
        <group group_id="E3">
          <title>Long Message</title>
          <description>Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.</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="554"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="277"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="309"/>
              </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="554"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="277"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="309"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Main outcome is self-reported adherence. Study was restricted to urban population with mobile phone ownership.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr Günther Fink</name_or_title>
      <organization>Harvard School of Public Health</organization>
      <phone>6174327389</phone>
      <email>gfink@hsph.harvard.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/NCT01722734
org study id: 19850-101
nct id: NCT01722734
lead sponsor: 
has dmc: No
A randomized controlled trial was conducted to assess the effectiveness of text reminders
      sent to ACT users through an automated text messaging system short-message-system.

      Study hypothesis: text message reminders increase adherence
A randomized controlled trial was conducted to assess the effectiveness of text reminders
      sent to ACT users through an automated text messaging system short-message-system. Patients
      were enrolled at clinics and pharmacies upon receipt of ACTs and enrolled in the automated
      system for 3 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Self-reported Adherence to Artemisinin-combination Therapy (ACT) Treatment
time frame: 70 hours
description: Percentage of participants completing full ACT treatment regimen 70 hours after treatment initiation. Subjects were visited at home, and asked to report when each of the prescribed six doses were taken. Adherence was defined as the (self-reported) completion of all six doses.
arm group label: Control
arm group type: No Intervention
description: Patients in the control arm only got a generic health message at the end of the study.
arm group label: Short Message
arm group type: Active Comparator
description: Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.
arm group label: Long message
arm group type: Active Comparator
description: Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.
intervention type: Behavioral
intervention name: Text message reminders
description: Patients in the two treatment arms receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals to remind them to take their malaria medication as prescribed.
arm group label: Long message
arm group label: Short Message
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Gunther Fink, PhD
role: Principal Investigator
affiliation: Harvard School of Public Health (HSPH)
facility: 
country: Ghana
responsible party type: Principal Investigator
investigator affiliation: Harvard School of Public Health (HSPH)
investigator full name: Günther Fink
investigator title: Assistant Professor of International Health Economics
mesh term: Malaria
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Main outcome is self-reported adherence. Study was restricted to urban population with mobile phone ownership.
point of contact: 