<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/NCT03292913</url>
  </required_header>
  <id_info>
    <org_study_id>1U18PS004967-01</org_study_id>
    <nct_id>NCT03292913</nct_id>
  </id_info>
  <brief_title>Positive Health Check Evaluation Trial</brief_title>
  <acronym>(PHC)</acronym>
  <official_title>Positive Health Check Evaluation Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RTI International</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>RTI International</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate the effect of Positive Health Check (PHC), an online&#xD;
      intervention that delivers tailored, evidence-based prevention messages to HIV positive&#xD;
      patients, on improving clinical outcomes and retention in care of people who are HIV positive&#xD;
      and have unsuppressed viral loads. The costs and processes of implementation will also be&#xD;
      assessed to inform future dissemination.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Positive Health Check (PHC) Evaluation Trial uses a randomized trial to test if a brief&#xD;
      web-based counseling intervention can improve clinical outcomes among people living with&#xD;
      human immunodeficiency virus (HIV). The study will also assess implementation processes,&#xD;
      collect data to determine cost effectiveness, and document the standard of care in each&#xD;
      clinic. The study will take place in four locations including Atlanta Veterans Affairs (VA)&#xD;
      Medical Center (Atlanta, GA), Hillsborough County Health Department (Tampa, FL), Rutgers&#xD;
      Infectious Disease Practice (Newark, NJ) and Crescent Care (New Orleans, LA). The objectives&#xD;
      of the PHC Evaluation Trial are four-fold: Objective 1) Implement a randomized trial to test&#xD;
      if the PHC intervention improves clinical health outcomes, specifically viral load&#xD;
      suppression and retention in care. While Positive Health Check (PHC) is designed to improve&#xD;
      antiretroviral therapy (ART) initiation, ART adherence and retention in care as well as&#xD;
      reduce unprotected sex and promote safe injection practices, the primary outcome on which the&#xD;
      trial is powered is viral suppression; Objective 2) Conduct an implementation evaluation to&#xD;
      determine effective implementation strategies and integration of Positive Health Check (PHC)&#xD;
      into human immunodeficiency virus (HIV) primary care clinics; Objective 3) Collect and&#xD;
      document data on the cost of the PHC intervention implementation; Objective 4) Document the&#xD;
      standard of care at each participating site. Positive Health Check (PHC) is a web-based&#xD;
      intervention that delivers tailored evidence-based prevention messages to human&#xD;
      immunodeficiency virus (HIV) positive patients through a series of brief interactive videos&#xD;
      designed to simulate a conversation with an human immunodeficiency virus (HIV) primary care&#xD;
      provider. Web-based interventions have been shown to be effective in improving adherence and&#xD;
      reducing sexual risk. Eligible patients, who use the intervention, are given a tablet with a&#xD;
      privacy screen, a set of headphones, a unique login identification (ID) and will be prompted&#xD;
      to create their own private password. Once logged in, the intervention guides a patient&#xD;
      through tailored messaging from a video doctor on patient-selected topics including treatment&#xD;
      initiation or adherence, retention in care, sexual risk reduction, pregnancy, and intravenous&#xD;
      drug use. Throughout the intervention patients answer tailoring questions about themselves&#xD;
      and based on their answers, are given tailored messages from their chosen video doctor.&#xD;
      Positive Health Check (PHC) is designed to facilitate patient-provider communication on these&#xD;
      topics. In the intervention, patients can select which questions they have for their doctor&#xD;
      on the topics covered and which health promotion strategies they want to practice before&#xD;
      their next visit. The questions and chosen health promotion strategies (&quot;tips&quot;) automatically&#xD;
      populate to a handout which is given to the patient after logging off. Patients also have&#xD;
      access to another module that provides other information about human immunodeficiency virus&#xD;
      (HIV) management, how to prevent transmission, and living a healthy lifestyle while being&#xD;
      human immunodeficiency virus (HIV) positive. The intervention will be considered implemented&#xD;
      with fidelity if a patient completes the intervention in the clinic before or after seeing&#xD;
      their primary care provider, or before or after a blood draw or ancillary appointment in&#xD;
      advance of their appointment with their clinical provider. A patient may also begin the&#xD;
      intervention in the clinic and complete it after the appointment or at home within 21 days.&#xD;
      Evaluation of the intervention will include comparisons of the intervention and control arms&#xD;
      on the primary outcome using data abstracted via electronic medical records, with the 12-&#xD;
      month viral load value considered the primary outcome measure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 27, 2018</start_date>
  <completion_date type="Actual">October 31, 2020</completion_date>
  <primary_completion_date type="Actual">October 31, 2020</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Viral Load Suppression</measure>
    <time_frame>Targeted time frame is 12 months post-randomization with a possible range of 10-16 months to account for variable timing of clinic visits.</time_frame>
    <description>Viral load suppression was defined as having viral load &lt; 200 copies/mL by the end of each participant's 12 months of follow-up assessment (with a window from start of 10 months through the end of 16 months post-randomization to accommodate timing of clinical visits).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Retained in Care at 12-month Follow up</measure>
    <time_frame>Up to 12 months post randomization</time_frame>
    <description>Retention in care is a patient defined as having at least one visit in each 6-month period within 12 months post-randomization separated by at least two months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retention in Care</measure>
    <time_frame>12 months of randomization</time_frame>
    <description>A 6-month visit gap was defined as having at least 189 days between two sequentially kept visits, post-randomization.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">799</enrollment>
  <condition>Human Immunodeficiency Virus (HIV) Positive</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receives the Positive Health Check intervention plus standard of care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Receives standard of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Positive Health Check</intervention_name>
    <description>Positive Health Check (PHC) is an online intervention that delivers tailored evidence-based prevention messages to human immunodeficiency virus (HIV) positive patients through a series of brief interactive videos designed to simulate a conversation with an human immunodeficiency virus (HIV) primary care provider.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Standard of care for patients with human immunodeficiency virus (HIV) (this includes standard of care practices around antiretroviral therapy (ART) initiation, adherence and retention)</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 years of age or older;&#xD;
&#xD;
          2. Diagnosed with human immunodeficiency virus (HIV);&#xD;
&#xD;
          3. English-speaking;&#xD;
&#xD;
          4. Attending one of the four clinical sites;&#xD;
&#xD;
          5. Meet at least one of the following: a) Most recent viral load lab result of ≥ 200&#xD;
             copies/mL, b) Attended an initial human immunodeficiency virus human immunodeficiency&#xD;
             virus (HIV) appointment with a provider at one of the four sites within the past 12&#xD;
             months; c) Out of care (last attended appointment at the clinic was more than 12&#xD;
             months ago);&#xD;
&#xD;
          6. Not involved in any other intervention that would bias outcome assessment,&#xD;
&#xD;
          7. Deemed mentally competent and able to engage with the intervention.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Under 18 years of age;&#xD;
&#xD;
          2. Human immunodeficiency virus (HIV) negative;&#xD;
&#xD;
          3. Does not speak English;&#xD;
&#xD;
          4. Does not attend one of the four clinical sites for (HIV) primary care;&#xD;
&#xD;
          5. Meets all of the following: a) Most recent viral load lab result of &lt; 200 copies/mL,&#xD;
             b) Did not attend an initial human immunodeficiency virus (HIV) appointment with a&#xD;
             provider at one of the four sites within the past 12 months, c) Last attended&#xD;
             appointment at the clinic was less than 12 months ago)&#xD;
&#xD;
          6. Involved in an intervention that would bias outcome assessment;&#xD;
&#xD;
          7. Deemed mentally incompetent to engage with the intervention.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Megan Lewis, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>RTI International</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hillsborough County Health Department</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta VA Medical Center</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Crescent Care</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rutgers Infectious Disease Practice</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://positivehealthcheck.cdc.gov</url>
    <description>Positive Health Check tool</description>
  </link>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <results_first_submitted>December 6, 2021</results_first_submitted>
  <results_first_submitted_qc>August 1, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">August 2, 2022</results_first_posted>
  <last_update_submitted>August 1, 2022</last_update_submitted>
  <last_update_submitted_qc>August 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Human Immunodeficiency Virus (HIV)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
    <mesh_term>HIV Seropositivity</mesh_term>
    <mesh_term>Immunologic Deficiency Syndromes</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 24, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT03292913/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 3, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT03292913/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 22, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT03292913/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intervention Group</title>
          <description>Receives the Positive Health Check intervention plus standard of care&#xD;
Positive Health Check: PHC is an online intervention that delivers tailored evidence-based prevention messages to HIV positive patients through a series of brief interactive videos designed to simulate a conversation with an HIV primary care provider.</description>
        </group>
        <group group_id="P2">
          <title>Control Group</title>
          <description>Receives standard of care&#xD;
Standard of Care: Standard of care for patients with HIV (this includes standard of care practices around ART initiation, adherence and retention)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="397"/>
                <participants group_id="P2" count="402"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="315"/>
                <participants group_id="P2" count="314"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="82"/>
                <participants group_id="P2" count="88"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
                <participants group_id="P2" count="49"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Clinic closed due to COVID</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>One of the 397 participants in the Positive Health Check and Standard of Care group and one of the 402 participants in the Standard of Care group were missing data for age because it was not included in their patient charts.</population>
      <group_list>
        <group group_id="B1">
          <title>Intervention Group</title>
          <description>Positive Health Check and Standard of Care&#xD;
Participants with HIV diagnosis received Positive Health Check intervention and standard of care</description>
        </group>
        <group group_id="B2">
          <title>Control Group</title>
          <description>Standard of care&#xD;
Participants with HIV diagnosis received standard of care only</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="397"/>
            <count group_id="B2" value="402"/>
            <count group_id="B3" value="799"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>2 participants, 1 from each group did not declare their age.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Participants</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="396"/>
                    <count group_id="B2" value="401"/>
                    <count group_id="B3" value="797"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="376"/>
                    <measurement group_id="B2" value="383"/>
                    <measurement group_id="B3" value="759"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <population>One of the 397 participants in the Positive Health Check and Standard of Care group and one of the 402 participants in the Standard of Care group were missing data for age because it was not included in their patient charts.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="396"/>
                    <count group_id="B2" value="401"/>
                    <count group_id="B3" value="797"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45.4" spread="13.0"/>
                    <measurement group_id="B2" value="44.5" spread="12.6"/>
                    <measurement group_id="B3" value="44.9" spread="12.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>1 participant did not declare gender/sex</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Participants</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="397"/>
                    <count group_id="B2" value="401"/>
                    <count group_id="B3" value="798"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="303"/>
                    <measurement group_id="B2" value="306"/>
                    <measurement group_id="B3" value="609"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="94"/>
                    <measurement group_id="B2" value="95"/>
                    <measurement group_id="B3" value="189"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="397"/>
                    <count group_id="B2" value="402"/>
                    <count group_id="B3" value="799"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="359"/>
                    <measurement group_id="B2" value="365"/>
                    <measurement group_id="B3" value="724"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="397"/>
                    <count group_id="B2" value="402"/>
                    <count group_id="B3" value="799"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="299"/>
                    <measurement group_id="B2" value="301"/>
                    <measurement group_id="B3" value="600"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="88"/>
                    <measurement group_id="B3" value="173"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <description>All participants data were included in the trial data that was analyzed regardless of the missing demographics data.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="397"/>
                    <count group_id="B2" value="402"/>
                    <count group_id="B3" value="799"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="397"/>
                    <measurement group_id="B2" value="402"/>
                    <measurement group_id="B3" value="799"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Viral Load Suppression</title>
        <description>Viral load suppression was defined as having viral load &lt; 200 copies/mL by the end of each participant's 12 months of follow-up assessment (with a window from start of 10 months through the end of 16 months post-randomization to accommodate timing of clinical visits).</description>
        <time_frame>Targeted time frame is 12 months post-randomization with a possible range of 10-16 months to account for variable timing of clinic visits.</time_frame>
        <population>All participants with a viral load measurement at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>Positive Health Check intervention plus standard of care</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Standard of care only</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Viral Load Suppression</title>
          <description>Viral load suppression was defined as having viral load &lt; 200 copies/mL by the end of each participant's 12 months of follow-up assessment (with a window from start of 10 months through the end of 16 months post-randomization to accommodate timing of clinical visits).</description>
          <population>All participants with a viral load measurement at baseline.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="368"/>
                <count group_id="O2" value="372"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="210"/>
                    <measurement group_id="O2" value="213"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Outcome measure for this analysis is viral load suppression. A priori threshold for statistical significance is p-value less than 0.05.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.220</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Risk ratio is adjusted for sex, age, race, site, viral load suppression at baseline, and new to care.</method_desc>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.96</ci_lower_limit>
            <ci_upper_limit>1.21</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Retained in Care at 12-month Follow up</title>
        <description>Retention in care is a patient defined as having at least one visit in each 6-month period within 12 months post-randomization separated by at least two months.</description>
        <time_frame>Up to 12 months post randomization</time_frame>
        <population>All participants</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>Participants with HIV diagnosis who received Positive Health Check intervention plus standard of care</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Patients with HIV diagnosis who received standard of care only</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Retained in Care at 12-month Follow up</title>
          <description>Retention in care is a patient defined as having at least one visit in each 6-month period within 12 months post-randomization separated by at least two months.</description>
          <population>All participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="397"/>
                <count group_id="O2" value="402"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="257"/>
                    <measurement group_id="O2" value="247"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Outcome measure for this analysis is retention in care. A priori threshold for statistical significance is p-value less than 0.05.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.481</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Risk ratio is adjusted for sex, age, race, site, and new to care.</method_desc>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.94</ci_lower_limit>
            <ci_upper_limit>1.15</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Retention in Care</title>
        <description>A 6-month visit gap was defined as having at least 189 days between two sequentially kept visits, post-randomization.</description>
        <time_frame>12 months of randomization</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>Participants with human immunodeficiency virus (HIV) diagnosis who received Positive Health Check intervention plus standard of care</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Patients with human immunodeficiency virus (HIV) diagnosis who received standard of care only</description>
          </group>
        </group_list>
        <measure>
          <title>Retention in Care</title>
          <description>A 6-month visit gap was defined as having at least 189 days between two sequentially kept visits, post-randomization.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="397"/>
                <count group_id="O2" value="402"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="113"/>
                    <measurement group_id="O2" value="164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Outcome measure for this analysis is a 6-month visit gap defined ashaving at least 189 days between two sequentially kept visits, post-randomization. A priori threshold for statistical significance is p-value less than 0.05.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.093</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Risk ratio is adjusted for sex, age, race, site, and new to care.</method_desc>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.72</ci_lower_limit>
            <ci_upper_limit>1.03</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline to 12 months post randomization</time_frame>
      <desc>Each death was reviewed by the respective site's study Institutional Review Board (IRB) and deemed not related with the trial.</desc>
      <group_list>
        <group group_id="E1">
          <title>Intervention Group</title>
          <description>Receives the Positive Health Check intervention plus standard of care&#xD;
Positive Health Check: PHC is an online intervention that delivers tailored evidence-based prevention messages to HIV positive patients through a series of brief interactive videos designed to simulate a conversation with an HIV primary care provider.</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>Receives standard of care&#xD;
Standard of Care: Standard of care for patients with HIV (this includes standard of care practices around ART initiation, adherence and retention)</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="397"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="402"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="397"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="402"/>
              </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="397"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="402"/>
              </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>
    <point_of_contact>
      <name_or_title>Megan Lewis</name_or_title>
      <organization>RTI International Institute</organization>
      <phone>206-268-3613</phone>
      <email>melewis@rti.org</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/NCT03292913
org study id: 1U18PS004967-01
nct id: NCT03292913
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to evaluate the effect of Positive Health Check (PHC), an online
      intervention that delivers tailored, evidence-based prevention messages to HIV positive
      patients, on improving clinical outcomes and retention in care of people who are HIV positive
      and have unsuppressed viral loads. The costs and processes of implementation will also be
      assessed to inform future dissemination.
The Positive Health Check (PHC) Evaluation Trial uses a randomized trial to test if a brief
      web-based counseling intervention can improve clinical outcomes among people living with
      human immunodeficiency virus (HIV). The study will also assess implementation processes,
      collect data to determine cost effectiveness, and document the standard of care in each
      clinic. The study will take place in four locations including Atlanta Veterans Affairs (VA)
      Medical Center (Atlanta, GA), Hillsborough County Health Department (Tampa, FL), Rutgers
      Infectious Disease Practice (Newark, NJ) and Crescent Care (New Orleans, LA). The objectives
      of the PHC Evaluation Trial are four-fold: Objective 1) Implement a randomized trial to test
      if the PHC intervention improves clinical health outcomes, specifically viral load
      suppression and retention in care. While Positive Health Check (PHC) is designed to improve
      antiretroviral therapy (ART) initiation, ART adherence and retention in care as well as
      reduce unprotected sex and promote safe injection practices, the primary outcome on which the
      trial is powered is viral suppression; Objective 2) Conduct an implementation evaluation to
      determine effective implementation strategies and integration of Positive Health Check (PHC)
      into human immunodeficiency virus (HIV) primary care clinics; Objective 3) Collect and
      document data on the cost of the PHC intervention implementation; Objective 4) Document the
      standard of care at each participating site. Positive Health Check (PHC) is a web-based
      intervention that delivers tailored evidence-based prevention messages to human
      immunodeficiency virus (HIV) positive patients through a series of brief interactive videos
      designed to simulate a conversation with an human immunodeficiency virus (HIV) primary care
      provider. Web-based interventions have been shown to be effective in improving adherence and
      reducing sexual risk. Eligible patients, who use the intervention, are given a tablet with a
      privacy screen, a set of headphones, a unique login identification (ID) and will be prompted
      to create their own private password. Once logged in, the intervention guides a patient
      through tailored messaging from a video doctor on patient-selected topics including treatment
      initiation or adherence, retention in care, sexual risk reduction, pregnancy, and intravenous
      drug use. Throughout the intervention patients answer tailoring questions about themselves
      and based on their answers, are given tailored messages from their chosen video doctor.
      Positive Health Check (PHC) is designed to facilitate patient-provider communication on these
      topics. In the intervention, patients can select which questions they have for their doctor
      on the topics covered and which health promotion strategies they want to practice before
      their next visit. The questions and chosen health promotion strategies ("tips") automatically
      populate to a handout which is given to the patient after logging off. Patients also have
      access to another module that provides other information about human immunodeficiency virus
      (HIV) management, how to prevent transmission, and living a healthy lifestyle while being
      human immunodeficiency virus (HIV) positive. The intervention will be considered implemented
      with fidelity if a patient completes the intervention in the clinic before or after seeing
      their primary care provider, or before or after a blood draw or ancillary appointment in
      advance of their appointment with their clinical provider. A patient may also begin the
      intervention in the clinic and complete it after the appointment or at home within 21 days.
      Evaluation of the intervention will include comparisons of the intervention and control arms
      on the primary outcome using data abstracted via electronic medical records, with the 12-
      month viral load value considered the primary outcome measure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of Participants With Viral Load Suppression
time frame: Targeted time frame is 12 months post-randomization with a possible range of 10-16 months to account for variable timing of clinic visits.
description: Viral load suppression was defined as having viral load < 200 copies/mL by the end of each participant's 12 months of follow-up assessment (with a window from start of 10 months through the end of 16 months post-randomization to accommodate timing of clinical visits).
measure: Number of Participants Retained in Care at 12-month Follow up
time frame: Up to 12 months post randomization
description: Retention in care is a patient defined as having at least one visit in each 6-month period within 12 months post-randomization separated by at least two months.
measure: Retention in Care
time frame: 12 months of randomization
description: A 6-month visit gap was defined as having at least 189 days between two sequentially kept visits, post-randomization.
arm group label: Intervention Group
arm group type: Experimental
description: Receives the Positive Health Check intervention plus standard of care
arm group label: Control Group
arm group type: Other
description: Receives standard of care
intervention type: Behavioral
intervention name: Positive Health Check
description: Positive Health Check (PHC) is an online intervention that delivers tailored evidence-based prevention messages to human immunodeficiency virus (HIV) positive patients through a series of brief interactive videos designed to simulate a conversation with an human immunodeficiency virus (HIV) primary care provider.
arm group label: Intervention Group
intervention type: Behavioral
intervention name: Standard of Care
description: Standard of care for patients with human immunodeficiency virus (HIV) (this includes standard of care practices around antiretroviral therapy (ART) initiation, adherence and retention)
arm group label: Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Megan Lewis, PhD
role: Principal Investigator
affiliation: RTI International
facility: 
facility: 
facility: 
facility: 
country: United States
url: https://positivehealthcheck.cdc.gov
description: Positive Health Check tool
responsible party type: Sponsor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: HIV Seropositivity
mesh term: Immunologic Deficiency Syndromes
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 