<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/NCT03839394</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00085562</org_study_id>
    <secondary_id>K23HL137611-01A1</secondary_id>
    <nct_id>NCT03839394</nct_id>
  </id_info>
  <brief_title>Case Managers for CVD Risk Reduction in HIV Clinic</brief_title>
  <official_title>A Clinic-Based Case Manager Administered Telephone Intervention to Reduce Cardiovascular Disease Risk in Persons Living With HIV</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</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 assess the efficacy of a case manager/social worker&#xD;
      administered, telephone-based educational curriculum in improving cardiovascular disease&#xD;
      related outcomes among HIV-infected clinic patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fifty high Cardiovascular Disease Risk (CVD) risk clinic patients will be randomized 1:1 to&#xD;
      receive either a series of educational pamphlets on CVD risk reduction plus a telephone-based&#xD;
      CVD risk reduction curriculum delivered over 24 weeks [intervention arm], or the educational&#xD;
      pamphlets alone [control arm]. Anthropomorphic data, blood pressure and lipid profiles will&#xD;
      be obtained from patients to assess the efficacy of the intervention in reducing blood&#xD;
      pressure and serum low-density lipoprotein levels (LDL).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 12, 2020</start_date>
  <completion_date type="Anticipated">September 15, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 15, 2023</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in ambulatory systolic blood pressure</measure>
    <time_frame>baseline, 24 weeks, 48 weeks, 72 weeks</time_frame>
    <description>Change of systolic blood pressure will be assessed as an absolute continuous variable, and as a proportion or persons who achieve &gt;5mmHg reduction in systolic blood pressure from baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in fasting LDL-c levels</measure>
    <time_frame>baseline, 24 weeks, 48 weeks, 72 weeks</time_frame>
    <description>Assessment of the absolute change in fasting calculated low density lipoprotein cholesterol over the study period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total weight loss</measure>
    <time_frame>baseline, 24 weeks, 48 weeks, 72 weeks</time_frame>
    <description>Total weight loss from baseline over the study period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 10-year atherosclerotic cardiovascular disease (ASCVD) risk score</measure>
    <time_frame>baseline, 24 weeks, 48 weeks, 72 weeks</time_frame>
    <description>The global cardiovascular disease risk as calculated by the American College of Cardiology/American Heart Association's 10-year risk calculator.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Cardiovascular Disease</condition>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Educational pamphlets + telephone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Educational pamphlets</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telephone</intervention_name>
    <description>A series of educational pamphlets on CVD risk reduction plus a telephone-based CVD risk reduction curriculum will be administered by Clinic-Based Case Managers (CCMs). Six modules will be given over 24 weeks in a rotating fashion on topics relevant to CVD risk. Subjects will be given the pamphlets every 2 weeks corresponding with the first time they receive the telephone - based module.</description>
    <arm_group_label>Educational pamphlets + telephone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational pamphlets</intervention_name>
    <description>A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website.</description>
    <arm_group_label>Educational pamphlets</arm_group_label>
    <arm_group_label>Educational pamphlets + telephone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  In care at the Duke Infectious Diseases Clinic for HIV and for at least 24 months&#xD;
&#xD;
          -  On antiretroviral therapy&#xD;
&#xD;
          -  2013 American Heart Association 10-year ASCVD risk score ≥ 15%, with a diagnosis of&#xD;
             either hypertension or hyperlipidemia&#xD;
&#xD;
          -  English literate (able to speak and read at a 6th grade level)&#xD;
&#xD;
          -  Subjects must have the capacity to give legally effective consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with prior diagnosis of acute coronary syndrome, stroke, peripheral vascular&#xD;
             disease, and end stage renal disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nwora L Okeke, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.learningaboutdiabetes.org</url>
    <description>Website referring to educational materials to be shared as part of this intervention</description>
  </link>
  <link>
    <url>https://www.heart.org/</url>
    <description>Website referring to educational materials to be shared as part of this intervention</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>July 25, 2023</last_update_submitted>
  <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <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>June 29, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03839394/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03839394
org study id: Pro00085562
secondary id: K23HL137611-01A1
nct id: NCT03839394
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to assess the efficacy of a case manager/social worker
      administered, telephone-based educational curriculum in improving cardiovascular disease
      related outcomes among HIV-infected clinic patients.
Fifty high Cardiovascular Disease Risk (CVD) risk clinic patients will be randomized 1:1 to
      receive either a series of educational pamphlets on CVD risk reduction plus a telephone-based
      CVD risk reduction curriculum delivered over 24 weeks [intervention arm], or the educational
      pamphlets alone [control arm]. Anthropomorphic data, blood pressure and lipid profiles will
      be obtained from patients to assess the efficacy of the intervention in reducing blood
      pressure and serum low-density lipoprotein levels (LDL).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in ambulatory systolic blood pressure
time frame: baseline, 24 weeks, 48 weeks, 72 weeks
description: Change of systolic blood pressure will be assessed as an absolute continuous variable, and as a proportion or persons who achieve >5mmHg reduction in systolic blood pressure from baseline
measure: Change in fasting LDL-c levels
time frame: baseline, 24 weeks, 48 weeks, 72 weeks
description: Assessment of the absolute change in fasting calculated low density lipoprotein cholesterol over the study period.
measure: Total weight loss
time frame: baseline, 24 weeks, 48 weeks, 72 weeks
description: Total weight loss from baseline over the study period.
measure: Change in 10-year atherosclerotic cardiovascular disease (ASCVD) risk score
time frame: baseline, 24 weeks, 48 weeks, 72 weeks
description: The global cardiovascular disease risk as calculated by the American College of Cardiology/American Heart Association's 10-year risk calculator.
arm group label: Educational pamphlets + telephone
arm group type: Experimental
arm group label: Educational pamphlets
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Telephone
description: A series of educational pamphlets on CVD risk reduction plus a telephone-based CVD risk reduction curriculum will be administered by Clinic-Based Case Managers (CCMs). Six modules will be given over 24 weeks in a rotating fashion on topics relevant to CVD risk. Subjects will be given the pamphlets every 2 weeks corresponding with the first time they receive the telephone - based module.
arm group label: Educational pamphlets + telephone
intervention type: Other
intervention name: Educational pamphlets
description: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website.
arm group label: Educational pamphlets
arm group label: Educational pamphlets + telephone
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Nwora L Okeke, MD, MPH
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
url: http://www.learningaboutdiabetes.org
description: Website referring to educational materials to be shared as part of this intervention
url: https://www.heart.org/
description: Website referring to educational materials to be shared as part of this intervention
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
sharing ipd: No
provided document: 