<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/NCT03790501</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00013048</org_study_id>
    <secondary_id>R01NR018391</secondary_id>
    <nct_id>NCT03790501</nct_id>
  </id_info>
  <brief_title>Impact of Physical Activity and Diet on Symptom Experience in People Living With HIV</brief_title>
  <acronym>PROSPER-HIV</acronym>
  <official_title>Impact of Physical Activity Routines and Dietary Intake on the Longitudinal Symptom Experience of People Living With HIV</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Nursing Research (NINR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</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>
      We will conduct a four-year, observational study of 850 participants to measure physical&#xD;
      activity and diet, once a year for three years. All participants will also complete the&#xD;
      standard Centers for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS)&#xD;
      patient-reported outcomes (PRO) and clinical assessment procedures. An enhanced PRO&#xD;
      assessment (consisting measures of physical activity, diet intake and anthropomorphic&#xD;
      factors) will be included after the routine patient clinic visit at four CNICS sites: Case&#xD;
      Western Reserve University, University of Alabama at Birmingham, University of Washington,&#xD;
      and Fenway Health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PROSPER-HIV is a four-year, prospective, observational study of 850 CNICS participants who&#xD;
      will complete an enhanced patient-reported outcome (PRO) assessment to measure physical&#xD;
      activity and diet intake, once a year for three years. All participants will also complete&#xD;
      the standard CNICS PRO and clinical assessment procedures. We propose to integrate the&#xD;
      following measures, physical activity (triaxial accelerometery), dietary intake (24-hour diet&#xD;
      recalls), and anthropomorphic factors (waist-hip-ratio), into an enhanced annual assessment&#xD;
      of patient reported outcomes at four CNICS sites: Case Western Reserve University, University&#xD;
      of Alabama at Birmingham, University of Washington, and Fenway Health. Our four primary&#xD;
      objectives are to:&#xD;
&#xD;
        1. Identify and characterize longitudinal, objectively measured, physical activity and&#xD;
           dietary patterns among PLHIV&#xD;
&#xD;
        2. Examine the relationship between objectively-measured physical activity and&#xD;
           self-reported physical activity on the Lipid Research Clinics Physical Activity&#xD;
           Questionnaire.&#xD;
&#xD;
        3. Determine which aspects of physical activity patterns and diet quality are associated&#xD;
           with decreased symptom burden and intensity in PLHIV, and if this relationship is&#xD;
           moderated by age and sex.&#xD;
&#xD;
        4. Explore the potential mediating effect of anthropomorphic and physical fitness variables&#xD;
           on the relationships between physical activity, dietary patterns, and symptom burden and&#xD;
           intensity in PLHIV.&#xD;
&#xD;
      We hypothesize that people living with HIV who 1) have more intense, frequent and longer&#xD;
      physical activity bouts will have age- and sex-dependent reduced symptom burden; 2) eat&#xD;
      better quality diets (e.g., more fiber and protein, fewer carbohydrates) will have reduced&#xD;
      symptom burden and intensity and that this relationship will also vary by age and sex.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 22, 2019</start_date>
  <completion_date type="Anticipated">April 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2023</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>Symptom Distress</measure>
    <time_frame>Four years</time_frame>
    <description>Symptom distress will be measured with the-20 item HIV Symptom Index. As recommended, our primary endpoints include 1) total symptom count (sum all symptoms that are reported as having the symptom and it bothers the participant at least a little); and 2) a total count of symptoms that bother the participant a lot (high symptom distress).</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">850</enrollment>
  <condition>HIV/AIDS</condition>
  <arm_group>
    <arm_group_label>People living with HIV (PLHIV).</arm_group_label>
    <description>We will recruit and enroll 850 people living with HIV (PLHIV) to participate in this longitudinal observational study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>As an observational study, no intervention will be associated with the study group.</description>
    <arm_group_label>People living with HIV (PLHIV).</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We will recruit and enroll 850 people living with HIV (PLHIV) who participate in the&#xD;
        Centers for AIDS Research Network of Integrated Clinical Systems cohort to participate in&#xD;
        this longitudinal observational study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Be an active CNICS participant&#xD;
&#xD;
          2. aged ≥18 years&#xD;
&#xD;
          3. prescribed HIV antiretroviral therapy, and&#xD;
&#xD;
          4. have an undetectable HIV viral load: defined as the most recent HIV viral load &lt;200&#xD;
             copies/mL, checked within the past year.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1) Did not complete the HIV Symptom Index in the PRO assessment (2) No reliable access to a&#xD;
        telephone or internet-enable telephone services needed to complete the 24-diet recalls (3)&#xD;
        Was pregnant, breast-feeding, or planning a pregnancy at the time of PRO assessment (4)&#xD;
        Planning to move out of the area in the next 36 months, or (5) Non-English speaking.&#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>Allison Webel, BSN, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vitor Oliveira, PhD</last_name>
    <phone>216-972-2713</phone>
    <email>vitorhfo@uw.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tammi Thomas, BS</last_name>
      <phone>205-934-7839</phone>
      <email>tamms@uabmc.edu</email>
    </contact>
    <investigator>
      <last_name>Amanda Willig, RD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fenway Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matteo Peretti</last_name>
      <phone>206-616-0201</phone>
      <email>MPeretti@fenwayhealth.org</email>
    </contact>
    <investigator>
      <last_name>Julia Fleming, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Case Western Reserve University</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laurie Smith, BA</last_name>
      <phone>206-616-0101</phone>
      <email>laursmit@uw.edu</email>
    </contact>
    <investigator>
      <last_name>Heidi Crane, MD, MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>December 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>June 3, 2021</last_update_submitted>
  <last_update_submitted_qc>June 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Allison Webel</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data will be shared consistent with the CNICS Data Sharing Policy found here: https://www.uab.edu/cnics/images/CNICSdatasharing_policy_v081515.pdf</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_url>https://www.uab.edu/cnics/images/CNICSdatasharing_policy_v081515.pdf</ipd_url>
  </patient_data>
  <!-- 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/NCT03790501
org study id: STUDY00013048
secondary id: R01NR018391
nct id: NCT03790501
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
We will conduct a four-year, observational study of 850 participants to measure physical
      activity and diet, once a year for three years. All participants will also complete the
      standard Centers for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS)
      patient-reported outcomes (PRO) and clinical assessment procedures. An enhanced PRO
      assessment (consisting measures of physical activity, diet intake and anthropomorphic
      factors) will be included after the routine patient clinic visit at four CNICS sites: Case
      Western Reserve University, University of Alabama at Birmingham, University of Washington,
      and Fenway Health.
PROSPER-HIV is a four-year, prospective, observational study of 850 CNICS participants who
      will complete an enhanced patient-reported outcome (PRO) assessment to measure physical
      activity and diet intake, once a year for three years. All participants will also complete
      the standard CNICS PRO and clinical assessment procedures. We propose to integrate the
      following measures, physical activity (triaxial accelerometery), dietary intake (24-hour diet
      recalls), and anthropomorphic factors (waist-hip-ratio), into an enhanced annual assessment
      of patient reported outcomes at four CNICS sites: Case Western Reserve University, University
      of Alabama at Birmingham, University of Washington, and Fenway Health. Our four primary
      objectives are to:

        1. Identify and characterize longitudinal, objectively measured, physical activity and
           dietary patterns among PLHIV

        2. Examine the relationship between objectively-measured physical activity and
           self-reported physical activity on the Lipid Research Clinics Physical Activity
           Questionnaire.

        3. Determine which aspects of physical activity patterns and diet quality are associated
           with decreased symptom burden and intensity in PLHIV, and if this relationship is
           moderated by age and sex.

        4. Explore the potential mediating effect of anthropomorphic and physical fitness variables
           on the relationships between physical activity, dietary patterns, and symptom burden and
           intensity in PLHIV.

      We hypothesize that people living with HIV who 1) have more intense, frequent and longer
      physical activity bouts will have age- and sex-dependent reduced symptom burden; 2) eat
      better quality diets (e.g., more fiber and protein, fewer carbohydrates) will have reduced
      symptom burden and intensity and that this relationship will also vary by age and sex.
observational model: Cohort
time perspective: Prospective
measure: Symptom Distress
time frame: Four years
description: Symptom distress will be measured with the-20 item HIV Symptom Index. As recommended, our primary endpoints include 1) total symptom count (sum all symptoms that are reported as having the symptom and it bothers the participant at least a little); and 2) a total count of symptoms that bother the participant a lot (high symptom distress).
arm group label: People living with HIV (PLHIV).
description: We will recruit and enroll 850 people living with HIV (PLHIV) to participate in this longitudinal observational study.
intervention type: Other
intervention name: No intervention
description: As an observational study, no intervention will be associated with the study group.
arm group label: People living with HIV (PLHIV).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Allison Webel, BSN, PhD
role: Principal Investigator
affiliation: University of Washington
last name: Vitor Oliveira, PhD
phone: 216-972-2713
email: vitorhfo@uw.edu
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Allison Webel
investigator title: Assistant Professor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
sharing ipd: Yes
ipd description: Data will be shared consistent with the CNICS Data Sharing Policy found here: https://www.uab.edu/cnics/images/CNICSdatasharing_policy_v081515.pdf
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd url: https://www.uab.edu/cnics/images/CNICSdatasharing_policy_v081515.pdf