<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/NCT01673750</url>
  </required_header>
  <id_info>
    <org_study_id>HIVBI</org_study_id>
    <nct_id>NCT01673750</nct_id>
  </id_info>
  <brief_title>Body Image in Youth With HIV</brief_title>
  <official_title>Body Image in Youth With HIV</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Jude Children's Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Jude Children's Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an observational study that seeks to gather information about perceptions of body&#xD;
      image through the use of a one-time questionnaire completed by participants at the time of&#xD;
      study enrollment.&#xD;
&#xD;
      Effective management of Human Acquired Immune Deficiency Syndrome (AIDS) caused by the Human&#xD;
      Immunodeficiency Virus (HIV) has become possible through the use of Highly Active&#xD;
      Antiretroviral Treatment (HAART). As a result of more successful treatment options, HIV/AIDS&#xD;
      has transitioned from a terminal illness to one which is treated as a chronic condition. One&#xD;
      particular group that has been impacted tremendously by HIV in the United States is the&#xD;
      adolescent population. As youth are living longer with HIV/AIDS, clinicians and researchers&#xD;
      are beginning to examine ways in which the disease can affect one's physical health, mental&#xD;
      health, and other psychosocial factors. Research emerging involving adults with HIV/AIDS has&#xD;
      suggested that increased attention to and negative views of one's body image may be found at&#xD;
      a higher rate in this group. To our knowledge, very few studies have examined this&#xD;
      relationship in adolescents with HIV.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this exploratory study is to characterize body image perceptions among youth&#xD;
      with perinatally and behaviorally acquired HIV. In a cross-sectional design, adolescents will&#xD;
      be asked to complete an ACASI questionnaire that will assess body image, medication&#xD;
      adherence, depressive symptoms, medical, and other sociodemographic variables which may&#xD;
      relate to adolescents with HIV. Information regarding the adolescents' medical history,&#xD;
      medications, and physical functioning also will be abstracted from his or her medical record.&#xD;
      Guided by the Intervention Mapping (IM) approach, findings from this study will inform future&#xD;
      intervention studies designed to enhance HIV disease management among adolescents.&#xD;
&#xD;
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      To characterize body image perceptions among youth with HIV.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Reported level of normative body image and discrepancy between perceived body image and preferred body image</measure>
    <time_frame>Once at time of participant enrollment</time_frame>
    <description>The MBSRQ-AS is a well-validated self-report inventory for the assessment of body image (BI). It has five subscales: Appearance Evaluation, Appearance Orientation, Overweight Preoccupation, Self-Classified Weight, Body Areas Satisfaction Scale. Descriptive analyses (means and standard deviations of overall scores and means for each subscale) will be reported.&#xD;
The Figure Rating Scale is a culturally relevant measure modeled after Stunkard's widely used nine-figure scale of schematic figures of varying size. Participants will be asked to identify which BI they find most similar to their current body type and which BI would be ideal or preferred. A BI discrepancy (BID) score will be calculated for each subject based on their responses on the Figure Rating Scale: negative BID score indicates the subject's ideal BI is larger than perceived; positive BID score indicates the subject wants to be smaller/thinner than perceived; score of zero indicates the subject prefers his/her perceived BI.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">146</enrollment>
  <condition>Human Immunodeficiency Virus</condition>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Participants</arm_group_label>
    <description>Participants will have documented HIV infection and are aware of their diagnosis. They will complete a one-time questionnaire.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>The primary outcome, characterizing body image among HIV infected adolescents, will be measured using a questionnaire administered to study participants through Audio Computer Assisted Self-Interview (ACASI) technology.</description>
    <arm_group_label>Participants</arm_group_label>
    <other_name>Audio Computer Assisted Self-Interview</other_name>
    <other_name>ACASI</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with documented HIV infection between the ages of 16 and 24 who are willing and&#xD;
        able to consent.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of HIV infection as documented in adolescent's medical record&#xD;
&#xD;
          -  Adolescent is aware of his/her HIV diagnosis&#xD;
&#xD;
          -  The adolescent/caregiver's primary language in English&#xD;
&#xD;
          -  Adolescent is ≥ 16 and &lt; 24 years old&#xD;
&#xD;
          -  Adolescent is willing and able to provide consent per institutional guidelines&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adolescent has documented diagnosis of mental retardation or a significant motor or&#xD;
             sensory impairment that would preclude participation in the study survey.&#xD;
&#xD;
          -  Adolescent has known acute psychiatric illness, including suicidal ideation, homicidal&#xD;
             ideation or active psychosis.&#xD;
&#xD;
          -  Adolescent is a pregnant female.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>23 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Megan Wilkins, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Jude Children's Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Jude Children's Research Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.stjude.org</url>
    <description>St. Jude Children's Research Hospital</description>
  </link>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>April 11, 2014</last_update_submitted>
  <last_update_submitted_qc>April 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 14, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adolescents</keyword>
  <keyword>Body Image</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>
  </condition_browse>
  <!-- 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/NCT01673750
org study id: HIVBI
nct id: NCT01673750
lead sponsor: 
has dmc: No
This is an observational study that seeks to gather information about perceptions of body
      image through the use of a one-time questionnaire completed by participants at the time of
      study enrollment.

      Effective management of Human Acquired Immune Deficiency Syndrome (AIDS) caused by the Human
      Immunodeficiency Virus (HIV) has become possible through the use of Highly Active
      Antiretroviral Treatment (HAART). As a result of more successful treatment options, HIV/AIDS
      has transitioned from a terminal illness to one which is treated as a chronic condition. One
      particular group that has been impacted tremendously by HIV in the United States is the
      adolescent population. As youth are living longer with HIV/AIDS, clinicians and researchers
      are beginning to examine ways in which the disease can affect one's physical health, mental
      health, and other psychosocial factors. Research emerging involving adults with HIV/AIDS has
      suggested that increased attention to and negative views of one's body image may be found at
      a higher rate in this group. To our knowledge, very few studies have examined this
      relationship in adolescents with HIV.
The purpose of this exploratory study is to characterize body image perceptions among youth
      with perinatally and behaviorally acquired HIV. In a cross-sectional design, adolescents will
      be asked to complete an ACASI questionnaire that will assess body image, medication
      adherence, depressive symptoms, medical, and other sociodemographic variables which may
      relate to adolescents with HIV. Information regarding the adolescents' medical history,
      medications, and physical functioning also will be abstracted from his or her medical record.
      Guided by the Intervention Mapping (IM) approach, findings from this study will inform future
      intervention studies designed to enhance HIV disease management among adolescents.

      PRIMARY OBJECTIVE:

      To characterize body image perceptions among youth with HIV.
observational model: Cohort
time perspective: Prospective
measure: Reported level of normative body image and discrepancy between perceived body image and preferred body image
time frame: Once at time of participant enrollment
description: The MBSRQ-AS is a well-validated self-report inventory for the assessment of body image (BI). It has five subscales: Appearance Evaluation, Appearance Orientation, Overweight Preoccupation, Self-Classified Weight, Body Areas Satisfaction Scale. Descriptive analyses (means and standard deviations of overall scores and means for each subscale) will be reported.
The Figure Rating Scale is a culturally relevant measure modeled after Stunkard's widely used nine-figure scale of schematic figures of varying size. Participants will be asked to identify which BI they find most similar to their current body type and which BI would be ideal or preferred. A BI discrepancy (BID) score will be calculated for each subject based on their responses on the Figure Rating Scale: negative BID score indicates the subject's ideal BI is larger than perceived; positive BID score indicates the subject wants to be smaller/thinner than perceived; score of zero indicates the subject prefers his/her perceived BI.
arm group label: Participants
description: Participants will have documented HIV infection and are aware of their diagnosis. They will complete a one-time questionnaire.
intervention type: Other
intervention name: Questionnaire
description: The primary outcome, characterizing body image among HIV infected adolescents, will be measured using a questionnaire administered to study participants through Audio Computer Assisted Self-Interview (ACASI) technology.
arm group label: Participants
other name: Audio Computer Assisted Self-Interview
other name: ACASI
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: 23 Years
healthy volunteers: No
last name: Megan Wilkins, PhD
role: Principal Investigator
affiliation: St. Jude Children's Research Hospital
facility: 
country: United States
url: http://www.stjude.org
description: St. Jude Children's Research Hospital
responsible party type: Sponsor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections