<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/NCT03238586</url>
  </required_header>
  <id_info>
    <org_study_id>WELL</org_study_id>
    <secondary_id>1U01AA021995-01</secondary_id>
    <nct_id>NCT03238586</nct_id>
  </id_info>
  <brief_title>HIV/AIDS &amp; Alcohol-Related Outcomes: Translational Evidence-Based Interventions</brief_title>
  <acronym>WELL</acronym>
  <official_title>HIV/AIDS &amp; Alcohol-Related Outcomes: Translational Evidence-Based Interventions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Louisiana State University Health Sciences Center in New Orleans</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Louisiana State University Health Sciences Center in New Orleans</source>
  <brief_summary>
    <textblock>
      A clinical study for patients with HIV that investigates the best way to reduce HIV&#xD;
      transmission risk, and to improve the overall health of people living with HIV/AIDS.&#xD;
      Participants will complete four assessments over the course of one year and will be randomly&#xD;
      assigned to a five-week treatment program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main purpose of this research study is to investigate the best way to reduce HIV&#xD;
      transmission risk and to improve the overall health of people living with HIV/AIDS. This&#xD;
      study tests an intervention program that aims to improve knowledge, motivation, and skills.&#xD;
      The intervention program is designed to motivate participants to take their medications&#xD;
      routinely, improve the quality of life for those living with HIV, and decrease risky&#xD;
      behaviors that may lead to HIV transmission.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2012</start_date>
  <completion_date type="Actual">August 2019</completion_date>
  <primary_completion_date type="Actual">July 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Viral load</measure>
    <time_frame>Change from baseline at 3 months, 6 months and 1 year</time_frame>
    <description>The primary outcome measure will be disease progression or more specifically, the proportion of patients achieving viral suppression.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">232</enrollment>
  <condition>HIV/AIDS</condition>
  <arm_group>
    <arm_group_label>WELL Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Five-week treatment program that aims to improve knowledge, motivation, and skills. It is designed to motivate participants to take their medications routinely, improve the quality of life for those living with HIV, and decrease risky behaviors that may lead to HIV transmission.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Five-week standard of care program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>WELL Program</intervention_name>
    <arm_group_label>WELL Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV positive&#xD;
&#xD;
          -  Recent alcohol use&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#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>Patricia Molina, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Louisiana State University Health Sciences Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Medical Center New Orleans Infectious Disease Services</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>February 18, 2020</last_update_submitted>
  <last_update_submitted_qc>February 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Louisiana State University Health Sciences Center in New Orleans</investigator_affiliation>
    <investigator_full_name>Patricia Molina</investigator_full_name>
    <investigator_title>Richard Ashman, PhD Professor and Head Department of Physiology; Director Alcohol and Drug Abuse Center of Excellence</investigator_title>
  </responsible_party>
  <keyword>hiv</keyword>
  <keyword>aids</keyword>
  <keyword>alcohol</keyword>
  <keyword>health</keyword>
  <keyword>knowledge</keyword>
  <keyword>motivation</keyword>
  <keyword>skills</keyword>
  <keyword>behavior</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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03238586
org study id: WELL
secondary id: 1U01AA021995-01
nct id: NCT03238586
lead sponsor: 
collaborator: 
A clinical study for patients with HIV that investigates the best way to reduce HIV
      transmission risk, and to improve the overall health of people living with HIV/AIDS.
      Participants will complete four assessments over the course of one year and will be randomly
      assigned to a five-week treatment program.
The main purpose of this research study is to investigate the best way to reduce HIV
      transmission risk and to improve the overall health of people living with HIV/AIDS. This
      study tests an intervention program that aims to improve knowledge, motivation, and skills.
      The intervention program is designed to motivate participants to take their medications
      routinely, improve the quality of life for those living with HIV, and decrease risky
      behaviors that may lead to HIV transmission.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Viral load
time frame: Change from baseline at 3 months, 6 months and 1 year
description: The primary outcome measure will be disease progression or more specifically, the proportion of patients achieving viral suppression.
arm group label: WELL Program
arm group type: Experimental
description: Five-week treatment program that aims to improve knowledge, motivation, and skills. It is designed to motivate participants to take their medications routinely, improve the quality of life for those living with HIV, and decrease risky behaviors that may lead to HIV transmission.
arm group label: Standard of Care
arm group type: No Intervention
description: Five-week standard of care program.
intervention type: Behavioral
intervention name: WELL Program
arm group label: WELL Program
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Patricia Molina, MD, PhD
role: Principal Investigator
affiliation: Louisiana State University Health Sciences Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Louisiana State University Health Sciences Center in New Orleans
investigator full name: Patricia Molina
investigator title: Richard Ashman, PhD Professor and Head Department of Physiology; Director Alcohol and Drug Abuse Center of Excellence
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
sharing ipd: Undecided