<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/NCT03300908</url>
  </required_header>
  <id_info>
    <org_study_id>AAAL7007</org_study_id>
    <secondary_id>K01DA036411</secondary_id>
    <nct_id>NCT03300908</nct_id>
  </id_info>
  <brief_title>Contextualizing &amp; Responding to HIV Risk Behaviors</brief_title>
  <official_title>Contextualizing &amp; Responding to HIV Risk Behaviors Among Black Drug Offenders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Columbia University</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 this study was to pilot test the potential for improvement in antiretroviral&#xD;
      medication adherence of a an adapted group-based, multi-session, community-based&#xD;
      Antiretroviral Therapy (ART) adherence and risk reduction intervention, Project ADHerence&#xD;
      Education and Risk Evaluation (ADHERE). Project ADHERE was compared to a single-session&#xD;
      group-based medication adherence intervention, Medication Adherence and Care Engagement&#xD;
      (MACE).&#xD;
&#xD;
      A secondary aim was to examine the impact of Project ADHERE on HIV risk behaviors (i.e.,&#xD;
      illicit drug use and unprotected sexual behavior).&#xD;
&#xD;
      This study was designed to inform, design, and pilot test the two antiretroviral medication&#xD;
      adherence interventions for HIV-infected formerly incarcerated individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Formerly incarcerated Black drug offenders are at an elevated risk for HIV infection. Despite&#xD;
      substantial research expressing the need for HIV prevention services for ex-offenders&#xD;
      postrelease, this population has limited access to quality programming and services related&#xD;
      to HIV risk reduction. This K01 application seeks to inform and adapt an HIV risk reduction&#xD;
      intervention to address the needs of formerly incarcerated Black drug offenders who are being&#xD;
      released from prisons in the New York City metropolitan area.The study will utilize&#xD;
      qualitative and quantitative methods to inform and adapt an HIV prevention intervention for&#xD;
      this study population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 5, 2016</start_date>
  <completion_date type="Actual">December 21, 2016</completion_date>
  <primary_completion_date type="Actual">December 21, 2016</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>
    <intervention_model_description>Participants were randomly assigned to Project ADHERE, or the control condition, MACE. The randomization process was described to participants during the informed consent process.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants were not aware of which intervention they were assigned to. A randomization scheme was developed and participants were assigned to treatment groups accordingly.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants who reached at least 85% medication adherence rate.</measure>
    <time_frame>Over a 3-month period</time_frame>
    <description>Self-report data and viral loads to test for medication adherence will be collected and analyzed to yield the rate (%).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants with HIV risk behaviors</measure>
    <time_frame>Over a 3-month period</time_frame>
    <description>Information on illicit drug use and unprotected sexual behavior wil be collected and analyzed. We sought to reduce the frequency of illicit drug use, and instance of unprotected sexual behavior as calculated in the percentage of participants.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Human Immunodeficiency Virus</condition>
  <arm_group>
    <arm_group_label>Project ADHERE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a 3-session antiretroviral medication adherence and risk reduction intervention called Project ADHERE.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control MACE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive a one-session antiretroviral medication adherence intervention called MACE.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Project ADHERE</intervention_name>
    <description>This is a 3-session ART medication adherence and risk reduction intervention. Participants are educated about the importance of staying healthy and taking their medication as prescribed; to discuss importance of improved immune functioning and what their &quot;viral load&quot; means; reminded that they can still infect others with HIV, and that there currently is no cure for HIV; expected to generate strategies to overcome adherence barriers; educated about sexually transmitted infections (STI)/HIV transmission modes; assisted in devising an appropriate medication adherence and risk reduction plan. Participants will report their progress and discuss challenges experienced when implementing their medication adherence and risk reduction plans while establishing short- and long-term goals.</description>
    <arm_group_label>Project ADHERE</arm_group_label>
    <other_name>Project ADHerence Education and Risk Evaluation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MACE</intervention_name>
    <description>This one-session medication adherence intervention covers the following content: 1) a discussion on what viral load represents and what HIV does to the body; 2) referral to a provider for participants without a provider; 3) the importance of maintaining regular contact with a health care provider; and 4) benefits of being retained in care.</description>
    <arm_group_label>Control MACE</arm_group_label>
    <other_name>Medication Adherence and Care Engagement</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ≥18 years of age&#xD;
&#xD;
          2. HIV seropositive with &quot;detectable&quot; viral load (VL)(defined as &gt;50 copies/mL)&#xD;
&#xD;
          3. history of drug use (used illicit drugs within the past year)&#xD;
&#xD;
          4. experienced incarceration in prison or jail within the past five years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. living in a healthcare or assisted living facility&#xD;
&#xD;
          2. experienced incarceration longer than five years ago&#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>Tawandra Rowell-Cunsolo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Professor of Social Welfare Science (in Nursing), Nursing Scholarship &amp; Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>September 29, 2017</last_update_submitted>
  <last_update_submitted_qc>September 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Tawandra Rowell-Cunsolo</investigator_full_name>
    <investigator_title>Assistant Professor of Social Welfare Science</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>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/NCT03300908
org study id: AAAL7007
secondary id: K01DA036411
nct id: NCT03300908
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study was to pilot test the potential for improvement in antiretroviral
      medication adherence of a an adapted group-based, multi-session, community-based
      Antiretroviral Therapy (ART) adherence and risk reduction intervention, Project ADHerence
      Education and Risk Evaluation (ADHERE). Project ADHERE was compared to a single-session
      group-based medication adherence intervention, Medication Adherence and Care Engagement
      (MACE).

      A secondary aim was to examine the impact of Project ADHERE on HIV risk behaviors (i.e.,
      illicit drug use and unprotected sexual behavior).

      This study was designed to inform, design, and pilot test the two antiretroviral medication
      adherence interventions for HIV-infected formerly incarcerated individuals.
Formerly incarcerated Black drug offenders are at an elevated risk for HIV infection. Despite
      substantial research expressing the need for HIV prevention services for ex-offenders
      postrelease, this population has limited access to quality programming and services related
      to HIV risk reduction. This K01 application seeks to inform and adapt an HIV risk reduction
      intervention to address the needs of formerly incarcerated Black drug offenders who are being
      released from prisons in the New York City metropolitan area.The study will utilize
      qualitative and quantitative methods to inform and adapt an HIV prevention intervention for
      this study population.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants were randomly assigned to Project ADHERE, or the control condition, MACE. The randomization process was described to participants during the informed consent process.
primary purpose: Supportive Care
masking: Single (Participant)
masking description: Participants were not aware of which intervention they were assigned to. A randomization scheme was developed and participants were assigned to treatment groups accordingly.
measure: Number of participants who reached at least 85% medication adherence rate.
time frame: Over a 3-month period
description: Self-report data and viral loads to test for medication adherence will be collected and analyzed to yield the rate (%).
measure: Percentage of participants with HIV risk behaviors
time frame: Over a 3-month period
description: Information on illicit drug use and unprotected sexual behavior wil be collected and analyzed. We sought to reduce the frequency of illicit drug use, and instance of unprotected sexual behavior as calculated in the percentage of participants.
arm group label: Project ADHERE
arm group type: Experimental
description: Participants will receive a 3-session antiretroviral medication adherence and risk reduction intervention called Project ADHERE.
arm group label: Control MACE
arm group type: Active Comparator
description: Participants will receive a one-session antiretroviral medication adherence intervention called MACE.
intervention type: Behavioral
intervention name: Project ADHERE
description: This is a 3-session ART medication adherence and risk reduction intervention. Participants are educated about the importance of staying healthy and taking their medication as prescribed; to discuss importance of improved immune functioning and what their "viral load" means; reminded that they can still infect others with HIV, and that there currently is no cure for HIV; expected to generate strategies to overcome adherence barriers; educated about sexually transmitted infections (STI)/HIV transmission modes; assisted in devising an appropriate medication adherence and risk reduction plan. Participants will report their progress and discuss challenges experienced when implementing their medication adherence and risk reduction plans while establishing short- and long-term goals.
arm group label: Project ADHERE
other name: Project ADHerence Education and Risk Evaluation
intervention type: Behavioral
intervention name: MACE
description: This one-session medication adherence intervention covers the following content: 1) a discussion on what viral load represents and what HIV does to the body; 2) referral to a provider for participants without a provider; 3) the importance of maintaining regular contact with a health care provider; and 4) benefits of being retained in care.
arm group label: Control MACE
other name: Medication Adherence and Care Engagement
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tawandra Rowell-Cunsolo, MD
role: Principal Investigator
affiliation: Assistant Professor of Social Welfare Science (in Nursing), Nursing Scholarship & Research
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Tawandra Rowell-Cunsolo
investigator title: Assistant Professor of Social Welfare Science
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
sharing ipd: Undecided