<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/NCT01690494</url>
  </required_header>
  <id_info>
    <org_study_id>AAAK0206</org_study_id>
    <secondary_id>1R01DA033168-01A1</secondary_id>
    <nct_id>NCT01690494</nct_id>
  </id_info>
  <brief_title>Protect and Connect: Couple HIV Prevention for Drug Involved Male Offenders</brief_title>
  <acronym>PACT</acronym>
  <official_title>Protect and Connect: Couple HIV Prevention for Drug Involved Male Offenders, An Effectiveness Trial</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>
      This study is a randomized controlled trial (RCT) that will rigorously evaluate the&#xD;
      implementation, effectiveness and cost-effectiveness of a couple-based integrated human&#xD;
      immunodeficiency virus (HIV) and drug abuse prevention intervention (Connect II) with&#xD;
      drug-involved male offenders charged with misdemeanors and their primary female sexual&#xD;
      partners, implemented by frontline providers in Criminal Court, Community Court or probation&#xD;
      (CCP) sites in NYC, compared to CCP standard treatment of care services (TAU). The primary&#xD;
      outcomes are to reduce sexually transmitted infections (STIs) and increase condom use.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      HIV/acquired immune deficiency syndrome (AIDS) and criminal justice involvement are critical&#xD;
      intersecting public health issues for drug-involved men. Low income, Black and Hispanic men&#xD;
      especially bear the burden of the HIV epidemic and are over-represented in the U.S. criminal&#xD;
      justice system. Recent Centers for Disease Control and Prevention (CDC) surveillance data&#xD;
      suggest that the health disparity in HIV rates is actually increasing for Black men: current&#xD;
      estimates suggest 1 in 16 Black men in the U.S. will be infected with HIV in their life time.&#xD;
      These HIV/STI transmission risks are fueled by high rates of poverty, incarceration,&#xD;
      unemployment, and lack of access to health care and prevention services. The proposed study&#xD;
      thus targets an underserved population at the epicenter of the epidemic in the U.S.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 11, 2013</start_date>
  <completion_date type="Actual">September 30, 2017</completion_date>
  <primary_completion_date type="Actual">September 30, 2017</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in biologically confirmed sexually transmitted infections</measure>
    <time_frame>Baseline and up to 12 months post intervention</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in proportion of unprotected sexual acts</measure>
    <time_frame>Baseline and up to 12 months post intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in drug use</measure>
    <time_frame>Baseline and up to 12 months post intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in utilization of drug treatment</measure>
    <time_frame>Baseline and up to 12 months post intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in recidivism</measure>
    <time_frame>Up to 12 months post intervention</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">480</enrollment>
  <condition>Sexually Transmitted Diseases</condition>
  <condition>Unsafe Sex</condition>
  <condition>Substance-Related Disorders</condition>
  <arm_group>
    <arm_group_label>PACT + TAU</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4-session PACT delivered to both partners together + standard treatment of care services (TAU) delivered to the male participant</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAU</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TAU control condition delivered to the male participant</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PACT</intervention_name>
    <description>Couple-based behavioral HIV/STI preventive intervention</description>
    <arm_group_label>PACT + TAU</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TAU</intervention_name>
    <description>Standard treatment of care services provided to male offenders by the Criminal Court, Community Court or probation sites</description>
    <arm_group_label>PACT + TAU</arm_group_label>
    <arm_group_label>TAU</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Couples&#xD;
&#xD;
          -  Both partners are aged 18 or older&#xD;
&#xD;
          -  Identify each other as their primary sexual partner of opposite sex&#xD;
&#xD;
          -  Relationship has existed at least 3 months&#xD;
&#xD;
          -  At least one partner reports having unprotected vaginal or anal intercourse with the&#xD;
             other partner in the past 90 days&#xD;
&#xD;
          -  At least one partner reports exposure to an outside HIV risk in the past year&#xD;
&#xD;
          -  Male partner reports and is verified by court records of being charged with a&#xD;
             misdemeanor&#xD;
&#xD;
          -  Male partner is currently under court supervision or probation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Either partner shows evidence of significant psychiatric or could impairment as&#xD;
             confirmed by the MacArthur Competence Assessment Tool during the screening eligibility&#xD;
             interview.&#xD;
&#xD;
          -  Either partner reports severe physical or sexual violence perpetrated by the other&#xD;
             partner in the past year as measured on the Revised Conflict Tactics Scale&#xD;
&#xD;
          -  Either partner is unable to commit to participate in the study through to completion&#xD;
&#xD;
          -  Either partner reports that the couple is planning a pregnancy within the next 12&#xD;
             months&#xD;
&#xD;
          -  Either partner is not fluent in English as determined during Informed Consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nabila El-Bassel, DSW</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>El-Bassel N, Gilbert L, Wu E, Witte SS, Chang M, Hill J, Remien RH. Couple-based HIV prevention for low-income drug users from New York City: a randomized controlled trial to reduce dual risks. J Acquir Immune Defic Syndr. 2011 Oct 1;58(2):198-206. doi: 10.1097/QAI.0b013e318229eab1.</citation>
    <PMID>21725249</PMID>
  </reference>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>July 16, 2018</last_update_submitted>
  <last_update_submitted_qc>July 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Nabila El-Bassel, PhD</investigator_full_name>
    <investigator_title>Professor of Social Work</investigator_title>
  </responsible_party>
  <keyword>STI</keyword>
  <keyword>sexually transmitted infection</keyword>
  <keyword>HIV</keyword>
  <keyword>criminal justice</keyword>
  <keyword>probation</keyword>
  <keyword>couples</keyword>
  <keyword>drug use</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sexually Transmitted Diseases</mesh_term>
    <mesh_term>Substance-Related Disorders</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/NCT01690494
org study id: AAAK0206
secondary id: 1R01DA033168-01A1
nct id: NCT01690494
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a randomized controlled trial (RCT) that will rigorously evaluate the
      implementation, effectiveness and cost-effectiveness of a couple-based integrated human
      immunodeficiency virus (HIV) and drug abuse prevention intervention (Connect II) with
      drug-involved male offenders charged with misdemeanors and their primary female sexual
      partners, implemented by frontline providers in Criminal Court, Community Court or probation
      (CCP) sites in NYC, compared to CCP standard treatment of care services (TAU). The primary
      outcomes are to reduce sexually transmitted infections (STIs) and increase condom use.
HIV/acquired immune deficiency syndrome (AIDS) and criminal justice involvement are critical
      intersecting public health issues for drug-involved men. Low income, Black and Hispanic men
      especially bear the burden of the HIV epidemic and are over-represented in the U.S. criminal
      justice system. Recent Centers for Disease Control and Prevention (CDC) surveillance data
      suggest that the health disparity in HIV rates is actually increasing for Black men: current
      estimates suggest 1 in 16 Black men in the U.S. will be infected with HIV in their life time.
      These HIV/STI transmission risks are fueled by high rates of poverty, incarceration,
      unemployment, and lack of access to health care and prevention services. The proposed study
      thus targets an underserved population at the epicenter of the epidemic in the U.S.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Change in biologically confirmed sexually transmitted infections
time frame: Baseline and up to 12 months post intervention
measure: Change in proportion of unprotected sexual acts
time frame: Baseline and up to 12 months post intervention
measure: Change in drug use
time frame: Baseline and up to 12 months post intervention
measure: Change in utilization of drug treatment
time frame: Baseline and up to 12 months post intervention
measure: Change in recidivism
time frame: Up to 12 months post intervention
arm group label: PACT + TAU
arm group type: Experimental
description: 4-session PACT delivered to both partners together + standard treatment of care services (TAU) delivered to the male participant
arm group label: TAU
arm group type: Active Comparator
description: TAU control condition delivered to the male participant
intervention type: Behavioral
intervention name: PACT
description: Couple-based behavioral HIV/STI preventive intervention
arm group label: PACT + TAU
intervention type: Behavioral
intervention name: TAU
description: Standard treatment of care services provided to male offenders by the Criminal Court, Community Court or probation sites
arm group label: PACT + TAU
arm group label: TAU
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nabila El-Bassel, DSW
role: Principal Investigator
affiliation: Columbia University
facility: 
country: United States
citation: El-Bassel N, Gilbert L, Wu E, Witte SS, Chang M, Hill J, Remien RH. Couple-based HIV prevention for low-income drug users from New York City: a randomized controlled trial to reduce dual risks. J Acquir Immune Defic Syndr. 2011 Oct 1;58(2):198-206. doi: 10.1097/QAI.0b013e318229eab1.
PMID: 21725249
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Nabila El-Bassel, PhD
investigator title: Professor of Social Work
mesh term: Sexually Transmitted Diseases
mesh term: Substance-Related Disorders
sharing ipd: Undecided