<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/NCT03025191</url>
  </required_header>
  <id_info>
    <org_study_id>15-00604</org_study_id>
    <nct_id>NCT03025191</nct_id>
  </id_info>
  <brief_title>Prison Connect-STI/HIV Prevention Intervention for Couples Affected by Incarceration</brief_title>
  <official_title>Development and Acceptability Evaluation of a Novel STI/HIV Prevention Intervention for Couples Affected by Incarceration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NYU Langone Health</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 is to adapt an existing couples-level HIV prevention intervention&#xD;
      for community populations (CONNECT I/II; PI: El-Bassel) to enable implementation among&#xD;
      couples affected by incarceration (PRISON CONNECT) and pilot test its feasibility and&#xD;
      acceptability among men incarcerated in the Connecticut Department of Correction (CTDOC) and&#xD;
      their community-dwelling committed female partners.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This pilot study will recruit male inmates in the Connecticut Department of Correction and&#xD;
      their community-dwelling female partner. Using an adapted version of an efficacious&#xD;
      couples-level HIV prevention intervention for community populations (CONNECT; PI: El-Bassel),&#xD;
      this study will pilot test a single in-prison intervention session using face-to-face or&#xD;
      teleconferencing modalities and a brief community follow-up session. Feasibility and&#xD;
      acceptability among the inmates and their partners will be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptability of intervention procedures and content by administration of a brief acceptability questionnaire among incarcerated men and their partners</measure>
    <time_frame>15 Minutes</time_frame>
    <description>Questions about how participant feels about the program activities.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptability of follow-up procedures and follow-up intervention content by administration of a brief acceptability questionnaire among male releasees and their partners.</measure>
    <time_frame>15 Minutes</time_frame>
    <description>Using tracking information provided at the time of in-prison session of PRISON CONNECT investigators will initiate contact with couples within the first month of release and conduct the follow-up visit at a location/time convenient for couples (e.g., team's research facility in New Haven, CT). The session will include a review of PRISON CONNECT intervention content.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Incarceration</condition>
  <arm_group>
    <arm_group_label>Prison Connect</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Speaker/Listener technique</intervention_name>
    <description>Couple will learn taking turns as the speaker and as the listener who paraphrases the speaker's point.The couple will then identify an issue they have faced in their relationship and will role-play using the technique to discuss it.</description>
    <arm_group_label>Prison Connect</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Social Support</intervention_name>
    <description>Identification of and mapping sources of social support and the types of support provided by members of the network. Participants will also identify the strengths and weaknesses of their support network and think through ways to strengthen those networks.</description>
    <arm_group_label>Prison Connect</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Problem-Solving</intervention_name>
    <description>Couple will be taught steps to systematically analyze a problem and brainstorm solutions through a short video. Steps include identify the trigger/problem; identify the goal for addressing the problem; brainstorm possible solutions for each partner; evaluate the solutions and pick the best; and act on the best solution.</description>
    <arm_group_label>Prison Connect</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Goal Setting</intervention_name>
    <description>Couple will be introduced to the concept of short- and long-term goal setting, including components of goal and planning for potential barriers. The couple will then set a goal for themselves that incorporates the skills obtained during the intervention, such as strengthening ties in their social support network. Participants will fill in a worksheet outlining their goal, potential barriers, and solutions to those barriers.</description>
    <arm_group_label>Prison Connect</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  eight HIV-positive and HIV-negative/unknown status male inmates and their partners&#xD;
             (N=16 couples, 32 participants).&#xD;
&#xD;
        Male Participants&#xD;
&#xD;
          -  at least 18 years of age&#xD;
&#xD;
          -  able to communicate in English, currently&#xD;
&#xD;
          -  incarcerated in the Connecticut Department of Correction (CTDOC), due to be released&#xD;
             within three months.&#xD;
&#xD;
          -  have a committed female partner who is not currently incarcerated and willing to&#xD;
             participate in the study, and is&#xD;
&#xD;
          -  not concerned participation will cause violence in the relationship.&#xD;
&#xD;
        Female partners&#xD;
&#xD;
          -  be able to communicate in English&#xD;
&#xD;
          -  not currently incarcerated&#xD;
&#xD;
          -  confirm the committed partnership with the male inmate and willingness to participate&#xD;
             in the study&#xD;
&#xD;
          -  not concerned participation in the study would cause violence in the relationship.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  restricted to English-speaking participants due to language availability of staff and&#xD;
             intervention materials.&#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>Maria Khan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>New York University Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York University School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>December 12, 2017</last_update_submitted>
  <last_update_submitted_qc>December 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>incarceration</keyword>
  <keyword>HIV</keyword>
  <!-- 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/NCT03025191
org study id: 15-00604
nct id: NCT03025191
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to adapt an existing couples-level HIV prevention intervention
      for community populations (CONNECT I/II; PI: El-Bassel) to enable implementation among
      couples affected by incarceration (PRISON CONNECT) and pilot test its feasibility and
      acceptability among men incarcerated in the Connecticut Department of Correction (CTDOC) and
      their community-dwelling committed female partners.
This pilot study will recruit male inmates in the Connecticut Department of Correction and
      their community-dwelling female partner. Using an adapted version of an efficacious
      couples-level HIV prevention intervention for community populations (CONNECT; PI: El-Bassel),
      this study will pilot test a single in-prison intervention session using face-to-face or
      teleconferencing modalities and a brief community follow-up session. Feasibility and
      acceptability among the inmates and their partners will be assessed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Acceptability of intervention procedures and content by administration of a brief acceptability questionnaire among incarcerated men and their partners
time frame: 15 Minutes
description: Questions about how participant feels about the program activities.
measure: Acceptability of follow-up procedures and follow-up intervention content by administration of a brief acceptability questionnaire among male releasees and their partners.
time frame: 15 Minutes
description: Using tracking information provided at the time of in-prison session of PRISON CONNECT investigators will initiate contact with couples within the first month of release and conduct the follow-up visit at a location/time convenient for couples (e.g., team's research facility in New Haven, CT). The session will include a review of PRISON CONNECT intervention content.
arm group label: Prison Connect
arm group type: Experimental
intervention type: Behavioral
intervention name: Speaker/Listener technique
description: Couple will learn taking turns as the speaker and as the listener who paraphrases the speaker's point.The couple will then identify an issue they have faced in their relationship and will role-play using the technique to discuss it.
arm group label: Prison Connect
intervention type: Behavioral
intervention name: Social Support
description: Identification of and mapping sources of social support and the types of support provided by members of the network. Participants will also identify the strengths and weaknesses of their support network and think through ways to strengthen those networks.
arm group label: Prison Connect
intervention type: Behavioral
intervention name: Problem-Solving
description: Couple will be taught steps to systematically analyze a problem and brainstorm solutions through a short video. Steps include identify the trigger/problem; identify the goal for addressing the problem; brainstorm possible solutions for each partner; evaluate the solutions and pick the best; and act on the best solution.
arm group label: Prison Connect
intervention type: Behavioral
intervention name: Goal Setting
description: Couple will be introduced to the concept of short- and long-term goal setting, including components of goal and planning for potential barriers. The couple will then set a goal for themselves that incorporates the skills obtained during the intervention, such as strengthening ties in their social support network. Participants will fill in a worksheet outlining their goal, potential barriers, and solutions to those barriers.
arm group label: Prison Connect
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Maria Khan, MD
role: Principal Investigator
affiliation: New York University Medical School
facility: 
country: United States
responsible party type: Sponsor