<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/NCT03834779</url>
  </required_header>
  <id_info>
    <org_study_id>STU 082017-022</org_study_id>
    <secondary_id>1R34DA045592-01</secondary_id>
    <nct_id>NCT03834779</nct_id>
  </id_info>
  <brief_title>HIV+ Substance Users Released From Jail</brief_title>
  <official_title>A Community-Clinic Collaboration to Improve Outcomes in HIV+ Substance Users Released From Jail</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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 long-term goal of this project is to improve HIV and substance use outcomes and reduce&#xD;
      recidivism for HIV+ substance users released from jail. The overall objective of the proposed&#xD;
      R34 project is to develop and pilot test a multi-sector community-clinic collaborative&#xD;
      intervention that can subsequently be implemented on a larger scale (as part of a future R01)&#xD;
      to achieve this goal. Our central hypothesis is that HIV+ substance users released from jail&#xD;
      can successfully overcome obstacles to re-entry and continuity of HIV care with&#xD;
      individualized, culturally competent assistance in navigating both social and medical&#xD;
      services.&#xD;
&#xD;
      Aim 1: Develop and refine a collaborative CHW and re-entry program intervention that targets&#xD;
      HIV outcomes, substance use and recidivism in HIV+ jail releasees.&#xD;
&#xD;
      Aim 2: Conduct a pilot randomized controlled trial comparing the collaborative intervention&#xD;
      (n=40) compared to treatment as usual (n=40) in HIV+ substance users released from jail.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim 1 Introduction: This first aim will be critical to successful implementation of the&#xD;
      CHW-DOORS intervention. Employing a formerly incarcerated CHW to assist individuals leaving&#xD;
      prison in order to connect to healthcare has been successfully implemented in different&#xD;
      settings, but it has not been applied specifically to HIV patients or those leaving jail (v.&#xD;
      prison), nor has it been integrated into a community based organization. The objective of&#xD;
      this aim is to adapt the evidence-based CHW intervention to the HIV population and to the&#xD;
      jail setting and to integrate the CHW into existing processes at DOORS and the outpatient HIV&#xD;
      clinic system.&#xD;
&#xD;
      Research Design. Aim 1.1: The first step of Aim 1 will be to train the CHW using the&#xD;
      transitions clinic approach, add modules on HIV and substance use and familiarize the CHW&#xD;
      with DOORS processes and HIV clinic workflow.&#xD;
&#xD;
      Aim 1.2: The second step will be to complete qualitative interviews with stakeholders in&#xD;
      three different settings- the jail, the HIV clinic and DOORS. All interviews will be&#xD;
      semi-structured, one-on-one interviews, with an estimated 4-7 interviews in each setting.&#xD;
&#xD;
      The structured component of the interview guide will prompt interviewee input on study design&#xD;
      (e.g. recruitment, intervention, follow-up visits), content of the intervention (e.g. high&#xD;
      demand services) and an open-ended component eliciting possible barriers to study&#xD;
      implementation.&#xD;
&#xD;
      Aim 1.3: The final step in Aim 1 will be to complete pilot testing with 5 subjects, which&#xD;
      will focus on refining recruitment/enrollment protocols, streamlining study assessments and&#xD;
      evaluating the intervention.&#xD;
&#xD;
      Recruitment: In order to protect patient confidentiality, potential subjects will be referred&#xD;
      by medical staff who provide clinical care to HIV+ inmates. When an inmate enters the Dallas&#xD;
      County Jail, he/she is evaluated by a medical provider within 24 hours (medical assessment&#xD;
      program, MAP). At this visit, the inmate can disclose any medical conditions that they have&#xD;
      including HIV, in which case he/she will be referred to the jail HIV clinic (scheduled within&#xD;
      1-7 days of jail entry). In addition, HIV testing is offered in an opt-out manner when&#xD;
      inmates have blood drawn for any reason (approximately 10% of jail population) and by inmate&#xD;
      request, and those with positive test results are referred to jail HIV clinic. Candidates&#xD;
      coming through the MAP or HIV clinics who agree to be approached will be contacted by a&#xD;
      research assistant (RA). The RA will explain the study to interested individuals, will obtain&#xD;
      additional contact information (additional phone numbers, address or location in community&#xD;
      where patient could be found) and permission to contact the individual after release. Clinic&#xD;
      staff will also routinely request this information from interested individuals in case they&#xD;
      are released prior to RA visit in jail. Once released, the research team will contact the&#xD;
      individual releasee to schedule an enrollment visit. At this visit, which will occur as soon&#xD;
      as possible after jail release (maximum within 30 days of release), the research team will&#xD;
      obtain informed consent and enroll the participant into the study. The enrollment may occur&#xD;
      at the UT Southwestern HIV research unit (located above the main HIV clinic) or in the&#xD;
      community as per participant preference.&#xD;
&#xD;
      Enrollment: In order to be enrolled, individuals must (a) be ≥18 years old, (b) have a&#xD;
      confirmed diagnosis of HIV, (c) have evidence of uncontrolled HIV (viral load &gt;200 copies/mL&#xD;
      within 90 days of enrollment, self-reported non-adherence to HIV medications or no community&#xD;
      clinic visit in the 6 months preceding incarceration), (d) report or have medical records&#xD;
      documenting any opioid (illicit or prescription misuse), stimulant (cocaine, ecstasy, or&#xD;
      amphetamines), or heavy alcohol use (as determined by the 3-item Alcohol Use Disorders&#xD;
      Identification Test (AUDIT-C) within the past 12 months, and (e) provide at least 2 forms of&#xD;
      contact information. They will also be asked to provide a release of information for their&#xD;
      medical records at the jail and community clinics/ hospitals. No randomization will occur in&#xD;
      Aim 1 as all 5 participants in the pilot testing phase will be assigned to the intervention.&#xD;
      Baseline assessments will occur after informed consent is obtained and enrollment is&#xD;
      complete. These assessments will focus on variables in the conceptual model, with collection&#xD;
      of demographics (age, race/ethnicity, gender, HIV risk factor) and social variables (marital&#xD;
      status, housing, education, employment/income, insurance, benefits, social support). Subjects&#xD;
      will also be asked about HIV care (engagement in care, antiretroviral therapy, adherence to&#xD;
      medications (using visual analog scale), barriers to care), mental illness, and substance use&#xD;
      (using ASSIST questionnaire).&#xD;
&#xD;
      Intervention: The first meeting with the CHW will occur at the time of enrollment if&#xD;
      possible, depending on availability of the participant and CHW, otherwise it may occur&#xD;
      anytime within 14 days of enrollment. After release from jail, the CHW will help the&#xD;
      participant navigate to DOORS, where they will meet with a &quot;broker&quot;, someone who helps the&#xD;
      client/participant arrange and negotiate referrals to services within the extensive&#xD;
      partner/provider network. The first broker meeting will typically occur within 2-4 weeks&#xD;
      after release, as this is a critical window for re-engagement in care, underscored by the&#xD;
      fact that this is also a high-risk period for increased unprotected sex and return to&#xD;
      substance use. Per DOORS' standard practice, the broker will complete a comprehensive needs&#xD;
      assessment with the participant. Based on these assessments, together with the participant,&#xD;
      the broker will develop a personalized re-entry plan with a detailed list of referrals and&#xD;
      calendar of scheduled visits with relevant agencies within the DOORS network.&#xD;
&#xD;
      Follow-up visits and assessments: Research visits will be scheduled at 3 months, 6 months and&#xD;
      12 months. A 4-week window before and 8-week window after the target follow-up dates will be&#xD;
      permitted for study assessments. Assessments will be completed at each follow-up visit,&#xD;
      including substance use, adherence, healthcare utilization and recidivism, with blood draw&#xD;
      for HIV viral load collected at the 6-month visit. In order to maximize efficient utilization&#xD;
      of resources, for baseline and other follow-up visits, HIV viral load will be abstracted from&#xD;
      medical records. In order to have sufficient time to enroll and complete 12 month study&#xD;
      visits for the 80 participants in Aim 2, the 5 pilot participants from Aim 1.3 need to reach&#xD;
      at least the 3 month time point but not 6 or 12-month visits before beginning study&#xD;
      enrollment for Aim 2. Pilot participants will complete through 12-month visits as this will&#xD;
      provide insight as to how best to conduct these later follow-up visits. All participants will&#xD;
      receive financial reimbursement for study visits ($25 for each visit), unless they are&#xD;
      incarcerated at the time of the visit. Jail inmates are not permitted to receive any&#xD;
      financial incentives during incarceration.&#xD;
&#xD;
      AIM 2: Conduct a pilot randomized controlled trial comparing the collaborative intervention&#xD;
      (n=40) compared to treatment as usual (n=40) in HIV+ substance users released from jail.&#xD;
&#xD;
      Introduction. In this aim, we will test the CHW-DOORS intervention that was refined in Aim 1&#xD;
      in a randomized fashion. The goal of this aim is to establish feasibility of a randomized&#xD;
      controlled trial in this setting, to determine preliminary efficacy of the intervention and&#xD;
      to inform sample size calculations for a fully powered trial. In addition, this aim will&#xD;
      provide data regarding key factors involved in HIV+ substance users accessing substance use&#xD;
      treatment and HIV care after jail release. Our working hypothesis is that from the&#xD;
      stakeholder input and pilot testing completed in Aim 1, we will be able to successfully&#xD;
      conduct a pilot randomized controlled trial and gain valuable insight into key predisposing&#xD;
      and enabling factors influencing healthcare needs and utilization in this population, and how&#xD;
      these may impact HIV viral load, substance use and recidivism.&#xD;
&#xD;
      Research Design. Potential participants will be referred to the research study by Dallas&#xD;
      County jail medical providers as described in Aim 1.3. Candidates who agree to be approached&#xD;
      will be contacted by a RA who will recruit, and review eligibility criteria (see Aim 1.3).&#xD;
      After release, potential participants will be contacted in order to complete informed&#xD;
      consent, study enrollment and randomization (to be completed within 30 days of release from&#xD;
      jail). All participants will provide 2 specific forms of locator information (telephone&#xD;
      number for themselves, friend/family member, address, email, specific location where they may&#xD;
      be located to aid in retention efforts). Participants will complete baseline assessments and&#xD;
      will then be randomized to the intervention CHW-DOORS versus treatment as usual (TAU).&#xD;
      Randomization will occur by random assignment using a computer program, without block&#xD;
      randomization given the small sample size. TAU participants will receive standard of care,&#xD;
      which involves passive referral by jail medical staff to the outpatient HIV clinic.&#xD;
&#xD;
      Intervention. Participants randomized to the intervention arm will meet with the CHW and a&#xD;
      staff member from DOORS as outlined in Aim 1.3. Any modifications to this protocol after&#xD;
      pilot testing in Aim 1.3 will be implemented in Aim 2. The general premise will be the same,&#xD;
      where the DOORS broker will complete a needs assessment, generate an individualized re-entry&#xD;
      plan and make referrals to providers in the extensive DOORS network. The CHW will assist the&#xD;
      participant in navigating these referrals, specifically with regards to HIV care, substance&#xD;
      use treatment and mental healthcare. The measurement of the intervention will be as noted in&#xD;
      Aim 1.3, with the DOORS broker following routine agency processes for referrals and&#xD;
      measurement using the PIECES technology program and the CHW will record specifics (where,&#xD;
      when, duration) of each visit and what was addressed during these intervention visits.&#xD;
&#xD;
      Study Assessments. All participants will complete baseline assessments prior to randomization&#xD;
      and will have follow-up visits at 3, 6 and 12 months as noted in Aim 1.3. A blood draw will&#xD;
      be performed for 6-month HIV viral load. Follow-up visits will assess HIV viral load&#xD;
      (abstracted from medical record for all visits other than 6 month), substance use (using&#xD;
      ASSIST), healthcare utilization including attendance of HIV clinic visits, emergency room&#xD;
      visits, hospitalizations and reincarceration. If individuals are reincarcerated at the Dallas&#xD;
      County Jail at the time of the follow-up visits, an attempt will be made to complete study&#xD;
      visits at the jail.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 29, 2019</start_date>
  <completion_date type="Actual">August 25, 2021</completion_date>
  <primary_completion_date type="Actual">April 29, 2021</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Undetectable HIV Viral Load</measure>
    <time_frame>At 6 months after enrollment</time_frame>
    <description>Number of participants with an undetectable HIV viral load (&lt;200 copies/mL) is assessed via blood work.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Are Positive/Negative for Substance Use as Assessed Via Urine Drug Screen</measure>
    <time_frame>At 6 months after enrollment</time_frame>
    <description>Number of participants who are positive/negative for Substance use are assessed via urine drug screen</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Substance Use for Reported Drug of Choice From Baseline at 6 Months After Enrollment as Assessed Via ASSIST Questionnaire</measure>
    <time_frame>Baseline and 6 months after enrollment</time_frame>
    <description>Change in substance use from baseline at 6 months after enrollment (result reported is the baseline minus the 6 month value) is assessed via ASSIST(Alcohol, Smoking, and Substance Involvement Screening Test) v3.1 questionnaire. For the participant's reported DRUG OF CHOICE, the score on the relevant subscale will be used: (A) ASSIST risk score for tobacco (range 0-31); (B) alcohol (range 0-39); (C) cannabis (range 0-39); (D) cocaine (range 0-39); (E) amphetamine-type stimulants (range 0-39); (F) inhalants (range 0-39); (G) for sedatives or sleeping pills (range 0-39); (H) hallucinogens (range 0-39); (I) opioids (range 0-39); (J) 'other' drugs (range 0-39); High values indicate a worse outcome. Subscales are not combined;&#xD;
Score interpretation:&#xD;
Lower Risk: Alcohol (0-10), All other substances (0-3); Moderate Risk: Alcohol (11-26), All other substances (4-26); High risk: Alcohol (26+), All other substances (27+);</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants Who Experienced Recidivism</measure>
    <time_frame>at 12 months after enrollment</time_frame>
    <description>Number of participants who experienced recidivism is measured by the count of participants who had a re-incarceration in jail or prison at 12 months</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>HIV/AIDS</condition>
  <condition>Substance Use Disorders</condition>
  <arm_group>
    <arm_group_label>DOORS-CHW Intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The type of intervention is behavioral.&#xD;
Participants randomized to the intervention arm will meet with the Community Health Worker (CHW) and a staff member from Unlocking DOORS. The Unlocking DOORS broker will complete a needs assessment, generate an individualized re-entry plan and make referrals to providers in the extensive Unlocking DOORS network. The CHW will assist the participant in navigating these referrals, specifically with regards to HIV care, substance use treatment and mental healthcare.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment As Usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>TAU participants will receive standard of care, which involves passive referral by jail medical staff to the outpatient HIV clinic.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>DOORS-CHW Intervention</intervention_name>
    <description>The behavioral intervention has been developed for a collaborative CHW and re-entry program intervention that targets HIV outcomes, substance use and recidivism in HIV+ jail releasees.&#xD;
Participants will be randomized to the DOORS+CHW intervention versus TAU and all participants will undergo study follow-up visits at 3, 6 and 12 months. In other words, participants randomized to the intervention arm will meet with the CHW and a staff member from DOORS. One of the primary study aims is a randomized controlled trial of an intervention which has a reasonable probability of improving the health and well-being of the subject by improving linkage to social services and the HIV clinic. The control arm will receive standard of care (referrals to case management).</description>
    <arm_group_label>DOORS-CHW Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV-infected AND&#xD;
&#xD;
          -  ≥18 years old AND&#xD;
&#xD;
          -  report or have medical records documenting any opioid (illicit or prescription&#xD;
             misuse), stimulant (cocaine, ecstasy, or amphetamines), or heavy alcohol use (as&#xD;
             determined by the 3-item Alcohol Use Disorders Identification Test (AUDIT-C) within&#xD;
             the past 12 months&#xD;
&#xD;
          -  Provide two forms of contact information (address, phone number, email, other locator&#xD;
             info) AND&#xD;
&#xD;
          -  HIV VL &gt;200 copies/mL within past 90 days OR&#xD;
&#xD;
          -  No HIV visit in 6 months OR Self-reported non-adherence to medications&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwilling to participate&#xD;
&#xD;
          -  Unable to consent&#xD;
&#xD;
          -  Does not speak English&#xD;
&#xD;
          -  Unwilling to participate&#xD;
&#xD;
          -  Unable to consent&#xD;
&#xD;
          -  Does not plan to remain in greater Dallas area after release Sentenced to prison or&#xD;
             other court-mandated program for ≥6 months&#xD;
&#xD;
          -  Does not speak English&#xD;
&#xD;
          -  Have an acute medical or psychiatric disorder that would, in the judgment of the PI,&#xD;
             make participation difficult or unsafe.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ank E Nijhawan, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas Southwestern Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Amelia Court, HIV Research Unit</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <results_first_submitted>October 3, 2022</results_first_submitted>
  <results_first_submitted_qc>January 17, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 13, 2023</results_first_posted>
  <last_update_submitted>January 17, 2023</last_update_submitted>
  <last_update_submitted_qc>January 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>Ank Nijhawan</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>AIDS</keyword>
  <keyword>Substance Use</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>As this is a pilot study and there was not direct mention of data sharing in the informed consent form, there is not plan to share IPD with other researchers.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 11, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT03834779/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT03834779/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 23, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT03834779/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>31 individuals enrolled and assigned to study arms, all 31 who were enrolled were deemed eligible</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>DOORS-CHW Intervention</title>
          <description>The type of intervention is behavioral.&#xD;
Participants randomized to the intervention arm will meet with the Community Health Worker (CHW) and a staff member from Unlocking DOORS. The Unlocking DOORS broker will complete a needs assessment, generate an individualized re-entry plan and make referrals to providers in the extensive Unlocking DOORS network. The CHW will assist the participant in navigating these referrals, specifically with regards to HIV care, substance use treatment and mental healthcare.&#xD;
DOORS-CHW Intervention: The behavioral intervention has been developed for a collaborative CHW and re-entry program intervention that targets HIV outcomes, substance use and recidivism in HIV+ jail releasees.&#xD;
Participants will be randomized to the DOORS+CHW intervention versus TAU and all participants will undergo study follow-up visits at 3, 6 and 12 months.</description>
        </group>
        <group group_id="P2">
          <title>Treatment As Usual</title>
          <description>TAU participants will receive standard of care, which involves passive referral by jail medical staff to the outpatient HIV clinic.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Analysis population same as assigned treatment group</population>
      <group_list>
        <group group_id="B1">
          <title>DOORS-CHW Intervention</title>
          <description>The type of intervention is behavioral.&#xD;
Participants randomized to the intervention arm will meet with the Community Health Worker (CHW) and a staff member from Unlocking DOORS. The Unlocking DOORS broker will complete a needs assessment, generate an individualized re-entry plan and make referrals to providers in the extensive Unlocking DOORS network. The CHW will assist the participant in navigating these referrals, specifically with regards to HIV care, substance use treatment and mental healthcare.&#xD;
DOORS-CHW Intervention: The behavioral intervention has been developed for a collaborative CHW and re-entry program intervention that targets HIV outcomes, substance use and recidivism in HIV+ jail releasees.&#xD;
Participants will be randomized to the DOORS+CHW intervention versus TAU and all participants will undergo study follow-up visits at 3, 6 and 12 months.</description>
        </group>
        <group group_id="B2">
          <title>Treatment As Usual</title>
          <description>TAU participants will receive standard of care, which involves passive referral by jail medical staff to the outpatient HIV clinic.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="17"/>
            <count group_id="B2" value="14"/>
            <count group_id="B3" value="31"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.9" spread="9.7"/>
                    <measurement group_id="B2" value="34.7" spread="9.3"/>
                    <measurement group_id="B3" value="35.9" spread="9.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Gender</title>
              <category_list>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Transgender female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race/ethnicity</title>
              <category_list>
                <category>
                  <title>Non-Hispanic White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-Hispanic Black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>CD count</title>
          <description>CD4 count is measured at baseline as cells per cubic millimeter of blood</description>
          <units>cells per cubic millimeter of blood</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="412" spread="359"/>
                    <measurement group_id="B2" value="371" spread="275"/>
                    <measurement group_id="B3" value="388" spread="306"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Undetectable HIV Viral Load</title>
        <description>Number of participants with an undetectable HIV viral load (&lt;200 copies/mL) is assessed via blood work.</description>
        <time_frame>At 6 months after enrollment</time_frame>
        <population>All participants who had viral load completed at 6 months</population>
        <group_list>
          <group group_id="O1">
            <title>DOORS-CHW Intervention</title>
            <description>The type of intervention is behavioral.&#xD;
Participants randomized to the intervention arm will meet with the Community Health Worker (CHW) and a staff member from Unlocking DOORS. The Unlocking DOORS broker will complete a needs assessment, generate an individualized re-entry plan and make referrals to providers in the extensive Unlocking DOORS network. The CHW will assist the participant in navigating these referrals, specifically with regards to HIV care, substance use treatment and mental healthcare.&#xD;
DOORS-CHW Intervention: The behavioral intervention has been developed for a collaborative CHW and re-entry program intervention that targets HIV outcomes, substance use and recidivism in HIV+ jail releasees.&#xD;
Participants will be randomized to the DOORS+CHW intervention versus TAU and all participants will undergo study follow-up visits at 3, 6 and 12 months. In other words, participants randomized to the intervention arm will meet with the CHW and a staff member from DOORS. One of the primary study aims is a randomized controlled trial of an intervention which has a reasonable probability of improving the health and well-being of the subject by improving linkage to social services and the HIV clinic. The control arm will receive standard of care (referrals to case management).</description>
          </group>
          <group group_id="O2">
            <title>Treatment As Usual</title>
            <description>TAU participants will receive standard of care, which involves passive referral by jail medical staff to the outpatient HIV clinic.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Undetectable HIV Viral Load</title>
          <description>Number of participants with an undetectable HIV viral load (&lt;200 copies/mL) is assessed via blood work.</description>
          <population>All participants who had viral load completed at 6 months</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Are Positive/Negative for Substance Use as Assessed Via Urine Drug Screen</title>
        <description>Number of participants who are positive/negative for Substance use are assessed via urine drug screen</description>
        <time_frame>At 6 months after enrollment</time_frame>
        <population>All participants who had urine toxicology screen at 6 months were assessed</population>
        <group_list>
          <group group_id="O1">
            <title>DOORS-CHW Intervention</title>
            <description>The type of intervention is behavioral.&#xD;
Participants randomized to the intervention arm will meet with the Community Health Worker (CHW) and a staff member from Unlocking DOORS. The Unlocking DOORS broker will complete a needs assessment, generate an individualized re-entry plan and make referrals to providers in the extensive Unlocking DOORS network. The CHW will assist the participant in navigating these referrals, specifically with regards to HIV care, substance use treatment and mental healthcare.&#xD;
DOORS-CHW Intervention: The behavioral intervention has been developed for a collaborative CHW and re-entry program intervention that targets HIV outcomes, substance use and recidivism in HIV+ jail releasees.&#xD;
Participants will be randomized to the DOORS+CHW intervention versus TAU and all participants will undergo study follow-up visits at 3, 6 and 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Treatment As Usual</title>
            <description>TAU participants will receive standard of care, which involves passive referral by jail medical staff to the outpatient HIV clinic.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Are Positive/Negative for Substance Use as Assessed Via Urine Drug Screen</title>
          <description>Number of participants who are positive/negative for Substance use are assessed via urine drug screen</description>
          <population>All participants who had urine toxicology screen at 6 months were assessed</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>positive for stimulants</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not positive for stimulants</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Substance Use for Reported Drug of Choice From Baseline at 6 Months After Enrollment as Assessed Via ASSIST Questionnaire</title>
        <description>Change in substance use from baseline at 6 months after enrollment (result reported is the baseline minus the 6 month value) is assessed via ASSIST(Alcohol, Smoking, and Substance Involvement Screening Test) v3.1 questionnaire. For the participant's reported DRUG OF CHOICE, the score on the relevant subscale will be used: (A) ASSIST risk score for tobacco (range 0-31); (B) alcohol (range 0-39); (C) cannabis (range 0-39); (D) cocaine (range 0-39); (E) amphetamine-type stimulants (range 0-39); (F) inhalants (range 0-39); (G) for sedatives or sleeping pills (range 0-39); (H) hallucinogens (range 0-39); (I) opioids (range 0-39); (J) 'other' drugs (range 0-39); High values indicate a worse outcome. Subscales are not combined;&#xD;
Score interpretation:&#xD;
Lower Risk: Alcohol (0-10), All other substances (0-3); Moderate Risk: Alcohol (11-26), All other substances (4-26); High risk: Alcohol (26+), All other substances (27+);</description>
        <time_frame>Baseline and 6 months after enrollment</time_frame>
        <population>participants completing ASSIST score at baseline and 6 months</population>
        <group_list>
          <group group_id="O1">
            <title>DOORS-CHW Intervention</title>
            <description>The type of intervention is behavioral.&#xD;
Participants randomized to the intervention arm will meet with the Community Health Worker (CHW) and a staff member from Unlocking DOORS. The Unlocking DOORS broker will complete a needs assessment, generate an individualized re-entry plan and make referrals to providers in the extensive Unlocking DOORS network. The CHW will assist the participant in navigating these referrals, specifically with regards to HIV care, substance use treatment and mental healthcare.&#xD;
DOORS-CHW Intervention: The behavioral intervention has been developed for a collaborative CHW and re-entry program intervention that targets HIV outcomes, substance use and recidivism in HIV+ jail releasees.&#xD;
Participants will be randomized to the DOORS+CHW intervention versus TAU and all participants will undergo study follow-up visits at 3, 6 and 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Treatment As Usual</title>
            <description>TAU participants will receive standard of care, which involves passive referral by jail medical staff to the outpatient HIV clinic.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Substance Use for Reported Drug of Choice From Baseline at 6 Months After Enrollment as Assessed Via ASSIST Questionnaire</title>
          <description>Change in substance use from baseline at 6 months after enrollment (result reported is the baseline minus the 6 month value) is assessed via ASSIST(Alcohol, Smoking, and Substance Involvement Screening Test) v3.1 questionnaire. For the participant's reported DRUG OF CHOICE, the score on the relevant subscale will be used: (A) ASSIST risk score for tobacco (range 0-31); (B) alcohol (range 0-39); (C) cannabis (range 0-39); (D) cocaine (range 0-39); (E) amphetamine-type stimulants (range 0-39); (F) inhalants (range 0-39); (G) for sedatives or sleeping pills (range 0-39); (H) hallucinogens (range 0-39); (I) opioids (range 0-39); (J) 'other' drugs (range 0-39); High values indicate a worse outcome. Subscales are not combined;&#xD;
Score interpretation:&#xD;
Lower Risk: Alcohol (0-10), All other substances (0-3); Moderate Risk: Alcohol (11-26), All other substances (4-26); High risk: Alcohol (26+), All other substances (27+);</description>
          <population>participants completing ASSIST score at baseline and 6 months</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>All</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7" spread="14.9"/>
                    <measurement group_id="O2" value="12" spread="12.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with tobacco as their drug of choice</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Participants with alcohol as their drug of choice</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" spread="0"/>
                    <measurement group_id="O2" value="-3" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with cannabis as their drug of choice</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Participants with cocaine as their drug of choice</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.2" spread="16.7"/>
                    <measurement group_id="O2" value="-4.8" spread="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with amphetamine-type stimulants as their drug of choice</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.3" spread="11.8"/>
                    <measurement group_id="O2" value="-1.6" spread="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with inhalants as their drug of choice</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Participants with sedatives or sleeping pills as their drug of choice</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Participants with hallucinogens as their drug of choice</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-24" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with opioids as their drug of choice</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with 'other' drugs as their drug of choice</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants Who Experienced Recidivism</title>
        <description>Number of participants who experienced recidivism is measured by the count of participants who had a re-incarceration in jail or prison at 12 months</description>
        <time_frame>at 12 months after enrollment</time_frame>
        <population>participants who were alive at the end of the study and were reincarcerated</population>
        <group_list>
          <group group_id="O1">
            <title>DOORS-CHW Intervention</title>
            <description>The type of intervention is behavioral.&#xD;
Participants randomized to the intervention arm will meet with the Community Health Worker (CHW) and a staff member from Unlocking DOORS. The Unlocking DOORS broker will complete a needs assessment, generate an individualized re-entry plan and make referrals to providers in the extensive Unlocking DOORS network. The CHW will assist the participant in navigating these referrals, specifically with regards to HIV care, substance use treatment and mental healthcare.&#xD;
DOORS-CHW Intervention: The behavioral intervention has been developed for a collaborative CHW and re-entry program intervention that targets HIV outcomes, substance use and recidivism in HIV+ jail releasees.&#xD;
Participants will be randomized to the DOORS+CHW intervention versus TAU and all participants will undergo study follow-up visits at 3, 6 and 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Treatment As Usual</title>
            <description>TAU participants will receive standard of care, which involves passive referral by jail medical staff to the outpatient HIV clinic.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced Recidivism</title>
          <description>Number of participants who experienced recidivism is measured by the count of participants who had a re-incarceration in jail or prison at 12 months</description>
          <population>participants who were alive at the end of the study and were reincarcerated</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>DOORS-CHW Intervention</title>
          <description>The type of intervention is behavioral.&#xD;
Participants randomized to the intervention arm will meet with the Community Health Worker (CHW) and a staff member from Unlocking DOORS. The Unlocking DOORS broker will complete a needs assessment, generate an individualized re-entry plan and make referrals to providers in the extensive Unlocking DOORS network. The CHW will assist the participant in navigating these referrals, specifically with regards to HIV care, substance use treatment and mental healthcare.&#xD;
DOORS-CHW Intervention: The behavioral intervention has been developed for a collaborative CHW and re-entry program intervention that targets HIV outcomes, substance use and recidivism in HIV+ jail releasees.&#xD;
Participants will be randomized to the DOORS+CHW intervention versus TAU and all participants will undergo study follow-up visits at 3, 6 and 12 months.</description>
        </group>
        <group group_id="E2">
          <title>Treatment As Usual</title>
          <description>TAU participants will receive standard of care, which involves passive referral by jail medical staff to the outpatient HIV clinic.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization</sub_title>
                <description>Inpatient stay</description>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="17"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Limitations: This study (1) was initiated just before the COVID-19 pandemic which limited recruitment and decreased opportunities for in-person interaction between participants and staff. However, efforts were made to connect with participants outdoors or through virtual methods whenever possible. (2) is a single center study localized in a large Southern city with a focus on both substance use - primarily stimulants - and HIV and therefore may not be applicable to other locations/populations.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Ank Nijhawan</name_or_title>
      <organization>UT Southwestern Medical Center</organization>
      <phone>214-648-2777</phone>
      <email>ank.nijhawan@utsouthwestern.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03834779
org study id: STU 082017-022
secondary id: 1R34DA045592-01
nct id: NCT03834779
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The long-term goal of this project is to improve HIV and substance use outcomes and reduce
      recidivism for HIV+ substance users released from jail. The overall objective of the proposed
      R34 project is to develop and pilot test a multi-sector community-clinic collaborative
      intervention that can subsequently be implemented on a larger scale (as part of a future R01)
      to achieve this goal. Our central hypothesis is that HIV+ substance users released from jail
      can successfully overcome obstacles to re-entry and continuity of HIV care with
      individualized, culturally competent assistance in navigating both social and medical
      services.

      Aim 1: Develop and refine a collaborative CHW and re-entry program intervention that targets
      HIV outcomes, substance use and recidivism in HIV+ jail releasees.

      Aim 2: Conduct a pilot randomized controlled trial comparing the collaborative intervention
      (n=40) compared to treatment as usual (n=40) in HIV+ substance users released from jail.
Aim 1 Introduction: This first aim will be critical to successful implementation of the
      CHW-DOORS intervention. Employing a formerly incarcerated CHW to assist individuals leaving
      prison in order to connect to healthcare has been successfully implemented in different
      settings, but it has not been applied specifically to HIV patients or those leaving jail (v.
      prison), nor has it been integrated into a community based organization. The objective of
      this aim is to adapt the evidence-based CHW intervention to the HIV population and to the
      jail setting and to integrate the CHW into existing processes at DOORS and the outpatient HIV
      clinic system.

      Research Design. Aim 1.1: The first step of Aim 1 will be to train the CHW using the
      transitions clinic approach, add modules on HIV and substance use and familiarize the CHW
      with DOORS processes and HIV clinic workflow.

      Aim 1.2: The second step will be to complete qualitative interviews with stakeholders in
      three different settings- the jail, the HIV clinic and DOORS. All interviews will be
      semi-structured, one-on-one interviews, with an estimated 4-7 interviews in each setting.

      The structured component of the interview guide will prompt interviewee input on study design
      (e.g. recruitment, intervention, follow-up visits), content of the intervention (e.g. high
      demand services) and an open-ended component eliciting possible barriers to study
      implementation.

      Aim 1.3: The final step in Aim 1 will be to complete pilot testing with 5 subjects, which
      will focus on refining recruitment/enrollment protocols, streamlining study assessments and
      evaluating the intervention.

      Recruitment: In order to protect patient confidentiality, potential subjects will be referred
      by medical staff who provide clinical care to HIV+ inmates. When an inmate enters the Dallas
      County Jail, he/she is evaluated by a medical provider within 24 hours (medical assessment
      program, MAP). At this visit, the inmate can disclose any medical conditions that they have
      including HIV, in which case he/she will be referred to the jail HIV clinic (scheduled within
      1-7 days of jail entry). In addition, HIV testing is offered in an opt-out manner when
      inmates have blood drawn for any reason (approximately 10% of jail population) and by inmate
      request, and those with positive test results are referred to jail HIV clinic. Candidates
      coming through the MAP or HIV clinics who agree to be approached will be contacted by a
      research assistant (RA). The RA will explain the study to interested individuals, will obtain
      additional contact information (additional phone numbers, address or location in community
      where patient could be found) and permission to contact the individual after release. Clinic
      staff will also routinely request this information from interested individuals in case they
      are released prior to RA visit in jail. Once released, the research team will contact the
      individual releasee to schedule an enrollment visit. At this visit, which will occur as soon
      as possible after jail release (maximum within 30 days of release), the research team will
      obtain informed consent and enroll the participant into the study. The enrollment may occur
      at the UT Southwestern HIV research unit (located above the main HIV clinic) or in the
      community as per participant preference.

      Enrollment: In order to be enrolled, individuals must (a) be ≥18 years old, (b) have a
      confirmed diagnosis of HIV, (c) have evidence of uncontrolled HIV (viral load >200 copies/mL
      within 90 days of enrollment, self-reported non-adherence to HIV medications or no community
      clinic visit in the 6 months preceding incarceration), (d) report or have medical records
      documenting any opioid (illicit or prescription misuse), stimulant (cocaine, ecstasy, or
      amphetamines), or heavy alcohol use (as determined by the 3-item Alcohol Use Disorders
      Identification Test (AUDIT-C) within the past 12 months, and (e) provide at least 2 forms of
      contact information. They will also be asked to provide a release of information for their
      medical records at the jail and community clinics/ hospitals. No randomization will occur in
      Aim 1 as all 5 participants in the pilot testing phase will be assigned to the intervention.
      Baseline assessments will occur after informed consent is obtained and enrollment is
      complete. These assessments will focus on variables in the conceptual model, with collection
      of demographics (age, race/ethnicity, gender, HIV risk factor) and social variables (marital
      status, housing, education, employment/income, insurance, benefits, social support). Subjects
      will also be asked about HIV care (engagement in care, antiretroviral therapy, adherence to
      medications (using visual analog scale), barriers to care), mental illness, and substance use
      (using ASSIST questionnaire).

      Intervention: The first meeting with the CHW will occur at the time of enrollment if
      possible, depending on availability of the participant and CHW, otherwise it may occur
      anytime within 14 days of enrollment. After release from jail, the CHW will help the
      participant navigate to DOORS, where they will meet with a "broker", someone who helps the
      client/participant arrange and negotiate referrals to services within the extensive
      partner/provider network. The first broker meeting will typically occur within 2-4 weeks
      after release, as this is a critical window for re-engagement in care, underscored by the
      fact that this is also a high-risk period for increased unprotected sex and return to
      substance use. Per DOORS' standard practice, the broker will complete a comprehensive needs
      assessment with the participant. Based on these assessments, together with the participant,
      the broker will develop a personalized re-entry plan with a detailed list of referrals and
      calendar of scheduled visits with relevant agencies within the DOORS network.

      Follow-up visits and assessments: Research visits will be scheduled at 3 months, 6 months and
      12 months. A 4-week window before and 8-week window after the target follow-up dates will be
      permitted for study assessments. Assessments will be completed at each follow-up visit,
      including substance use, adherence, healthcare utilization and recidivism, with blood draw
      for HIV viral load collected at the 6-month visit. In order to maximize efficient utilization
      of resources, for baseline and other follow-up visits, HIV viral load will be abstracted from
      medical records. In order to have sufficient time to enroll and complete 12 month study
      visits for the 80 participants in Aim 2, the 5 pilot participants from Aim 1.3 need to reach
      at least the 3 month time point but not 6 or 12-month visits before beginning study
      enrollment for Aim 2. Pilot participants will complete through 12-month visits as this will
      provide insight as to how best to conduct these later follow-up visits. All participants will
      receive financial reimbursement for study visits ($25 for each visit), unless they are
      incarcerated at the time of the visit. Jail inmates are not permitted to receive any
      financial incentives during incarceration.

      AIM 2: Conduct a pilot randomized controlled trial comparing the collaborative intervention
      (n=40) compared to treatment as usual (n=40) in HIV+ substance users released from jail.

      Introduction. In this aim, we will test the CHW-DOORS intervention that was refined in Aim 1
      in a randomized fashion. The goal of this aim is to establish feasibility of a randomized
      controlled trial in this setting, to determine preliminary efficacy of the intervention and
      to inform sample size calculations for a fully powered trial. In addition, this aim will
      provide data regarding key factors involved in HIV+ substance users accessing substance use
      treatment and HIV care after jail release. Our working hypothesis is that from the
      stakeholder input and pilot testing completed in Aim 1, we will be able to successfully
      conduct a pilot randomized controlled trial and gain valuable insight into key predisposing
      and enabling factors influencing healthcare needs and utilization in this population, and how
      these may impact HIV viral load, substance use and recidivism.

      Research Design. Potential participants will be referred to the research study by Dallas
      County jail medical providers as described in Aim 1.3. Candidates who agree to be approached
      will be contacted by a RA who will recruit, and review eligibility criteria (see Aim 1.3).
      After release, potential participants will be contacted in order to complete informed
      consent, study enrollment and randomization (to be completed within 30 days of release from
      jail). All participants will provide 2 specific forms of locator information (telephone
      number for themselves, friend/family member, address, email, specific location where they may
      be located to aid in retention efforts). Participants will complete baseline assessments and
      will then be randomized to the intervention CHW-DOORS versus treatment as usual (TAU).
      Randomization will occur by random assignment using a computer program, without block
      randomization given the small sample size. TAU participants will receive standard of care,
      which involves passive referral by jail medical staff to the outpatient HIV clinic.

      Intervention. Participants randomized to the intervention arm will meet with the CHW and a
      staff member from DOORS as outlined in Aim 1.3. Any modifications to this protocol after
      pilot testing in Aim 1.3 will be implemented in Aim 2. The general premise will be the same,
      where the DOORS broker will complete a needs assessment, generate an individualized re-entry
      plan and make referrals to providers in the extensive DOORS network. The CHW will assist the
      participant in navigating these referrals, specifically with regards to HIV care, substance
      use treatment and mental healthcare. The measurement of the intervention will be as noted in
      Aim 1.3, with the DOORS broker following routine agency processes for referrals and
      measurement using the PIECES technology program and the CHW will record specifics (where,
      when, duration) of each visit and what was addressed during these intervention visits.

      Study Assessments. All participants will complete baseline assessments prior to randomization
      and will have follow-up visits at 3, 6 and 12 months as noted in Aim 1.3. A blood draw will
      be performed for 6-month HIV viral load. Follow-up visits will assess HIV viral load
      (abstracted from medical record for all visits other than 6 month), substance use (using
      ASSIST), healthcare utilization including attendance of HIV clinic visits, emergency room
      visits, hospitalizations and reincarceration. If individuals are reincarcerated at the Dallas
      County Jail at the time of the follow-up visits, an attempt will be made to complete study
      visits at the jail.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Number of Participants With Undetectable HIV Viral Load
time frame: At 6 months after enrollment
description: Number of participants with an undetectable HIV viral load (<200 copies/mL) is assessed via blood work.
measure: Number of Participants Who Are Positive/Negative for Substance Use as Assessed Via Urine Drug Screen
time frame: At 6 months after enrollment
description: Number of participants who are positive/negative for Substance use are assessed via urine drug screen
measure: Change in Substance Use for Reported Drug of Choice From Baseline at 6 Months After Enrollment as Assessed Via ASSIST Questionnaire
time frame: Baseline and 6 months after enrollment
description: Change in substance use from baseline at 6 months after enrollment (result reported is the baseline minus the 6 month value) is assessed via ASSIST(Alcohol, Smoking, and Substance Involvement Screening Test) v3.1 questionnaire. For the participant's reported DRUG OF CHOICE, the score on the relevant subscale will be used: (A) ASSIST risk score for tobacco (range 0-31); (B) alcohol (range 0-39); (C) cannabis (range 0-39); (D) cocaine (range 0-39); (E) amphetamine-type stimulants (range 0-39); (F) inhalants (range 0-39); (G) for sedatives or sleeping pills (range 0-39); (H) hallucinogens (range 0-39); (I) opioids (range 0-39); (J) 'other' drugs (range 0-39); High values indicate a worse outcome. Subscales are not combined;
Score interpretation:
Lower Risk: Alcohol (0-10), All other substances (0-3); Moderate Risk: Alcohol (11-26), All other substances (4-26); High risk: Alcohol (26+), All other substances (27+);
measure: Number of Participants Who Experienced Recidivism
time frame: at 12 months after enrollment
description: Number of participants who experienced recidivism is measured by the count of participants who had a re-incarceration in jail or prison at 12 months
arm group label: DOORS-CHW Intervention
arm group type: Other
description: The type of intervention is behavioral.
Participants randomized to the intervention arm will meet with the Community Health Worker (CHW) and a staff member from Unlocking DOORS. The Unlocking DOORS broker will complete a needs assessment, generate an individualized re-entry plan and make referrals to providers in the extensive Unlocking DOORS network. The CHW will assist the participant in navigating these referrals, specifically with regards to HIV care, substance use treatment and mental healthcare.
arm group label: Treatment As Usual
arm group type: No Intervention
description: TAU participants will receive standard of care, which involves passive referral by jail medical staff to the outpatient HIV clinic.
intervention type: Behavioral
intervention name: DOORS-CHW Intervention
description: The behavioral intervention has been developed for a collaborative CHW and re-entry program intervention that targets HIV outcomes, substance use and recidivism in HIV+ jail releasees.
Participants will be randomized to the DOORS+CHW intervention versus TAU and all participants will undergo study follow-up visits at 3, 6 and 12 months. In other words, participants randomized to the intervention arm will meet with the CHW and a staff member from DOORS. One of the primary study aims is a randomized controlled trial of an intervention which has a reasonable probability of improving the health and well-being of the subject by improving linkage to social services and the HIV clinic. The control arm will receive standard of care (referrals to case management).
arm group label: DOORS-CHW Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: No
last name: Ank E Nijhawan, M.D.
role: Principal Investigator
affiliation: University of Texas Southwestern Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: Ank Nijhawan
investigator title: Associate Professor
mesh term: Substance-Related Disorders
sharing ipd: No
ipd description: As this is a pilot study and there was not direct mention of data sharing in the informed consent form, there is not plan to share IPD with other researchers.
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Limitations: This study (1) was initiated just before the COVID-19 pandemic which limited recruitment and decreased opportunities for in-person interaction between participants and staff. However, efforts were made to connect with participants outdoors or through virtual methods whenever possible. (2) is a single center study localized in a large Southern city with a focus on both substance use - primarily stimulants - and HIV and therefore may not be applicable to other locations/populations.
point of contact: 