xml: <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/NCT06025006</url>
    </required_header>
    <id_info>
      <org_study_id>2018-61</org_study_id>
      <nct_id>NCT06025006</nct_id>
    </id_info>
    <brief_title>Impact of an Alternative to Incarceration by Housing and Support by Assertive Community Treatment Team for Homeless People With Severe Psychiatric Disorders Referred to Immediate Referral Procedure: AILSI Program</brief_title>
    <acronym>AILSI</acronym>
    <official_title>Impact of an Alternative to Incarceration by Housing and Support by Assertive Community Treatment Team (AILSI Program) for People Who Are Homeless With Severe Psychiatric Disorders and Referred to Immediate Referral Procedure, in Comparison With Usual Services: a Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assistance Publique Hopitaux De Marseille</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assistance Publique Hopitaux De Marseille</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>
        People who are homeless with severe psychiatric disorders have to negotiate discontinuous&#xD;
        mental health care pathways including high use of emergency departement and enforced&#xD;
        hospitalisation, poor access to ambulatory care, poor access to common rights services and a&#xD;
        greater risk of incarceration.&#xD;
  &#xD;
        In order to reduce morbidity, improve social integration and outpatient care for people with&#xD;
        severe psychiatric disorders and multiple factors of social vulnerability, the concept of&#xD;
        therapeutic jurisprudence has led to the emergence of mental health courts in Anglo-Saxon&#xD;
        nations. These courts aim to condition alternatives to incarceration through community-based&#xD;
        intensive care (assertive community treatment-ACT). ACT Teams offer direct access to housing&#xD;
        without any prerequisite of treatment or abstinence. This model of community-based intensive&#xD;
        care tends to demonstrate medical and legal effectiveness while being associated with greater&#xD;
        care acceptability by patients. In France, very little data exists on the subject.&#xD;
  &#xD;
        Médecins du Monde (NGO), in collaboration with the Public Prosecutor's department of&#xD;
        Marseille, proposes the implementation of the AILSI strategy for people who homeless with&#xD;
        severe psychiatric disorders and referred to immediate referral procedure. The research unit&#xD;
        EA 3279 - CEReSS is in charge of the independent evaluation of this innovative intervention.&#xD;
  &#xD;
        This is an randomized coontrolled study, with two groups: AILSI group (intervention) and TAU&#xD;
        group (usual services). A total of 220 patients will be included (100 in the AILSI group /&#xD;
        120 in the TAU group).&#xD;
  &#xD;
        The main objective is to evaluate the effectiveness of the innovative program (AILSI)&#xD;
        compared to usual services by assessing the duration of reincarceration at 18 months in each&#xD;
        group, weighted by exposure time.&#xD;
  &#xD;
        . Duration of inclusion: 30 months; Duration of follow-up: 18 months; Total duration of the&#xD;
        study: 54 months.&#xD;
  &#xD;
        Both quantitative and qualitative analyses will be conducted to address overall outcomes.&#xD;
        Univariate and multivariate analyzes will be performed on the primary outcome as well as the&#xD;
        secondary outcomes in order to highlight significant differences between the two groups and&#xD;
        to identify predictive factors for improved effectiveness. The analysis will be conducted in&#xD;
        accordance with Good Epidemiological Practices, and the final report will be written&#xD;
        according to the CONSORT (Consolidated Standards of Reporting Trials) recommendations.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 2, 2022</start_date>
    <completion_date type="Anticipated">August 2, 2026</completion_date>
    <primary_completion_date type="Anticipated">February 2, 2026</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>Duration of reincarceration, weighted by exposure time</measure>
      <time_frame>18 months</time_frame>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">220</enrollment>
    <condition>Severe Psychiatric Disorder</condition>
    <arm_group>
      <arm_group_label>AILSI</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>the standard of care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>alternative to incarceration</intervention_name>
      <description>place of respite with housing plus intensive follow-up</description>
      <arm_group_label>AILSI</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  At least 18 years old&#xD;
  &#xD;
            -  Being defered in immediate appearance to the Public Prosecutor's department of&#xD;
               Marseille&#xD;
  &#xD;
            -  Being homeless (ETHOS 1 to 8.3)&#xD;
  &#xD;
            -  Presenting a diagnosis of a severe psychiatric disorder as defined by DSM-IV-TR&#xD;
  &#xD;
            -  Having effective health coverage&#xD;
  &#xD;
            -  Having signed an informed consent to participate in the study&#xD;
  &#xD;
            -  Having declared to want to stay in the area at least 18 months after inclusion in the&#xD;
               study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Less than 18 years old;&#xD;
  &#xD;
            -  Do not have any criteria for ETHOS 1 to 8.3 classification&#xD;
  &#xD;
            -  Do not present a diagnosis of a severe psychiatric disorder as defined by DSM-IV-TR&#xD;
  &#xD;
            -  Presenting cognitive impairment that limits comprehension,&#xD;
  &#xD;
            -  Being under guardianship,&#xD;
  &#xD;
            -  Do not have effective health coverage&#xD;
  &#xD;
            -  Having refused to participate in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>François CREMIEUX</last_name>
      <role>Study Director</role>
      <affiliation>AP-HM</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Pascal AUQUIER</last_name>
      <phone>33(0)4 91 38 47 44</phone>
      <email>pascal.auquier@univ-amu.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Claire MORANDO</last_name>
      <email>claire.morando@ap-hm.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Service Epidémiologie et Economie de la Santé - AP-HM</name>
        <address>
          <city>Marseille</city>
          <zip>13354</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Pascal AUQUIER</last_name>
        <phone>33(0)4 91 38 47 44</phone>
        <email>pascal.auquier@univ-amu.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 11, 2019</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mental Disorders</mesh_term>
      <mesh_term>Problem Behavior</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06025006
  org study id: 2018-61
  nct id: NCT06025006
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  People who are homeless with severe psychiatric disorders have to negotiate discontinuous
        mental health care pathways including high use of emergency departement and enforced
        hospitalisation, poor access to ambulatory care, poor access to common rights services and a
        greater risk of incarceration.
  
        In order to reduce morbidity, improve social integration and outpatient care for people with
        severe psychiatric disorders and multiple factors of social vulnerability, the concept of
        therapeutic jurisprudence has led to the emergence of mental health courts in Anglo-Saxon
        nations. These courts aim to condition alternatives to incarceration through community-based
        intensive care (assertive community treatment-ACT). ACT Teams offer direct access to housing
        without any prerequisite of treatment or abstinence. This model of community-based intensive
        care tends to demonstrate medical and legal effectiveness while being associated with greater
        care acceptability by patients. In France, very little data exists on the subject.
  
        Médecins du Monde (NGO), in collaboration with the Public Prosecutor's department of
        Marseille, proposes the implementation of the AILSI strategy for people who homeless with
        severe psychiatric disorders and referred to immediate referral procedure. The research unit
        EA 3279 - CEReSS is in charge of the independent evaluation of this innovative intervention.
  
        This is an randomized coontrolled study, with two groups: AILSI group (intervention) and TAU
        group (usual services). A total of 220 patients will be included (100 in the AILSI group /
        120 in the TAU group).
  
        The main objective is to evaluate the effectiveness of the innovative program (AILSI)
        compared to usual services by assessing the duration of reincarceration at 18 months in each
        group, weighted by exposure time.
  
        . Duration of inclusion: 30 months; Duration of follow-up: 18 months; Total duration of the
        study: 54 months.
  
        Both quantitative and qualitative analyses will be conducted to address overall outcomes.
        Univariate and multivariate analyzes will be performed on the primary outcome as well as the
        secondary outcomes in order to highlight significant differences between the two groups and
        to identify predictive factors for improved effectiveness. The analysis will be conducted in
        accordance with Good Epidemiological Practices, and the final report will be written
        according to the CONSORT (Consolidated Standards of Reporting Trials) recommendations.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Duration of reincarceration, weighted by exposure time
  time frame: 18 months
  arm group label: AILSI
  arm group type: Experimental
  arm group label: the standard of care
  arm group type: No Intervention
  intervention type: Other
  intervention name: alternative to incarceration
  description: place of respite with housing plus intensive follow-up
  arm group label: AILSI
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: François CREMIEUX
  role: Study Director
  affiliation: AP-HM
  last name: Pascal AUQUIER
  phone: 33(0)4 91 38 47 44
  email: pascal.auquier@univ-amu.fr
  last name: Claire MORANDO
  email: claire.morando@ap-hm.fr
  facility: 
  status: Recruiting
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Mental Disorders
  mesh term: Problem Behavior