<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/NCT03799276</url>
  </required_header>
  <id_info>
    <org_study_id>CREPATS 08</org_study_id>
    <nct_id>NCT03799276</nct_id>
  </id_info>
  <brief_title>Optimisation of Care in Vulnerable HIV Infected Individuals</brief_title>
  <acronym>OPTICARE</acronym>
  <official_title>Optimisation of Care and Antiretroviral Therapy in Vulnerable HIV Infected Individuals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ViiV Healthcare</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut de Sante Publique, d'Epidemiologie et de Developpement</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida</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>
      Antiretroviral therapy is currently the only way to control HIV disease progression in HIV&#xD;
      infected subjects and to prevent transmission. However a sustained virological control&#xD;
      through antiretroviral therapy is requested for these objectives. There is currently 8-10% of&#xD;
      patients who failed therapy for many reasons other than virological resistance including&#xD;
      social unstability, psychiatric disorders, migrant status, drug or alcohol addictions.&#xD;
      Because many of these vulnerabilities can be managed and patients helped for following&#xD;
      adequately cares and treatments, study team designed the OPTICARE Program to help reduce&#xD;
      impact of the patients' vulnerabilities.&#xD;
&#xD;
      The OPTICARE study is designed as a prospective implementation interventional study which&#xD;
      aims to improve retention in care among vulnerable HIV infected patients over 48 weeks.&#xD;
&#xD;
      The OPTICARE program is a support program dedicated to patients either lost to follow up or&#xD;
      in highly fraility situation that will offer an individualized care management to fill their&#xD;
      gaps towards optimized care and control of viral replication. Our aim is, in patients virally&#xD;
      failing in relation with poor adherence to care and treatment to test first part whether&#xD;
      tracking proactively lost to follow up patients or detecting frail individuals at risk of&#xD;
      lost to care is effective and secondly to evaluate the efficacy, the feasibility and the&#xD;
      acceptability of an intervention tailored to each individual to get them to treatment success&#xD;
      with viral suppression. In our context, a randomized approach would not be seen as ethical or&#xD;
      possible in an environment where investigators need to evaluate such intervention as a pilot&#xD;
      approach. Investigators therefore enrolled patients in a cohort population study OPTICARE&#xD;
      program aim to actively identify vulnerable HIV+ population and promote optimal access to&#xD;
      health care to this population using retention in care program in order to enable long term&#xD;
      HIV infection control.&#xD;
&#xD;
      The primary objective is to assess the feasability and the effectiveness of the OPTICARE&#xD;
      program. The OPTICARE program aims to propose an individualized care to vulnerable HIV&#xD;
      infected patients (UNAIDS/Second 90% goal) and to drive them to treatment success&#xD;
      (UNAIDS/Third 90% goal) within a one-year period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The OPTICARE program is an individualized program proposed to vulnerable HIV infected&#xD;
      patients according to a baseline evaluation of the clinical, social, psychological and&#xD;
      cultural aspects.&#xD;
&#xD;
      Once enrolled in the OPTICARE program, each patient will benefit of:&#xD;
&#xD;
        -  A comprehensive and complete check up personal interview, through a daily visit, with a&#xD;
           physician, an educational nurse, a social worker and a cultural mediator (if needed), in&#xD;
           order to identify mains issues&#xD;
&#xD;
        -  A specific follow up will be set up with obligatory visits at week 4, week 12, week 24,&#xD;
           week 36 and week 48 to assess the evolution of the previously identified issues. If&#xD;
           needed, additional visits will be set up.&#xD;
&#xD;
        -  Regular (Day 15 and monthly) phone calls will be set up during the first six months of&#xD;
           the OPTICARE program.&#xD;
&#xD;
        -  Each patient will be accompanied by a tutoring nurse who will be in direct contact with&#xD;
           the patient.&#xD;
&#xD;
      Regarding the specific needs, each patient may benefit of:&#xD;
&#xD;
        -  a personal assistance to complete administrative procedures (update health insurance,&#xD;
           assistance to fill administrative papers, provide a budget for photo ID, transport&#xD;
           tickets)&#xD;
&#xD;
        -  a personalized medical follow up with regular phone calls, home visits (if the patient&#xD;
           agrees), assistance in taking HIV medication (set up pillbox, therapeutic education)&#xD;
&#xD;
        -  a close psychological and social support (connection with HIV organizations,&#xD;
           participation to monthly support group)&#xD;
&#xD;
        -  a specific assistance related to dependence issues (connection with addiction&#xD;
           organization, sex therapist consultation)&#xD;
&#xD;
      A multidisciplinary team (physician, educational nurse, psychotherapist, social worker and&#xD;
      cultural mediator) will proactively assist the patient (home visits, recall) during a one&#xD;
      year follow up.&#xD;
&#xD;
      The program is initially proposed to the patient. In case of non-acceptance, the patient can&#xD;
      further join the program after 3 months.&#xD;
&#xD;
      Patients who do not accept the OPTICARE program will be followed up in standard of care&#xD;
      according to French HIV management guidelines.&#xD;
      (https://cns.sante.fr/actualites/prise-en-charge-du-vih-recommandations-du-groupe-dexperts/).&#xD;
      All administratives and social procedures will be given to the social district.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Anticipated">December 15, 2023</completion_date>
  <primary_completion_date type="Actual">June 15, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measure of plasma viral load to assess the effectiveness of the OPTICARE Program to attend HIV plasma viral load &lt; 50 cp/ml at week 48</measure>
    <time_frame>12 months</time_frame>
    <description>Measure of plasma viral load assessed by RNA quantification using COBAS 6800 system (Roche)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>Opticare study</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phase I: Identification and Selection of study population The first step will include an active search by OPTICARE team for vulnerable and lost to follow up patients&#xD;
Phase II: Implementation of the individualized follow-up program The patients who agree to participate to the program will be defined as the OPTICARE population.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Opticare study</intervention_name>
    <description>Each patient will be evaluated by&#xD;
An HIV physician&#xD;
A nurse&#xD;
A social worker&#xD;
A psychological therapist&#xD;
A cultural mediator/member of patients community if needed for migrants&#xD;
Following these interviews and visits, a multisciplinary team will define for each patient an individualized OPTICARE program based on the following items: clinical, psychological/psychiatric, social status and follow up visits will be planned with the patient.&#xD;
Regular (Day 15 and monthly) phone calls will be set up during the first six months of the OPTICARE program, to assess the clinical status and ART adherence.&#xD;
Patients will have their medical, biological and social status assessed through visits at W4, W12, W24, W36 (medical and social status only) and W 48 with all members of the OPTICARE team.</description>
    <arm_group_label>Opticare study</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients Lost to follow-up defined as a patient with no clinical visit:&#xD;
&#xD;
               -  In the 12 months period for patients &gt; 250/mm3 CD4 cells or&#xD;
&#xD;
               -  In the 6 months period for patients &lt; 250/mm3 CD4 cells or&#xD;
&#xD;
               -  In the 3 months period following a new HIV + diagnosis or an AIDS defining&#xD;
                  illnesses&#xD;
&#xD;
             AND with HIV plasma viral load &gt; 400 cp/ml (following French HIV guidelines)&#xD;
&#xD;
          2. HIV+ patients with virological failure defined as HIV plasma viral load (pVL) &gt; 400&#xD;
             cp/ml (2 determinations with at least two weeks apart)&#xD;
&#xD;
          3. HIV+ patients presenting with an AIDS defining (&lt;3 months) event in a context of lost&#xD;
             to care prior to the event&#xD;
&#xD;
          4. HIV+ patients newly diagnosed with virological failure 6 months after ART initiation&#xD;
             (virological failure defined by two HIV plasma viral load &gt; 50cp/ml following French&#xD;
             HIV guidelines *) and with one of the following vulnerable risk factors :&#xD;
&#xD;
               -  Social frailty (lack of health insurance, homeless, accommodation by&#xD;
                  family/friends, post incarceration)&#xD;
&#xD;
               -  Migrants with a first arrival in France in the last 6 months&#xD;
&#xD;
               -  Women in postpartum period (3 months after delivery)&#xD;
&#xD;
               -  Psychiatric disease&#xD;
&#xD;
               -  Intravenous drug users, alcohol consumers (women &gt; 40g/day or &gt; 2 standard drinks&#xD;
                  /day; men &gt; 60g/day ou &gt; 3 standard drinks/day)&#xD;
&#xD;
        A standard glass is defined by a quantity of pure alcohol of 10 grams, corresponding to&#xD;
        approximately 10 cl of wine, 25 cl of beer at 5% vol, or 3 cl of alcohol at 40% vol.&#xD;
        (https://www.sfalcoologie.asso.fr/download/RBP2014-SFA-Mesusage-AA.pdf)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unwilling to participate.&#xD;
&#xD;
          -  Patients with HIV plasma viral load &lt; 50 cp/ml&#xD;
&#xD;
        https://cns.sante.fr/actualites/prise-en-charge-du-vih-recommandations-du-groupe-dexperts&#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>Sophie Seang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pitie Salpetriere Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yasmine Dudoit</last_name>
    <phone>33142164181</phone>
    <email>yasmine.dudoit@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sophie Seang, MD</last_name>
    <phone>33142164183</phone>
    <email>sophie.seang@aphp.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Yasmine Dudoit</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yasmine Dudoit</last_name>
      <phone>330142164181</phone>
      <email>yasmine.dudoit@aphp.fr</email>
    </contact>
    <contact_backup>
      <last_name>Sophie Seang, MD</last_name>
      <phone>33142164183</phone>
      <email>sophie.seang@aphp.fr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>May 11, 2023</last_update_submitted>
  <last_update_submitted_qc>May 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 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>HIV Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03799276
org study id: CREPATS 08
nct id: NCT03799276
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Antiretroviral therapy is currently the only way to control HIV disease progression in HIV
      infected subjects and to prevent transmission. However a sustained virological control
      through antiretroviral therapy is requested for these objectives. There is currently 8-10% of
      patients who failed therapy for many reasons other than virological resistance including
      social unstability, psychiatric disorders, migrant status, drug or alcohol addictions.
      Because many of these vulnerabilities can be managed and patients helped for following
      adequately cares and treatments, study team designed the OPTICARE Program to help reduce
      impact of the patients' vulnerabilities.

      The OPTICARE study is designed as a prospective implementation interventional study which
      aims to improve retention in care among vulnerable HIV infected patients over 48 weeks.

      The OPTICARE program is a support program dedicated to patients either lost to follow up or
      in highly fraility situation that will offer an individualized care management to fill their
      gaps towards optimized care and control of viral replication. Our aim is, in patients virally
      failing in relation with poor adherence to care and treatment to test first part whether
      tracking proactively lost to follow up patients or detecting frail individuals at risk of
      lost to care is effective and secondly to evaluate the efficacy, the feasibility and the
      acceptability of an intervention tailored to each individual to get them to treatment success
      with viral suppression. In our context, a randomized approach would not be seen as ethical or
      possible in an environment where investigators need to evaluate such intervention as a pilot
      approach. Investigators therefore enrolled patients in a cohort population study OPTICARE
      program aim to actively identify vulnerable HIV+ population and promote optimal access to
      health care to this population using retention in care program in order to enable long term
      HIV infection control.

      The primary objective is to assess the feasability and the effectiveness of the OPTICARE
      program. The OPTICARE program aims to propose an individualized care to vulnerable HIV
      infected patients (UNAIDS/Second 90% goal) and to drive them to treatment success
      (UNAIDS/Third 90% goal) within a one-year period.
The OPTICARE program is an individualized program proposed to vulnerable HIV infected
      patients according to a baseline evaluation of the clinical, social, psychological and
      cultural aspects.

      Once enrolled in the OPTICARE program, each patient will benefit of:

        -  A comprehensive and complete check up personal interview, through a daily visit, with a
           physician, an educational nurse, a social worker and a cultural mediator (if needed), in
           order to identify mains issues

        -  A specific follow up will be set up with obligatory visits at week 4, week 12, week 24,
           week 36 and week 48 to assess the evolution of the previously identified issues. If
           needed, additional visits will be set up.

        -  Regular (Day 15 and monthly) phone calls will be set up during the first six months of
           the OPTICARE program.

        -  Each patient will be accompanied by a tutoring nurse who will be in direct contact with
           the patient.

      Regarding the specific needs, each patient may benefit of:

        -  a personal assistance to complete administrative procedures (update health insurance,
           assistance to fill administrative papers, provide a budget for photo ID, transport
           tickets)

        -  a personalized medical follow up with regular phone calls, home visits (if the patient
           agrees), assistance in taking HIV medication (set up pillbox, therapeutic education)

        -  a close psychological and social support (connection with HIV organizations,
           participation to monthly support group)

        -  a specific assistance related to dependence issues (connection with addiction
           organization, sex therapist consultation)

      A multidisciplinary team (physician, educational nurse, psychotherapist, social worker and
      cultural mediator) will proactively assist the patient (home visits, recall) during a one
      year follow up.

      The program is initially proposed to the patient. In case of non-acceptance, the patient can
      further join the program after 3 months.

      Patients who do not accept the OPTICARE program will be followed up in standard of care
      according to French HIV management guidelines.
      (https://cns.sante.fr/actualites/prise-en-charge-du-vih-recommandations-du-groupe-dexperts/).
      All administratives and social procedures will be given to the social district.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Measure of plasma viral load to assess the effectiveness of the OPTICARE Program to attend HIV plasma viral load < 50 cp/ml at week 48
time frame: 12 months
description: Measure of plasma viral load assessed by RNA quantification using COBAS 6800 system (Roche)
arm group label: Opticare study
arm group type: Experimental
description: Phase I: Identification and Selection of study population The first step will include an active search by OPTICARE team for vulnerable and lost to follow up patients
Phase II: Implementation of the individualized follow-up program The patients who agree to participate to the program will be defined as the OPTICARE population.
intervention type: Other
intervention name: Opticare study
description: Each patient will be evaluated by
An HIV physician
A nurse
A social worker
A psychological therapist
A cultural mediator/member of patients community if needed for migrants
Following these interviews and visits, a multisciplinary team will define for each patient an individualized OPTICARE program based on the following items: clinical, psychological/psychiatric, social status and follow up visits will be planned with the patient.
Regular (Day 15 and monthly) phone calls will be set up during the first six months of the OPTICARE program, to assess the clinical status and ART adherence.
Patients will have their medical, biological and social status assessed through visits at W4, W12, W24, W36 (medical and social status only) and W 48 with all members of the OPTICARE team.
arm group label: Opticare study
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sophie Seang, MD
role: Principal Investigator
affiliation: Pitie Salpetriere Hospital
last name: Yasmine Dudoit
phone: 33142164181
email: yasmine.dudoit@aphp.fr
last name: Sophie Seang, MD
phone: 33142164183
email: sophie.seang@aphp.fr
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
responsible party type: Sponsor
mesh term: HIV Infections
sharing ipd: No