<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/NCT04481373</url>
  </required_header>
  <id_info>
    <org_study_id>H-47444</org_study_id>
    <nct_id>NCT04481373</nct_id>
  </id_info>
  <brief_title>Targeting HIV Retention and Improved Viral Load Through Engagement ('THRIVE')</brief_title>
  <official_title>Targeting HIV Retention and Improved Viral Load Through Engagement ('THRIVE')</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Iowa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brown University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Texas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Baylor College of Medicine</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>
      Many people with HIV infection are not consistently engaged in outpatient HIV care, and&#xD;
      avoidance, stigma and denial contribute to poor engagement in HIV care. This project will&#xD;
      develop and pilot test a new intervention, &quot;THRIVE,&quot; for hospitalized persons who are out of&#xD;
      HIV care and endorse avoidance, to improve how well they stay in outpatient HIV care after&#xD;
      discharge. If successfully developed, the intervention will undergo large scale testing in&#xD;
      later studies and could improve the health of persons with HIV infection and help end the HIV&#xD;
      epidemic in the United States.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Poor retention in HIV primary care results in lower rates of HIV viral suppression, higher&#xD;
      rates of HIV transmission, and exacerbates racial and ethnic disparities in health outcomes,&#xD;
      including survival. To date, there are no interventions that effectively relink and retain&#xD;
      PWH in care when they are found outside the HIV clinic. Many persons with HIV infection (PWH)&#xD;
      are hospitalized with life-threatening but preventable complications of inadequately treated&#xD;
      HIV infection. They are among the most important patients to retain in care. Our previous&#xD;
      research shows that among PWH who are out of care and hospitalized, avoidance coping, stigma,&#xD;
      and mental health difficulties were nearly universal. Further, avoidance coping was a&#xD;
      predictor of failure to re-engage in care after discharge. Acceptance and Commitment Therapy&#xD;
      (ACT) is a transdiagnostic intervention with the capacity to address a range of psychosocial&#xD;
      and behavior-related issues that PWH experience. ACT helps patients overcome avoidance,&#xD;
      particularly avoidance of uncomfortable internal states and the situations that trigger such&#xD;
      states, by promoting acceptance-based coping and re-engagement in meaningful and valued-life&#xD;
      activities. Brief ACT interventions appear to be feasible, acceptable, and at least&#xD;
      preliminarily, have efficacy. The investigators propose to develop, refine, and pilot a brief&#xD;
      (4-5 contact hours) ACT intervention for hospitalized, out-of-care PWH. 'Targeting HIV&#xD;
      Retention and Improved Viral load through Engagement' ('THRIVE') will aim to help patients&#xD;
      overcome avoidance, a maladaptive coping strategy implicated in a range of problems,&#xD;
      including depression, anxiety, substance abuse, and HIV-related self-stigma, all of which&#xD;
      constitute barriers to care. Delivering THRIVE in the hospital with a phone booster session&#xD;
      after discharge will increase therapy initiation and completion, the lack of which is often&#xD;
      the greatest obstacle to effective delivery of mental health services for PWH. In Aim 1, a&#xD;
      brief hospital-based transdiagnostic, individually delivered ACT intervention (THRIVE)&#xD;
      tailored specifically for out-of-care hospitalized PWH will be developed. Input from a&#xD;
      multi-disciplinary team of expert care providers and PHW will be utilized to create the&#xD;
      therapist protocol and patient workbook. The investigators will then pilot THRIVE in 10&#xD;
      hospitalized out-of-care PWH who will provide qualitative feedback on the intervention. The&#xD;
      feedback, along with input from patients and the multi-disciplinary team, will be used to&#xD;
      refine THRIVE. In Aim 2, the investigators will conduct a pilot randomized clinical trial&#xD;
      (RCT) of the refined THRIVE intervention (N=35) compared to treatment as usual (N=35). This&#xD;
      pilot RCT will 1) evaluate feasibility and acceptability for a full-scale RCT; and 2) examine&#xD;
      trends in outcomes of interest for the definitive RCT. The investigators will then be&#xD;
      positioned to submit a separate grant to test the efficacy of THRIVE in a fully powered&#xD;
      randomized trial. This work has the potential to decrease HIV morbidity and racial/ethnic&#xD;
      disparities and contribute to ending the HIV epidemic in the United States, which are NIH&#xD;
      priorities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 3, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptability of enrollment and randomization</measure>
    <time_frame>6 months</time_frame>
    <description>The number of eligible PWH who agree and decline to participate, and reasons for declining;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability of enrollment and randomization</measure>
    <time_frame>6 months</time_frame>
    <description>The number of PWH who are not eligible to participate and the reasons for lack of eligibility.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability of the intervention</measure>
    <time_frame>6 months</time_frame>
    <description>Intervention completion rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability of the intervention</measure>
    <time_frame>6 months</time_frame>
    <description>Retention of participants in follow-up assessments</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability of the intervention</measure>
    <time_frame>6 months</time_frame>
    <description>Duration of contacts</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Viral Load Improvement</measure>
    <time_frame>6 months</time_frame>
    <description>Change in Viral Load</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients who are retained in HIV Care</measure>
    <time_frame>6 months</time_frame>
    <description>Number of patients who complete at least 2 visits with an HIV clinician within 6 months</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Internalized AIDS-Related Stigma Scale (IARSS)</measure>
    <time_frame>6 months</time_frame>
    <description>This is a 6-item measure examines internalized stigma. Response scores range from 0 (low stigma)-6 (high stigma) with higher scores representing higher levels of stigma.</description>
  </other_outcome>
  <other_outcome>
    <measure>Depression Anxiety and Stress Scale (DASS-21).</measure>
    <time_frame>6 months</time_frame>
    <description>This is a 21-item measure. The total score ranges from 0-120 with higher scores reflecting higher levels of distress including depression, anxiety, and stress.</description>
  </other_outcome>
  <other_outcome>
    <measure>Alcohol Use Disorders Identification Test (AUDIT)</measure>
    <time_frame>6 months</time_frame>
    <description>This 3-item screener that identifies problem alcohol use for both men and women. Participants respond on a 5-point scale. Higher numbers represent more difficulty.</description>
  </other_outcome>
  <other_outcome>
    <measure>The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)</measure>
    <time_frame>6 months</time_frame>
    <description>This measure asks about substance use of 7 categories of drugs in the previous 3 months and in a person's life time. Participants respond YES or NO to each category of drugs.</description>
  </other_outcome>
  <other_outcome>
    <measure>Coping with HIV/AIDS scale</measure>
    <time_frame>6 months</time_frame>
    <description>This is a 16 item measure that examines positive coping, avoidant coping, and social support. Items are scores from 1-3 with higher scores reflecting greater positive coping, greater avoidant coping, and greater social support.</description>
  </other_outcome>
  <other_outcome>
    <measure>Client Satisfaction Questionnaire (CSQ)</measure>
    <time_frame>6 months</time_frame>
    <description>This 8-item measure assesses patient satisfaction with services. Scores range from 8-32 with higher scores representing greater satisfaction.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Human Immunodeficiency Virus</condition>
  <condition>Depression</condition>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>THRIVE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acceptance and Commitment Therapy plus Education about HIV A master's level mental health professional will provide the 4-5 hour intervention for out-of-care PWH during a hospitalization. There are two important components to the intervention: Acceptance and Commitment Therapy (ACT) content, targeting avoidance with acceptance-based coping and active engagement in values-based living, and HIV education.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as Usual</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients get usual care at the hospital. Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>THRIVE</intervention_name>
    <description>The ACT components (3-3.5 hours) will focus on clarifying patient values and goals and identifying obstacles that may be getting in the way of living a rich life. Short-and long-term effects of avoidance will be discussed (e.g., avoidance reduces immediate contact with distressing experiences and provides short-term relief but leads to greater dysfunction in long run). Patients will be taught acceptance, mindfulness, and perspective taking to help patient cope with difficult emotions and thoughts that may interfere with living a values-driven life. Individuals will also be encouraged to examine the costs of stigmatization on their life (e.g. avoidance of medical care, sense of isolation).&#xD;
Education will include medical information about HIV, services available at the clinic, and health needs related to comorbidities. This content to be delivered in 30 minutes.</description>
    <arm_group_label>THRIVE</arm_group_label>
    <other_name>Acceptance and Commitment Therapy plus Education</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment as Usual</intervention_name>
    <description>Patients get usual care at the hospital. Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care.</description>
    <arm_group_label>Treatment as Usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospitalized at Ben Taub Hospital, Houston, TX;&#xD;
&#xD;
          -  at least 18 years of age;&#xD;
&#xD;
          -  able to speak English or Spanish;&#xD;
&#xD;
          -  HIV infected;&#xD;
&#xD;
          -  able to provide informed consent and participate in the study (patients who are&#xD;
             temporarily unable to participate will be followed and approached for enrollment if&#xD;
             and when they are cognitively and physically capable of consenting and participating);&#xD;
&#xD;
          -  HIV VL&gt;1000 c/mL;&#xD;
&#xD;
          -  never in care or currently out of HIV care, defined as not meeting the 'visit&#xD;
             constancy' measure (≥1 completed HIV primary care visit at Thomas Street Health Center&#xD;
             (TSHC), Houston, TX, in each of the three 4-month intervals preceding admission); or&#xD;
             ≥2 &quot;no shows&quot; to HIV primary care visits at TSHC in the last year.&#xD;
&#xD;
          -  endorse one of two avoidance coping statements with the highest factor loadings on the&#xD;
             Avoidant Coping Subscale from the Coping with HIV/AIDS scale&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  intending to use a source of HIV primary care other than TSHC after discharge, because&#xD;
             their outcomes cannot be evaluated;&#xD;
&#xD;
          -  in the opinion of the primary medical team caring for the patient, likely to be&#xD;
             discharged to an institutional setting, die in the hospital or enter hospice;&#xD;
&#xD;
          -  incarcerated or expected to be discharged to prison or jail;&#xD;
&#xD;
          -  enrolled in another research study with prospective follow-up;&#xD;
&#xD;
          -  pregnant, since pregnant women receive additional efforts to be linked and retained in&#xD;
             care;&#xD;
&#xD;
          -  admitted with acute psychosis which would preclude informed consent or meaningful&#xD;
             participation with the intervention.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ben Taub Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 17, 2023</last_update_submitted>
  <last_update_submitted_qc>July 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Thomas Giordano</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Acceptance and Commitment Therapy</keyword>
  <keyword>HIV</keyword>
  <keyword>depression</keyword>
  <keyword>anxiety</keyword>
  <keyword>distress</keyword>
  <keyword>avoidance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <!-- 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/NCT04481373
org study id: H-47444
nct id: NCT04481373
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Many people with HIV infection are not consistently engaged in outpatient HIV care, and
      avoidance, stigma and denial contribute to poor engagement in HIV care. This project will
      develop and pilot test a new intervention, "THRIVE," for hospitalized persons who are out of
      HIV care and endorse avoidance, to improve how well they stay in outpatient HIV care after
      discharge. If successfully developed, the intervention will undergo large scale testing in
      later studies and could improve the health of persons with HIV infection and help end the HIV
      epidemic in the United States.
Poor retention in HIV primary care results in lower rates of HIV viral suppression, higher
      rates of HIV transmission, and exacerbates racial and ethnic disparities in health outcomes,
      including survival. To date, there are no interventions that effectively relink and retain
      PWH in care when they are found outside the HIV clinic. Many persons with HIV infection (PWH)
      are hospitalized with life-threatening but preventable complications of inadequately treated
      HIV infection. They are among the most important patients to retain in care. Our previous
      research shows that among PWH who are out of care and hospitalized, avoidance coping, stigma,
      and mental health difficulties were nearly universal. Further, avoidance coping was a
      predictor of failure to re-engage in care after discharge. Acceptance and Commitment Therapy
      (ACT) is a transdiagnostic intervention with the capacity to address a range of psychosocial
      and behavior-related issues that PWH experience. ACT helps patients overcome avoidance,
      particularly avoidance of uncomfortable internal states and the situations that trigger such
      states, by promoting acceptance-based coping and re-engagement in meaningful and valued-life
      activities. Brief ACT interventions appear to be feasible, acceptable, and at least
      preliminarily, have efficacy. The investigators propose to develop, refine, and pilot a brief
      (4-5 contact hours) ACT intervention for hospitalized, out-of-care PWH. 'Targeting HIV
      Retention and Improved Viral load through Engagement' ('THRIVE') will aim to help patients
      overcome avoidance, a maladaptive coping strategy implicated in a range of problems,
      including depression, anxiety, substance abuse, and HIV-related self-stigma, all of which
      constitute barriers to care. Delivering THRIVE in the hospital with a phone booster session
      after discharge will increase therapy initiation and completion, the lack of which is often
      the greatest obstacle to effective delivery of mental health services for PWH. In Aim 1, a
      brief hospital-based transdiagnostic, individually delivered ACT intervention (THRIVE)
      tailored specifically for out-of-care hospitalized PWH will be developed. Input from a
      multi-disciplinary team of expert care providers and PHW will be utilized to create the
      therapist protocol and patient workbook. The investigators will then pilot THRIVE in 10
      hospitalized out-of-care PWH who will provide qualitative feedback on the intervention. The
      feedback, along with input from patients and the multi-disciplinary team, will be used to
      refine THRIVE. In Aim 2, the investigators will conduct a pilot randomized clinical trial
      (RCT) of the refined THRIVE intervention (N=35) compared to treatment as usual (N=35). This
      pilot RCT will 1) evaluate feasibility and acceptability for a full-scale RCT; and 2) examine
      trends in outcomes of interest for the definitive RCT. The investigators will then be
      positioned to submit a separate grant to test the efficacy of THRIVE in a fully powered
      randomized trial. This work has the potential to decrease HIV morbidity and racial/ethnic
      disparities and contribute to ending the HIV epidemic in the United States, which are NIH
      priorities.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Acceptability of enrollment and randomization
time frame: 6 months
description: The number of eligible PWH who agree and decline to participate, and reasons for declining;
measure: Acceptability of enrollment and randomization
time frame: 6 months
description: The number of PWH who are not eligible to participate and the reasons for lack of eligibility.
measure: Acceptability of the intervention
time frame: 6 months
description: Intervention completion rate
measure: Acceptability of the intervention
time frame: 6 months
description: Retention of participants in follow-up assessments
measure: Acceptability of the intervention
time frame: 6 months
description: Duration of contacts
measure: Viral Load Improvement
time frame: 6 months
description: Change in Viral Load
measure: Number of patients who are retained in HIV Care
time frame: 6 months
description: Number of patients who complete at least 2 visits with an HIV clinician within 6 months
measure: Internalized AIDS-Related Stigma Scale (IARSS)
time frame: 6 months
description: This is a 6-item measure examines internalized stigma. Response scores range from 0 (low stigma)-6 (high stigma) with higher scores representing higher levels of stigma.
measure: Depression Anxiety and Stress Scale (DASS-21).
time frame: 6 months
description: This is a 21-item measure. The total score ranges from 0-120 with higher scores reflecting higher levels of distress including depression, anxiety, and stress.
measure: Alcohol Use Disorders Identification Test (AUDIT)
time frame: 6 months
description: This 3-item screener that identifies problem alcohol use for both men and women. Participants respond on a 5-point scale. Higher numbers represent more difficulty.
measure: The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
time frame: 6 months
description: This measure asks about substance use of 7 categories of drugs in the previous 3 months and in a person's life time. Participants respond YES or NO to each category of drugs.
measure: Coping with HIV/AIDS scale
time frame: 6 months
description: This is a 16 item measure that examines positive coping, avoidant coping, and social support. Items are scores from 1-3 with higher scores reflecting greater positive coping, greater avoidant coping, and greater social support.
measure: Client Satisfaction Questionnaire (CSQ)
time frame: 6 months
description: This 8-item measure assesses patient satisfaction with services. Scores range from 8-32 with higher scores representing greater satisfaction.
arm group label: THRIVE
arm group type: Experimental
description: Acceptance and Commitment Therapy plus Education about HIV A master's level mental health professional will provide the 4-5 hour intervention for out-of-care PWH during a hospitalization. There are two important components to the intervention: Acceptance and Commitment Therapy (ACT) content, targeting avoidance with acceptance-based coping and active engagement in values-based living, and HIV education.
arm group label: Treatment as Usual
arm group type: Other
description: Patients get usual care at the hospital. Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care.
intervention type: Behavioral
intervention name: THRIVE
description: The ACT components (3-3.5 hours) will focus on clarifying patient values and goals and identifying obstacles that may be getting in the way of living a rich life. Short-and long-term effects of avoidance will be discussed (e.g., avoidance reduces immediate contact with distressing experiences and provides short-term relief but leads to greater dysfunction in long run). Patients will be taught acceptance, mindfulness, and perspective taking to help patient cope with difficult emotions and thoughts that may interfere with living a values-driven life. Individuals will also be encouraged to examine the costs of stigmatization on their life (e.g. avoidance of medical care, sense of isolation).
Education will include medical information about HIV, services available at the clinic, and health needs related to comorbidities. This content to be delivered in 30 minutes.
arm group label: THRIVE
other name: Acceptance and Commitment Therapy plus Education
intervention type: Other
intervention name: Treatment as Usual
description: Patients get usual care at the hospital. Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care.
arm group label: Treatment as Usual
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Thomas Giordano
investigator title: Professor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: Depression