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/NCT05991622</url>
    </required_header>
    <id_info>
      <org_study_id>1R34DA055498</org_study_id>
      <nct_id>NCT05991622</nct_id>
    </id_info>
    <brief_title>Combined Injectable Treatment for HIV and OUD</brief_title>
    <acronym>CHOICE</acronym>
    <official_title>Integrating Long-Acting Injectable Treatment to Improve Medication Adherence Among Persons Living With HIV and Opioid Use Disorder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rhode Island Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Rhode Island Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a one-year study that seeks to evaluate perspectives of combined injectable treatment&#xD;
        for HIV and OUD. Specifically, with the development of new long-acting medications such as&#xD;
        cabotegravir co-administered with rilpivirine (CAB/RPV) and extended-release buprenorphine&#xD;
        (XR-B) there is a need to better understand factors that influence the delivery and uptake of&#xD;
        this type of treatment. Therefore, this study will conduct qualitative (1:1) interviews with&#xD;
        32-45 key stakeholders to assess interest, knowledge, attitudes, barriers, and facilitators&#xD;
        to integrated injectable treatment. Our team will utilize qualitative findings to inform&#xD;
        clinical strategies to promote uptake and maintenance of long-acting injectable medications&#xD;
        for HIV and OUD.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Treatment services for HIV and OUD have historically been delivered across multiple settings&#xD;
        leading to fragmented and uncoordinated care. Models of behavior change suggest that&#xD;
        addressing multiple health conditions simultaneously through integrated, evidence-based,&#xD;
        interventions has the potential to overcome traditional barriers to optimize engagement and&#xD;
        improve clinical outcomes. Consistent with this perspective, numerous studies have documented&#xD;
        that receipt of opioid agonist treatment, in the context of HIV care, is associated with ART&#xD;
        adherence and decreased HIV viral loads. Recent pharmacological advancements have led to the&#xD;
        development of novel long-acting, injectable, medications for HIV [cabotegravir&#xD;
        co-administered with rilpivirine (CAB/RPV)] and OUD (extended-release buprenorphine). These&#xD;
        therapies have the potential to dramatically improve adherence, lead to better control of&#xD;
        both diseases, and reduce mortality rates for this vulnerable population. However, currently,&#xD;
        little is known about 1) the perceived acceptability/feasibility of combining HIV and OUD&#xD;
        treatment into a single point of care; and 2) how best to deliver integrated, monthly&#xD;
        injectable, treatment for HIV and OUD to facilitate future implementation. The long-term goal&#xD;
        of this line of research is to disseminate an efficacious, integrated, injectable treatment&#xD;
        program for HIV and OUD. The objective of this application is to develop, through formative&#xD;
        evaluation, clinical strategies that promote best practices for combined HIV and OUD care&#xD;
        using long-acting injectable therapies. In-depth, individual, interviews will be conducted&#xD;
        with patients with a history of HIV and OUD as well as clinical content experts to assess&#xD;
        interest, knowledge, attitudes, barriers, and facilitators to uptake of integrated injectable&#xD;
        treatment. The investigators expect that, as a result of this project, the investigators will&#xD;
        have developed a clinical protocol, with high degrees of feasibility and acceptability, to&#xD;
        promote uptake of long-acting injectable medications for HIV and OUD. This work will serve as&#xD;
        the foundation for a future NIH Hybrid Type 1 Effectiveness-Implementation study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 1, 2022</start_date>
    <completion_date type="Anticipated">October 2024</completion_date>
    <primary_completion_date type="Anticipated">April 2024</primary_completion_date>
    <phase>Early Phase 1</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Recruitment rates</measure>
      <time_frame>6 months</time_frame>
      <description>percent of patients interested in the treatment, patient eligibility rate, consent rate, rate of recruitment, percent of participants who initiate injectables, follow-up completion rate (through 6 months), and reasons for refusal</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability</measure>
      <time_frame>6 months</time_frame>
      <description>study dropout rate (those who were lost to follow-up) and rate of discontinuation of injectables (those who decided to transition back to oral/sublingual regimen) as indices of</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility/Acceptability</measure>
      <time_frame>6 months</time_frame>
      <description>Client Satisfaction Questionnaire-Revised: assess consumer satisfaction with health and human services including governmental and public benefit programs and services</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Self-report of engagement in treatment</measure>
      <time_frame>6 months</time_frame>
      <description>Treatment Effectiveness Assessment : elicits patient responses that help the patient and the clinician quickly gauge patient progress in treatment and in recovery, according to the patients' sense of what is important within four domains -- substance use, health, lifestyle, community,</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility/Acceptability</measure>
      <time_frame>6 months</time_frame>
      <description>Qualitative interviews to explore the acceptability and feasibility of the intervention format (e.g. processes and procedures, access to support services, tolerability of medication) and how the intervention could be strengthened, identifying areas needing refinement or improvement for future iterations.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Substance use</measure>
      <time_frame>6 months</time_frame>
      <description>National Epidemiologic Survey on Alcohol and Related Conditions (NESARC)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Substance use</measure>
      <time_frame>6 months</time_frame>
      <description>NIDA-modified ASSIST - tool to identify risky substance use</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Substance use</measure>
      <time_frame>6 months</time_frame>
      <description>urine drug screens from the individual's electronic medical record</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>HIV Risk Behavior</measure>
      <time_frame>6 months</time_frame>
      <description>Texas Christian University (TCU) HIV/AIDS Risk Assessment: a measure of overall sex and drug risk behavior</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment services</measure>
      <time_frame>6 months</time_frame>
      <description>Treatment Services Review will be used to assess receipt of case management, psychiatric, peer recovery coaching, and other treatment services, including utilization of other medications for OUD (e.g., if a participant has transitioned to Methadone).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Quality of life</measure>
      <time_frame>6 months</time_frame>
      <description>Q-LES-Q-SF, a psychometrically sound shorter version of the original Q-LES-Q. It consists of a self-reported 16-item questionnaire that has shown internal consistency, rest-retest reliability, and convergent and criterion validity (80% sensitivity, 100% specificity)</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Human Immunodeficiency Virus</condition>
    <condition>Opioid Use Disorder</condition>
    <arm_group>
      <arm_group_label>Preliminary Test of Combined LAI Treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The combined injectable treatment includes a dual-administration of rilpivirine (CAB/RPV) &quot;cabenuva&quot; for HIV and extended-release buprenorphine (XR-B) &quot;sublocade&quot; for OUD.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Combined LAI Treatment: Cabenuva and Sublocade</intervention_name>
      <description>A preliminary test of the combined LAI treatment will be conducted with a total of 40 individuals diagnosed with HIV and OUD that meet all other study inclusion criteria. Treatment will take place primarily at TMH IC (n=30), however, about one-quarter of participants will undergo the pilot test at the RIDOC (n=10). Participants will complete a baseline interview, receive the combined LAI treatment (described below), and complete follow-up assessments at 1-, 3-, and 6-months following initiation of injectable medication. Of the 40 participants, 25 will be purposefully selected to engage in qualitative interviews to assess the strengths and limitations of the clinical protocol and combined treatment as well as describe their reasons for LAI uptake or discontinuation. We will also elicit feedback from clinic staff and other key stakeholders regarding the delivery of the clinical protocol and other implementation factors</description>
      <arm_group_label>Preliminary Test of Combined LAI Treatment</arm_group_label>
      <other_name>rilpivirine (CAB/RPV) &quot;cabenuva&quot;</other_name>
      <other_name>extended-release buprenorphine (XR-B) &quot;sublocade&quot;</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18-65 years of age&#xD;
  &#xD;
            -  HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or&#xD;
               chemiluminescence immunoassay&#xD;
  &#xD;
            -  Current diagnosis of OUD according to DSM-5&#xD;
  &#xD;
            -  Able to understand and speak English and to provide written and verbal informed&#xD;
               consent&#xD;
  &#xD;
            -  Participants recruited through RIDOC will have an additional requirement of&#xD;
               anticipated release from jail/prison within 6 months.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Currently pregnant, breastfeeding, planning to become pregnant or breastfeed during&#xD;
               the study period&#xD;
  &#xD;
            -  Coinfection of Hepatitis B or plans to get treated for Hepatitis C during the study&#xD;
               period&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kirsten K Langdon, Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Rhode Island Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kirsten K Langdon, Ph.D.</last_name>
      <phone>401-606-4198</phone>
      <email>kirsten.langdon@lifespan.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Kirsten J Langdon, Ph.D.</last_name>
      <phone>401-606-4198</phone>
      <email>kirsten.langdon@lifespan.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Rhode Island Hospital</name>
        <address>
          <city>Providence</city>
          <state>Rhode Island</state>
          <zip>02903</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kirsten Langdon</last_name>
        <phone>401-606-4198</phone>
        <email>kirsten.langdon@lifespan.org</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Rhode Island Hospital</investigator_affiliation>
      <investigator_full_name>Kirsten J Langdon</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <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>Opioid-Related Disorders</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Rilpivirine</mesh_term>
      <mesh_term>Cabotegravir, rilpivirine drug combination</mesh_term>
      <mesh_term>Buprenorphine</mesh_term>
    </intervention_browse>
    <provided_document_section>
      <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 20, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT05991622/ICF_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT05991622
  org study id: 1R34DA055498
  nct id: NCT05991622
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  This is a one-year study that seeks to evaluate perspectives of combined injectable treatment
        for HIV and OUD. Specifically, with the development of new long-acting medications such as
        cabotegravir co-administered with rilpivirine (CAB/RPV) and extended-release buprenorphine
        (XR-B) there is a need to better understand factors that influence the delivery and uptake of
        this type of treatment. Therefore, this study will conduct qualitative (1:1) interviews with
        32-45 key stakeholders to assess interest, knowledge, attitudes, barriers, and facilitators
        to integrated injectable treatment. Our team will utilize qualitative findings to inform
        clinical strategies to promote uptake and maintenance of long-acting injectable medications
        for HIV and OUD.
  Treatment services for HIV and OUD have historically been delivered across multiple settings
        leading to fragmented and uncoordinated care. Models of behavior change suggest that
        addressing multiple health conditions simultaneously through integrated, evidence-based,
        interventions has the potential to overcome traditional barriers to optimize engagement and
        improve clinical outcomes. Consistent with this perspective, numerous studies have documented
        that receipt of opioid agonist treatment, in the context of HIV care, is associated with ART
        adherence and decreased HIV viral loads. Recent pharmacological advancements have led to the
        development of novel long-acting, injectable, medications for HIV [cabotegravir
        co-administered with rilpivirine (CAB/RPV)] and OUD (extended-release buprenorphine). These
        therapies have the potential to dramatically improve adherence, lead to better control of
        both diseases, and reduce mortality rates for this vulnerable population. However, currently,
        little is known about 1) the perceived acceptability/feasibility of combining HIV and OUD
        treatment into a single point of care; and 2) how best to deliver integrated, monthly
        injectable, treatment for HIV and OUD to facilitate future implementation. The long-term goal
        of this line of research is to disseminate an efficacious, integrated, injectable treatment
        program for HIV and OUD. The objective of this application is to develop, through formative
        evaluation, clinical strategies that promote best practices for combined HIV and OUD care
        using long-acting injectable therapies. In-depth, individual, interviews will be conducted
        with patients with a history of HIV and OUD as well as clinical content experts to assess
        interest, knowledge, attitudes, barriers, and facilitators to uptake of integrated injectable
        treatment. The investigators expect that, as a result of this project, the investigators will
        have developed a clinical protocol, with high degrees of feasibility and acceptability, to
        promote uptake of long-acting injectable medications for HIV and OUD. This work will serve as
        the foundation for a future NIH Hybrid Type 1 Effectiveness-Implementation study.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Recruitment rates
  time frame: 6 months
  description: percent of patients interested in the treatment, patient eligibility rate, consent rate, rate of recruitment, percent of participants who initiate injectables, follow-up completion rate (through 6 months), and reasons for refusal
  measure: Acceptability
  time frame: 6 months
  description: study dropout rate (those who were lost to follow-up) and rate of discontinuation of injectables (those who decided to transition back to oral/sublingual regimen) as indices of
  measure: Feasibility/Acceptability
  time frame: 6 months
  description: Client Satisfaction Questionnaire-Revised: assess consumer satisfaction with health and human services including governmental and public benefit programs and services
  measure: Self-report of engagement in treatment
  time frame: 6 months
  description: Treatment Effectiveness Assessment : elicits patient responses that help the patient and the clinician quickly gauge patient progress in treatment and in recovery, according to the patients' sense of what is important within four domains -- substance use, health, lifestyle, community,
  measure: Feasibility/Acceptability
  time frame: 6 months
  description: Qualitative interviews to explore the acceptability and feasibility of the intervention format (e.g. processes and procedures, access to support services, tolerability of medication) and how the intervention could be strengthened, identifying areas needing refinement or improvement for future iterations.
  measure: Substance use
  time frame: 6 months
  description: National Epidemiologic Survey on Alcohol and Related Conditions (NESARC)
  measure: Substance use
  time frame: 6 months
  description: NIDA-modified ASSIST - tool to identify risky substance use
  measure: Substance use
  time frame: 6 months
  description: urine drug screens from the individual's electronic medical record
  measure: HIV Risk Behavior
  time frame: 6 months
  description: Texas Christian University (TCU) HIV/AIDS Risk Assessment: a measure of overall sex and drug risk behavior
  measure: Treatment services
  time frame: 6 months
  description: Treatment Services Review will be used to assess receipt of case management, psychiatric, peer recovery coaching, and other treatment services, including utilization of other medications for OUD (e.g., if a participant has transitioned to Methadone).
  measure: Overall Quality of life
  time frame: 6 months
  description: Q-LES-Q-SF, a psychometrically sound shorter version of the original Q-LES-Q. It consists of a self-reported 16-item questionnaire that has shown internal consistency, rest-retest reliability, and convergent and criterion validity (80% sensitivity, 100% specificity)
  arm group label: Preliminary Test of Combined LAI Treatment
  arm group type: Experimental
  description: The combined injectable treatment includes a dual-administration of rilpivirine (CAB/RPV) "cabenuva" for HIV and extended-release buprenorphine (XR-B) "sublocade" for OUD.
  intervention type: Drug
  intervention name: Combined LAI Treatment: Cabenuva and Sublocade
  description: A preliminary test of the combined LAI treatment will be conducted with a total of 40 individuals diagnosed with HIV and OUD that meet all other study inclusion criteria. Treatment will take place primarily at TMH IC (n=30), however, about one-quarter of participants will undergo the pilot test at the RIDOC (n=10). Participants will complete a baseline interview, receive the combined LAI treatment (described below), and complete follow-up assessments at 1-, 3-, and 6-months following initiation of injectable medication. Of the 40 participants, 25 will be purposefully selected to engage in qualitative interviews to assess the strengths and limitations of the clinical protocol and combined treatment as well as describe their reasons for LAI uptake or discontinuation. We will also elicit feedback from clinic staff and other key stakeholders regarding the delivery of the clinical protocol and other implementation factors
  arm group label: Preliminary Test of Combined LAI Treatment
  other name: rilpivirine (CAB/RPV) "cabenuva"
  other name: extended-release buprenorphine (XR-B) "sublocade"
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Kirsten K Langdon, Ph.D.
  role: Principal Investigator
  affiliation: Rhode Island Hospital
  last name: Kirsten K Langdon, Ph.D.
  phone: 401-606-4198
  email: kirsten.langdon@lifespan.org
  last name: Kirsten J Langdon, Ph.D.
  phone: 401-606-4198
  email: kirsten.langdon@lifespan.org
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Rhode Island Hospital
  investigator full name: Kirsten J Langdon
  investigator title: Principal Investigator
  mesh term: Acquired Immunodeficiency Syndrome
  mesh term: HIV Infections
  mesh term: Opioid-Related Disorders
  mesh term: Rilpivirine
  mesh term: Cabotegravir, rilpivirine drug combination
  mesh term: Buprenorphine
  provided document: 