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/NCT05968573</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY-22-01162</org_study_id>
      <secondary_id>1R01DA055533-01</secondary_id>
      <nct_id>NCT05968573</nct_id>
    </id_info>
    <brief_title>Persuasive Health Communication Intervention for HIV/HCV</brief_title>
    <official_title>Evaluation of a Persuasive Health Communication Intervention Designed to Increase HIV/HCV Screening Among Emergency Departments Patients Who Currently, Formerly or Never Injected Drugs.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Icahn School of Medicine at Mount Sinai</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Drug Abuse (NIDA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Icahn School of Medicine at Mount Sinai</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        A major impediment to emergency department (ED)-based HIV/HCV screening success is that often&#xD;
        ED patients at risk for, or later diagnosed with, HIV and HCV decline testing. In this R01&#xD;
        project, the research team will assess how well a promising, easy-to-use, one-time,&#xD;
        minimal-training-needed, very brief persuasive health communication intervention (PHCI)&#xD;
        increases acceptance of testing among adult ED patients who either currently, formerly or&#xD;
        never injected drugs and initially declined HIV/HCV screening. The research team will conduct&#xD;
        a randomized, controlled trial (RCT) at two EDs within the Mount Sinai Health System to&#xD;
        compare the efficacy of the PHCI when delivered by a video vs. an HIV/HCV counselor. Patients&#xD;
        who initially declined HIV/HCV screening will be stratified by injection-drug use (IDU)&#xD;
        history cohorts: (1) current/former PWIDs, (2) never/non-PWIDs. Within each IDU history&#xD;
        cohort, the research team will randomly assign participants (1:1) to a PHCI delivered by: (1)&#xD;
        a video, or (2) an HIV/HCV counselor. This R01 project will be conducted at The Mount Sinai&#xD;
        Hospital and Mount Sinai Beth Israel Hospital EDs. For Aim 1, the research team will&#xD;
        determine which delivery form of the PHCI (video or HIV/HCV counselor) results in more ED&#xD;
        patients accepting HIV/HCV screening, independent of their history of IDU. For Aim 2, the&#xD;
        research team will determine if screening acceptance is similar across IDU history cohorts.&#xD;
        For Aim 3, the research team will further compare the two delivery forms of the PHCI through&#xD;
        a health economics assessment, both independent of IDU history and within each IDU history&#xD;
        cohort.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        As part of routine practice at The Mount Sinai Hospital and Mount Sinai Beth Israel Emergency&#xD;
        Departments, the ED Nurses initiate HIV/HCV screening for all patients able to provide&#xD;
        consent. ED patients eligible for recruitment into the RCT portion of the study are those who&#xD;
        declined HIV/HCV screening. RCs will review the EHRs of patients present in the ED during&#xD;
        data collection periods and determine which patients are potentially eligible.&#xD;
  &#xD;
        Participation in the RCT involves a one-time encounter. All research-related activities will&#xD;
        occur in the ED. As such, drop-out during this brief RCT (&lt;30 minutes from recruitment&#xD;
        through final study questionnaires) is expected to be minimal (&lt;5%). RCs will coordinate with&#xD;
        participants and ED staff to facilitate participant involvement while they are receiving&#xD;
        medical care. If necessary, participants can continue participating in designated areas of&#xD;
        the ED (e.g., waiting room, family room) after they are discharged and there are&#xD;
        study-related tasks remaining. There are no research related follow-ups needed.&#xD;
  &#xD;
        The research team will enroll a total of 2,000 adult ED patients who meet all study criteria&#xD;
        and agree to participate in the RCT, stratified by IDU history. Assuming 0.6 participants&#xD;
        completing the study/hour (1 study completion/75 minutes of recruitment, enrollment, and data&#xD;
        collection), the research team could recruit up to ≈5,184 participants (720 collection days x&#xD;
        12 hours/data collection/day x 0.6 participants/hour) over 3 years.&#xD;
  &#xD;
        The research team will be collecting data using the QDS™ (NOVA Research Company) program&#xD;
        installed on a tablet computer. The program has the ability to encrypt collected data, to&#xD;
        which only the researcher has ability to de-crypt data sets (NOVA Research cannot recover&#xD;
        lost passwords for the researcher). The program also has a data management system, allowing&#xD;
        data export for use in analytical packages like SPSS, Stata. Internet access is not necessary&#xD;
        for this program to function. The data can be stored on the tablet computer for the meantime,&#xD;
        then synced once internet is available.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 8, 2027</completion_date>
    <primary_completion_date type="Anticipated">December 8, 2027</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>
      <intervention_model_description>This study has two parts:&#xD;
  Part A: Modification of the PHCI with the assistance of current and former people who inject drugs (PWID) ED patients.&#xD;
  Part B: Randomized Controlled Trial - this will only be conducted after completion of Part A.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>Participants will be told during consent that they will be randomized and assigned to a group. Participants will be told that the two groups are to watch a video or listen to a health educator. Therefore, participants are not prevented from having knowledge of the interventions assigned to them.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Number of patients who accept HIV/HCV testing after watching the video</measure>
      <time_frame>Day 1, up to 5 minutes after intervention</time_frame>
      <description>The number of patients who accept HIV/HCV testing after watching the video</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of patients who accept HIV/HCV testing after speaking with a health educator</measure>
      <time_frame>Day 1, up to 5 minutes after intervention</time_frame>
      <description>The number of patients who accept HIV/HCV testing after speaking with a health educator.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The number of patients that accept HIV/HCV testing by no prior injection-drug use</measure>
      <time_frame>Day 1, up to 5 minutes after intervention</time_frame>
      <description>The number of patients that accept HIV/HCV testing by no prior injection-drug use</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The number of patients that accept HIV/HCV testing by former injection-drug use</measure>
      <time_frame>Day 1, up to 5 minutes after intervention</time_frame>
      <description>The number of patients that accept HIV/HCV testing by former injection-drug use</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The number of patients that accept HIV/HCV testing by current injection-drug use</measure>
      <time_frame>Day 1, up to 5 minutes after intervention</time_frame>
      <description>The number of patients that accept HIV/HCV testing by current injection-drug use</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health economics assessment of PHCI</measure>
      <time_frame>End of study, at 5 years</time_frame>
      <description>The research team will further compare the two delivery forms of the PHCI through a health economics assessment, both independent of IDU history and within each IDU history cohort. This will measure cost-benefit analysis in terms of cost of each intervention in relation to how effective it is on persuading real world populations to test for HIV and HCV.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">2000</enrollment>
    <condition>Human Immunodeficiency Virus (HIV)</condition>
    <condition>Hepatitis C (HCV)</condition>
    <arm_group>
      <arm_group_label>Persuasive Health Communication Intervention delivered in video format</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>A video created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Persuasive Health Communication Intervention delivered by Health Educator</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Healthcare provider educator getting patients screened for HIV/HCV.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Video Format</intervention_name>
      <description>A video created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening.</description>
      <arm_group_label>Persuasive Health Communication Intervention delivered in video format</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Health Educator</intervention_name>
      <description>The video created by the research will be compared to a healthcare provider in terms of effectiveness in getting patients screened for HIV/HCV.</description>
      <arm_group_label>Persuasive Health Communication Intervention delivered by Health Educator</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ≥18 years-old&#xD;
  &#xD;
            -  Speak English or Spanish, and able to provide informed consent for study participation&#xD;
  &#xD;
            -  Not HIV AND HCV infected/Antibody+ (per EHR review and patient report)&#xD;
  &#xD;
            -  Not already participating in a HIV or HCV study (e.g., HIV PrEP, HIV vaccine)&#xD;
  &#xD;
            -  Not tested for HIV OR HCV within the past 12 months (per EHR review and patient&#xD;
               report)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  &lt;18 years old&#xD;
  &#xD;
            -  Unable to speak Spanish or English&#xD;
  &#xD;
            -  HIV or HCV positive&#xD;
  &#xD;
            -  Currently enrolled in another HIV or HCV research study&#xD;
  &#xD;
            -  Has tested for HIV or HCV in the past 12 months&#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>Roland C Merchant, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Roland C Merchant, MD</last_name>
      <phone>(212) 524-9814</phone>
      <email>Roland.Merchant@mountsinai.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Icahn School of Medicine at Mount Sinai</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10128</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Roland C Merchant, MD</last_name>
        <phone>212-524-9814</phone>
        <email>Roland.Merchant@mountsinai.org</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 6, 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
      <investigator_full_name>Roland Merchant</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hepatitis C</mesh_term>
      <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
      <mesh_term>HIV Infections</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>All of the individual participant data collected during the trial, after deidentification.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>Specify Other Time FrameAfter last patient enrolled up to a year from that time point.</ipd_time_frame>
      <ipd_access_criteria>Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.&#xD;
  To achieve aims in the approved proposal. Specify Other Mechanism Secured excel file sent through email.</ipd_access_criteria>
    </patient_data>
    <!-- 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/NCT05968573
  org study id: STUDY-22-01162
  secondary id: 1R01DA055533-01
  nct id: NCT05968573
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  A major impediment to emergency department (ED)-based HIV/HCV screening success is that often
        ED patients at risk for, or later diagnosed with, HIV and HCV decline testing. In this R01
        project, the research team will assess how well a promising, easy-to-use, one-time,
        minimal-training-needed, very brief persuasive health communication intervention (PHCI)
        increases acceptance of testing among adult ED patients who either currently, formerly or
        never injected drugs and initially declined HIV/HCV screening. The research team will conduct
        a randomized, controlled trial (RCT) at two EDs within the Mount Sinai Health System to
        compare the efficacy of the PHCI when delivered by a video vs. an HIV/HCV counselor. Patients
        who initially declined HIV/HCV screening will be stratified by injection-drug use (IDU)
        history cohorts: (1) current/former PWIDs, (2) never/non-PWIDs. Within each IDU history
        cohort, the research team will randomly assign participants (1:1) to a PHCI delivered by: (1)
        a video, or (2) an HIV/HCV counselor. This R01 project will be conducted at The Mount Sinai
        Hospital and Mount Sinai Beth Israel Hospital EDs. For Aim 1, the research team will
        determine which delivery form of the PHCI (video or HIV/HCV counselor) results in more ED
        patients accepting HIV/HCV screening, independent of their history of IDU. For Aim 2, the
        research team will determine if screening acceptance is similar across IDU history cohorts.
        For Aim 3, the research team will further compare the two delivery forms of the PHCI through
        a health economics assessment, both independent of IDU history and within each IDU history
        cohort.
  As part of routine practice at The Mount Sinai Hospital and Mount Sinai Beth Israel Emergency
        Departments, the ED Nurses initiate HIV/HCV screening for all patients able to provide
        consent. ED patients eligible for recruitment into the RCT portion of the study are those who
        declined HIV/HCV screening. RCs will review the EHRs of patients present in the ED during
        data collection periods and determine which patients are potentially eligible.
  
        Participation in the RCT involves a one-time encounter. All research-related activities will
        occur in the ED. As such, drop-out during this brief RCT (<30 minutes from recruitment
        through final study questionnaires) is expected to be minimal (<5%). RCs will coordinate with
        participants and ED staff to facilitate participant involvement while they are receiving
        medical care. If necessary, participants can continue participating in designated areas of
        the ED (e.g., waiting room, family room) after they are discharged and there are
        study-related tasks remaining. There are no research related follow-ups needed.
  
        The research team will enroll a total of 2,000 adult ED patients who meet all study criteria
        and agree to participate in the RCT, stratified by IDU history. Assuming 0.6 participants
        completing the study/hour (1 study completion/75 minutes of recruitment, enrollment, and data
        collection), the research team could recruit up to ≈5,184 participants (720 collection days x
        12 hours/data collection/day x 0.6 participants/hour) over 3 years.
  
        The research team will be collecting data using the QDS™ (NOVA Research Company) program
        installed on a tablet computer. The program has the ability to encrypt collected data, to
        which only the researcher has ability to de-crypt data sets (NOVA Research cannot recover
        lost passwords for the researcher). The program also has a data management system, allowing
        data export for use in analytical packages like SPSS, Stata. Internet access is not necessary
        for this program to function. The data can be stored on the tablet computer for the meantime,
        then synced once internet is available.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This study has two parts:
  Part A: Modification of the PHCI with the assistance of current and former people who inject drugs (PWID) ED patients.
  Part B: Randomized Controlled Trial - this will only be conducted after completion of Part A.
  primary purpose: Health Services Research
  masking: None (Open Label)
  masking description: Participants will be told during consent that they will be randomized and assigned to a group. Participants will be told that the two groups are to watch a video or listen to a health educator. Therefore, participants are not prevented from having knowledge of the interventions assigned to them.
  measure: Number of patients who accept HIV/HCV testing after watching the video
  time frame: Day 1, up to 5 minutes after intervention
  description: The number of patients who accept HIV/HCV testing after watching the video
  measure: Number of patients who accept HIV/HCV testing after speaking with a health educator
  time frame: Day 1, up to 5 minutes after intervention
  description: The number of patients who accept HIV/HCV testing after speaking with a health educator.
  measure: The number of patients that accept HIV/HCV testing by no prior injection-drug use
  time frame: Day 1, up to 5 minutes after intervention
  description: The number of patients that accept HIV/HCV testing by no prior injection-drug use
  measure: The number of patients that accept HIV/HCV testing by former injection-drug use
  time frame: Day 1, up to 5 minutes after intervention
  description: The number of patients that accept HIV/HCV testing by former injection-drug use
  measure: The number of patients that accept HIV/HCV testing by current injection-drug use
  time frame: Day 1, up to 5 minutes after intervention
  description: The number of patients that accept HIV/HCV testing by current injection-drug use
  measure: Health economics assessment of PHCI
  time frame: End of study, at 5 years
  description: The research team will further compare the two delivery forms of the PHCI through a health economics assessment, both independent of IDU history and within each IDU history cohort. This will measure cost-benefit analysis in terms of cost of each intervention in relation to how effective it is on persuading real world populations to test for HIV and HCV.
  arm group label: Persuasive Health Communication Intervention delivered in video format
  arm group type: Active Comparator
  description: A video created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening.
  arm group label: Persuasive Health Communication Intervention delivered by Health Educator
  arm group type: Active Comparator
  description: Healthcare provider educator getting patients screened for HIV/HCV.
  intervention type: Other
  intervention name: Video Format
  description: A video created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening.
  arm group label: Persuasive Health Communication Intervention delivered in video format
  intervention type: Other
  intervention name: Health Educator
  description: The video created by the research will be compared to a healthcare provider in terms of effectiveness in getting patients screened for HIV/HCV.
  arm group label: Persuasive Health Communication Intervention delivered by Health Educator
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Roland C Merchant, MD
  role: Principal Investigator
  affiliation: Icahn School of Medicine at Mount Sinai
  last name: Roland C Merchant, MD
  phone: (212) 524-9814
  email: Roland.Merchant@mountsinai.org
  facility: 
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Icahn School of Medicine at Mount Sinai
  investigator full name: Roland Merchant
  investigator title: Professor
  mesh term: Hepatitis C
  mesh term: Acquired Immunodeficiency Syndrome
  mesh term: HIV Infections
  sharing ipd: Yes
  ipd description: All of the individual participant data collected during the trial, after deidentification.
  ipd info type: Study Protocol
  ipd time frame: Specify Other Time FrameAfter last patient enrolled up to a year from that time point.
  ipd access criteria: Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.
  To achieve aims in the approved proposal. Specify Other Mechanism Secured excel file sent through email.