<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/NCT03252483</url>
  </required_header>
  <id_info>
    <org_study_id>2012-491</org_study_id>
    <nct_id>NCT03252483</nct_id>
  </id_info>
  <brief_title>Integrating HIV and Hepatitis C Screening in an Urban Emergency Department</brief_title>
  <official_title>A Randomized Controlled Trial to Evaluate Feasibility of Bundled HCV/HIV Rapid Screening</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>New York City Health and Hospitals Corporation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>New York City Health and Hospitals Corporation</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized controlled trial was implemented to evaluate the effect of integrating rapid&#xD;
      Hepatitis C (HCV) testing into a pre-existing screening program for Human Immunodeficiency&#xD;
      Virus (HIV) on HIV test acceptance and diagnosis of both HCV and HIV. A sample of 478 adults&#xD;
      in a New York City Emergency Department participated in the study. Participants were&#xD;
      randomized to receive either an offer of bundled HIV/HCV testing or HIV testing alone. Public&#xD;
      Health Advocates approached eligible patients in the Emergency Department, performed HIV and&#xD;
      HCV raid testing, and delivered test results to participants with post-test counseling. The&#xD;
      primary outcome, HIV test acceptance, was compared between the two groups to evaluate whether&#xD;
      the addition of an HCV test adversely impacted participants' consent to test for HIV.&#xD;
      Questionnaires were also distributed to participants to assess HCV knowledge.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The high prevalence of HIV and HCV co-infection, similarity in testing strategies, and&#xD;
      interrelated risk factors suggest a practical overlap in integrating screening services. This&#xD;
      integration could effectively utilize existing resources and infrastructure to address both&#xD;
      epidemics and facilitate the linkage of HCV-infected individuals to care.&#xD;
&#xD;
      The objective of this study was to integrate rapid HCV testing into a well-established HIV&#xD;
      testing and counseling program to evaluate the effect of rapid bundled screening on HIV test&#xD;
      acceptance rate. Secondary outcomes include HCV test acceptance, identification of newly&#xD;
      diagnosed HCV- and HIV-positive patients, HCV knowledge, risk assessment, and refusal&#xD;
      reasons.&#xD;
&#xD;
      The two-armed, randomized controlled trial was conducted at Jacobi Medical Center, a Level 1&#xD;
      trauma and tertiary care center located in the Bronx, New York. Upon recruitment, all&#xD;
      participants completed questionnaires that included demographic information, HCV risk&#xD;
      assessment, and HCV knowledge questions. Participants were randomized either to the control&#xD;
      arm or the intervention arm. The control arm was offered HIV testing only and the&#xD;
      intervention arm was offered HIV testing concurrently with HCV testing (bundled HIV/HCV&#xD;
      screening).&#xD;
&#xD;
      Sample size was determined using the following parameters: 1) 80% power; 2) significance&#xD;
      level of 0.05; 3) two-sided significant test; and 4) 10% difference between groups on the&#xD;
      acceptance of HIV testing. Using these parameters, a sample of 227 in each group was needed&#xD;
      to test the primary outcome: acceptance of an integrated screening program for HIV and HCV&#xD;
      infection. Groups of at least 333 were used to allow for drop-outs and protocol violations.&#xD;
&#xD;
      Patients were recruited from the adult Emergency Department (ED) at Jacobi Medical Center.&#xD;
      Recruitment took place during a six-month period from December 2012 to May 2013, and 478&#xD;
      patients were enrolled in the study.&#xD;
&#xD;
      Research Assistants were trained as Public Health Advocates to perform HIV and HCV testing&#xD;
      and counseling. The Public Health Advocates approached eligible patients in the ED and&#xD;
      followed a script to ask patients if they were interested in participating in a study through&#xD;
      which they would be offered free screenings recommended for their general health. Patients&#xD;
      who refused the offer of the HIV and/or HCV tests completed a test-refusal questionnaire. All&#xD;
      enrolled participants completed a questionnaire including demographic information, HCV risk&#xD;
      assessment, and HCV knowledge.&#xD;
&#xD;
      After providing verbal consent, participants were randomized to either an HIV test only group&#xD;
      (control) or a bundled HIV/HCV test group (intervention). Randomization was performed by an&#xD;
      independent statistician who used a computer generated allocation schedule. Randomization&#xD;
      assignments were placed in sealed opaque envelopes that were opened sequentially after verbal&#xD;
      consent was obtained for the study.&#xD;
&#xD;
      Those randomized to the control group were offered only an HIV test, and those randomized to&#xD;
      the intervention group were offered both HCV and HIV tests. The OraQuick® HCV Rapid Antibody&#xD;
      Test was employed as a rapid blood fingerstick test for HCV antibodies. The OraQuick Rapid&#xD;
      Antibody Test Advance® HIV-1/2 Antibody test was used to test for HIV-1 and HIV-2 antibodies&#xD;
      in oral fluid. Both point-of-care tests provide results in 20 minutes.&#xD;
&#xD;
      A Public Health Advocate delivered the test(s) results to the patient and conducted post-test&#xD;
      counseling. In the case of a preliminary positive result on either test, the Public Health&#xD;
      Advocate informed the patient and the patient's provider and scheduled a follow up&#xD;
      appointment for the patient.&#xD;
&#xD;
      Data was recorded in an electronic database using Microsoft Excel (Microsoft Corp., Redmond,&#xD;
      WA). Data obtained from subjects were entered using unique subject numbers, without specific&#xD;
      identifiers. Acceptance rates for HIV testing in experimental and intervention arms was&#xD;
      compared using chi square with fisher's exact derived confidence intervals. Stata statistical&#xD;
      software was used to tabulate participant demographics and testing frequencies for HIV, HCV,&#xD;
      or both.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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>Screening</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HIV Test Acceptance</measure>
    <time_frame>Through study completion, 6 months</time_frame>
    <description>Participant agreement to test for HIV with a rapid Oraquick oral swab</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HCV Test Acceptance</measure>
    <time_frame>Through study completion, 6 months</time_frame>
    <description>Participant agreement to test for HCV with a rapid Orasure fingerstick</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HIV and HCV Incidence</measure>
    <time_frame>Through study completion, 6 months</time_frame>
    <description>Diagnoses of either infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HCV Knowledge and Risk</measure>
    <time_frame>Through study completion, 6 months</time_frame>
    <description>As assessed from a knowledge and risk assessment questionnaire distributed to each participant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Test Refusals</measure>
    <time_frame>Through study completion, 6 months</time_frame>
    <description>Reasons for refusal of either HIV or HCV tests</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">478</enrollment>
  <condition>Hepatitis C</condition>
  <condition>Hiv</condition>
  <condition>HIV/AIDS</condition>
  <condition>HCV Coinfection</condition>
  <condition>HIV/AIDS and Infections</condition>
  <arm_group>
    <arm_group_label>HIV Only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Those randomized to the control group were offered only an HIV test.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bundled HCV/HIV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Those randomized to the intervention group were offered both HCV and HIV test.s</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Bundled HCV/HIV Screening</intervention_name>
    <description>Participants were randomized to a bundled HIV/HCV test group (intervention) to evaluate whether integrating HIV and HCV rapid screening would adversely impact HIV test acceptance.</description>
    <arm_group_label>Bundled HCV/HIV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HIV Screening</intervention_name>
    <description>Participants were randomized to an HIV-only screening group as a control comparator.</description>
    <arm_group_label>HIV Only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults 18 years of age or older&#xD;
&#xD;
          -  Speak English or Spanish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to consent&#xD;
&#xD;
          -  Medically unstable as determined by healthcare provider&#xD;
&#xD;
          -  Does not speak English or Spanish&#xD;
&#xD;
          -  Known HIV and/or HCV positive&#xD;
&#xD;
          -  Already tested for HIV and/or HCV within past 6 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>Jason Leider, MD, PhD, FACP</last_name>
    <role>Study Chair</role>
    <affiliation>Jacobi Medical Center; Albert Einstein College of Medicine; New York City Health and Hospitals Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jacobi Medical Center</name>
      <address>
        <city>The Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 15, 2017</last_update_submitted>
  <last_update_submitted_qc>August 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>New York City Health and Hospitals Corporation</investigator_affiliation>
    <investigator_full_name>Jason Leider</investigator_full_name>
    <investigator_title>Director of Adult HIV Services</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
    <mesh_term>Coinfection</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data includes HIV/HCV screening information and HCV knowledge and risk assessment. Study has been completed.</ipd_description>
  </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/NCT03252483
org study id: 2012-491
nct id: NCT03252483
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This randomized controlled trial was implemented to evaluate the effect of integrating rapid
      Hepatitis C (HCV) testing into a pre-existing screening program for Human Immunodeficiency
      Virus (HIV) on HIV test acceptance and diagnosis of both HCV and HIV. A sample of 478 adults
      in a New York City Emergency Department participated in the study. Participants were
      randomized to receive either an offer of bundled HIV/HCV testing or HIV testing alone. Public
      Health Advocates approached eligible patients in the Emergency Department, performed HIV and
      HCV raid testing, and delivered test results to participants with post-test counseling. The
      primary outcome, HIV test acceptance, was compared between the two groups to evaluate whether
      the addition of an HCV test adversely impacted participants' consent to test for HIV.
      Questionnaires were also distributed to participants to assess HCV knowledge.
The high prevalence of HIV and HCV co-infection, similarity in testing strategies, and
      interrelated risk factors suggest a practical overlap in integrating screening services. This
      integration could effectively utilize existing resources and infrastructure to address both
      epidemics and facilitate the linkage of HCV-infected individuals to care.

      The objective of this study was to integrate rapid HCV testing into a well-established HIV
      testing and counseling program to evaluate the effect of rapid bundled screening on HIV test
      acceptance rate. Secondary outcomes include HCV test acceptance, identification of newly
      diagnosed HCV- and HIV-positive patients, HCV knowledge, risk assessment, and refusal
      reasons.

      The two-armed, randomized controlled trial was conducted at Jacobi Medical Center, a Level 1
      trauma and tertiary care center located in the Bronx, New York. Upon recruitment, all
      participants completed questionnaires that included demographic information, HCV risk
      assessment, and HCV knowledge questions. Participants were randomized either to the control
      arm or the intervention arm. The control arm was offered HIV testing only and the
      intervention arm was offered HIV testing concurrently with HCV testing (bundled HIV/HCV
      screening).

      Sample size was determined using the following parameters: 1) 80% power; 2) significance
      level of 0.05; 3) two-sided significant test; and 4) 10% difference between groups on the
      acceptance of HIV testing. Using these parameters, a sample of 227 in each group was needed
      to test the primary outcome: acceptance of an integrated screening program for HIV and HCV
      infection. Groups of at least 333 were used to allow for drop-outs and protocol violations.

      Patients were recruited from the adult Emergency Department (ED) at Jacobi Medical Center.
      Recruitment took place during a six-month period from December 2012 to May 2013, and 478
      patients were enrolled in the study.

      Research Assistants were trained as Public Health Advocates to perform HIV and HCV testing
      and counseling. The Public Health Advocates approached eligible patients in the ED and
      followed a script to ask patients if they were interested in participating in a study through
      which they would be offered free screenings recommended for their general health. Patients
      who refused the offer of the HIV and/or HCV tests completed a test-refusal questionnaire. All
      enrolled participants completed a questionnaire including demographic information, HCV risk
      assessment, and HCV knowledge.

      After providing verbal consent, participants were randomized to either an HIV test only group
      (control) or a bundled HIV/HCV test group (intervention). Randomization was performed by an
      independent statistician who used a computer generated allocation schedule. Randomization
      assignments were placed in sealed opaque envelopes that were opened sequentially after verbal
      consent was obtained for the study.

      Those randomized to the control group were offered only an HIV test, and those randomized to
      the intervention group were offered both HCV and HIV tests. The OraQuick® HCV Rapid Antibody
      Test was employed as a rapid blood fingerstick test for HCV antibodies. The OraQuick Rapid
      Antibody Test Advance® HIV-1/2 Antibody test was used to test for HIV-1 and HIV-2 antibodies
      in oral fluid. Both point-of-care tests provide results in 20 minutes.

      A Public Health Advocate delivered the test(s) results to the patient and conducted post-test
      counseling. In the case of a preliminary positive result on either test, the Public Health
      Advocate informed the patient and the patient's provider and scheduled a follow up
      appointment for the patient.

      Data was recorded in an electronic database using Microsoft Excel (Microsoft Corp., Redmond,
      WA). Data obtained from subjects were entered using unique subject numbers, without specific
      identifiers. Acceptance rates for HIV testing in experimental and intervention arms was
      compared using chi square with fisher's exact derived confidence intervals. Stata statistical
      software was used to tabulate participant demographics and testing frequencies for HIV, HCV,
      or both.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Single (Participant)
measure: HIV Test Acceptance
time frame: Through study completion, 6 months
description: Participant agreement to test for HIV with a rapid Oraquick oral swab
measure: HCV Test Acceptance
time frame: Through study completion, 6 months
description: Participant agreement to test for HCV with a rapid Orasure fingerstick
measure: HIV and HCV Incidence
time frame: Through study completion, 6 months
description: Diagnoses of either infection
measure: HCV Knowledge and Risk
time frame: Through study completion, 6 months
description: As assessed from a knowledge and risk assessment questionnaire distributed to each participant
measure: Test Refusals
time frame: Through study completion, 6 months
description: Reasons for refusal of either HIV or HCV tests
arm group label: HIV Only
arm group type: Active Comparator
description: Those randomized to the control group were offered only an HIV test.
arm group label: Bundled HCV/HIV
arm group type: Experimental
description: Those randomized to the intervention group were offered both HCV and HIV test.s
intervention type: Other
intervention name: Bundled HCV/HIV Screening
description: Participants were randomized to a bundled HIV/HCV test group (intervention) to evaluate whether integrating HIV and HCV rapid screening would adversely impact HIV test acceptance.
arm group label: Bundled HCV/HIV
intervention type: Other
intervention name: HIV Screening
description: Participants were randomized to an HIV-only screening group as a control comparator.
arm group label: HIV Only
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jason Leider, MD, PhD, FACP
role: Study Chair
affiliation: Jacobi Medical Center; Albert Einstein College of Medicine; New York City Health and Hospitals Corporation
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: New York City Health and Hospitals Corporation
investigator full name: Jason Leider
investigator title: Director of Adult HIV Services
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: Coinfection
mesh term: Hepatitis
sharing ipd: No
ipd description: Individual participant data includes HIV/HCV screening information and HCV knowledge and risk assessment. Study has been completed.