<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/NCT04427202</url>
  </required_header>
  <id_info>
    <org_study_id>IRB17-1630</org_study_id>
    <secondary_id>4UH3DA044829-03</secondary_id>
    <nct_id>NCT04427202</nct_id>
  </id_info>
  <brief_title>Ending Transmission of HIV, HCV, and STDs and Overdose in Rural Communities of People Who Inject Drugs (ETHIC)</brief_title>
  <acronym>ETHIC</acronym>
  <official_title>Ending Transmission of HIV, HCV, and STDs and Overdose in Rural Communities of People Who Inject Drugs (ETHIC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Southern Illinois University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Community Action Place, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>New York University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Illinois at Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Chicago</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the referral to harm reduction services (HRS) including syringe&#xD;
      services, naloxone overdose prevention, substance use treatment referral, HIV, HCV, and STD&#xD;
      testing and referral and linkage to care through capacity building of existing programs&#xD;
      through client services data.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective longitudinal Type 1 Hybrid Implementation Effectiveness Study on the&#xD;
      expansion of harm reduction services for people who inject drugs (PWID) and people who use&#xD;
      opioids (PWUO) residing in high risk areas of rural southern Illinois. This study record&#xD;
      describes one component of the larger Ending transmission of HIV, HCV, and STDs and overdose&#xD;
      in rural communities of people who inject drugs (ETHIC) study Community Response Plan (CRP)&#xD;
      framework, specifically the expansion of harm reduction services intervention (HRS). The aim&#xD;
      is to assess the effectiveness of expansion of evidenced based harm reduction services&#xD;
      through our CRP framework comprising: a) geographically targeted recruitment based on hot&#xD;
      spot and vulnerability analyses, b) community engagement, c) recruitment via Respondent&#xD;
      Driven Sampling (RDS), d) expanded surveillance for HIV and HCV, and e) concomitant HCV and&#xD;
      opioid use treatment capacity expansion through the Extension of Community Healthcare&#xD;
      Outcomes (ECHO) model. Examination of facilitators and barriers impacting implementation of&#xD;
      service delivery is evaluated through mixed methods process evaluation. The Type 1 Hybrid&#xD;
      design is supported by conditions including the existing evidence based for benefits and&#xD;
      minimal harm of &quot;harm reduction services&quot; and strong base for applicability of this&#xD;
      intervention in the study setting (ie rural opioid use)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 14, 2020</start_date>
  <completion_date type="Actual">August 16, 2023</completion_date>
  <primary_completion_date type="Actual">August 16, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Referrals to the harm reduction organization</measure>
    <time_frame>2 years</time_frame>
    <description>Number of participants who accept referral to the intervention (divided by the total enrolled)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of locations where participants received most of syringes or needles</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of times clean syringes and/or equipment obtained from an intervention</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of times participants used a syringe or needle that they knew was used by somebody else</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of times participants used a cotton, cooker, spoon, or water for rinsing or mixing that they knew was used by somebody else</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of times participants let someone else use a cotton, cooker, spoon, or water for rinsing or mixing after they used it</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of time to travel to the nearest syringe or needle exchange</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants that currently have naloxone</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of substance use disorders (SUD) treatment referrals made</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of HIV screenings and referrals</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of HCV screenings and referrals</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with knowledge of PrEP</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants diagnosed with HIV who have access to HIV care</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants diagnosed with HCV who have access to HCV care</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants who have condomless sex (vaginal or anal)</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">309</enrollment>
  <condition>HIV</condition>
  <condition>Hepatitis C</condition>
  <condition>Opioid-use Disorder</condition>
  <condition>Injection Drug Use</condition>
  <arm_group>
    <arm_group_label>Referral to harm reduction services</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will be taken through the study survey and interview, blood and urine toxicology testing and given a referral to a harm reduction organization.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Referral to harm reduction services</intervention_name>
    <description>Participants are referred to harm reduction services</description>
    <arm_group_label>Referral to harm reduction services</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  15 years of age and older&#xD;
&#xD;
          -  Injected any drug in the past 30 days&#xD;
&#xD;
          -  Used any opioids non-medically in the past 30 days&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Able to provide informed consent at the time of the study visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 15 years of age&#xD;
&#xD;
          -  Not injected any drug in the past 30 days&#xD;
&#xD;
          -  Not used any opioids non-medically in past 30 days&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  Has not injected any opioid drug to get high in the past 30 days&#xD;
&#xD;
          -  Unable to provide informed consent at the time of the study visit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mai Pho, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Southern Illinois University</name>
      <address>
        <city>Carbondale</city>
        <state>Illinois</state>
        <zip>62901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Community Action Place, Inc.</name>
      <address>
        <city>Murphysboro</city>
        <state>Illinois</state>
        <zip>62966</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>August 18, 2023</last_update_submitted>
  <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>Hepatitis C</keyword>
  <keyword>Opioid-use Disorder</keyword>
  <keyword>Injection Drug Use</keyword>
  <keyword>Harm Reduction Services</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Opioid-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The ETHIC study is participating site of the Rural Opioid Initiative (ROI), a collaborative funded by NIDA. The ROI includes a Data Coordinating Center (DCC) housed at the University of Washington. The University of Chicago will submit de-identified data from the study to the DCC as covered under a data use agreement for the purposes of performing cross-site analyses using a harmonized data set. No parties outside of the ROI will have access to the combined dataset. All project proposals will be subject to approval by the ROI. The data will be available after encrypted submission to the DCC and will remain for the duration in accordance to the data use agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will be available at the DCC for the time frame indicated in the data use agreement.</ipd_time_frame>
    <ipd_access_criteria>Data will be shared among researchers in the Rural Opioid Initiative (ROI) cooperative agreement as described above</ipd_access_criteria>
  </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/NCT04427202
org study id: IRB17-1630
secondary id: 4UH3DA044829-03
nct id: NCT04427202
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will evaluate the referral to harm reduction services (HRS) including syringe
      services, naloxone overdose prevention, substance use treatment referral, HIV, HCV, and STD
      testing and referral and linkage to care through capacity building of existing programs
      through client services data.
This is a prospective longitudinal Type 1 Hybrid Implementation Effectiveness Study on the
      expansion of harm reduction services for people who inject drugs (PWID) and people who use
      opioids (PWUO) residing in high risk areas of rural southern Illinois. This study record
      describes one component of the larger Ending transmission of HIV, HCV, and STDs and overdose
      in rural communities of people who inject drugs (ETHIC) study Community Response Plan (CRP)
      framework, specifically the expansion of harm reduction services intervention (HRS). The aim
      is to assess the effectiveness of expansion of evidenced based harm reduction services
      through our CRP framework comprising: a) geographically targeted recruitment based on hot
      spot and vulnerability analyses, b) community engagement, c) recruitment via Respondent
      Driven Sampling (RDS), d) expanded surveillance for HIV and HCV, and e) concomitant HCV and
      opioid use treatment capacity expansion through the Extension of Community Healthcare
      Outcomes (ECHO) model. Examination of facilitators and barriers impacting implementation of
      service delivery is evaluated through mixed methods process evaluation. The Type 1 Hybrid
      design is supported by conditions including the existing evidence based for benefits and
      minimal harm of "harm reduction services" and strong base for applicability of this
      intervention in the study setting (ie rural opioid use)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Referrals to the harm reduction organization
time frame: 2 years
description: Number of participants who accept referral to the intervention (divided by the total enrolled)
measure: Number of locations where participants received most of syringes or needles
time frame: 2 years
measure: Number of times clean syringes and/or equipment obtained from an intervention
time frame: 2 years
measure: Number of times participants used a syringe or needle that they knew was used by somebody else
time frame: 2 years
measure: Number of times participants used a cotton, cooker, spoon, or water for rinsing or mixing that they knew was used by somebody else
time frame: 2 years
measure: Number of times participants let someone else use a cotton, cooker, spoon, or water for rinsing or mixing after they used it
time frame: 2 years
measure: Amount of time to travel to the nearest syringe or needle exchange
time frame: 2 years
measure: Number of participants that currently have naloxone
time frame: 2 years
measure: Number of substance use disorders (SUD) treatment referrals made
time frame: 2 years
measure: Number of HIV screenings and referrals
time frame: 2 years
measure: Number of HCV screenings and referrals
time frame: 2 years
measure: Number of participants with knowledge of PrEP
time frame: 2 years
measure: Number of participants diagnosed with HIV who have access to HIV care
time frame: 2 years
measure: Number of participants diagnosed with HCV who have access to HCV care
time frame: 2 years
measure: Number of participants who have condomless sex (vaginal or anal)
time frame: 2 years
arm group label: Referral to harm reduction services
arm group type: Other
description: Participants will be taken through the study survey and interview, blood and urine toxicology testing and given a referral to a harm reduction organization.
intervention type: Behavioral
intervention name: Referral to harm reduction services
description: Participants are referred to harm reduction services
arm group label: Referral to harm reduction services
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
last name: Mai Pho, PhD
role: Principal Investigator
affiliation: University of Chicago
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hepatitis C
mesh term: Hepatitis
mesh term: Opioid-Related Disorders
sharing ipd: Yes
ipd description: The ETHIC study is participating site of the Rural Opioid Initiative (ROI), a collaborative funded by NIDA. The ROI includes a Data Coordinating Center (DCC) housed at the University of Washington. The University of Chicago will submit de-identified data from the study to the DCC as covered under a data use agreement for the purposes of performing cross-site analyses using a harmonized data set. No parties outside of the ROI will have access to the combined dataset. All project proposals will be subject to approval by the ROI. The data will be available after encrypted submission to the DCC and will remain for the duration in accordance to the data use agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Analytic Code
ipd time frame: Data will be available at the DCC for the time frame indicated in the data use agreement.
ipd access criteria: Data will be shared among researchers in the Rural Opioid Initiative (ROI) cooperative agreement as described above