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/NCT05977881</url>
    </required_header>
    <id_info>
      <org_study_id>00017498</org_study_id>
      <secondary_id>5R01DA053184</secondary_id>
      <nct_id>NCT05977881</nct_id>
    </id_info>
    <brief_title>Substance Checking Outreach and Pre-Exposure Prophylaxis (PrEP) Engagement Study</brief_title>
    <acronym>SCOPE</acronym>
    <official_title>Impact of a Novel HIV Peer Navigation and Overdose Prevention Intervention on Engagement in the HIV Prevention and Treatment Cascade</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Johns Hopkins Bloomberg School of Public Health</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institutes of Health (NIH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>Baltimore City Health Department</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>National Institute on Drug Abuse (NIDA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Johns Hopkins Bloomberg School of Public Health</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>
        Through the proposed Substance Checking Outreach and Pre-Exposure Prophylaxis (PrEP)&#xD;
        Engagement (SCOPE) study, the investigators will design and evaluate an overdose prevention&#xD;
        and HIV prevention study among people who use drugs (PWUD). Specifically, SCOPE will provide&#xD;
        access to drug-checking services for PWUD to better understand the contents of the drug&#xD;
        supply, in combination with PrEP for those who are HIV-, to both reduce overdose and HIV&#xD;
        among PWUD in Baltimore City.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        specific study aims are:&#xD;
  &#xD;
          1. To prepare the drug-checking technology for deployment in the community through a&#xD;
             three-phase process.&#xD;
  &#xD;
               1. To calibrate drug-checking technology through testing samples of illicit substances&#xD;
                  on the Bruker Alpha obtained from the Baltimore Police crime lab (N=335) and those&#xD;
                  obtained through the SPARC outreach sessions (N=100).&#xD;
  &#xD;
               2. To validate the drug-checking technology, measuring sensitivity and specificity in&#xD;
                  detecting illicit substances of public health relevance, by testing samples&#xD;
                  obtained through partnerships through Baltimore-based harm reduction organizations&#xD;
                  and comparing findings to the gold standard (laboratory testing).&#xD;
  &#xD;
               3. To pilot the study Bruker Alpha Fourier Transform Infrared Spectroscopy (FT-IR)&#xD;
                  drug checking machine among People who use drugs (PWUD) (N=20).&#xD;
  &#xD;
          2. To develop a community-level, mobile, integrated drug checking and PrEP intervention&#xD;
             aimed to increase PWUD engagement in the PrEP care continuum and reduce the burden of&#xD;
             overdose.&#xD;
  &#xD;
          3. To recruit a longitudinal cohort of people who use drugs (N=600) and follow-up at&#xD;
             6-month intervals for 18 months.&#xD;
  &#xD;
          4. To implement the intervention and evaluate its impact on engagement in PrEP care&#xD;
             (primary outcome) and overdose prevention among PWUD.&#xD;
  &#xD;
               1. To determine the incremental cost-effectiveness of the intervention in terms of HIV&#xD;
                  cases averted among PWUD.&#xD;
  &#xD;
        The initial nonhuman subjects research plan focused on Aim's 1 drug checking machine&#xD;
        calibration among samples procured from the Baltimore Police Forensics Lab tested in Dr.&#xD;
        William Clarke's lab and from individuals interacting with SPARC staff during the outreach&#xD;
        which occurs 3-4 times per week. These activities are referred to as &quot;Phase 1&quot; throughout&#xD;
        this research plan. Based on emerging best practices and in consultation with other drug&#xD;
        checking initiatives nationwide, the investigators have now expanded Aim 1 of the study to&#xD;
        include three steps needed to prepare the machine for deployment in the field: The first (1a)&#xD;
        was calibration of the machine to the local drug supply, as described above; the second (1b)&#xD;
        which the investigators are adding in this amendment is an additional validation of the&#xD;
        machine's functionality and comparison with gold standard technology; and the third (1c) is&#xD;
        piloting the machine with 20 PWUD prior to rolling it out citywide.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 28, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 2025</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>
      <intervention_model_description>The study interventional model is at the community level; the intervention will be offered in all areas in which the cohort will be recruited.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Current PrEP status as assessed by study team instrument items</measure>
      <time_frame>Measured at Baseline, 6, 12, and 18 months</time_frame>
      <description>Investigators will measure current PrEP status by assessing participant self-report using an internally developed questionnaire. Change in current PrEP status will be measured using three survey items asking participants 1) if they are currently prescribed either form of PrEP (pill form or injection), 2) currently taking/not taking the prescription, and 3) which type/brand of PrEP are they currently taking. The response range options for current prescription and currently taking PrEP are binary (yes/no) and nominal (choices) for type of PrEP prescribed. Participants will indicate whether they are currently prescribed PrEP, currently taking PrEP and which type prescribed/taking at each study visit.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in PrEP uptake as assessed by study team instrument items</measure>
      <time_frame>Measured at 6, 12, 18 months</time_frame>
      <description>Change in PrEP status (uptake) at follow-up is measured using three items with response range options for current prescription and currently taking PrEP are binary (yes/no) and nominal (choices) for type of PrEP prescribed. If participants self-report current PrEP use at follow-up, investigators will confirm the biological presence of PrEP using dried blood spot (DBS) sampling. Samples will be transported to the Clinical Pharmacology Analytical Laboratory (CPAL) where they will be processed using FDA-validated assays analyzing drug and metabolite concentrations. Sample results will be used to compare participant self-report on the study team survey instrument (e.g., what is the concordance/discordance between PrEP presence in DBS samples and yes/no responses to the currently taking PrEP survey item).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in HIV Risk Behaviors as assessed by study team instrument items</measure>
      <time_frame>Measured at Baseline, 6, 12, 18 months</time_frame>
      <description>Investigators will measure change in HIV risk behaviors using self-report with an internally developed questionnaire; there are several items in the instrument to capture 1) episodes of syringe sharing in the prior 30 days and 2) episodes of unprotected vaginal or anal intercourse. Response options for HIV risk behaviors are continuous (counts # of times of episodes) and response options for HIV prevention techniques used are nominal; e.g., 'used a condom with my main sexual partner', or 'take HIV PrEP', or, 'did you use syringes after someone else?'.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">600</enrollment>
    <condition>HIV Infections</condition>
    <arm_group>
      <arm_group_label>SCOPE Cohort</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>A cohort of PWUD (N=600) living in Baltimore. We will follow-up with participants every 6 months (for 18 months) in five recruitment zones throughout Baltimore (n=120/zone). The five recruitment zones will overlap the intervention sites. There will be 4 study visits (baseline, 6 months, 12 months, 18 months) total for participants.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>CHECKIT!</intervention_name>
      <description>Participants will not be assigned to the intervention as it will be available to everyone.&#xD;
  Check it will be a van-based HIV- and overdose-prevention program offered in the 5 areas of Baltimore city from which study participants are recruited. Intervention services will include point-of-care drug checking and PrEP assessment, prescription, and management, and they will be available to everyone, regardless of whether they are part of the SCOPE study cohort or not.&#xD;
  Individual-level service usage data collected by intervention staff will not be considered in analysis of outcomes. However, study participants will self-report Check it utilization on the internally-developed surveys at 6, 12, and 18 months.</description>
      <arm_group_label>SCOPE Cohort</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years or older,&#xD;
  &#xD;
            -  self-reports having used illicit stimulants or opioids at least once in the past 3&#xD;
               months,&#xD;
  &#xD;
            -  self-reports being HIV negative&#xD;
  &#xD;
            -  reports injection drug use in the past 6 months OR reports at least one of the&#xD;
               following indicators of sexual HIV risk exposure in the past 6 months:&#xD;
  &#xD;
                 1. Sexually Transmitted Infection (STI) diagnosis in the past 6 months&#xD;
  &#xD;
                 2. &quot;Condom-less&quot; vaginal or anal sex in the past 6 months&#xD;
  &#xD;
            -  Willing to provide a urine sample for urine drug screening of substances&#xD;
  &#xD;
            -  Willing to undergo rapid HIV testing&#xD;
  &#xD;
            -  Willing to undergo STI testing&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Determined to be too high or drunk or cognitively impaired, less than 18 years of age&#xD;
  &#xD;
            -  unwilling to provide all required biological specimens (Phase 3 only)&#xD;
  &#xD;
            -  unwilling/unable to give consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Susan Sherman, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Johns Hopkins Bloomberg School of Public Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Miles Morris, MPH</last_name>
      <phone>410-502-4435</phone>
      <email>mmorr100@jhu.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Susan G Sherman, PhD</last_name>
      <phone>410-614-3518</phone>
      <email>ssherman@jhu.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Johns Hopkins School of Public Health</name>
        <address>
          <city>Baltimore</city>
          <state>Maryland</state>
          <zip>21205</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Susan G Sherman, PhD</last_name>
        <phone>410-614-3518</phone>
        <email>ssherman@jhu.edu</email>
      </contact>
      <contact_backup>
        <last_name>Miles Morris, MPH</last_name>
        <phone>410-502-4435</phone>
        <email>mmorr100@jhu.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Saba Rouhani, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Brian Weir, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Kristin Schneider, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>William Clarke, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Seun Falade-Nwulia, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Danielle Nestadt-Friedman, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.cdc.gov/media/releases/2020/p1218-overdose-deaths-covid-19.html</url>
      <description>Centers for Disease Control and Prevention. Overdose Deaths Accelerating during Covid-19.</description>
    </link>
    <link>
      <url>https://www.nih.gov/news-events/news-releases/substance-use-disorders-linked-covid-19-susceptibility</url>
      <description>National Institutes of Health. Substance Use Disorders Linked to Covid-19 Susceptibility</description>
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    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Drug Use</keyword>
    <keyword>Overdose</keyword>
    <keyword>PrEP</keyword>
    <keyword>Harm Reduction</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>HIV Infections</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05977881
  org study id: 00017498
  secondary id: 5R01DA053184
  nct id: NCT05977881
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Through the proposed Substance Checking Outreach and Pre-Exposure Prophylaxis (PrEP)
        Engagement (SCOPE) study, the investigators will design and evaluate an overdose prevention
        and HIV prevention study among people who use drugs (PWUD). Specifically, SCOPE will provide
        access to drug-checking services for PWUD to better understand the contents of the drug
        supply, in combination with PrEP for those who are HIV-, to both reduce overdose and HIV
        among PWUD in Baltimore City.
  specific study aims are:
  
          1. To prepare the drug-checking technology for deployment in the community through a
             three-phase process.
  
               1. To calibrate drug-checking technology through testing samples of illicit substances
                  on the Bruker Alpha obtained from the Baltimore Police crime lab (N=335) and those
                  obtained through the SPARC outreach sessions (N=100).
  
               2. To validate the drug-checking technology, measuring sensitivity and specificity in
                  detecting illicit substances of public health relevance, by testing samples
                  obtained through partnerships through Baltimore-based harm reduction organizations
                  and comparing findings to the gold standard (laboratory testing).
  
               3. To pilot the study Bruker Alpha Fourier Transform Infrared Spectroscopy (FT-IR)
                  drug checking machine among People who use drugs (PWUD) (N=20).
  
          2. To develop a community-level, mobile, integrated drug checking and PrEP intervention
             aimed to increase PWUD engagement in the PrEP care continuum and reduce the burden of
             overdose.
  
          3. To recruit a longitudinal cohort of people who use drugs (N=600) and follow-up at
             6-month intervals for 18 months.
  
          4. To implement the intervention and evaluate its impact on engagement in PrEP care
             (primary outcome) and overdose prevention among PWUD.
  
               1. To determine the incremental cost-effectiveness of the intervention in terms of HIV
                  cases averted among PWUD.
  
        The initial nonhuman subjects research plan focused on Aim's 1 drug checking machine
        calibration among samples procured from the Baltimore Police Forensics Lab tested in Dr.
        William Clarke's lab and from individuals interacting with SPARC staff during the outreach
        which occurs 3-4 times per week. These activities are referred to as "Phase 1" throughout
        this research plan. Based on emerging best practices and in consultation with other drug
        checking initiatives nationwide, the investigators have now expanded Aim 1 of the study to
        include three steps needed to prepare the machine for deployment in the field: The first (1a)
        was calibration of the machine to the local drug supply, as described above; the second (1b)
        which the investigators are adding in this amendment is an additional validation of the
        machine's functionality and comparison with gold standard technology; and the third (1c) is
        piloting the machine with 20 PWUD prior to rolling it out citywide.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: The study interventional model is at the community level; the intervention will be offered in all areas in which the cohort will be recruited.
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Current PrEP status as assessed by study team instrument items
  time frame: Measured at Baseline, 6, 12, and 18 months
  description: Investigators will measure current PrEP status by assessing participant self-report using an internally developed questionnaire. Change in current PrEP status will be measured using three survey items asking participants 1) if they are currently prescribed either form of PrEP (pill form or injection), 2) currently taking/not taking the prescription, and 3) which type/brand of PrEP are they currently taking. The response range options for current prescription and currently taking PrEP are binary (yes/no) and nominal (choices) for type of PrEP prescribed. Participants will indicate whether they are currently prescribed PrEP, currently taking PrEP and which type prescribed/taking at each study visit.
  measure: Change in PrEP uptake as assessed by study team instrument items
  time frame: Measured at 6, 12, 18 months
  description: Change in PrEP status (uptake) at follow-up is measured using three items with response range options for current prescription and currently taking PrEP are binary (yes/no) and nominal (choices) for type of PrEP prescribed. If participants self-report current PrEP use at follow-up, investigators will confirm the biological presence of PrEP using dried blood spot (DBS) sampling. Samples will be transported to the Clinical Pharmacology Analytical Laboratory (CPAL) where they will be processed using FDA-validated assays analyzing drug and metabolite concentrations. Sample results will be used to compare participant self-report on the study team survey instrument (e.g., what is the concordance/discordance between PrEP presence in DBS samples and yes/no responses to the currently taking PrEP survey item).
  measure: Change in HIV Risk Behaviors as assessed by study team instrument items
  time frame: Measured at Baseline, 6, 12, 18 months
  description: Investigators will measure change in HIV risk behaviors using self-report with an internally developed questionnaire; there are several items in the instrument to capture 1) episodes of syringe sharing in the prior 30 days and 2) episodes of unprotected vaginal or anal intercourse. Response options for HIV risk behaviors are continuous (counts # of times of episodes) and response options for HIV prevention techniques used are nominal; e.g., 'used a condom with my main sexual partner', or 'take HIV PrEP', or, 'did you use syringes after someone else?'.
  arm group label: SCOPE Cohort
  arm group type: Other
  description: A cohort of PWUD (N=600) living in Baltimore. We will follow-up with participants every 6 months (for 18 months) in five recruitment zones throughout Baltimore (n=120/zone). The five recruitment zones will overlap the intervention sites. There will be 4 study visits (baseline, 6 months, 12 months, 18 months) total for participants.
  intervention type: Other
  intervention name: CHECKIT!
  description: Participants will not be assigned to the intervention as it will be available to everyone.
  Check it will be a van-based HIV- and overdose-prevention program offered in the 5 areas of Baltimore city from which study participants are recruited. Intervention services will include point-of-care drug checking and PrEP assessment, prescription, and management, and they will be available to everyone, regardless of whether they are part of the SCOPE study cohort or not.
  Individual-level service usage data collected by intervention staff will not be considered in analysis of outcomes. However, study participants will self-report Check it utilization on the internally-developed surveys at 6, 12, and 18 months.
  arm group label: SCOPE Cohort
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Susan Sherman, PhD
  role: Principal Investigator
  affiliation: Johns Hopkins Bloomberg School of Public Health
  last name: Miles Morris, MPH
  phone: 410-502-4435
  email: mmorr100@jhu.edu
  last name: Susan G Sherman, PhD
  phone: 410-614-3518
  email: ssherman@jhu.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: United States
  url: https://www.cdc.gov/media/releases/2020/p1218-overdose-deaths-covid-19.html
  description: Centers for Disease Control and Prevention. Overdose Deaths Accelerating during Covid-19.
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  description: National Institutes of Health. Substance Use Disorders Linked to Covid-19 Susceptibility
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  responsible party type: Sponsor
  mesh term: HIV Infections
  sharing ipd: No