<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/NCT04430257</url>
  </required_header>
  <id_info>
    <org_study_id>2011002841</org_study_id>
    <secondary_id>R01DA051849-01</secondary_id>
    <nct_id>NCT04430257</nct_id>
  </id_info>
  <brief_title>Pre-exposure Prophylaxis (PrEP) for Health</brief_title>
  <acronym>PrEP</acronym>
  <official_title>Efficacy of a Community-based PrEP Uptake Intervention for People Who Inject Drugs (PWID) in the US Northeast</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brown University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Fenway Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>AIDS Action Committee of Massachusetts</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Greater Lawrence Family Health Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Brown University</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 randomized controlled trial will test the efficacy of &quot;PrEP for Health,&quot; a behavioral&#xD;
      intervention to improve the use of antiretroviral pre-exposure prophylaxis (PrEP) among&#xD;
      at-risk people who inject drugs (PWID) in two syringe service program (SSP) settings in&#xD;
      Lawrence and Boston/Cambridge, Massachusetts. The investigators will equally randomize 200&#xD;
      PWID to receive either (a) the &quot;PrEP for Health&quot; intervention condition involving&#xD;
      theory-informed HIV and PrEP education, motivational interviewing, problem-solving and&#xD;
      planning, and ongoing patient navigation (n=100), or (b) the standard of care condition&#xD;
      involving PrEP information and referrals (n=100). Successful PrEP uptake (via&#xD;
      medical/pharmacy records), post-treatment PrEP adherence (assessed at 3 months via drug&#xD;
      levels in hair), and longer-term PrEP adherence (assessed at 6 and 12 months via drug levels&#xD;
      in hair) will be evaluated. The degree to which intervention efficacy occurs through specific&#xD;
      conceptual mediators and differs according to hypothesized moderators will also be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall goal of this proposal is to evaluate the efficacy of the &quot;PrEP for Health&quot;&#xD;
      navigator delivered behavioral intervention in improving PrEP uptake (via medical/pharmacy&#xD;
      records), post-treatment PrEP adherence (assessed at 3 months via drug levels in hair), and&#xD;
      longer-term PrEP adherence (assessed at 6 and 12 months via drug levels in hair) among PWID&#xD;
      in SSPs. Eligible PWID (n=200 total; 100 recruited from each study site) will be equally&#xD;
      randomized to an active PrEP for Health intervention arm (n=100) or a Standard of Care&#xD;
      control condition (n=100). Assessments will be conducted at baseline and 1, 3, 6, and 12&#xD;
      months after randomization.&#xD;
&#xD;
      We hypothesize that brief, multi-component behavioral intervention sessions with ongoing&#xD;
      support delivered by trained PrEP Navigators within Syringe Service Programs (SSPs) will&#xD;
      improve PrEP uptake, adherence, and long-term adherence in PWID by increasing HIV and PrEP&#xD;
      knowledge (including alleviating concerns about side effects), increasing HIV risk&#xD;
      perceptions and PrEP interest and motivation, improving PrEP use self-efficacy and behavioral&#xD;
      skills, and reducing structural barriers over time. Based on our formative research, we also&#xD;
      hypothesize that the strength of intervention effects may differ by key individual&#xD;
      characteristics (age, gender, baseline sexual risk, polysubstance, and stimulant use).&#xD;
&#xD;
      This is a randomized control trial (RCT). Participants will be recruited via outreach&#xD;
      specialist at SSP sites and during routine community outreach practices of the organizations.&#xD;
      After eligibility confirmation and baseline assessments, participants will be randomized to&#xD;
      one of two study arms: 1) Standard of Care (SOC) Control Condition: as routinely provided&#xD;
      through the SSP study sites, participants will receive information and services according to&#xD;
      routine practice and a brief video that describes what PrEP is and how it works to prevent&#xD;
      HIV via sexual and injection transmission; 2) &quot;PrEP for Health&quot; Intervention Condition: a&#xD;
      trained PrEP Navigator will deliver a manualized PrEP uptake and adherence intervention in&#xD;
      private counseling rooms at SSPs followed by 3 months of additional PrEP navigation support&#xD;
      through in-person, phone, and text interactions as needed. Participants will complete a total&#xD;
      of four follow-up visits over a 12-month period. Participants who initiate PrEP will have a&#xD;
      hair sample collected at 3-, 6-, and 12-month visits. All participants will receive a rapid&#xD;
      HIV screening test at 12-month follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 2, 2021</start_date>
  <completion_date type="Anticipated">June 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2025</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Individuals collecting the primary outcome data will be blinded to intervention condition.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>PrEP uptake</measure>
    <time_frame>3 months</time_frame>
    <description>PrEP uptake will be assessed via medical/pharmacy records</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-treatment PrEP adherence</measure>
    <time_frame>3 months</time_frame>
    <description>PrEP adherence will be assessed by drug levels in hair samples at the acute follow up time point (3 months post-baseline)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Longer-term PrEP adherence</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Longer-term PrEP adherence will be assessed by drug levels in hair samples at 6 and 12-month post-baseline</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Substance Dependence</condition>
  <condition>HIV (Human Immunodeficiency Virus)</condition>
  <arm_group>
    <arm_group_label>PrEP for health</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the PrEP (pre-exposure prophylaxis) for health arm will receive theory informed HIV and PrEP education, motivational interviewing, problem-solving and planning, and ongoing patient navigation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in the standard of care arm will receive PrEP information and referrals.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HIV and PrEP education</intervention_name>
    <description>Navigators will deliver Social Cognitive Theory-informed HIV and PrEP education.</description>
    <arm_group_label>PrEP for health</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motivational interviewing</intervention_name>
    <description>Bachelors-level PrEP Navigators who are trained in motivational interviewing (MI) will use MI to promote the behavioral intervention.</description>
    <arm_group_label>PrEP for health</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Problem-solving and planning</intervention_name>
    <description>Bachelors-level PrEP Navigators will assist participants with problem-solving and planning.</description>
    <arm_group_label>PrEP for health</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Patient navigation</intervention_name>
    <description>Ongoing PrEP navigation support to promote participants' initial and continued engagement with PrEP clinics affiliated with the two study sites</description>
    <arm_group_label>PrEP for health</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PrEP information</intervention_name>
    <description>A brief video that describes what PrEP is and how it works to prevent HIV via sexual and injection transmission will be shown to participants.</description>
    <arm_group_label>PrEP for health</arm_group_label>
    <arm_group_label>Standard of care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Referrals</intervention_name>
    <description>Study staff will provide basic information about PrEP and referrals to PrEP clinicians.</description>
    <arm_group_label>Standard of care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV-uninfected (verified by rapid/4th generation test)&#xD;
&#xD;
          -  Reporting past-month injection of any drugs&#xD;
&#xD;
          -  One or more HIV risk behaviors (past-month receptive syringe sharing, transactional&#xD;
             sex, or condomless sex with an HIV-infected or unknown-status partner)&#xD;
&#xD;
          -  Not currently on and never taken PrEP&#xD;
&#xD;
          -  Able to understand and speak English or Spanish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide informed consent due to severe mental or physical illness, cognitive&#xD;
             impairment, or substance intoxication at the time of enrollment&#xD;
&#xD;
          -  Living in Massachusetts (MA) for &lt;3 months&#xD;
&#xD;
          -  Planning to move out of MA within a year&#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>Katie Biello, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brown University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Angela Bazzi, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Diego</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Katie Biello, PhD, MPH</last_name>
    <phone>401-863-6551</phone>
    <email>katie_biello@brown.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Angela Bazzi, PhD</last_name>
    <email>abazzi@health.ucsd.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>AIDS Action</name>
      <address>
        <city>Cambridge</city>
        <state>Massachusetts</state>
        <zip>02139</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cassidy Ockene</last_name>
      <phone>617-927-6286</phone>
      <email>cockene@fenwayhealth.org</email>
    </contact>
    <investigator>
      <last_name>Michelle Bordeu, MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Greater Lawrence Family Health Center</name>
      <address>
        <city>Lawrence</city>
        <state>Massachusetts</state>
        <zip>01841</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christopher Bositis, MD</last_name>
      <phone>978-689-6444</phone>
      <email>cbositis@glfhc.org</email>
    </contact>
    <investigator>
      <last_name>Christopher Bositis, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Katrina Baumgartner, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>July 31, 2023</last_update_submitted>
  <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PrEP (pre-exposure prophylaxis )</keyword>
  <keyword>PWID (people who inject drugs)</keyword>
  <keyword>SSP (syringe service program)</keyword>
  <keyword>HIV education</keyword>
  <keyword>Motivational interviewing</keyword>
  <keyword>Self efficacy</keyword>
  <keyword>Social cognitive theory</keyword>
  <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>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>By request to the study investigators</ipd_description>
    <ipd_time_frame>Data will be available after the study has closed and after publication of the primary study findings.</ipd_time_frame>
    <ipd_access_criteria>Requests will be reviewed by the principal investigators.</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/NCT04430257
org study id: 2011002841
secondary id: R01DA051849-01
nct id: NCT04430257
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This randomized controlled trial will test the efficacy of "PrEP for Health," a behavioral
      intervention to improve the use of antiretroviral pre-exposure prophylaxis (PrEP) among
      at-risk people who inject drugs (PWID) in two syringe service program (SSP) settings in
      Lawrence and Boston/Cambridge, Massachusetts. The investigators will equally randomize 200
      PWID to receive either (a) the "PrEP for Health" intervention condition involving
      theory-informed HIV and PrEP education, motivational interviewing, problem-solving and
      planning, and ongoing patient navigation (n=100), or (b) the standard of care condition
      involving PrEP information and referrals (n=100). Successful PrEP uptake (via
      medical/pharmacy records), post-treatment PrEP adherence (assessed at 3 months via drug
      levels in hair), and longer-term PrEP adherence (assessed at 6 and 12 months via drug levels
      in hair) will be evaluated. The degree to which intervention efficacy occurs through specific
      conceptual mediators and differs according to hypothesized moderators will also be evaluated.
The overall goal of this proposal is to evaluate the efficacy of the "PrEP for Health"
      navigator delivered behavioral intervention in improving PrEP uptake (via medical/pharmacy
      records), post-treatment PrEP adherence (assessed at 3 months via drug levels in hair), and
      longer-term PrEP adherence (assessed at 6 and 12 months via drug levels in hair) among PWID
      in SSPs. Eligible PWID (n=200 total; 100 recruited from each study site) will be equally
      randomized to an active PrEP for Health intervention arm (n=100) or a Standard of Care
      control condition (n=100). Assessments will be conducted at baseline and 1, 3, 6, and 12
      months after randomization.

      We hypothesize that brief, multi-component behavioral intervention sessions with ongoing
      support delivered by trained PrEP Navigators within Syringe Service Programs (SSPs) will
      improve PrEP uptake, adherence, and long-term adherence in PWID by increasing HIV and PrEP
      knowledge (including alleviating concerns about side effects), increasing HIV risk
      perceptions and PrEP interest and motivation, improving PrEP use self-efficacy and behavioral
      skills, and reducing structural barriers over time. Based on our formative research, we also
      hypothesize that the strength of intervention effects may differ by key individual
      characteristics (age, gender, baseline sexual risk, polysubstance, and stimulant use).

      This is a randomized control trial (RCT). Participants will be recruited via outreach
      specialist at SSP sites and during routine community outreach practices of the organizations.
      After eligibility confirmation and baseline assessments, participants will be randomized to
      one of two study arms: 1) Standard of Care (SOC) Control Condition: as routinely provided
      through the SSP study sites, participants will receive information and services according to
      routine practice and a brief video that describes what PrEP is and how it works to prevent
      HIV via sexual and injection transmission; 2) "PrEP for Health" Intervention Condition: a
      trained PrEP Navigator will deliver a manualized PrEP uptake and adherence intervention in
      private counseling rooms at SSPs followed by 3 months of additional PrEP navigation support
      through in-person, phone, and text interactions as needed. Participants will complete a total
      of four follow-up visits over a 12-month period. Participants who initiate PrEP will have a
      hair sample collected at 3-, 6-, and 12-month visits. All participants will receive a rapid
      HIV screening test at 12-month follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: Individuals collecting the primary outcome data will be blinded to intervention condition.
measure: PrEP uptake
time frame: 3 months
description: PrEP uptake will be assessed via medical/pharmacy records
measure: Post-treatment PrEP adherence
time frame: 3 months
description: PrEP adherence will be assessed by drug levels in hair samples at the acute follow up time point (3 months post-baseline)
measure: Longer-term PrEP adherence
time frame: 6 and 12 months
description: Longer-term PrEP adherence will be assessed by drug levels in hair samples at 6 and 12-month post-baseline
arm group label: PrEP for health
arm group type: Experimental
description: Participants in the PrEP (pre-exposure prophylaxis) for health arm will receive theory informed HIV and PrEP education, motivational interviewing, problem-solving and planning, and ongoing patient navigation.
arm group label: Standard of care
arm group type: Active Comparator
description: Participants in the standard of care arm will receive PrEP information and referrals.
intervention type: Other
intervention name: HIV and PrEP education
description: Navigators will deliver Social Cognitive Theory-informed HIV and PrEP education.
arm group label: PrEP for health
intervention type: Behavioral
intervention name: Motivational interviewing
description: Bachelors-level PrEP Navigators who are trained in motivational interviewing (MI) will use MI to promote the behavioral intervention.
arm group label: PrEP for health
intervention type: Behavioral
intervention name: Problem-solving and planning
description: Bachelors-level PrEP Navigators will assist participants with problem-solving and planning.
arm group label: PrEP for health
intervention type: Behavioral
intervention name: Patient navigation
description: Ongoing PrEP navigation support to promote participants' initial and continued engagement with PrEP clinics affiliated with the two study sites
arm group label: PrEP for health
intervention type: Other
intervention name: PrEP information
description: A brief video that describes what PrEP is and how it works to prevent HIV via sexual and injection transmission will be shown to participants.
arm group label: PrEP for health
arm group label: Standard of care
intervention type: Other
intervention name: Referrals
description: Study staff will provide basic information about PrEP and referrals to PrEP clinicians.
arm group label: Standard of care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Katie Biello, PhD, MPH
role: Principal Investigator
affiliation: Brown University
last name: Angela Bazzi, PhD, MPH
role: Principal Investigator
affiliation: University of California, San Diego
last name: Katie Biello, PhD, MPH
phone: 401-863-6551
email: katie_biello@brown.edu
last name: Angela Bazzi, PhD
email: abazzi@health.ucsd.edu
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: Substance-Related Disorders
sharing ipd: Yes
ipd description: By request to the study investigators
ipd time frame: Data will be available after the study has closed and after publication of the primary study findings.
ipd access criteria: Requests will be reviewed by the principal investigators.