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/NCT05984966</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00000657</org_study_id>
      <nct_id>NCT05984966</nct_id>
    </id_info>
    <brief_title>Supported Employment COVID-19 Rapid Testing for PWID</brief_title>
    <official_title>Supported Employment to Create a Community Culture of COVID-19 Rapid Testing Among People Who Inject Drugs: PeerConnect2Test</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Oregon</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Oregon</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>
        This community-engaged project aims to improve the accessibility of rapid tests through a&#xD;
        supported employment program for people who inject drugs (PWID). The program is called Peer&#xD;
        Connect2Test (PeerC2T). PWID will be recruited by a community partner who provides syringe&#xD;
        exchange services. PWID will the trained by the community partner to become peer health&#xD;
        workers (PHW) to distribute SARS-CoV-2 rapid tests to other PWID. Investigators expect that&#xD;
        PeerC2T will improve knowledge, self-efficacy, and health behaviors among PHW (Aim 1). The&#xD;
        study will use the RE-AIM framework in Aims 2 and 3 to evaluate whether PeerC2T improves&#xD;
        SARS-CoV-2 testing uptake among other PWID (RE; Aim 2), and identify intervention&#xD;
        considerations (AIM; Aim 3). The overall goal of this project is develop a transformative&#xD;
        community-driven intervention in partnership with a community partner to promote widespread&#xD;
        access to rapid testing among PWID.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2024</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Qualitative semi-structured interview with PWID Peer Health Worker</measure>
      <time_frame>3 months post intervention involvement</time_frame>
      <description>Includes:(a) provided participant with purpose and meaning; (b) helped them create more meaningful social relationships; (c) provided opportunities for engaging with society in a positive way; (d) helped them feel competent and capable; and (e) facilitated optimism about the future. Coded using NVivo text-analysis software.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Self-efficacy of PWID Peer Health Worker</measure>
      <time_frame>Change from Baseline Self-efficacy at 3 months</time_frame>
      <description>To test Aim 1 using qualitative data, we will develop self-efficacy items based on skills taught in the supported employment training 5-point response option (1 = Strongly disagree, 5 = strongly agree).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Behavioral Intentions of Peer Health Worker</measure>
      <time_frame>Change from Baseline Behavior at 3 months</time_frame>
      <description>To test Aim 1, we will adapt questions from the Preventative Medicine Attitudes and Activities Questionnaire, and using the same response option, reframe the items based on how often they intend to engage in the behavior. We will develop the knowledge items based on skills taught in the training. Higher scores indicate greater behavioral intentions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Flourishing Scale (Well-Being)</measure>
      <time_frame>Change from Baseline Flourishing (well-being) at 3 months</time_frame>
      <description>To test Aim 1, we will use an 8-item summary measure of self-perceived success in important areas such as relationships, self-esteem, purpose, and optimism. Questions pertain to experiences over the past 4-weeks (e.g., My social relationships are supportive and rewarding, I am engaged and interested in my daily activities) and responses are indicated on a 7-point scale (1 = Strongly disagree, 7 = Strongly agree). The possible range of scores is from 8 (lowest possible) to 56 (highest PWB possible). A high score represents a person with many psychological resources and strengths</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percent of people who inject drugs who agree to testing for COVID-19</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Peer Health Workers will offer a rapid test to 1000 PWID. The percent of PWID who agree to take the test serves as this measure for Aim 2a.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">350</enrollment>
    <condition>Health Behavior</condition>
    <arm_group>
      <arm_group_label>Supported Employment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Supported employment program (Peer Connect2Test) for people who inject drugs to provide SARS-CoV-2 rapid tests to others in their networks</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Supported Employment</intervention_name>
      <description>PeerC2T is part of a supported employment program where PWID are trained and supported to provide PWID with job skills to be able to act as Peer Health Worker to facilitate distribution of rapid SARS-CoV-2 testing to other PWID. The effect of the training on the Peer Health Worker themself will be evaluated (Aim 1). In addition, in Aim 2 they will distribute the rapid test kits in places of residence such as tents, shelters, apartments, trailers, or houses or locations where other PWID frequently engage with services such as syringe exchange. The kit is the BinaxNOW COVID-19 Antigen Self Test, which is approved to be used as a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. PWID community members will be offered a free test kit, and the Peer Health Worker will record whether the community member elected to take the test (yes/no), and they will also collect administrative demographic data on the PWID.</description>
      <arm_group_label>Supported Employment</arm_group_label>
      <other_name>Peer Connect2Test</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18 and older, understand English&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#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_contact>
      <last_name>Camille C Cioffi</last_name>
      <phone>541-346-4755</phone>
      <email>ccioffi@uoregon.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Oregon</name>
        <address>
          <city>Eugene</city>
          <state>Oregon</state>
          <zip>97403</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>February 2023</verification_date>
    <study_first_submitted>February 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>We will share data with the RADx-UP Data Coordination Center at Duke University. Data will be de-identified and available to other researchers for further use.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>Upon study completion. Timeframe available determined by the National Institutes of Health.</ipd_time_frame>
      <ipd_url>https://radx-up.org/research/cdes/</ipd_url>
    </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/NCT05984966
  org study id: STUDY00000657
  nct id: NCT05984966
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This community-engaged project aims to improve the accessibility of rapid tests through a
        supported employment program for people who inject drugs (PWID). The program is called Peer
        Connect2Test (PeerC2T). PWID will be recruited by a community partner who provides syringe
        exchange services. PWID will the trained by the community partner to become peer health
        workers (PHW) to distribute SARS-CoV-2 rapid tests to other PWID. Investigators expect that
        PeerC2T will improve knowledge, self-efficacy, and health behaviors among PHW (Aim 1). The
        study will use the RE-AIM framework in Aims 2 and 3 to evaluate whether PeerC2T improves
        SARS-CoV-2 testing uptake among other PWID (RE; Aim 2), and identify intervention
        considerations (AIM; Aim 3). The overall goal of this project is develop a transformative
        community-driven intervention in partnership with a community partner to promote widespread
        access to rapid testing among PWID.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Qualitative semi-structured interview with PWID Peer Health Worker
  time frame: 3 months post intervention involvement
  description: Includes:(a) provided participant with purpose and meaning; (b) helped them create more meaningful social relationships; (c) provided opportunities for engaging with society in a positive way; (d) helped them feel competent and capable; and (e) facilitated optimism about the future. Coded using NVivo text-analysis software.
  measure: Change in Self-efficacy of PWID Peer Health Worker
  time frame: Change from Baseline Self-efficacy at 3 months
  description: To test Aim 1 using qualitative data, we will develop self-efficacy items based on skills taught in the supported employment training 5-point response option (1 = Strongly disagree, 5 = strongly agree).
  measure: Change in Behavioral Intentions of Peer Health Worker
  time frame: Change from Baseline Behavior at 3 months
  description: To test Aim 1, we will adapt questions from the Preventative Medicine Attitudes and Activities Questionnaire, and using the same response option, reframe the items based on how often they intend to engage in the behavior. We will develop the knowledge items based on skills taught in the training. Higher scores indicate greater behavioral intentions.
  measure: Change in Flourishing Scale (Well-Being)
  time frame: Change from Baseline Flourishing (well-being) at 3 months
  description: To test Aim 1, we will use an 8-item summary measure of self-perceived success in important areas such as relationships, self-esteem, purpose, and optimism. Questions pertain to experiences over the past 4-weeks (e.g., My social relationships are supportive and rewarding, I am engaged and interested in my daily activities) and responses are indicated on a 7-point scale (1 = Strongly disagree, 7 = Strongly agree). The possible range of scores is from 8 (lowest possible) to 56 (highest PWB possible). A high score represents a person with many psychological resources and strengths
  measure: Percent of people who inject drugs who agree to testing for COVID-19
  time frame: through study completion, an average of 1 year
  description: Peer Health Workers will offer a rapid test to 1000 PWID. The percent of PWID who agree to take the test serves as this measure for Aim 2a.
  arm group label: Supported Employment
  arm group type: Experimental
  description: Supported employment program (Peer Connect2Test) for people who inject drugs to provide SARS-CoV-2 rapid tests to others in their networks
  intervention type: Behavioral
  intervention name: Supported Employment
  description: PeerC2T is part of a supported employment program where PWID are trained and supported to provide PWID with job skills to be able to act as Peer Health Worker to facilitate distribution of rapid SARS-CoV-2 testing to other PWID. The effect of the training on the Peer Health Worker themself will be evaluated (Aim 1). In addition, in Aim 2 they will distribute the rapid test kits in places of residence such as tents, shelters, apartments, trailers, or houses or locations where other PWID frequently engage with services such as syringe exchange. The kit is the BinaxNOW COVID-19 Antigen Self Test, which is approved to be used as a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. PWID community members will be offered a free test kit, and the Peer Health Worker will record whether the community member elected to take the test (yes/no), and they will also collect administrative demographic data on the PWID.
  arm group label: Supported Employment
  other name: Peer Connect2Test
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Camille C Cioffi
  phone: 541-346-4755
  email: ccioffi@uoregon.edu
  facility: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: We will share data with the RADx-UP Data Coordination Center at Duke University. Data will be de-identified and available to other researchers for further use.
  ipd info type: Study Protocol
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: Upon study completion. Timeframe available determined by the National Institutes of Health.
  ipd url: https://radx-up.org/research/cdes/