<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/NCT03304912</url>
  </required_header>
  <id_info>
    <org_study_id>1R21DA043417-01A1</org_study_id>
    <nct_id>NCT03304912</nct_id>
  </id_info>
  <brief_title>Packaging PrEP to Prevent HIV Among WWID</brief_title>
  <official_title>Packaging Pre-Exposure Prophylaxis (PrEP) to Prevent HIV Transmission Among Women Who Inject Drugs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Drexel University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Drexel 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>
      Evidence suggests women who inject drugs (WWID) are disproportionately vulnerable to HIV. If&#xD;
      HIV incidence continues unchecked, 1 in 23 WWID in the United States will acquire HIV. This&#xD;
      observational study will evaluate a novel approach for the delivery of pre-exposure&#xD;
      prophylaxis (PrEP) care: pairing PrEP with community-based syringe exchange program (SEP)&#xD;
      services. The rationale is that (1) SEPs may currently provide prescription medications and&#xD;
      long-term monitoring for other conditions such as buprenorphine for opioid dependence, so&#xD;
      providing PrEP care is a natural extension of what is already being done successfully; (2)&#xD;
      SEPs are a viable access point for many HIV-uninfected WWID who would be considered eligible&#xD;
      for PrEP under current clinical guidelines; and (3) PrEP interventions, delivered in settings&#xD;
      already utilized and trusted by WWID, will increase uptake, adherence and retention in PrEP.&#xD;
      We will enroll a cohort of 125 women and follow-them over six months. At their first study&#xD;
      visit, they will educated about and offered a prescription for PrEP. Those who indicate an&#xD;
      interest in PrEP will be able to return to the SEP one week later to obtain a paper PrEP&#xD;
      prescription or medication. All participants will be followed for six months using&#xD;
      qualitative interviews and surveys to understand facilitators and barriers to PrEP uptake and&#xD;
      engagement over time. In addition, we will collect urine and test it to detect the level of&#xD;
      drug concentration among women who initiate PrEP. This will allow us to know whether their&#xD;
      level of adherence translated to prevention effective drug levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective mixed methods study will be initiated within the largest SEP in the&#xD;
      mid-Atlantic region. Over six months, we will use semi-structured and in-depth interviews&#xD;
      based on the Behavioral Model for Vulnerable Populations, and drug-level monitoring for&#xD;
      emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) adherence, to address the following&#xD;
      specific aims: (1) Describe WWID's engagement in the PrEP care continuum (focusing on&#xD;
      critical moments when women could disengage or need additional support to remain in care).&#xD;
      (2) Identify factors from the Behavioral Model for Vulnerable Populations that are associated&#xD;
      with WWID's engagement in the PrEP care continuum. (3) Explore how and why model factors are&#xD;
      associated with WWID's decisions and ability to engage in PrEP care. A paired model of PrEP&#xD;
      and SEP services has yet to be tested.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 3, 2018</start_date>
  <completion_date type="Actual">October 8, 2019</completion_date>
  <primary_completion_date type="Actual">October 8, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>PrEP Uptake at Week 1</measure>
    <time_frame>1 week</time_frame>
    <description>Number of WWID accepting a paper Truvada prescription to fill at their preferred pharmacy or obtaining Truvada from the SSP among those who returned to care as verified in electronic medical records.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PrEP Uptake at Week 12</measure>
    <time_frame>12 weeks</time_frame>
    <description>Number of WWID accepting a paper Truvada prescription to fill at their preferred pharmacy or obtaining Truvada from the SSP among those who returned to care as verified in electronic medical records.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PrEP Adherence Based on Urinalysis at 12 Weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>Protection effective emtricitabine (FTC) concentration (&gt;1000 ng/ml) in urine. Analyzed only among women with available urine-analysis data that self-reported PrEP use at 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PrEP Adherence Based on Self-report at 12 Weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>Self-reported adherence was assessed with a single item administered on a computer assisted self-interview. The item, &quot;How many PrEP pills have you missed in the past 7 days?,&quot; had numerical response options ranging from zero to seven. Responses were recoded into: took zero doses within 7 days (operationalized as non-adherent), took 1-5 doses within 7 days defined as inconsistent operationalized), and took 6-7 doses within 7 days (operationalized as consistent adherence).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PrEP Uptake at Week 24</measure>
    <time_frame>24 weeks</time_frame>
    <description>Number of WWID accepting a paper Truvada prescription to fill at their preferred pharmacy or obtaining Truvada from the SSP among those who returned to care as verified in electronic medical records.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">105</enrollment>
  <condition>HIV/AIDS</condition>
  <arm_group>
    <arm_group_label>Women who inject drugs who are eligible for PrEP</arm_group_label>
    <description>Women who inject drugs who are eligible for PrEP are provided PrEP Education and option to accept a PrEP prescription.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PrEP Education and option to accept a PrEP prescription</intervention_name>
    <description>Participants will receive educational information about PrEP, be offered a PrEP prescription, and those who choose to initiated PrEP will be monitored for side-effects and adherence at their follow-up visit. There is no group assignment within this study and WWID do not have to choose to initiate PrEP. Rather, the goal of this study is to understand factors that impact PrEP initiation (and engagement in the PrEP care continuum).</description>
    <arm_group_label>Women who inject drugs who are eligible for PrEP</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Community sample to be recruited from a syringe exchange program.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV sero-negative&#xD;
&#xD;
          -  Females&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Reporting non-prescription injection drug use and any of the following:&#xD;
&#xD;
               1. Syringe sharing&#xD;
&#xD;
               2. Injecting drugs with a HIV-positive partner&#xD;
&#xD;
               3. Recent opioid agonist treatment but still injecting drugs&#xD;
&#xD;
               4. Sex exchange&#xD;
&#xD;
               5. Inconsistent condom use&#xD;
&#xD;
               6. Recent bacterial sexually transmitted infection (STI)&#xD;
&#xD;
               7. and/or sex with a HIV-positive partner&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HIV seropositivity&#xD;
&#xD;
          -  Currently taking PrEP&#xD;
&#xD;
          -  Pregnant, breastfeeding or trying to become pregnant&#xD;
&#xD;
          -  Previous enrollment in the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</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>Alexis M Roth, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Drexel University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Drexel University Dornsife School of Public Health</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <results_first_submitted>April 4, 2023</results_first_submitted>
  <results_first_submitted_qc>June 21, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">July 12, 2023</results_first_posted>
  <last_update_submitted>June 21, 2023</last_update_submitted>
  <last_update_submitted_qc>June 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Drexel University</investigator_affiliation>
    <investigator_full_name>Alexis Roth</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Pre-Exposure Prophylaxis</keyword>
  <keyword>Injection Drug Use</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>N/A, Individual Participant Data (IPD) will not be shared.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT03304912/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 13, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT03304912/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>10 participants were withdrawn following enrollment because we were unable to draw blood in order to be able to prescribe PrEP medication.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Women Who Inject Drugs (WWID) Who Are Eligible for Pre-exposure Prophylaxis (PrEP)</title>
          <description>The cohort will be comprised of WWID who are eligible for PrEP.&#xD;
PrEP Education and option to accept a PrEP prescription: Participants will receive educational information about PrEP, be offered a PrEP prescription, and those who choose to initiated PrEP will be monitored for side-effects and adherence at their follow-up visit. There is no group assignment within this study and WWID do not have to choose to initiate PrEP. Rather, the goal of this study is to understand factors that impact PrEP initiation (and engagement in the PrEP care continuum).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="95"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>PrEP Education and Option to Accept a PrEP Prescription</title>
          <description>Participants will receive educational information about PrEP, be offered a PrEP prescription, and those who choose to initiated PrEP will be monitored for side-effects and adherence at their follow-up visit. There is no group assignment within this study and WWID do not have to choose to initiate PrEP.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="95"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="95"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="95"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="84"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>PrEP Uptake at Week 1</title>
        <description>Number of WWID accepting a paper Truvada prescription to fill at their preferred pharmacy or obtaining Truvada from the SSP among those who returned to care as verified in electronic medical records.</description>
        <time_frame>1 week</time_frame>
        <population>Of the 95 WWID who were offered a PrEP prescription, 89 women returned at week 1.</population>
        <group_list>
          <group group_id="O1">
            <title>PrEP Education and Option to Accept a PrEP Prescription</title>
            <description>Participants will receive educational information about PrEP, be offered a PrEP prescription, and those who choose to initiated PrEP will be monitored for side-effects and adherence at their follow-up visit. There is no group assignment within this study and WWID do not have to choose to initiate PrEP.</description>
          </group>
        </group_list>
        <measure>
          <title>PrEP Uptake at Week 1</title>
          <description>Number of WWID accepting a paper Truvada prescription to fill at their preferred pharmacy or obtaining Truvada from the SSP among those who returned to care as verified in electronic medical records.</description>
          <population>Of the 95 WWID who were offered a PrEP prescription, 89 women returned at week 1.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PrEP Uptake at Week 12</title>
        <description>Number of WWID accepting a paper Truvada prescription to fill at their preferred pharmacy or obtaining Truvada from the SSP among those who returned to care as verified in electronic medical records.</description>
        <time_frame>12 weeks</time_frame>
        <population>Number of WWID returning to care at week 12.</population>
        <group_list>
          <group group_id="O1">
            <title>WWID Who Are Eligible for PrEP</title>
            <description>The cohort will be comprised of women who inject drugs who are eligible for PrEP.&#xD;
PrEP Education and option to accept a PrEP prescription: Participants will receive educational information about PrEP, be offered a PrEP prescription, and those who choose to initiated PrEP will be monitored for side-effects and adherence at their follow-up visit. There is no group assignment within this study and WWID do not have to choose to initiate PrEP. Rather, the goal of this study is to understand factors that impact PrEP initiation (and engagement in the PrEP care continuum).</description>
          </group>
        </group_list>
        <measure>
          <title>PrEP Uptake at Week 12</title>
          <description>Number of WWID accepting a paper Truvada prescription to fill at their preferred pharmacy or obtaining Truvada from the SSP among those who returned to care as verified in electronic medical records.</description>
          <population>Number of WWID returning to care at week 12.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PrEP Adherence Based on Urinalysis at 12 Weeks</title>
        <description>Protection effective emtricitabine (FTC) concentration (&gt;1000 ng/ml) in urine. Analyzed only among women with available urine-analysis data that self-reported PrEP use at 12 weeks</description>
        <time_frame>12 weeks</time_frame>
        <population>Women with available urine-analysis data that self-reported PrEP use at 3-months</population>
        <group_list>
          <group group_id="O1">
            <title>WWID Who Are Eligible for PrEP</title>
            <description>The cohort will be comprised of women who inject drugs who are eligible for PrEP.&#xD;
PrEP Education and option to accept a PrEP prescription: Participants will receive educational information about PrEP, be offered a PrEP prescription, and those who choose to initiated PrEP will be monitored for side-effects and adherence at their follow-up visit. There is no group assignment within this study and WWID do not have to choose to initiate PrEP. Rather, the goal of this study is to understand factors that impact PrEP initiation (and engagement in the PrEP care continuum).</description>
          </group>
        </group_list>
        <measure>
          <title>PrEP Adherence Based on Urinalysis at 12 Weeks</title>
          <description>Protection effective emtricitabine (FTC) concentration (&gt;1000 ng/ml) in urine. Analyzed only among women with available urine-analysis data that self-reported PrEP use at 12 weeks</description>
          <population>Women with available urine-analysis data that self-reported PrEP use at 3-months</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PrEP Adherence Based on Self-report at 12 Weeks</title>
        <description>Self-reported adherence was assessed with a single item administered on a computer assisted self-interview. The item, &quot;How many PrEP pills have you missed in the past 7 days?,&quot; had numerical response options ranging from zero to seven. Responses were recoded into: took zero doses within 7 days (operationalized as non-adherent), took 1-5 doses within 7 days defined as inconsistent operationalized), and took 6-7 doses within 7 days (operationalized as consistent adherence).</description>
        <time_frame>12 weeks</time_frame>
        <population>Number of women responding to adherence measure on survey</population>
        <group_list>
          <group group_id="O1">
            <title>WWID Who Are Eligible for PrEP</title>
            <description>The cohort will be comprised of women who inject drugs who are eligible for PrEP.&#xD;
PrEP Education and option to accept a PrEP prescription: Participants will receive educational information about PrEP, be offered a PrEP prescription, and those who choose to initiated PrEP will be monitored for side-effects and adherence at their follow-up visit. There is no group assignment within this study and WWID do not have to choose to initiate PrEP. Rather, the goal of this study is to understand factors that impact PrEP initiation (and engagement in the PrEP care continuum).</description>
          </group>
        </group_list>
        <measure>
          <title>PrEP Adherence Based on Self-report at 12 Weeks</title>
          <description>Self-reported adherence was assessed with a single item administered on a computer assisted self-interview. The item, &quot;How many PrEP pills have you missed in the past 7 days?,&quot; had numerical response options ranging from zero to seven. Responses were recoded into: took zero doses within 7 days (operationalized as non-adherent), took 1-5 doses within 7 days defined as inconsistent operationalized), and took 6-7 doses within 7 days (operationalized as consistent adherence).</description>
          <population>Number of women responding to adherence measure on survey</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Non-adherence</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Inconsistent-adherence</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Adherence</title>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PrEP Uptake at Week 24</title>
        <description>Number of WWID accepting a paper Truvada prescription to fill at their preferred pharmacy or obtaining Truvada from the SSP among those who returned to care as verified in electronic medical records.</description>
        <time_frame>24 weeks</time_frame>
        <population>Number of women returning to care at week 24</population>
        <group_list>
          <group group_id="O1">
            <title>PrEP Education and Option to Accept a PrEP Prescription</title>
            <description>Participants will receive educational information about PrEP, be offered a PrEP prescription, and those who choose to initiated PrEP will be monitored for side-effects and adherence at their follow-up visit. There is no group assignment within this study and WWID do not have to choose to initiate PrEP.</description>
          </group>
        </group_list>
        <measure>
          <title>PrEP Uptake at Week 24</title>
          <description>Number of WWID accepting a paper Truvada prescription to fill at their preferred pharmacy or obtaining Truvada from the SSP among those who returned to care as verified in electronic medical records.</description>
          <population>Number of women returning to care at week 24</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <desc>The definitions of adverse events and serious adverse events did not differ from the clinicaltrials.gov.</desc>
      <group_list>
        <group group_id="E1">
          <title>Women Who Inject Drugs (WWID) Who Are Eligible for PrEP.</title>
          <description>The cohort will be comprised of women who inject drugs who are eligible for PrEP.&#xD;
PrEP Education and option to accept a PrEP prescription: Participants will receive educational information about PrEP, be offered a PrEP prescription, and those who choose to initiated PrEP will be monitored for side-effects and adherence at their follow-up visit. There is no group assignment within this study and WWID do not have to choose to initiate PrEP. Rather, the goal of this study is to understand factors that impact PrEP initiation (and engagement in the PrEP care continuum).</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization</sub_title>
                <description>Study participant is hospitalized whether it's determined to be related to study involvement or not.</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Victimization</sub_title>
                <description>Study participant reports they have been physically assaulted in some manner during the course of the study.</description>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Alexis Roth, PhD, MPH</name_or_title>
      <organization>Drexel University</organization>
      <phone>267.359.6123</phone>
      <email>alexisroth@drexel.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03304912
org study id: 1R21DA043417-01A1
nct id: NCT03304912
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Evidence suggests women who inject drugs (WWID) are disproportionately vulnerable to HIV. If
      HIV incidence continues unchecked, 1 in 23 WWID in the United States will acquire HIV. This
      observational study will evaluate a novel approach for the delivery of pre-exposure
      prophylaxis (PrEP) care: pairing PrEP with community-based syringe exchange program (SEP)
      services. The rationale is that (1) SEPs may currently provide prescription medications and
      long-term monitoring for other conditions such as buprenorphine for opioid dependence, so
      providing PrEP care is a natural extension of what is already being done successfully; (2)
      SEPs are a viable access point for many HIV-uninfected WWID who would be considered eligible
      for PrEP under current clinical guidelines; and (3) PrEP interventions, delivered in settings
      already utilized and trusted by WWID, will increase uptake, adherence and retention in PrEP.
      We will enroll a cohort of 125 women and follow-them over six months. At their first study
      visit, they will educated about and offered a prescription for PrEP. Those who indicate an
      interest in PrEP will be able to return to the SEP one week later to obtain a paper PrEP
      prescription or medication. All participants will be followed for six months using
      qualitative interviews and surveys to understand facilitators and barriers to PrEP uptake and
      engagement over time. In addition, we will collect urine and test it to detect the level of
      drug concentration among women who initiate PrEP. This will allow us to know whether their
      level of adherence translated to prevention effective drug levels.
This prospective mixed methods study will be initiated within the largest SEP in the
      mid-Atlantic region. Over six months, we will use semi-structured and in-depth interviews
      based on the Behavioral Model for Vulnerable Populations, and drug-level monitoring for
      emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) adherence, to address the following
      specific aims: (1) Describe WWID's engagement in the PrEP care continuum (focusing on
      critical moments when women could disengage or need additional support to remain in care).
      (2) Identify factors from the Behavioral Model for Vulnerable Populations that are associated
      with WWID's engagement in the PrEP care continuum. (3) Explore how and why model factors are
      associated with WWID's decisions and ability to engage in PrEP care. A paired model of PrEP
      and SEP services has yet to be tested.
observational model: Cohort
time perspective: Prospective
measure: PrEP Uptake at Week 1
time frame: 1 week
description: Number of WWID accepting a paper Truvada prescription to fill at their preferred pharmacy or obtaining Truvada from the SSP among those who returned to care as verified in electronic medical records.
measure: PrEP Uptake at Week 12
time frame: 12 weeks
description: Number of WWID accepting a paper Truvada prescription to fill at their preferred pharmacy or obtaining Truvada from the SSP among those who returned to care as verified in electronic medical records.
measure: PrEP Adherence Based on Urinalysis at 12 Weeks
time frame: 12 weeks
description: Protection effective emtricitabine (FTC) concentration (>1000 ng/ml) in urine. Analyzed only among women with available urine-analysis data that self-reported PrEP use at 12 weeks
measure: PrEP Adherence Based on Self-report at 12 Weeks
time frame: 12 weeks
description: Self-reported adherence was assessed with a single item administered on a computer assisted self-interview. The item, "How many PrEP pills have you missed in the past 7 days?," had numerical response options ranging from zero to seven. Responses were recoded into: took zero doses within 7 days (operationalized as non-adherent), took 1-5 doses within 7 days defined as inconsistent operationalized), and took 6-7 doses within 7 days (operationalized as consistent adherence).
measure: PrEP Uptake at Week 24
time frame: 24 weeks
description: Number of WWID accepting a paper Truvada prescription to fill at their preferred pharmacy or obtaining Truvada from the SSP among those who returned to care as verified in electronic medical records.
arm group label: Women who inject drugs who are eligible for PrEP
description: Women who inject drugs who are eligible for PrEP are provided PrEP Education and option to accept a PrEP prescription.
intervention type: Behavioral
intervention name: PrEP Education and option to accept a PrEP prescription
description: Participants will receive educational information about PrEP, be offered a PrEP prescription, and those who choose to initiated PrEP will be monitored for side-effects and adherence at their follow-up visit. There is no group assignment within this study and WWID do not have to choose to initiate PrEP. Rather, the goal of this study is to understand factors that impact PrEP initiation (and engagement in the PrEP care continuum).
arm group label: Women who inject drugs who are eligible for PrEP
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Alexis M Roth, PhD, MPH
role: Principal Investigator
affiliation: Drexel University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Drexel University
investigator full name: Alexis Roth
investigator title: Assistant Professor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
sharing ipd: No
ipd description: N/A, Individual Participant Data (IPD) will not be shared.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 