<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/NCT02213328</url>
  </required_header>
  <id_info>
    <org_study_id>CHAMPS PrEP</org_study_id>
    <secondary_id>11931</secondary_id>
    <nct_id>NCT02213328</nct_id>
  </id_info>
  <brief_title>Acceptability, Safety, and Use of Daily Truvada Pre-Exposure Prophylaxis in Adolescents</brief_title>
  <official_title>CHAMPS: Choices For Adolescent Prevention Methods For South Africa. Pilot Study B: 'PlusPills'</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institute of Allergy and Infectious Diseases (NIAID)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Truvada (emtricitabine/tenofovir disoproxil fumarate, or FTC/TDF) is a type of antiretroviral&#xD;
      (ARV) medicine that is commonly used to treat HIV. Truvada is also used as pre-exposure&#xD;
      prophylaxis (PrEP) to prevent HIV infection in HIV-negative adults. The purpose of this study&#xD;
      is to evaluate the acceptability, safety, and use of daily Truvada PrEP as part of a&#xD;
      comprehensive HIV prevention package in healthy, HIV-uninfected adolescents 15 to 19 years of&#xD;
      age.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Truvada PrEP is an approach used to protect HIV-uninfected adults against possible infection&#xD;
      with HIV. The approach involves taking Truvada every day to prevent HIV infection in case the&#xD;
      person is exposed to HIV (for example, through sex with an HIV-infected person). The purpose&#xD;
      of this study is to evaluate the acceptability, safety, and use of daily Truvada PrEP as part&#xD;
      of a comprehensive HIV prevention package in healthy, HIV-uninfected adolescents 15 to 19&#xD;
      years old. In addition to Truvada PrEP, the HIV prevention package will include HIV testing,&#xD;
      management of sexually transmitted infections (STIs), risk reduction counseling, access to&#xD;
      condoms, post-exposure prophylaxis (PEP), and circumcision counseling and referral for male&#xD;
      participants.&#xD;
&#xD;
      The study will enroll 150 healthy, HIV-uninfected adolescents 15 to 19 years of age. The&#xD;
      study will last for 12 months (52 weeks) and involve scheduled clinic visits at study entry&#xD;
      (Week 0) and Weeks 4, 8, 12, 24, 36, 48, and 52.&#xD;
&#xD;
      For the first 12 weeks of the study, all participants will be provided with a supply of&#xD;
      Truvada tablets to take once daily as part of the comprehensive HIV prevention package. At&#xD;
      Weeks 12, 24, 36, and 48, participants will be offered the following options: to continue&#xD;
      with the full HIV prevention package plus Truvada PrEP, to stop Truvada PrEP and continue&#xD;
      with rest of the HIV prevention package, or to re-start Truvada PrEP if previously stopped.&#xD;
      After Week 12 of the study, Truvada tablets will be given only to those participants who&#xD;
      decide to take PrEP and who do not have any medical reasons not to do so. Regardless whether&#xD;
      they choose to use Truvada PrEP after Week 12, all study participants will be followed&#xD;
      through Week 52 of the study.&#xD;
&#xD;
      All study visits will include blood collection, counseling before and after HIV testing,&#xD;
      urine collection for pregnancy testing (female participants only), completion of a sexual&#xD;
      risk behavior questionnaire, receipt of a supply of condoms, contraceptive counseling, a&#xD;
      medical history review, and disclosure of available test results. Select study visits may&#xD;
      include a physical exam, blood and urine collection, testing and treatment of STIs, adherence&#xD;
      counseling, and an acceptability assessment. Between Months 11 and 12 of the study, some&#xD;
      participants will be randomly selected to participate in focus groups to discuss their&#xD;
      experiences while taking Truvada PrEP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2015</start_date>
  <completion_date type="Actual">March 6, 2017</completion_date>
  <primary_completion_date type="Actual">March 6, 2017</primary_completion_date>
  <phase>Phase 2</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>The Percentage of Participants Who Report Willingness to Use the Study Regimen, Take up PrEP, and Remain on PrEP as Part of a Comprehensive Prevention Package</measure>
    <time_frame>Measured through Week 48</time_frame>
    <description>The percentage of participants who report willingness to use the study regimen, take up PrEP, and remain on PrEP as part of a comprehensive prevention package measured at different time points in the study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Acceptability as Per Questionnaire Administered at Week 48</measure>
    <time_frame>Measured at Week 48</time_frame>
    <description>Acceptability was assessed by asking partcipants if they liked truvada, at the week 48 visit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Adolescents Who Continue to Use PrEP (as Indicated by Dried Blood Spot [DBS] Levels) After the Initial 3-month Period</measure>
    <time_frame>Measured through Week 48</time_frame>
    <description>Number of adolescents who continued to use PrEP (as indicated by dried blood spot level) after the initial 3-month period as indicated by DBS at week 24/36/48</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Grades 2, 3, and 4 Clinical and Laboratory Adverse Events</measure>
    <time_frame>Measured through Week 48</time_frame>
    <description>Assessment of Grades 2, 3, and 4 clinical and laboratory adverse events measured through week 48 using the DAIDS table for grading adult and paediatric adverse events, dated Dec 2004, (clarification Aug 2009). Expedited Adverse Event (EAE) reporting followed standard reporting requirements as defined in the DAIDS Manual for Expedited Reporting of Adverse Events version 2·0, March 2011.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Adolescents Enrolled and Retained in the Study</measure>
    <time_frame>Measured through Week 52</time_frame>
    <description>Count of participants who had been enrolled in the study and successfully completed the study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Used PrEP at Any Time Point During the Study, Measured With Drug Levels at M4/8/12/24/36</measure>
    <time_frame>Measured through Week 48</time_frame>
    <description>Number of participants who used oral PrEP at any time during the study and had drug levels present at any time point</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Adolescents With Detectable Drug Levels Who Report Using PrEP</measure>
    <time_frame>Measured though Week 48</time_frame>
    <description>Proportion of adolescents with detectable drug levels who report using PrEP at weeks 12,24,36,48</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting Multiple Partners in the Preceding Year as Evidenced by Participant Responses to Interviewer Administered Questionnaires at Enrolment</measure>
    <time_frame>Baseline</time_frame>
    <description>Participants reporting multiple partners during interviewer administered questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reported Consistent Condom Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires Adminstered at the Enrolment Visit</measure>
    <time_frame>Baseline</time_frame>
    <description>Reported consistent condom use as evidenced by participant responses to interviewer-administered questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reported Alcohol and Substance Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires at the Enrolment Visit</measure>
    <time_frame>Baseline visit</time_frame>
    <description>Reported substance use and alcohol use as evidenced by participant responses to interviewer-administered questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Study Participants Who Seroconverted During the Study, Measured Until Month 52</measure>
    <time_frame>Measured through Week 52</time_frame>
    <description>Frequency of HIV infection as measured by seroconversion of study participants during the approximate 12 months of follow up. HIV rapid testing was done in parallel using Determine™ HIV-1/2 Ag/Ab Combo and Uni-Gold™ Recombigen® HIV-1/2. If the rapid HIV test was reactive, an HIV-1 RNA qualitative assay (Abbot) was performed. A positive test was confirmed with a second blood sample collected a week later.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">148</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>Truvada</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 52.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Truvada</intervention_name>
    <description>Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.</description>
    <arm_group_label>Truvada</arm_group_label>
    <other_name>emtricitabine/tenofovir disoproxil fumarate, FTC/TDF</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 15 to 19 years (inclusive) at screening, verified per study site standard&#xD;
             operating procedures (SOPs)&#xD;
&#xD;
          -  Able and willing to provide written informed consent/assent (age dependent) to be&#xD;
             screened for and to take part in the study&#xD;
&#xD;
          -  Have a guardian who is able and willing to provide written informed consent for his or&#xD;
             her child to be screened for and to take part in the study&#xD;
&#xD;
          -  Able and willing to provide adequate locator information, as defined in site standard&#xD;
             operating procedures (SOPs)&#xD;
&#xD;
          -  HIV-uninfected based on testing performed by study staff at screening and enrollment&#xD;
&#xD;
          -  Sexually active, as defined as a minimum of one act of (penile vaginal) sexual&#xD;
             intercourse in the last 12 months, per self-report&#xD;
&#xD;
          -  (For female participants) Negative pregnancy test at screening and enrollment and, per&#xD;
             participant report, does not intend to become pregnant in the next 12 months&#xD;
&#xD;
          -  (For female participants) Using an effective method of contraception at enrollment,&#xD;
             and intending to use an effective method for the study duration; effective methods&#xD;
             include low dose oral, implant, or injectable hormonal methods.&#xD;
&#xD;
          -  Does not report intention to relocate out of the study area during the course of the&#xD;
             study&#xD;
&#xD;
          -  Does not have job or other obligations that would require long absences from the area&#xD;
             (for more than 4 weeks at a time)&#xD;
&#xD;
          -  Willing to undergo all study-required procedures&#xD;
&#xD;
          -  At screening and enrollment, agrees not to participate in other research studies&#xD;
             involving drugs or medical devices for the next 12 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants who meet any of the following criteria, at baseline, are excluded from the&#xD;
        study:&#xD;
&#xD;
          -  As determined by the Site Investigator, any significant uncontrolled active or chronic&#xD;
             disease process such as but not limited to diabetes, hypertension, and other diseases&#xD;
             involving the cardiovascular, pulmonary, gastrointestinal, genitourinary,&#xD;
             musculoskeletal, and central nervous systems&#xD;
&#xD;
          -  Confirmed Grade 2 or greater hypophosphatemia&#xD;
&#xD;
          -  Presence of serious psychiatric symptoms (e.g., active hallucinations)&#xD;
&#xD;
          -  Visibly distraught at the time of consent (e.g., suicidal, homicidal, exhibiting&#xD;
             violent behavior)&#xD;
&#xD;
          -  Intoxicated or under the influence of alcohol or other drugs at the time of consent&#xD;
&#xD;
          -  Acute or chronic hepatitis B infection (i.e., if hepatitis B surface antigen positive)&#xD;
&#xD;
          -  Hepatitis B seronegative and refuses vaccination&#xD;
&#xD;
          -  Renal dysfunction (creatinine clearance less than 75 ml/min); Use Cockroft-Gault&#xD;
             equation as detailed in the protocol&#xD;
&#xD;
          -  Urine dipstick for protein and glucose, excluding values of &quot;1 +&quot; or greater&#xD;
&#xD;
          -  Any history of bone fractures not explained by trauma&#xD;
&#xD;
          -  Any Grade 2 or greater toxicity on screening tests and assessments&#xD;
&#xD;
          -  Concurrent participation in an HIV vaccine study or other investigational drug study&#xD;
&#xD;
          -  Known allergy/sensitivity to the study drug or its components&#xD;
&#xD;
          -  Use of disallowed medications (as detailed in the protocol)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Linda-Gail Bekker, MBChB, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Desmond Tutu HIV Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Desmond Tutu HIV Foundation Non-Network CRS</name>
      <address>
        <city>Cape Town</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Perinatal HIV Non-network Research CRS</name>
      <address>
        <city>Soweto</city>
        <zip>1862</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <results_first_submitted>March 19, 2018</results_first_submitted>
  <results_first_submitted_qc>June 14, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">July 3, 2023</results_first_posted>
  <last_update_submitted>June 14, 2023</last_update_submitted>
  <last_update_submitted_qc>June 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tenofovir</mesh_term>
    <mesh_term>Emtricitabine</mesh_term>
    <mesh_term>Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 29, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT02213328/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 29, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT02213328/SAP_001.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>July 24, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT02213328/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Truvada</title>
          <description>All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 48.&#xD;
Truvada: Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="148"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="120"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants are adolescent male and female 15-19 years old</population>
      <group_list>
        <group group_id="B1">
          <title>Truvada</title>
          <description>All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 48.&#xD;
Truvada: Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="148"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18" lower_limit="17" upper_limit="19"/>
                  </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="99"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="148"/>
                  </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="148"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>South Africa</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Percentage of Participants Who Report Willingness to Use the Study Regimen, Take up PrEP, and Remain on PrEP as Part of a Comprehensive Prevention Package</title>
        <description>The percentage of participants who report willingness to use the study regimen, take up PrEP, and remain on PrEP as part of a comprehensive prevention package measured at different time points in the study</description>
        <time_frame>Measured through Week 48</time_frame>
        <population>Enrolled participants</population>
        <group_list>
          <group group_id="O1">
            <title>Truvada</title>
            <description>All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 48.&#xD;
Truvada: Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.</description>
          </group>
        </group_list>
        <measure>
          <title>The Percentage of Participants Who Report Willingness to Use the Study Regimen, Take up PrEP, and Remain on PrEP as Part of a Comprehensive Prevention Package</title>
          <description>The percentage of participants who report willingness to use the study regimen, take up PrEP, and remain on PrEP as part of a comprehensive prevention package measured at different time points in the study</description>
          <population>Enrolled participants</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="148"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Percentage of partcipants who reported willingness to use the study regimen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of participants who took up PrEP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of participants who remained on PrEP at 12 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of participants who remained on PrEP at 24 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of participants who remained on PrEP at 36 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of participants who remained on PrEP at week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Acceptability as Per Questionnaire Administered at Week 48</title>
        <description>Acceptability was assessed by asking partcipants if they liked truvada, at the week 48 visit</description>
        <time_frame>Measured at Week 48</time_frame>
        <population>Participants attending week 48 visit and completing acceptability questionnaire</population>
        <group_list>
          <group group_id="O1">
            <title>Truvada</title>
            <description>All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 52.&#xD;
Truvada: Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Acceptability as Per Questionnaire Administered at Week 48</title>
          <description>Acceptability was assessed by asking partcipants if they liked truvada, at the week 48 visit</description>
          <population>Participants attending week 48 visit and completing acceptability questionnaire</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="117"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Adolescents Who Continue to Use PrEP (as Indicated by Dried Blood Spot [DBS] Levels) After the Initial 3-month Period</title>
        <description>Number of adolescents who continued to use PrEP (as indicated by dried blood spot level) after the initial 3-month period as indicated by DBS at week 24/36/48</description>
        <time_frame>Measured through Week 48</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Truvada</title>
            <description>All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 48&#xD;
Truvada: Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Adolescents Who Continue to Use PrEP (as Indicated by Dried Blood Spot [DBS] Levels) After the Initial 3-month Period</title>
          <description>Number of adolescents who continued to use PrEP (as indicated by dried blood spot level) after the initial 3-month period as indicated by DBS at week 24/36/48</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants with truvada in DBS at week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with truvada in DBS at week 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with truvada in DBS at week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Grades 2, 3, and 4 Clinical and Laboratory Adverse Events</title>
        <description>Assessment of Grades 2, 3, and 4 clinical and laboratory adverse events measured through week 48 using the DAIDS table for grading adult and paediatric adverse events, dated Dec 2004, (clarification Aug 2009). Expedited Adverse Event (EAE) reporting followed standard reporting requirements as defined in the DAIDS Manual for Expedited Reporting of Adverse Events version 2·0, March 2011.</description>
        <time_frame>Measured through Week 48</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Truvada</title>
            <description>All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 48.&#xD;
Truvada: Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Grades 2, 3, and 4 Clinical and Laboratory Adverse Events</title>
          <description>Assessment of Grades 2, 3, and 4 clinical and laboratory adverse events measured through week 48 using the DAIDS table for grading adult and paediatric adverse events, dated Dec 2004, (clarification Aug 2009). Expedited Adverse Event (EAE) reporting followed standard reporting requirements as defined in the DAIDS Manual for Expedited Reporting of Adverse Events version 2·0, March 2011.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Adolescents Enrolled and Retained in the Study</title>
        <description>Count of participants who had been enrolled in the study and successfully completed the study</description>
        <time_frame>Measured through Week 52</time_frame>
        <population>15-19 year old boys and girls</population>
        <group_list>
          <group group_id="O1">
            <title>Truvada</title>
            <description>All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 52.&#xD;
Truvada: Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Adolescents Enrolled and Retained in the Study</title>
          <description>Count of participants who had been enrolled in the study and successfully completed the study</description>
          <population>15-19 year old boys and girls</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="148"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of participants enrolled</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of participants completing the study</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Used PrEP at Any Time Point During the Study, Measured With Drug Levels at M4/8/12/24/36</title>
        <description>Number of participants who used oral PrEP at any time during the study and had drug levels present at any time point</description>
        <time_frame>Measured through Week 48</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Truvada</title>
            <description>All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 48.&#xD;
Truvada: Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Used PrEP at Any Time Point During the Study, Measured With Drug Levels at M4/8/12/24/36</title>
          <description>Number of participants who used oral PrEP at any time during the study and had drug levels present at any time point</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Adolescents With Detectable Drug Levels Who Report Using PrEP</title>
        <description>Proportion of adolescents with detectable drug levels who report using PrEP at weeks 12,24,36,48</description>
        <time_frame>Measured though Week 48</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Truvada</title>
            <description>All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 48.&#xD;
Truvada: Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Adolescents With Detectable Drug Levels Who Report Using PrEP</title>
          <description>Proportion of adolescents with detectable drug levels who report using PrEP at weeks 12,24,36,48</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>total enrolled participants</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reporting Multiple Partners in the Preceding Year as Evidenced by Participant Responses to Interviewer Administered Questionnaires at Enrolment</title>
        <description>Participants reporting multiple partners during interviewer administered questionnaires</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Truvada</title>
            <description>All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 48.&#xD;
Truvada: Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Multiple Partners in the Preceding Year as Evidenced by Participant Responses to Interviewer Administered Questionnaires at Enrolment</title>
          <description>Participants reporting multiple partners during interviewer administered questionnaires</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reported Consistent Condom Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires Adminstered at the Enrolment Visit</title>
        <description>Reported consistent condom use as evidenced by participant responses to interviewer-administered questionnaires</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Truvada</title>
            <description>All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 48.&#xD;
Truvada: Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.</description>
          </group>
        </group_list>
        <measure>
          <title>Reported Consistent Condom Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires Adminstered at the Enrolment Visit</title>
          <description>Reported consistent condom use as evidenced by participant responses to interviewer-administered questionnaires</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reported Alcohol and Substance Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires at the Enrolment Visit</title>
        <description>Reported substance use and alcohol use as evidenced by participant responses to interviewer-administered questionnaires</description>
        <time_frame>Baseline visit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Truvada</title>
            <description>All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 48.&#xD;
Truvada: Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.</description>
          </group>
        </group_list>
        <measure>
          <title>Reported Alcohol and Substance Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires at the Enrolment Visit</title>
          <description>Reported substance use and alcohol use as evidenced by participant responses to interviewer-administered questionnaires</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No. of participants reporting alcohol use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No. of participants reporting drug use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Study Participants Who Seroconverted During the Study, Measured Until Month 52</title>
        <description>Frequency of HIV infection as measured by seroconversion of study participants during the approximate 12 months of follow up. HIV rapid testing was done in parallel using Determine™ HIV-1/2 Ag/Ab Combo and Uni-Gold™ Recombigen® HIV-1/2. If the rapid HIV test was reactive, an HIV-1 RNA qualitative assay (Abbot) was performed. A positive test was confirmed with a second blood sample collected a week later.</description>
        <time_frame>Measured through Week 52</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Truvada</title>
            <description>All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 48.&#xD;
Truvada: Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Study Participants Who Seroconverted During the Study, Measured Until Month 52</title>
          <description>Frequency of HIV infection as measured by seroconversion of study participants during the approximate 12 months of follow up. HIV rapid testing was done in parallel using Determine™ HIV-1/2 Ag/Ab Combo and Uni-Gold™ Recombigen® HIV-1/2. If the rapid HIV test was reactive, an HIV-1 RNA qualitative assay (Abbot) was performed. A positive test was confirmed with a second blood sample collected a week later.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
              </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_list>

    <reported_events>
      <time_frame>Grades 2, 3, and 4 clinical and laboratory adverse events collected over 1 year.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Truvada</title>
          <description>All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 48.&#xD;
Truvada: Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (18.1)</default_vocab>
        <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="0" subjects_at_risk="148"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="148"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Incarcerated peri-umbilical hernia</sub_title>
                <description>Required emergency surgery</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="148"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <description>Secondary to gallstones</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="148"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Haemothorax</sub_title>
                <description>Haemothorax secondary to stab chest. Unrelated to study product.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="148"/>
              </event>
              <event>
                <sub_title>Para suicide attempt</sub_title>
                <description>Participant took an overdose of truvada after a fight with her mother</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="148"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (18.1)</default_vocab>
        <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="15" subjects_at_risk="148"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="148"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="148"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="148"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="148"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Weight Loss</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="148"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="148"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Drug Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="148"/>
              </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>Dr Katherine Gill</name_or_title>
      <organization>Desmond Tutu HIV Foundation</organization>
      <phone>+2721 785 3121</phone>
      <email>katherine.gill@hiv-research.org.za</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/NCT02213328
org study id: CHAMPS PrEP
secondary id: 11931
nct id: NCT02213328
lead sponsor: 
has dmc: Yes
Truvada (emtricitabine/tenofovir disoproxil fumarate, or FTC/TDF) is a type of antiretroviral
      (ARV) medicine that is commonly used to treat HIV. Truvada is also used as pre-exposure
      prophylaxis (PrEP) to prevent HIV infection in HIV-negative adults. The purpose of this study
      is to evaluate the acceptability, safety, and use of daily Truvada PrEP as part of a
      comprehensive HIV prevention package in healthy, HIV-uninfected adolescents 15 to 19 years of
      age.
Truvada PrEP is an approach used to protect HIV-uninfected adults against possible infection
      with HIV. The approach involves taking Truvada every day to prevent HIV infection in case the
      person is exposed to HIV (for example, through sex with an HIV-infected person). The purpose
      of this study is to evaluate the acceptability, safety, and use of daily Truvada PrEP as part
      of a comprehensive HIV prevention package in healthy, HIV-uninfected adolescents 15 to 19
      years old. In addition to Truvada PrEP, the HIV prevention package will include HIV testing,
      management of sexually transmitted infections (STIs), risk reduction counseling, access to
      condoms, post-exposure prophylaxis (PEP), and circumcision counseling and referral for male
      participants.

      The study will enroll 150 healthy, HIV-uninfected adolescents 15 to 19 years of age. The
      study will last for 12 months (52 weeks) and involve scheduled clinic visits at study entry
      (Week 0) and Weeks 4, 8, 12, 24, 36, 48, and 52.

      For the first 12 weeks of the study, all participants will be provided with a supply of
      Truvada tablets to take once daily as part of the comprehensive HIV prevention package. At
      Weeks 12, 24, 36, and 48, participants will be offered the following options: to continue
      with the full HIV prevention package plus Truvada PrEP, to stop Truvada PrEP and continue
      with rest of the HIV prevention package, or to re-start Truvada PrEP if previously stopped.
      After Week 12 of the study, Truvada tablets will be given only to those participants who
      decide to take PrEP and who do not have any medical reasons not to do so. Regardless whether
      they choose to use Truvada PrEP after Week 12, all study participants will be followed
      through Week 52 of the study.

      All study visits will include blood collection, counseling before and after HIV testing,
      urine collection for pregnancy testing (female participants only), completion of a sexual
      risk behavior questionnaire, receipt of a supply of condoms, contraceptive counseling, a
      medical history review, and disclosure of available test results. Select study visits may
      include a physical exam, blood and urine collection, testing and treatment of STIs, adherence
      counseling, and an acceptability assessment. Between Months 11 and 12 of the study, some
      participants will be randomly selected to participate in focus groups to discuss their
      experiences while taking Truvada PrEP.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: The Percentage of Participants Who Report Willingness to Use the Study Regimen, Take up PrEP, and Remain on PrEP as Part of a Comprehensive Prevention Package
time frame: Measured through Week 48
description: The percentage of participants who report willingness to use the study regimen, take up PrEP, and remain on PrEP as part of a comprehensive prevention package measured at different time points in the study
measure: Number of Participants With Acceptability as Per Questionnaire Administered at Week 48
time frame: Measured at Week 48
description: Acceptability was assessed by asking partcipants if they liked truvada, at the week 48 visit
measure: Number of Adolescents Who Continue to Use PrEP (as Indicated by Dried Blood Spot [DBS] Levels) After the Initial 3-month Period
time frame: Measured through Week 48
description: Number of adolescents who continued to use PrEP (as indicated by dried blood spot level) after the initial 3-month period as indicated by DBS at week 24/36/48
measure: Number of Participants With Grades 2, 3, and 4 Clinical and Laboratory Adverse Events
time frame: Measured through Week 48
description: Assessment of Grades 2, 3, and 4 clinical and laboratory adverse events measured through week 48 using the DAIDS table for grading adult and paediatric adverse events, dated Dec 2004, (clarification Aug 2009). Expedited Adverse Event (EAE) reporting followed standard reporting requirements as defined in the DAIDS Manual for Expedited Reporting of Adverse Events version 2·0, March 2011.
measure: Number of Adolescents Enrolled and Retained in the Study
time frame: Measured through Week 52
description: Count of participants who had been enrolled in the study and successfully completed the study
measure: Number of Participants Who Used PrEP at Any Time Point During the Study, Measured With Drug Levels at M4/8/12/24/36
time frame: Measured through Week 48
description: Number of participants who used oral PrEP at any time during the study and had drug levels present at any time point
measure: Proportion of Adolescents With Detectable Drug Levels Who Report Using PrEP
time frame: Measured though Week 48
description: Proportion of adolescents with detectable drug levels who report using PrEP at weeks 12,24,36,48
measure: Number of Participants Reporting Multiple Partners in the Preceding Year as Evidenced by Participant Responses to Interviewer Administered Questionnaires at Enrolment
time frame: Baseline
description: Participants reporting multiple partners during interviewer administered questionnaires
measure: Reported Consistent Condom Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires Adminstered at the Enrolment Visit
time frame: Baseline
description: Reported consistent condom use as evidenced by participant responses to interviewer-administered questionnaires
measure: Reported Alcohol and Substance Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires at the Enrolment Visit
time frame: Baseline visit
description: Reported substance use and alcohol use as evidenced by participant responses to interviewer-administered questionnaires
measure: Percentage of Study Participants Who Seroconverted During the Study, Measured Until Month 52
time frame: Measured through Week 52
description: Frequency of HIV infection as measured by seroconversion of study participants during the approximate 12 months of follow up. HIV rapid testing was done in parallel using Determine™ HIV-1/2 Ag/Ab Combo and Uni-Gold™ Recombigen® HIV-1/2. If the rapid HIV test was reactive, an HIV-1 RNA qualitative assay (Abbot) was performed. A positive test was confirmed with a second blood sample collected a week later.
arm group label: Truvada
arm group type: Experimental
description: All participants will take Truvada, once daily by mouth for the first 12 weeks of the study. After Week 12 of the study, only participants who indicate a willingness to use Truvada PrEP and who do not have any medical reasons not to do so will continue to receive the Truvada tablets through Week 52.
intervention type: Drug
intervention name: Truvada
description: Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.
arm group label: Truvada
other name: emtricitabine/tenofovir disoproxil fumarate, FTC/TDF
criteria: 
gender: All
minimum age: 15 Years
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Linda-Gail Bekker, MBChB, PhD
role: Principal Investigator
affiliation: Desmond Tutu HIV Centre
facility: 
facility: 
country: South Africa
responsible party type: Sponsor
mesh term: HIV Infections
mesh term: Tenofovir
mesh term: Emtricitabine
mesh term: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 