<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/NCT03242954</url>
  </required_header>
  <id_info>
    <org_study_id>17-0538</org_study_id>
    <secondary_id>5U24HD089880-02</secondary_id>
    <nct_id>NCT03242954</nct_id>
  </id_info>
  <brief_title>Innovative Approaches for Minor Consent: Consent 2.0</brief_title>
  <official_title>Innovative Approaches for Minor Consent: Consent 2.0 - A Multi-Center Study of the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Indiana University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine how the consent process affects the acceptability of&#xD;
      participation in biomedical HIV prevention trials, from the perspective of behaviorally&#xD;
      high-risk minors and the parents of minor adolescents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Potential participants will be recruited from clinical settings and HIV testing centers. If&#xD;
      interested in participation, they will take a short Computer Assisted Self-Interview (CASI)&#xD;
      screening survey to determine eligibility. Those eligible will take part in the one-day study&#xD;
      visit at that time or will provide contact information to set up the study visit at a later&#xD;
      date.&#xD;
&#xD;
      All study participants will attend a one-day study visit at their respective study site. Upon&#xD;
      arrival, participants will complete a CASI that collects demographic, social, behavioral, and&#xD;
      attitudinal measures. Next, participants will take part in a simulated consent process for&#xD;
      two hypothetical trials modeled after ATN 113 and HPTN 077. Study procedures differ for&#xD;
      adolescents and parents, so each group is described separately below:&#xD;
&#xD;
      Adolescent Participants: For each hypothetical trial, research staff will lead the&#xD;
      participant through a simulated consent process consistent with their randomized consent&#xD;
      condition. Then, the participant will complete a CASI assessing Willingness to Participate&#xD;
      (WTP) and will work with research staff to complete the University of San Diego (UCSD) Brief&#xD;
      Assessment of Capacity to Consent (UBACC).&#xD;
&#xD;
      Parent Participants: For each hypothetical trial, research staff will review the informed&#xD;
      consent forms with the parent. The parent will complete a CASI with three vignettes that&#xD;
      describe each of the three possible consent conditions. Parents will rate the acceptability&#xD;
      of each vignette. Then, the participant will work with research staff to complete the UCSD&#xD;
      Brief Assessment of Capacity to Consent (UBACC). Finally, the participant will answer a&#xD;
      series of questions via CASI.&#xD;
&#xD;
      A subset of 6-8 adolescents and 6-8 parents per study site will complete a debriefing&#xD;
      interview assessing adolescent and parent perspectives on the various consent conditions in&#xD;
      greater depth, and to better understand the role of study features, family, and adolescent&#xD;
      characteristics in willingness to participate/willingness to support the hypothetical&#xD;
      research studies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 7, 2017</start_date>
  <completion_date type="Actual">September 15, 2019</completion_date>
  <primary_completion_date type="Actual">September 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Consent 2.0 has a parallel group-like design for adolescents. Adolescents will be randomized into 1 of 3 consent conditions using a randomized block design that is stratified by study site and the adolescent's natal sex. The order in which the hypothetical trials are presented to adolescents will be randomized using a block design. A subset of 6-8 adolescents per site will be selected for a debriefing interview.&#xD;
Consent 2.0 has a crossover-like design for parents. Parents will provide feedback on all three consent conditions and for both hypothetical trials. The order in which the hypothetical trials are presented to parents will be determined using a randomized block design that is stratified by study site and the parent's adolescent's natal sex. The presentation order for the 3 consent condition vignettes for each hypothetical trial will be determined using a randomized block design. A subset of 6-8 parents by site will be selected for debriefing interview.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Adolescent WTP Scores</measure>
    <time_frame>Day 1</time_frame>
    <description>Comparing mean adolescent Willingness to Participate (WTP) scores across the three consent conditions and two trial types.&#xD;
WTP scores are based on the response to the question: &quot;If offered the chance, how likely would you be to participate in the study?&quot; Responses are collected using a Likert scale (definitely not participate, probably not participate, might or might not participate, probably participate, definitely participate) and converted to a numeric score with values ranging from 1 (definitely not participate) to 5 (definitely participate) for analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Parent WTS Scores</measure>
    <time_frame>Day 1</time_frame>
    <description>Comparing mean parent Willingness to Support (WTS) scores across the three consent conditions and two trial types.&#xD;
WTS scores are based on the response to the question: &quot;This is an acceptable approach to consent for your teenager's participation in the study.&quot; Responses are collected using a Likert scale (strongly disagree, disagree, neither disagree nor agree, agree, strongly agree) and converted to a numeric score with values ranging from 1 (strongly disagree) to 5 (strongly agree) for analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of the Study Agent (Stage of Development and Method of Delivery) on High-risk Minor Adolescents' WTP Scores</measure>
    <time_frame>Day 1</time_frame>
    <description>This data reflects adolescent Willingness to Participate (WTP) scores by study agent/trial type. After review of hypothetical consent documents for 2 study agents in different stages of development and with different methods of delivery (based on real-world studies ATN 113 and HPTN 077), adolescents are asked &quot;If offered the chance, how likely would you be to participate in the study?&quot; Responses are collected using a Likert scale (definitely not participate, probably not participate, might or might not participate, probably participate, definitely participate) and converted to a numeric score with values ranging from 1 (definitely not participate) to 5 (definitely participate) for analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of the Study Agent (Stage of Development and Method of Delivery) on Parents' Acceptability Scores</measure>
    <time_frame>Day 1</time_frame>
    <description>After review of hypothetical consent documents for 2 study agents in different stages of development and with different methods of delivery (based on real-world trials ATN 113 and HPTN 077), parents are presented with vignettes for the 3 different consent conditions (autonomous minor consent, adult permission required, parental permission required) and asked &quot;How acceptable is this approach to research consent?&quot;. Responses are collected on a Likert scale (completely unacceptable, unacceptable, neither unacceptable not acceptable, acceptable, completely acceptable) and converted to a numeric score with values ranging from 1 (definitely not acceptable) to 5 (definitely acceptable) for analysis.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">254</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Adolescents: Consent Condition 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Autonomous minor consent</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adolescents: Consent Condition 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Adult permission required</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adolescents: Consent Condition 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Parental permission required</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parents: Consent Conditions 1-3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Autonomous minor consent, adult permission required, and parental permission required</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Autonomous minor consent</intervention_name>
    <description>Consent requirement where the participant is not required to get anyone's permission to participate in the trial.</description>
    <arm_group_label>Adolescents: Consent Condition 1</arm_group_label>
    <arm_group_label>Parents: Consent Conditions 1-3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Adult permission required</intervention_name>
    <description>Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.</description>
    <arm_group_label>Adolescents: Consent Condition 2</arm_group_label>
    <arm_group_label>Parents: Consent Conditions 1-3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Parental permission required</intervention_name>
    <description>Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.</description>
    <arm_group_label>Adolescents: Consent Condition 3</arm_group_label>
    <arm_group_label>Parents: Consent Conditions 1-3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Note: Age limits apply to adolescent participants and to the adolescent children of parent&#xD;
        participants.&#xD;
&#xD;
        Adolescent Inclusion Criteria&#xD;
&#xD;
          -  Age 14-17 inclusive&#xD;
&#xD;
          -  Able to read and speak English&#xD;
&#xD;
          -  HIV status is negative or unknown&#xD;
&#xD;
          -  Engaged in high-risk sexual activity in the last six months&#xD;
&#xD;
        Adolescent Exclusion Criteria&#xD;
&#xD;
          -  Child of a parent already enrolled in the study&#xD;
&#xD;
        Parent Inclusion Criteria&#xD;
&#xD;
          -  Able to read and speak English&#xD;
&#xD;
          -  Parent or guardian of an adolescent who is between ages 14-17&#xD;
&#xD;
          -  The parent/guardian's adolescent's HIV status is either negative or unknown&#xD;
&#xD;
        Parent Exclusion Criteria&#xD;
&#xD;
          -  Parent of a child already enrolled in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amy Knopf, PhD, MPH, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Matthew Psioda, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital Colorado/Univ of Colorado SOM</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University/SOM</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <results_first_submitted>February 26, 2021</results_first_submitted>
  <results_first_submitted_qc>March 25, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 22, 2021</results_first_posted>
  <last_update_submitted>March 25, 2021</last_update_submitted>
  <last_update_submitted_qc>March 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Amelia Knopf</investigator_full_name>
    <investigator_title>Assistance Professor, IU School of Nursing</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified study data will be made available in the NICHD Data and Specimen Hub (DASH), a centralized resource for researchers to store de-identified data from NICHD supported studies for use in secondary research. NICHD DASH is a free public resource designed for the scientific research community.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Data will be made available after data analyses have been completed, data has been de-identified, and all DASH submission requirements have been met and approved. Data will be available according to NICHD DASH timelines.</ipd_time_frame>
    <ipd_access_criteria>Please see DASH guidelines for access criteria.</ipd_access_criteria>
    <ipd_url>https://dash.nichd.nih.gov/</ipd_url>
  </patient_data>
  <provided_document_section>
    <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>March 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/54/NCT03242954/ICF_000.pdf</document_url>
    </provided_document>
    <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>October 18, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/54/NCT03242954/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>1,366 individuals were screened at 4 study sites in the United States (Chicago, Denver, Baltimore, and Tampa) between May 2018 and September 2019. Of those screened, 422 met all eligibility criteria and 254 were randomized, enrolled, and completed the 1-time study visit.</recruitment_details>
      <pre_assignment_details>All parent participants are considered one study 'arm' as they were not randomized to just one of the three consent conditions (as the adolescent participants were), but rather were presented with information on all 3 consent conditions and commented on the acceptability of each.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Adolescents: Consent Condition 1</title>
          <description>Autonomous consent&#xD;
Autonomous consent: Consent requirement where the participant is not required to get anyone's permission to participate in the trial.</description>
        </group>
        <group group_id="P2">
          <title>Adolescents: Consent Condition 2</title>
          <description>Adult permission required&#xD;
Adult permission required: Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.</description>
        </group>
        <group group_id="P3">
          <title>Adolescents: Consent Condition 3</title>
          <description>Parental permission required&#xD;
Parental Permission Required: Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.</description>
        </group>
        <group group_id="P4">
          <title>Parents: Consent Conditions 1-3</title>
          <description>Autonomous consent, Adult permission required and Parental permission required&#xD;
Autonomous consent: Consent requirement where the participant is not required to get anyone's permission to participate in the trial.&#xD;
Adult permission required: Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.&#xD;
Parental Permission Required: Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="45"/>
                <participants group_id="P3" count="41"/>
                <participants group_id="P4" count="125"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="45"/>
                <participants group_id="P3" count="41"/>
                <participants group_id="P4" count="125"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All parent participants are considered one study arm as they were not randomized to just one of the three consent conditions (as the adolescent participants were), but rather were presented with information on all 3 consent conditions and commented on the acceptability of each.</population>
      <group_list>
        <group group_id="B1">
          <title>Adolescents: Consent Condition 1</title>
          <description>Autonomous minor consent&#xD;
Autonomous minor consent: Consent requirement where the participant is not required to get anyone's permission to participate in the trial.</description>
        </group>
        <group group_id="B2">
          <title>Adolescents: Consent Condition 2</title>
          <description>Adult permission required&#xD;
Adult permission required: Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.</description>
        </group>
        <group group_id="B3">
          <title>Adolescents: Consent Condition 3</title>
          <description>Parental permission required&#xD;
Parental permission required: Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.</description>
        </group>
        <group group_id="B4">
          <title>Parents: Consent Conditions 1-3</title>
          <description>Autonomous minor consent, adult permission required, and parental permission required&#xD;
Autonomous minor consent: Consent requirement where the participant is not required to get anyone's permission to participate in the trial.&#xD;
Adult permission required: Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.&#xD;
Parental permission required: Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="43"/>
            <count group_id="B2" value="45"/>
            <count group_id="B3" value="41"/>
            <count group_id="B4" value="125"/>
            <count group_id="B5" value="254"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="43"/>
                    <count group_id="B2" value="45"/>
                    <count group_id="B3" value="41"/>
                    <count group_id="B4" value="125"/>
                    <count group_id="B5" value="254"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>14 years old</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>15 years old</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>16 years old</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>17 years old</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="78"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;= 18 years old</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="125"/>
                    <measurement group_id="B5" value="125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>sex assigned at birth</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="43"/>
                    <count group_id="B2" value="45"/>
                    <count group_id="B3" value="41"/>
                    <count group_id="B4" value="125"/>
                    <count group_id="B5" value="254"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="63"/>
                    <measurement group_id="B5" value="132"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="62"/>
                    <measurement group_id="B5" value="122"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="43"/>
                    <count group_id="B2" value="45"/>
                    <count group_id="B3" value="41"/>
                    <count group_id="B4" value="125"/>
                    <count group_id="B5" value="254"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="32"/>
                    <measurement group_id="B4" value="103"/>
                    <measurement group_id="B5" value="198"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="8"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="43"/>
                    <count group_id="B2" value="45"/>
                    <count group_id="B3" value="41"/>
                    <count group_id="B4" value="125"/>
                    <count group_id="B5" value="254"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="73"/>
                    <measurement group_id="B5" value="140"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="31"/>
                    <measurement group_id="B5" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender Identity</title>
          <population>Gender identity data was not collected on Parent participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="43"/>
                    <count group_id="B2" value="45"/>
                    <count group_id="B3" value="41"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Woman</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B5" value="69"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Gender queer or gender non-conforming</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Man</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B5" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Trans woman</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B5" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Trans man</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sexual orientation</title>
          <population>sexual orientation data was not collected on parent participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="43"/>
                    <count group_id="B2" value="45"/>
                    <count group_id="B3" value="41"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Bisexual</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B5" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Gay, queer, or same gender loving</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B5" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Straight or heterosexual</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B5" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Questioning</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Adolescent WTP Scores</title>
        <description>Comparing mean adolescent Willingness to Participate (WTP) scores across the three consent conditions and two trial types.&#xD;
WTP scores are based on the response to the question: &quot;If offered the chance, how likely would you be to participate in the study?&quot; Responses are collected using a Likert scale (definitely not participate, probably not participate, might or might not participate, probably participate, definitely participate) and converted to a numeric score with values ranging from 1 (definitely not participate) to 5 (definitely participate) for analysis.</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Adolescents: Consent Condition 1</title>
            <description>Autonomous minor consent&#xD;
Autonomous consent: Consent requirement where the participant is not required to get anyone's permission to participate in the trial.</description>
          </group>
          <group group_id="O2">
            <title>Adolescents: Consent Condition 2</title>
            <description>Adult permission required&#xD;
Adult permission required: Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.</description>
          </group>
          <group group_id="O3">
            <title>Adolescents: Consent Condition 3</title>
            <description>Parental permission required&#xD;
Parental Permission Required: Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Adolescent WTP Scores</title>
          <description>Comparing mean adolescent Willingness to Participate (WTP) scores across the three consent conditions and two trial types.&#xD;
WTP scores are based on the response to the question: &quot;If offered the chance, how likely would you be to participate in the study?&quot; Responses are collected using a Likert scale (definitely not participate, probably not participate, might or might not participate, probably participate, definitely participate) and converted to a numeric score with values ranging from 1 (definitely not participate) to 5 (definitely participate) for analysis.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" spread="0.8"/>
                    <measurement group_id="O2" value="3.7" spread="1.2"/>
                    <measurement group_id="O3" value="3.5" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5148</p_value>
            <method>Regression, Linear</method>
            <param_type>Cohen's f square</param_type>
            <param_value>0.011</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.208</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.001</ci_lower_limit>
            <ci_upper_limit>0.101</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Parent WTS Scores</title>
        <description>Comparing mean parent Willingness to Support (WTS) scores across the three consent conditions and two trial types.&#xD;
WTS scores are based on the response to the question: &quot;This is an acceptable approach to consent for your teenager's participation in the study.&quot; Responses are collected using a Likert scale (strongly disagree, disagree, neither disagree nor agree, agree, strongly agree) and converted to a numeric score with values ranging from 1 (strongly disagree) to 5 (strongly agree) for analysis.</description>
        <time_frame>Day 1</time_frame>
        <population>All parent participants commented on their Willingness to Support (WTS) each of the three consent conditions (autonomous minor consent, adult permission required, and parental permission required). For this reason, the Number Analyzed in each row of the table equals the total number of parent participants for the study (n=125)</population>
        <group_list>
          <group group_id="O1">
            <title>Parents: Consent Conditions 1-3</title>
            <description>Autonomous minor consent, Adult permission required, and Parental permission required&#xD;
Autonomous minor consent: Consent requirement where the participant is not required to get anyone's permission to participate in the trial.&#xD;
Adult permission required: Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.&#xD;
Parental Permission Required: Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Parent WTS Scores</title>
          <description>Comparing mean parent Willingness to Support (WTS) scores across the three consent conditions and two trial types.&#xD;
WTS scores are based on the response to the question: &quot;This is an acceptable approach to consent for your teenager's participation in the study.&quot; Responses are collected using a Likert scale (strongly disagree, disagree, neither disagree nor agree, agree, strongly agree) and converted to a numeric score with values ranging from 1 (strongly disagree) to 5 (strongly agree) for analysis.</description>
          <population>All parent participants commented on their Willingness to Support (WTS) each of the three consent conditions (autonomous minor consent, adult permission required, and parental permission required). For this reason, the Number Analyzed in each row of the table equals the total number of parent participants for the study (n=125)</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Parent Consent Condition 1: Autonomous minor consent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Parent Consent Condition 2: Adult permission required</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Parent Consent Condition 3: Parental permission required</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Regression, Linear</method>
            <param_type>Cohen's f square</param_type>
            <param_value>0.306</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.149</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.169</ci_lower_limit>
            <ci_upper_limit>0.389</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Effects of the Study Agent (Stage of Development and Method of Delivery) on High-risk Minor Adolescents' WTP Scores</title>
        <description>This data reflects adolescent Willingness to Participate (WTP) scores by study agent/trial type. After review of hypothetical consent documents for 2 study agents in different stages of development and with different methods of delivery (based on real-world studies ATN 113 and HPTN 077), adolescents are asked &quot;If offered the chance, how likely would you be to participate in the study?&quot; Responses are collected using a Likert scale (definitely not participate, probably not participate, might or might not participate, probably participate, definitely participate) and converted to a numeric score with values ranging from 1 (definitely not participate) to 5 (definitely participate) for analysis.</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Adolescents: Consent Condition 1</title>
            <description>Autonomous minor consent&#xD;
Autonomous consent: Consent requirement where the participant is not required to get anyone's permission to participate in the trial.</description>
          </group>
          <group group_id="O2">
            <title>Adolescents: Consent Condition 2</title>
            <description>Adult permission required&#xD;
Adult permission required: Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.</description>
          </group>
          <group group_id="O3">
            <title>Adolescents: Consent Condition 3</title>
            <description>Parental permission required&#xD;
Parental Permission Required: Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.</description>
          </group>
        </group_list>
        <measure>
          <title>Effects of the Study Agent (Stage of Development and Method of Delivery) on High-risk Minor Adolescents' WTP Scores</title>
          <description>This data reflects adolescent Willingness to Participate (WTP) scores by study agent/trial type. After review of hypothetical consent documents for 2 study agents in different stages of development and with different methods of delivery (based on real-world studies ATN 113 and HPTN 077), adolescents are asked &quot;If offered the chance, how likely would you be to participate in the study?&quot; Responses are collected using a Likert scale (definitely not participate, probably not participate, might or might not participate, probably participate, definitely participate) and converted to a numeric score with values ranging from 1 (definitely not participate) to 5 (definitely participate) for analysis.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Study agent 1 - ATN 113</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="1.1"/>
                    <measurement group_id="O2" value="3.7" spread="1.3"/>
                    <measurement group_id="O3" value="3.6" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Study agent 2 - HPTN 077</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" spread="0.9"/>
                    <measurement group_id="O2" value="3.8" spread="1.2"/>
                    <measurement group_id="O3" value="3.4" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4324</p_value>
            <method>GEE Linear model</method>
            <param_type>Cohen's f square</param_type>
            <param_value>0.008</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.213</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.001</ci_lower_limit>
            <ci_upper_limit>0.073</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Effects of the Study Agent (Stage of Development and Method of Delivery) on Parents' Acceptability Scores</title>
        <description>After review of hypothetical consent documents for 2 study agents in different stages of development and with different methods of delivery (based on real-world trials ATN 113 and HPTN 077), parents are presented with vignettes for the 3 different consent conditions (autonomous minor consent, adult permission required, parental permission required) and asked &quot;How acceptable is this approach to research consent?&quot;. Responses are collected on a Likert scale (completely unacceptable, unacceptable, neither unacceptable not acceptable, acceptable, completely acceptable) and converted to a numeric score with values ranging from 1 (definitely not acceptable) to 5 (definitely acceptable) for analysis.</description>
        <time_frame>Day 1</time_frame>
        <population>All parent participants commented on their Willingness to Support (WTS) each of the three consent conditions for each of the 2 trial types. For this reason, the Number Analyzed in each row of this data table equals the total number of parent participants for the study (n=125) as they all answered WTS for each.</population>
        <group_list>
          <group group_id="O1">
            <title>Parents: Consent Conditions 1-3</title>
            <description>Autonomous minor consent, Adult permission required, and Parental permission required&#xD;
Autonomous minor consent: Consent requirement where the participant is not required to get anyone's permission to participate in the trial.&#xD;
Adult permission required: Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.&#xD;
Parental Permission Required: Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.</description>
          </group>
        </group_list>
        <measure>
          <title>Effects of the Study Agent (Stage of Development and Method of Delivery) on Parents' Acceptability Scores</title>
          <description>After review of hypothetical consent documents for 2 study agents in different stages of development and with different methods of delivery (based on real-world trials ATN 113 and HPTN 077), parents are presented with vignettes for the 3 different consent conditions (autonomous minor consent, adult permission required, parental permission required) and asked &quot;How acceptable is this approach to research consent?&quot;. Responses are collected on a Likert scale (completely unacceptable, unacceptable, neither unacceptable not acceptable, acceptable, completely acceptable) and converted to a numeric score with values ranging from 1 (definitely not acceptable) to 5 (definitely acceptable) for analysis.</description>
          <population>All parent participants commented on their Willingness to Support (WTS) each of the three consent conditions for each of the 2 trial types. For this reason, the Number Analyzed in each row of this data table equals the total number of parent participants for the study (n=125) as they all answered WTS for each.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Autonomous minor consent study agent ATN 113</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adult permission required study agent ATN 113</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Parental permission required study agent ATN 113</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Autonomous minor consent study agent HPTN 077</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adult permission required study agent HPTN 077</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Parental permission required study agent HPTN 077</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>GEE Linear model</method>
            <param_type>Cohen's f square</param_type>
            <param_value>0.260</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.149</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.175</ci_lower_limit>
            <ci_upper_limit>0.374</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected on all participants during their one-time study visit</time_frame>
      <desc>All parent participants are considered one study 'arm' as they were not randomized to just one of the three consent conditions (as the adolescent participants were), but rather were presented with information on all 3 consent conditions and commented on the acceptability of each.</desc>
      <group_list>
        <group group_id="E1">
          <title>Adolescents: Consent Condition 1</title>
          <description>Autonomous minor consent&#xD;
Autonomous minor consent: Consent requirement where the participant is not required to get anyone's permission to participate in the trial.</description>
        </group>
        <group group_id="E2">
          <title>Adolescents: Consent Condition 2</title>
          <description>Adult permission required&#xD;
Adult permission required: Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.</description>
        </group>
        <group group_id="E3">
          <title>Adolescents: Consent Condition 3</title>
          <description>Parental permission required&#xD;
Parental permission required: Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.</description>
        </group>
        <group group_id="E4">
          <title>Parents: Consent Conditions 1-3</title>
          <description>Autonomous minor consent, adult permission required, and parental permission required&#xD;
Autonomous minor consent: Consent requirement where the participant is not required to get anyone's permission to participate in the trial.&#xD;
Adult permission required: Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.&#xD;
Parental permission required: Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.</description>
        </group>
      </group_list>
      <serious_events>
        <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="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="125"/>
              </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>Amy Knopf</name_or_title>
      <organization>Indiana University School of Nursing</organization>
      <phone>206-356-9430</phone>
      <email>asknopf@iu.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/NCT03242954
org study id: 17-0538
secondary id: 5U24HD089880-02
nct id: NCT03242954
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to examine how the consent process affects the acceptability of
      participation in biomedical HIV prevention trials, from the perspective of behaviorally
      high-risk minors and the parents of minor adolescents.
Potential participants will be recruited from clinical settings and HIV testing centers. If
      interested in participation, they will take a short Computer Assisted Self-Interview (CASI)
      screening survey to determine eligibility. Those eligible will take part in the one-day study
      visit at that time or will provide contact information to set up the study visit at a later
      date.

      All study participants will attend a one-day study visit at their respective study site. Upon
      arrival, participants will complete a CASI that collects demographic, social, behavioral, and
      attitudinal measures. Next, participants will take part in a simulated consent process for
      two hypothetical trials modeled after ATN 113 and HPTN 077. Study procedures differ for
      adolescents and parents, so each group is described separately below:

      Adolescent Participants: For each hypothetical trial, research staff will lead the
      participant through a simulated consent process consistent with their randomized consent
      condition. Then, the participant will complete a CASI assessing Willingness to Participate
      (WTP) and will work with research staff to complete the University of San Diego (UCSD) Brief
      Assessment of Capacity to Consent (UBACC).

      Parent Participants: For each hypothetical trial, research staff will review the informed
      consent forms with the parent. The parent will complete a CASI with three vignettes that
      describe each of the three possible consent conditions. Parents will rate the acceptability
      of each vignette. Then, the participant will work with research staff to complete the UCSD
      Brief Assessment of Capacity to Consent (UBACC). Finally, the participant will answer a
      series of questions via CASI.

      A subset of 6-8 adolescents and 6-8 parents per study site will complete a debriefing
      interview assessing adolescent and parent perspectives on the various consent conditions in
      greater depth, and to better understand the role of study features, family, and adolescent
      characteristics in willingness to participate/willingness to support the hypothetical
      research studies.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Consent 2.0 has a parallel group-like design for adolescents. Adolescents will be randomized into 1 of 3 consent conditions using a randomized block design that is stratified by study site and the adolescent's natal sex. The order in which the hypothetical trials are presented to adolescents will be randomized using a block design. A subset of 6-8 adolescents per site will be selected for a debriefing interview.
Consent 2.0 has a crossover-like design for parents. Parents will provide feedback on all three consent conditions and for both hypothetical trials. The order in which the hypothetical trials are presented to parents will be determined using a randomized block design that is stratified by study site and the parent's adolescent's natal sex. The presentation order for the 3 consent condition vignettes for each hypothetical trial will be determined using a randomized block design. A subset of 6-8 parents by site will be selected for debriefing interview.
primary purpose: Other
masking: None (Open Label)
measure: Mean Adolescent WTP Scores
time frame: Day 1
description: Comparing mean adolescent Willingness to Participate (WTP) scores across the three consent conditions and two trial types.
WTP scores are based on the response to the question: "If offered the chance, how likely would you be to participate in the study?" Responses are collected using a Likert scale (definitely not participate, probably not participate, might or might not participate, probably participate, definitely participate) and converted to a numeric score with values ranging from 1 (definitely not participate) to 5 (definitely participate) for analysis.
measure: Mean Parent WTS Scores
time frame: Day 1
description: Comparing mean parent Willingness to Support (WTS) scores across the three consent conditions and two trial types.
WTS scores are based on the response to the question: "This is an acceptable approach to consent for your teenager's participation in the study." Responses are collected using a Likert scale (strongly disagree, disagree, neither disagree nor agree, agree, strongly agree) and converted to a numeric score with values ranging from 1 (strongly disagree) to 5 (strongly agree) for analysis.
measure: Effects of the Study Agent (Stage of Development and Method of Delivery) on High-risk Minor Adolescents' WTP Scores
time frame: Day 1
description: This data reflects adolescent Willingness to Participate (WTP) scores by study agent/trial type. After review of hypothetical consent documents for 2 study agents in different stages of development and with different methods of delivery (based on real-world studies ATN 113 and HPTN 077), adolescents are asked "If offered the chance, how likely would you be to participate in the study?" Responses are collected using a Likert scale (definitely not participate, probably not participate, might or might not participate, probably participate, definitely participate) and converted to a numeric score with values ranging from 1 (definitely not participate) to 5 (definitely participate) for analysis.
measure: Effects of the Study Agent (Stage of Development and Method of Delivery) on Parents' Acceptability Scores
time frame: Day 1
description: After review of hypothetical consent documents for 2 study agents in different stages of development and with different methods of delivery (based on real-world trials ATN 113 and HPTN 077), parents are presented with vignettes for the 3 different consent conditions (autonomous minor consent, adult permission required, parental permission required) and asked "How acceptable is this approach to research consent?". Responses are collected on a Likert scale (completely unacceptable, unacceptable, neither unacceptable not acceptable, acceptable, completely acceptable) and converted to a numeric score with values ranging from 1 (definitely not acceptable) to 5 (definitely acceptable) for analysis.
arm group label: Adolescents: Consent Condition 1
arm group type: Active Comparator
description: Autonomous minor consent
arm group label: Adolescents: Consent Condition 2
arm group type: Active Comparator
description: Adult permission required
arm group label: Adolescents: Consent Condition 3
arm group type: Active Comparator
description: Parental permission required
arm group label: Parents: Consent Conditions 1-3
arm group type: Active Comparator
description: Autonomous minor consent, adult permission required, and parental permission required
intervention type: Other
intervention name: Autonomous minor consent
description: Consent requirement where the participant is not required to get anyone's permission to participate in the trial.
arm group label: Adolescents: Consent Condition 1
arm group label: Parents: Consent Conditions 1-3
intervention type: Other
intervention name: Adult permission required
description: Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.
arm group label: Adolescents: Consent Condition 2
arm group label: Parents: Consent Conditions 1-3
intervention type: Other
intervention name: Parental permission required
description: Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.
arm group label: Adolescents: Consent Condition 3
arm group label: Parents: Consent Conditions 1-3
criteria: 
gender: All
minimum age: 14 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Amy Knopf, PhD, MPH, RN
role: Principal Investigator
affiliation: Indiana University School of Medicine
last name: Matthew Psioda, PhD
role: Study Director
affiliation: University of North Carolina, Chapel Hill
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: Amelia Knopf
investigator title: Assistance Professor, IU School of Nursing
sharing ipd: Yes
ipd description: De-identified study data will be made available in the NICHD Data and Specimen Hub (DASH), a centralized resource for researchers to store de-identified data from NICHD supported studies for use in secondary research. NICHD DASH is a free public resource designed for the scientific research community.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Data will be made available after data analyses have been completed, data has been de-identified, and all DASH submission requirements have been met and approved. Data will be available according to NICHD DASH timelines.
ipd access criteria: Please see DASH guidelines for access criteria.
ipd url: https://dash.nichd.nih.gov/
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 