<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/NCT03275168</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00148707</org_study_id>
    <secondary_id>1R21HD090498-01A1</secondary_id>
    <nct_id>NCT03275168</nct_id>
  </id_info>
  <brief_title>Developing a Dyadic Intervention for Sexually Transmitted Infection (STI)/HIV Prevention in Youth</brief_title>
  <official_title>Developing a Dyadic Intervention for STI/HIV Prevention in Youth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins 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>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot project will evaluate the feasibility, acceptability, and preliminary&#xD;
      effectiveness of a couples-based behavioral intervention [COUPLES] that augments individual&#xD;
      evidence-based interventions with joint health education counseling for STI-affected AYA&#xD;
      dyads within a primary care setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      While public health programs have demonstrated modest success in reducing the adolescent and&#xD;
      young adult (AYA) risk for STI/HIV, significant health disparities remain. The risk of&#xD;
      STI/HIV is not uniform among AYA. AYA residing in segregated urban communities with high STI&#xD;
      prevalence and complicated sexual networks face even greater risk for disease and associated&#xD;
      complications. Additional supports designed to increase engagement in care and reduce STI&#xD;
      acquisition and transmissions are urgently needed to meet the sexual health and reproductive&#xD;
      health goals for the nation. Overwhelmingly, AYA STI prevention interventions have targeted&#xD;
      individuals and individual-level factors. While effective, these interventions do not&#xD;
      adequately address other important influences affecting AYA risk for STI/HIV, such as partner&#xD;
      or relationship influences on sexual decision-making and behavior. Partner notification and&#xD;
      treatment is a key strategy for disease control and has previously been tested among adults&#xD;
      for STI/HIV prevention work but has yet to be evaluated for AYA. Our prior research&#xD;
      demonstrates that AYAs with complicated STIs are likely to notify their partners to seek&#xD;
      treatment (88-92%); however, AYAs receiving brief behavioral interventions, relative to those&#xD;
      receiving standard of care were 3 times more likely to be successful in arranging for their&#xD;
      partner's treatment. Thus, partner interventions may hold promise for harnessing the power of&#xD;
      relationship dynamics to enhance sexual decision-making, communication, and subsequent health&#xD;
      behaviors. The investigators propose to pilot test an intervention designed to change sexual&#xD;
      health outcomes by understanding partners and the learning environment related to sex&#xD;
      [COUPLES] by simultaneously delivering two evidence-based STI/HIV prevention interventions&#xD;
      Sister-to-Sister Teen and Focus on the Future. The simultaneous delivery of effective&#xD;
      interventions will be augmented with a joint partner health education counseling session&#xD;
      focused on enhancing communication and negotiation of safe sexual practices within the&#xD;
      relationship. If successful, this pilot will support the development of a larger trial&#xD;
      designed to evaluate the effectiveness of this approach in the busy primary care setting by&#xD;
      providing evidence that AYA can and will safely engage their partners in a supportive primary&#xD;
      care setting that integrates high quality treatment with evidence-based STI/HIV prevention&#xD;
      interventions delivered by health educator teams.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 15, 2018</start_date>
  <completion_date type="Anticipated">November 1, 2023</completion_date>
  <primary_completion_date type="Actual">October 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Single blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility as Assessed by the Number of Participants Who Are Enrolled With a Partner</measure>
    <time_frame>24 months</time_frame>
    <description>Recruitment (as a measure of feasibility) will be assessed by calculating the number of eligible patients who return with a partner to the study appointment and consent to participate in the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptability as Assessed by Number of Participants Available for Week 6-8 Interview</measure>
    <time_frame>6-8 weeks</time_frame>
    <description>Retention for the 6-8 week interview will also be calculated as a measure of acceptability.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Exposure to Sexually Transmissible Disorder (Event)</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention plus dyadic counseling and negotiation practice with partner</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention</intervention_name>
    <description>Sexual partners will receive dyadic counseling and support for condom negotiation after receipt of individual evidence based HIV/STI prevention intervention (Sister-to-Sister (female) and Focus on the Future (male).</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Individual evidence-based STI/HIV prevention intervention</intervention_name>
    <description>Sexual partners will receive individual evidence-based HIV/STI prevention counseling without partner debrief and/or practice negotiating condom use.</description>
    <arm_group_label>Control</arm_group_label>
    <other_name>Sister to Sister / Focus on the Future</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The index patient must be&#xD;
&#xD;
          -  16-25 years&#xD;
&#xD;
          -  Engage in male-female [heterosexual] intercourse&#xD;
&#xD;
          -  Permanently reside in the Greater Baltimore Metropolitan Area (GBMA)&#xD;
&#xD;
          -  Willing to recruit their main sexual partner for the study&#xD;
&#xD;
          -  Willing to participate in a single individual session with a health educator followed&#xD;
             by a joint debriefing session together&#xD;
&#xD;
          -  Willing to be contacted in 6-8 weeks for a telephone interview&#xD;
&#xD;
        The partner must be&#xD;
&#xD;
          -  16-30 years&#xD;
&#xD;
          -  Engage in male-female [heterosexual] intercourse with the index patient&#xD;
&#xD;
          -  Permanently reside in the greater Baltimore Metropolitan Area&#xD;
&#xD;
          -  Willing to participate in a single individual session with a health educator followed&#xD;
             by a joint debriefing session together&#xD;
&#xD;
          -  Willing to be contacted in 6-8 weeks for a telephone interview&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Index participants and partners who are unable to communicate with staff or&#xD;
             participate in study procedures due to cognitive, mental, or language difficulties&#xD;
             will not be eligible for recruitment into the study.&#xD;
&#xD;
          -  Dyads will also be excluded if in same-sex main partnership or a member of the couple&#xD;
             is currently enrolled in another sexual behavior study, one or both partners has a&#xD;
             known concurrent HIV infection, one or more partners has a pending incarceration,&#xD;
             there is more than five years age difference between the two partners and one partner&#xD;
             is &lt;16 years of age, or there is evidence of intimate partner violence (IPV) in the&#xD;
             relationship.&#xD;
&#xD;
          -  Individuals who screen positive for IPV will be referred to local resources for&#xD;
             assistance.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Heterosexual dyads based on female and male biology recruited for study.</gender_description>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria E Trent, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Medicine</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>December 2022</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <results_first_submitted>January 10, 2022</results_first_submitted>
  <results_first_submitted_qc>January 10, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">February 8, 2022</results_first_posted>
  <last_update_submitted>December 5, 2022</last_update_submitted>
  <last_update_submitted_qc>December 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>This is a small pilot trial. De-identified data will be presented in aggregate in professional presentations and publications.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 17, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT03275168/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>44 participants were eligible for enrollment in the control arm and 45 participants were eligible for enrollment in the intervention arm. However, 34 in the control arm and 34 in the intervention arm (of the total eligible subjects) returned to be enrolled in the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Control</title>
          <description>Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention&#xD;
Individual evidence-based STI/HIV prevention intervention: Sexual partners will receive individual evidence-based HIV/STI prevention counseling without partner debrief and/or practice negotiating condom use.</description>
        </group>
        <group group_id="P2">
          <title>Intervention</title>
          <description>Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention plus dyadic counseling and negotiation practice with partner&#xD;
Intervention: Sexual partners will receive dyadic counseling and support for condom negotiation after receipt of individual evidence based HIV/STI prevention intervention (Sister-to-Sister (female) and Focus on the Future (male).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Control</title>
          <description>Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention&#xD;
Individual evidence-based STI/HIV prevention intervention: Sexual partners will receive individual evidence-based HIV/STI prevention counseling without partner debrief and/or practice negotiating condom use.</description>
        </group>
        <group group_id="B2">
          <title>Intervention</title>
          <description>Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention plus dyadic counseling and negotiation practice with partner&#xD;
Intervention: Sexual partners will receive dyadic counseling and support for condom negotiation after receipt of individual evidence based HIV/STI prevention intervention (Sister-to-Sister (female) and Focus on the Future (male).</description>
        </group>
        <group group_id="B3">
          <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="34"/>
            <count group_id="B2" value="34"/>
            <count group_id="B3" value="68"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21.3" spread="2.6"/>
                    <measurement group_id="B2" value="23.5" spread="2.4"/>
                    <measurement group_id="B3" value="22.3" spread="2.5"/>
                  </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="16"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="35"/>
                  </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Feasibility as Assessed by the Number of Participants Who Are Enrolled With a Partner</title>
        <description>Recruitment (as a measure of feasibility) will be assessed by calculating the number of eligible patients who return with a partner to the study appointment and consent to participate in the study.</description>
        <time_frame>24 months</time_frame>
        <population>The population for analysis is the number of those who were eligible to enroll, not the number who were enrolled.</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention&#xD;
Individual evidence-based STI/HIV prevention intervention: Sexual partners will receive individual evidence-based HIV/STI prevention counseling without partner debrief and/or practice negotiating condom use.</description>
          </group>
          <group group_id="O2">
            <title>Intervention</title>
            <description>Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention plus dyadic counseling and negotiation practice with partner&#xD;
Intervention: Sexual partners will receive dyadic counseling and support for condom negotiation after receipt of individual evidence based HIV/STI prevention intervention (Sister-to-Sister (female) and Focus on the Future (male).</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility as Assessed by the Number of Participants Who Are Enrolled With a Partner</title>
          <description>Recruitment (as a measure of feasibility) will be assessed by calculating the number of eligible patients who return with a partner to the study appointment and consent to participate in the study.</description>
          <population>The population for analysis is the number of those who were eligible to enroll, not the number who were enrolled.</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="44"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Acceptability as Assessed by Number of Participants Available for Week 6-8 Interview</title>
        <description>Retention for the 6-8 week interview will also be calculated as a measure of acceptability.</description>
        <time_frame>6-8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention&#xD;
Individual evidence-based STI/HIV prevention intervention: Sexual partners will receive individual evidence-based HIV/STI prevention counseling without partner debrief and/or practice negotiating condom use.</description>
          </group>
          <group group_id="O2">
            <title>Intervention</title>
            <description>Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention plus dyadic counseling and negotiation practice with partner&#xD;
Intervention: Sexual partners will receive dyadic counseling and support for condom negotiation after receipt of individual evidence based HIV/STI prevention intervention (Sister-to-Sister (female) and Focus on the Future (male).</description>
          </group>
        </group_list>
        <measure>
          <title>Acceptability as Assessed by Number of Participants Available for Week 6-8 Interview</title>
          <description>Retention for the 6-8 week interview will also be calculated as a measure of acceptability.</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="34"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>8 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Control</title>
          <description>Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention&#xD;
Individual evidence-based STI/HIV prevention intervention: Sexual partners will receive individual evidence-based HIV/STI prevention counseling without partner debrief and/or practice negotiating condom use.</description>
        </group>
        <group group_id="E2">
          <title>Intervention</title>
          <description>Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention plus dyadic counseling and negotiation practice with partner&#xD;
Intervention: Sexual partners will receive dyadic counseling and support for condom negotiation after receipt of individual evidence based HIV/STI prevention intervention (Sister-to-Sister (female) and Focus on the Future (male).</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="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
              </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="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
              </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 Maria Trent</name_or_title>
      <organization>Johns Hopkins University</organization>
      <phone>4109552910</phone>
      <email>mtrent2@jhu.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/NCT03275168
org study id: IRB00148707
secondary id: 1R21HD090498-01A1
nct id: NCT03275168
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This pilot project will evaluate the feasibility, acceptability, and preliminary
      effectiveness of a couples-based behavioral intervention [COUPLES] that augments individual
      evidence-based interventions with joint health education counseling for STI-affected AYA
      dyads within a primary care setting.
While public health programs have demonstrated modest success in reducing the adolescent and
      young adult (AYA) risk for STI/HIV, significant health disparities remain. The risk of
      STI/HIV is not uniform among AYA. AYA residing in segregated urban communities with high STI
      prevalence and complicated sexual networks face even greater risk for disease and associated
      complications. Additional supports designed to increase engagement in care and reduce STI
      acquisition and transmissions are urgently needed to meet the sexual health and reproductive
      health goals for the nation. Overwhelmingly, AYA STI prevention interventions have targeted
      individuals and individual-level factors. While effective, these interventions do not
      adequately address other important influences affecting AYA risk for STI/HIV, such as partner
      or relationship influences on sexual decision-making and behavior. Partner notification and
      treatment is a key strategy for disease control and has previously been tested among adults
      for STI/HIV prevention work but has yet to be evaluated for AYA. Our prior research
      demonstrates that AYAs with complicated STIs are likely to notify their partners to seek
      treatment (88-92%); however, AYAs receiving brief behavioral interventions, relative to those
      receiving standard of care were 3 times more likely to be successful in arranging for their
      partner's treatment. Thus, partner interventions may hold promise for harnessing the power of
      relationship dynamics to enhance sexual decision-making, communication, and subsequent health
      behaviors. The investigators propose to pilot test an intervention designed to change sexual
      health outcomes by understanding partners and the learning environment related to sex
      [COUPLES] by simultaneously delivering two evidence-based STI/HIV prevention interventions
      Sister-to-Sister Teen and Focus on the Future. The simultaneous delivery of effective
      interventions will be augmented with a joint partner health education counseling session
      focused on enhancing communication and negotiation of safe sexual practices within the
      relationship. If successful, this pilot will support the development of a larger trial
      designed to evaluate the effectiveness of this approach in the busy primary care setting by
      providing evidence that AYA can and will safely engage their partners in a supportive primary
      care setting that integrates high quality treatment with evidence-based STI/HIV prevention
      interventions delivered by health educator teams.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
masking description: Single blind
measure: Feasibility as Assessed by the Number of Participants Who Are Enrolled With a Partner
time frame: 24 months
description: Recruitment (as a measure of feasibility) will be assessed by calculating the number of eligible patients who return with a partner to the study appointment and consent to participate in the study.
measure: Acceptability as Assessed by Number of Participants Available for Week 6-8 Interview
time frame: 6-8 weeks
description: Retention for the 6-8 week interview will also be calculated as a measure of acceptability.
arm group label: Control
arm group type: Active Comparator
description: Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention
arm group label: Intervention
arm group type: Experimental
description: Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention plus dyadic counseling and negotiation practice with partner
intervention type: Behavioral
intervention name: Intervention
description: Sexual partners will receive dyadic counseling and support for condom negotiation after receipt of individual evidence based HIV/STI prevention intervention (Sister-to-Sister (female) and Focus on the Future (male).
arm group label: Intervention
intervention type: Behavioral
intervention name: Individual evidence-based STI/HIV prevention intervention
description: Sexual partners will receive individual evidence-based HIV/STI prevention counseling without partner debrief and/or practice negotiating condom use.
arm group label: Control
other name: Sister to Sister / Focus on the Future
criteria: 
gender: All
gender based: Yes
gender description: Heterosexual dyads based on female and male biology recruited for study.
minimum age: 16 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maria E Trent, MD, MPH
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
ipd description: This is a small pilot trial. De-identified data will be presented in aggregate in professional presentations and publications.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 