<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/NCT03766165</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00008833</org_study_id>
    <secondary_id>K01MH107310</secondary_id>
    <nct_id>NCT03766165</nct_id>
  </id_info>
  <brief_title>Microenterprise Intervention to Reduce Sexual Risk Behaviors in Young Adults</brief_title>
  <acronym>EMERGE</acronym>
  <official_title>The Engaging Microenterprise for Resource Generation and Health Empowerment (EMERGE) Project: Feasibility Trial of an Enhanced Microenterprise Intervention to Reduce Sexual Risk Behaviors in Young Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins Bloomberg School of Public Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins Bloomberg School of Public Health</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 study team will conduct a two-group study to examine the feasibility of implementing an&#xD;
      enhanced microenterprise intervention to reduce sexual risk behaviors. The team will enroll&#xD;
      approximately 40 young adults. Participants will be randomly assigned to one of two groups.&#xD;
      The first group (&quot;control&quot;) will receive text messages with information on job openings. The&#xD;
      second group (&quot;intervention&quot;) will receive text messages with information on job openings&#xD;
      plus HIV prevention and business educational sessions, mentored apprenticeship, a start-up&#xD;
      grant (provided in 6 payments), and HIV behavioral economics text messages.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study team will conduct a two-group study to examine the feasibility of implementing an&#xD;
      enhanced microenterprise intervention to reduce sexual risk behaviors. The team will enroll&#xD;
      approximately 40 young adults, aged 18 to 24, who are African-American, homeless,&#xD;
      out-of-school, unemployed or under-employed, report unprotected/unsafe sex, and have access&#xD;
      to a cell phone. Participants will be randomly assigned to one of two groups. The first group&#xD;
      (&quot;control&quot;) will receive text messages with information on job openings. The second group&#xD;
      (&quot;intervention&quot;) will receive text messages with information on job openings plus HIV&#xD;
      prevention and business educational sessions, mentored apprenticeship, a start-up grant&#xD;
      (provided in 6 payments), and HIV behavioral economics text messages. Data will be collected&#xD;
      for 26 weeks (week 1 to week 26). Participants will undergo a baseline in-person interview at&#xD;
      the time of enrollment (week 1) and be randomized to a group after completing a 3-week run-in&#xD;
      period (week 1 to week 3). Each group will receive the assigned activities for 20 weeks (week&#xD;
      4 to week 23). An endline in-person interview will be conducted in and around week 26,&#xD;
      respectively. Participants will also complete a weekly text message survey from enrollment&#xD;
      (week 1) to the end of the study (week 26). The study team will collect feasibility&#xD;
      information pertaining to two primary outcomes: (i) the proportion of participants in both&#xD;
      groups who have responded to 70% or more of the weekly text message surveys at week 26 and&#xD;
      (ii) the proportion of participants in the intervention group who have completed 70% or more&#xD;
      of intervention activities (i.e., text message receipt, session attendance, grant spending,&#xD;
      and mentor contact) at week 23. As secondary outcomes, the study team will collect&#xD;
      feasibility information about the proportion of all participants who receive one or more&#xD;
      informational text messages each week, the proportion of all participants who respond to a&#xD;
      text message survey each week, the proportion of intervention participants who attend an&#xD;
      educational session each week, the proportion of intervention participants who receive one or&#xD;
      more mentor contacts each week, and the proportion of intervention participants who spend one&#xD;
      or more grant payments each week. The study team will also examine the completion and&#xD;
      variation in behavioral outcomes pertaining to the proportion of participants in each group&#xD;
      who report one or more unprotected/unsafe sex acts in the last week and last month, the&#xD;
      proportion of participants in each group who report one or more safer sex acts in the last&#xD;
      week and last month, the proportion of participants in each group who report one or more HIV&#xD;
      prevention care-seeking or information-seeking acts in the last week and last month, and the&#xD;
      proportion of participants in each group who report one or more paid hours of work in the&#xD;
      last week and last month. The study is anticipated to start in December 2018.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 5, 2018</start_date>
  <completion_date type="Actual">August 19, 2019</completion_date>
  <primary_completion_date type="Actual">August 19, 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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of Participants in Both Groups Who Have Responded to 70% or More of the Weekly Text Message Surveys</measure>
    <time_frame>Measured at week 26</time_frame>
    <description>Proportion of participants in both groups who have responded to 70% or more of the weekly text message surveys (description)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of Intervention Participants Who Have Completed 70% or More of Intervention Activities (i.e., Text Message Receipt, Session Attendance, Grant Spending, and Mentor Contact)</measure>
    <time_frame>Measured at week 23</time_frame>
    <description>Proportion of intervention participants who have completed 70% or more of intervention activities (i.e., text message receipt, session attendance, grant spending, and mentor contact) (description)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of All Participants Who Receive One or More Informational Text Messages</measure>
    <time_frame>Measured weekly at week 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23</time_frame>
    <description>Proportion of all participants who receive one or more informational text messages (description)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of All Participants Who Respond to the Text Message Survey</measure>
    <time_frame>Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26</time_frame>
    <description>Proportion of all participants who respond to the text message survey (description)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Intervention Participants Who Attend an Educational Session</measure>
    <time_frame>Measured weekly at week 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23</time_frame>
    <description>Proportion of intervention participants who attend an educational session (description)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Intervention Participants Who Receive One or More Mentor Contacts</measure>
    <time_frame>Measured weekly at week 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23</time_frame>
    <description>Proportion of intervention participants who receive one or more mentor contacts (description)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Intervention Participants Who Spend One or More Grant Payments</measure>
    <time_frame>Measured weekly at week 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23</time_frame>
    <description>Proportion of intervention participants who spend one or more grant payments (description)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants in Each Group Who Report One or More Unprotected Sex Acts in Last Week</measure>
    <time_frame>Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26</time_frame>
    <description>Proportion of participants in each group who report one or more unprotected sex acts in last week (description)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants in Each Group Who Report One or More Unprotected Sex Acts in Last Month</measure>
    <time_frame>Measured at week 1 and 26</time_frame>
    <description>Proportion of participants in each group who report one or more unprotected sex acts in last month (description)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants in Each Group Who Report One or More Safer Sex Acts in Last Week</measure>
    <time_frame>Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26</time_frame>
    <description>Proportion of participants in each group who report one or more safer sex acts in last week (description)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants in Each Group Who Report One or More Safer Sex Acts in Last Month</measure>
    <time_frame>Measured at week 1 and 26</time_frame>
    <description>Proportion of participants in each group who report one or more safer sex acts in last month (description)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants in Each Group Who Report One or More HIV Preventive Care-seeking or Information-seeking Acts in Last Week</measure>
    <time_frame>Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26</time_frame>
    <description>Proportion of participants in each group who report one or more HIV preventive care-seeking or information-seeking acts in last week (description)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants in Each Group Who Report One or More HIV Preventive Care-seeking or Information-seeking Acts in Last Month</measure>
    <time_frame>Measured at week 1 and 26</time_frame>
    <description>Proportion of participants in each group who report one or more HIV preventive care-seeking or information-seeking acts in last month (description)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants in Each Group Who Report One or More Paid Hours of Work in the Last Week</measure>
    <time_frame>Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26</time_frame>
    <description>Proportion of participants in each group who report one or more paid hours of work in the last week (description)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants in Each Group Who Report One or More Paid Hours of Work in the Last Month</measure>
    <time_frame>Measured weekly at week 1 and 26</time_frame>
    <description>Proportion of participants in each group who report one or more paid hours of work in the last month (description)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Feasibility</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Job announcements only</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention</intervention_name>
    <description>Participants will receive job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Participants will receive job announcements only.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria are:&#xD;
&#xD;
          -  African American;&#xD;
&#xD;
          -  Aged 18-24;&#xD;
&#xD;
          -  Living in Baltimore City;&#xD;
&#xD;
          -  Having experienced one episode of homelessness in last 12 months;&#xD;
&#xD;
          -  Unemployed or employed fewer than 10 hours per week;&#xD;
&#xD;
          -  Not enrolled in school;&#xD;
&#xD;
          -  Owning a mobile phone with text messaging function;&#xD;
&#xD;
          -  Reporting at least one episode of unprotected/unsafe sex in prior 12 months&#xD;
&#xD;
        Exclusion criteria are:&#xD;
&#xD;
          -  Aged 17 or younger;&#xD;
&#xD;
          -  Older than 24 years;&#xD;
&#xD;
          -  Unwilling to provide consent for study participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Larissa Jennings Mayo-Wilson, PhD MHS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins Bloomberg School of Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Bloomberg School of Public Health</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <results_first_submitted>August 26, 2020</results_first_submitted>
  <results_first_submitted_qc>September 29, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 22, 2020</results_first_posted>
  <last_update_submitted>September 29, 2020</last_update_submitted>
  <last_update_submitted_qc>September 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual patient data (IPD) will be shared.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>The IPD will be posted on a permanent online data repository within 36 months after study completion.</ipd_time_frame>
    <ipd_access_criteria>There are no access criteria.</ipd_access_criteria>
  </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>January 23, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT03766165/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>Job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.&#xD;
Intervention: Participants will receive job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Job announcements only&#xD;
Control: Participants will receive job announcements only.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>Job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.&#xD;
Intervention: Participants will receive job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Job announcements only&#xD;
Control: Participants will receive job announcements only.</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="19"/>
            <count group_id="B2" value="19"/>
            <count group_id="B3" value="38"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21" lower_limit="18" upper_limit="24"/>
                    <measurement group_id="B2" value="21" lower_limit="18" upper_limit="24"/>
                    <measurement group_id="B3" value="21" lower_limit="18" upper_limit="24"/>
                  </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="13"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </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="19"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="38"/>
                  </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>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>One or more episodes of homelessness within last 12 months</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Participants in Both Groups Who Have Responded to 70% or More of the Weekly Text Message Surveys</title>
        <description>Proportion of participants in both groups who have responded to 70% or more of the weekly text message surveys (description)</description>
        <time_frame>Measured at week 26</time_frame>
        <population>Participants in both groups</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.&#xD;
Intervention: Participants will receive job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Job announcements only&#xD;
Control: Participants will receive job announcements only.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants in Both Groups Who Have Responded to 70% or More of the Weekly Text Message Surveys</title>
          <description>Proportion of participants in both groups who have responded to 70% or more of the weekly text message surveys (description)</description>
          <population>Participants in both groups</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="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Intervention Participants Who Have Completed 70% or More of Intervention Activities (i.e., Text Message Receipt, Session Attendance, Grant Spending, and Mentor Contact)</title>
        <description>Proportion of intervention participants who have completed 70% or more of intervention activities (i.e., text message receipt, session attendance, grant spending, and mentor contact) (description)</description>
        <time_frame>Measured at week 23</time_frame>
        <population>Intervention participants</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.&#xD;
Intervention: Participants will receive job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Intervention Participants Who Have Completed 70% or More of Intervention Activities (i.e., Text Message Receipt, Session Attendance, Grant Spending, and Mentor Contact)</title>
          <description>Proportion of intervention participants who have completed 70% or more of intervention activities (i.e., text message receipt, session attendance, grant spending, and mentor contact) (description)</description>
          <population>Intervention participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of All Participants Who Receive One or More Informational Text Messages</title>
        <description>Proportion of all participants who receive one or more informational text messages (description)</description>
        <time_frame>Measured weekly at week 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23</time_frame>
        <population>All participants</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>All participants including those in intervention arm and control arm</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of All Participants Who Receive One or More Informational Text Messages</title>
          <description>Proportion of all participants who receive one or more informational text messages (description)</description>
          <population>All participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 11</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 17</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of All Participants Who Respond to the Text Message Survey</title>
        <description>Proportion of all participants who respond to the text message survey (description)</description>
        <time_frame>Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26</time_frame>
        <population>All participants including those in intervention arm and control arm</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>All participants including those in intervention arm and control arm</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of All Participants Who Respond to the Text Message Survey</title>
          <description>Proportion of all participants who respond to the text message survey (description)</description>
          <population>All participants including those in intervention arm and control arm</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="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 11</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 17</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 22</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 23</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 25</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Intervention Participants Who Attend an Educational Session</title>
        <description>Proportion of intervention participants who attend an educational session (description)</description>
        <time_frame>Measured weekly at week 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23</time_frame>
        <population>Intervention Participants Allowed on Site by CBO</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.&#xD;
Intervention: Participants will receive job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Intervention Participants Who Attend an Educational Session</title>
          <description>Proportion of intervention participants who attend an educational session (description)</description>
          <population>Intervention Participants Allowed on Site by CBO</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="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 11</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 17</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 22</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 23</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Intervention Participants Who Receive One or More Mentor Contacts</title>
        <description>Proportion of intervention participants who receive one or more mentor contacts (description)</description>
        <time_frame>Measured weekly at week 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23</time_frame>
        <population>Intervention Participants</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.&#xD;
Intervention: Participants will receive job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Intervention Participants Who Receive One or More Mentor Contacts</title>
          <description>Proportion of intervention participants who receive one or more mentor contacts (description)</description>
          <population>Intervention Participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 11</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 17</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 22</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 23</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Intervention Participants Who Spend One or More Grant Payments</title>
        <description>Proportion of intervention participants who spend one or more grant payments (description)</description>
        <time_frame>Measured weekly at week 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23</time_frame>
        <population>Intervention participants</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.&#xD;
Intervention: Participants will receive job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Intervention Participants Who Spend One or More Grant Payments</title>
          <description>Proportion of intervention participants who spend one or more grant payments (description)</description>
          <population>Intervention participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 11</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 17</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 22</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 23</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants in Each Group Who Report One or More Unprotected Sex Acts in Last Week</title>
        <description>Proportion of participants in each group who report one or more unprotected sex acts in last week (description)</description>
        <time_frame>Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26</time_frame>
        <population>Outcomes 8, 10, 12, 14 were collected using experimental text messages. As specified, if not feasible, an in-person pre- and post-intervention paper questionnaire would be used and report via Outcomes 9, 11, 13, 15 that are identical to Outcomes 8, 10, 12, 14, respectively. Text messages require modifications given high missing and accurate data.</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>All participants including those in intervention arm and control arm</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants in Each Group Who Report One or More Unprotected Sex Acts in Last Week</title>
          <description>Proportion of participants in each group who report one or more unprotected sex acts in last week (description)</description>
          <population>Outcomes 8, 10, 12, 14 were collected using experimental text messages. As specified, if not feasible, an in-person pre- and post-intervention paper questionnaire would be used and report via Outcomes 9, 11, 13, 15 that are identical to Outcomes 8, 10, 12, 14, respectively. Text messages require modifications given high missing and accurate data.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants in Each Group Who Report One or More Unprotected Sex Acts in Last Month</title>
        <description>Proportion of participants in each group who report one or more unprotected sex acts in last month (description)</description>
        <time_frame>Measured at week 1 and 26</time_frame>
        <population>Participants in each group</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.&#xD;
Intervention: Participants will receive job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Job announcements only&#xD;
Control: Participants will receive job announcements only.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants in Each Group Who Report One or More Unprotected Sex Acts in Last Month</title>
          <description>Proportion of participants in each group who report one or more unprotected sex acts in last month (description)</description>
          <population>Participants in each group</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="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants in Each Group Who Report One or More Safer Sex Acts in Last Week</title>
        <description>Proportion of participants in each group who report one or more safer sex acts in last week (description)</description>
        <time_frame>Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26</time_frame>
        <population>Outcomes 8, 10, 12, 14 were collected using experimental text messages. As specified, if not feasible, an in-person pre- and post-intervention paper questionnaire would be used and report via Outcomes 9, 11, 13, 15 that are identical to Outcomes 8, 10, 12, 14, respectively. Text messages require modifications given high missing and accurate data.</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>All participants including those in intervention arm and control arm</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants in Each Group Who Report One or More Safer Sex Acts in Last Week</title>
          <description>Proportion of participants in each group who report one or more safer sex acts in last week (description)</description>
          <population>Outcomes 8, 10, 12, 14 were collected using experimental text messages. As specified, if not feasible, an in-person pre- and post-intervention paper questionnaire would be used and report via Outcomes 9, 11, 13, 15 that are identical to Outcomes 8, 10, 12, 14, respectively. Text messages require modifications given high missing and accurate data.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants in Each Group Who Report One or More Safer Sex Acts in Last Month</title>
        <description>Proportion of participants in each group who report one or more safer sex acts in last month (description)</description>
        <time_frame>Measured at week 1 and 26</time_frame>
        <population>Participants in each group</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.&#xD;
Intervention: Participants will receive job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Job announcements only&#xD;
Control: Participants will receive job announcements only.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants in Each Group Who Report One or More Safer Sex Acts in Last Month</title>
          <description>Proportion of participants in each group who report one or more safer sex acts in last month (description)</description>
          <population>Participants in each group</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="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants in Each Group Who Report One or More HIV Preventive Care-seeking or Information-seeking Acts in Last Week</title>
        <description>Proportion of participants in each group who report one or more HIV preventive care-seeking or information-seeking acts in last week (description)</description>
        <time_frame>Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26</time_frame>
        <population>Outcomes 8, 10, 12, 14 were collected using experimental text messages. As specified, if not feasible, an in-person pre- and post-intervention paper questionnaire would be used and report via Outcomes 9, 11, 13, 15 that are identical to Outcomes 8, 10, 12, 14, respectively. Text messages require modifications given high missing and accurate data.</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>All participants including those in intervention arm and control arm</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants in Each Group Who Report One or More HIV Preventive Care-seeking or Information-seeking Acts in Last Week</title>
          <description>Proportion of participants in each group who report one or more HIV preventive care-seeking or information-seeking acts in last week (description)</description>
          <population>Outcomes 8, 10, 12, 14 were collected using experimental text messages. As specified, if not feasible, an in-person pre- and post-intervention paper questionnaire would be used and report via Outcomes 9, 11, 13, 15 that are identical to Outcomes 8, 10, 12, 14, respectively. Text messages require modifications given high missing and accurate data.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants in Each Group Who Report One or More HIV Preventive Care-seeking or Information-seeking Acts in Last Month</title>
        <description>Proportion of participants in each group who report one or more HIV preventive care-seeking or information-seeking acts in last month (description)</description>
        <time_frame>Measured at week 1 and 26</time_frame>
        <population>Participants in each group</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.&#xD;
Intervention: Participants will receive job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Job announcements only&#xD;
Control: Participants will receive job announcements only.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants in Each Group Who Report One or More HIV Preventive Care-seeking or Information-seeking Acts in Last Month</title>
          <description>Proportion of participants in each group who report one or more HIV preventive care-seeking or information-seeking acts in last month (description)</description>
          <population>Participants in each group</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="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants in Each Group Who Report One or More Paid Hours of Work in the Last Week</title>
        <description>Proportion of participants in each group who report one or more paid hours of work in the last week (description)</description>
        <time_frame>Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26</time_frame>
        <population>Outcomes 8, 10, 12, 14 were collected using experimental text messages. As specified, if not feasible, an in-person pre- and post-intervention paper questionnaire would be used and report via Outcomes 9, 11, 13, 15 that are identical to Outcomes 8, 10, 12, 14, respectively. Text messages require modifications given high missing and accurate data.</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>All participants including those in intervention arm and control arm</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants in Each Group Who Report One or More Paid Hours of Work in the Last Week</title>
          <description>Proportion of participants in each group who report one or more paid hours of work in the last week (description)</description>
          <population>Outcomes 8, 10, 12, 14 were collected using experimental text messages. As specified, if not feasible, an in-person pre- and post-intervention paper questionnaire would be used and report via Outcomes 9, 11, 13, 15 that are identical to Outcomes 8, 10, 12, 14, respectively. Text messages require modifications given high missing and accurate data.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants in Each Group Who Report One or More Paid Hours of Work in the Last Month</title>
        <description>Proportion of participants in each group who report one or more paid hours of work in the last month (description)</description>
        <time_frame>Measured weekly at week 1 and 26</time_frame>
        <population>Participants in each group</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.&#xD;
Intervention: Participants will receive job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Job announcements only&#xD;
Control: Participants will receive job announcements only.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants in Each Group Who Report One or More Paid Hours of Work in the Last Month</title>
          <description>Proportion of participants in each group who report one or more paid hours of work in the last month (description)</description>
          <population>Participants in each group</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="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>20 weeks</time_frame>
      <desc>The study used a structured weekly participant checklist to document whether each participant experienced an intervention-related adverse event.</desc>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>Job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.&#xD;
Intervention: Participants will receive job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Job announcements only&#xD;
Control: Participants will receive job announcements only.</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="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </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="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <limitations_and_caveats>All measures were self-reported and may be subject to reporting biases.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Larissa Jennings Mayo-Wilson</name_or_title>
      <organization>Johns Hopkins University; Indiana University</organization>
      <phone>1-812-856-0902</phone>
      <email>ljmayowi@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/NCT03766165
org study id: IRB00008833
secondary id: K01MH107310
nct id: NCT03766165
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study team will conduct a two-group study to examine the feasibility of implementing an
      enhanced microenterprise intervention to reduce sexual risk behaviors. The team will enroll
      approximately 40 young adults. Participants will be randomly assigned to one of two groups.
      The first group ("control") will receive text messages with information on job openings. The
      second group ("intervention") will receive text messages with information on job openings
      plus HIV prevention and business educational sessions, mentored apprenticeship, a start-up
      grant (provided in 6 payments), and HIV behavioral economics text messages.
The study team will conduct a two-group study to examine the feasibility of implementing an
      enhanced microenterprise intervention to reduce sexual risk behaviors. The team will enroll
      approximately 40 young adults, aged 18 to 24, who are African-American, homeless,
      out-of-school, unemployed or under-employed, report unprotected/unsafe sex, and have access
      to a cell phone. Participants will be randomly assigned to one of two groups. The first group
      ("control") will receive text messages with information on job openings. The second group
      ("intervention") will receive text messages with information on job openings plus HIV
      prevention and business educational sessions, mentored apprenticeship, a start-up grant
      (provided in 6 payments), and HIV behavioral economics text messages. Data will be collected
      for 26 weeks (week 1 to week 26). Participants will undergo a baseline in-person interview at
      the time of enrollment (week 1) and be randomized to a group after completing a 3-week run-in
      period (week 1 to week 3). Each group will receive the assigned activities for 20 weeks (week
      4 to week 23). An endline in-person interview will be conducted in and around week 26,
      respectively. Participants will also complete a weekly text message survey from enrollment
      (week 1) to the end of the study (week 26). The study team will collect feasibility
      information pertaining to two primary outcomes: (i) the proportion of participants in both
      groups who have responded to 70% or more of the weekly text message surveys at week 26 and
      (ii) the proportion of participants in the intervention group who have completed 70% or more
      of intervention activities (i.e., text message receipt, session attendance, grant spending,
      and mentor contact) at week 23. As secondary outcomes, the study team will collect
      feasibility information about the proportion of all participants who receive one or more
      informational text messages each week, the proportion of all participants who respond to a
      text message survey each week, the proportion of intervention participants who attend an
      educational session each week, the proportion of intervention participants who receive one or
      more mentor contacts each week, and the proportion of intervention participants who spend one
      or more grant payments each week. The study team will also examine the completion and
      variation in behavioral outcomes pertaining to the proportion of participants in each group
      who report one or more unprotected/unsafe sex acts in the last week and last month, the
      proportion of participants in each group who report one or more safer sex acts in the last
      week and last month, the proportion of participants in each group who report one or more HIV
      prevention care-seeking or information-seeking acts in the last week and last month, and the
      proportion of participants in each group who report one or more paid hours of work in the
      last week and last month. The study is anticipated to start in December 2018.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Proportion of Participants in Both Groups Who Have Responded to 70% or More of the Weekly Text Message Surveys
time frame: Measured at week 26
description: Proportion of participants in both groups who have responded to 70% or more of the weekly text message surveys (description)
measure: Proportion of Intervention Participants Who Have Completed 70% or More of Intervention Activities (i.e., Text Message Receipt, Session Attendance, Grant Spending, and Mentor Contact)
time frame: Measured at week 23
description: Proportion of intervention participants who have completed 70% or more of intervention activities (i.e., text message receipt, session attendance, grant spending, and mentor contact) (description)
measure: Proportion of All Participants Who Receive One or More Informational Text Messages
time frame: Measured weekly at week 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23
description: Proportion of all participants who receive one or more informational text messages (description)
measure: Proportion of All Participants Who Respond to the Text Message Survey
time frame: Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26
description: Proportion of all participants who respond to the text message survey (description)
measure: Proportion of Intervention Participants Who Attend an Educational Session
time frame: Measured weekly at week 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23
description: Proportion of intervention participants who attend an educational session (description)
measure: Proportion of Intervention Participants Who Receive One or More Mentor Contacts
time frame: Measured weekly at week 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23
description: Proportion of intervention participants who receive one or more mentor contacts (description)
measure: Proportion of Intervention Participants Who Spend One or More Grant Payments
time frame: Measured weekly at week 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23
description: Proportion of intervention participants who spend one or more grant payments (description)
measure: Proportion of Participants in Each Group Who Report One or More Unprotected Sex Acts in Last Week
time frame: Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26
description: Proportion of participants in each group who report one or more unprotected sex acts in last week (description)
measure: Proportion of Participants in Each Group Who Report One or More Unprotected Sex Acts in Last Month
time frame: Measured at week 1 and 26
description: Proportion of participants in each group who report one or more unprotected sex acts in last month (description)
measure: Proportion of Participants in Each Group Who Report One or More Safer Sex Acts in Last Week
time frame: Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26
description: Proportion of participants in each group who report one or more safer sex acts in last week (description)
measure: Proportion of Participants in Each Group Who Report One or More Safer Sex Acts in Last Month
time frame: Measured at week 1 and 26
description: Proportion of participants in each group who report one or more safer sex acts in last month (description)
measure: Proportion of Participants in Each Group Who Report One or More HIV Preventive Care-seeking or Information-seeking Acts in Last Week
time frame: Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26
description: Proportion of participants in each group who report one or more HIV preventive care-seeking or information-seeking acts in last week (description)
measure: Proportion of Participants in Each Group Who Report One or More HIV Preventive Care-seeking or Information-seeking Acts in Last Month
time frame: Measured at week 1 and 26
description: Proportion of participants in each group who report one or more HIV preventive care-seeking or information-seeking acts in last month (description)
measure: Proportion of Participants in Each Group Who Report One or More Paid Hours of Work in the Last Week
time frame: Measured weekly at week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26
description: Proportion of participants in each group who report one or more paid hours of work in the last week (description)
measure: Proportion of Participants in Each Group Who Report One or More Paid Hours of Work in the Last Month
time frame: Measured weekly at week 1 and 26
description: Proportion of participants in each group who report one or more paid hours of work in the last month (description)
arm group label: Intervention
arm group type: Experimental
description: Job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.
arm group label: Control
arm group type: Other
description: Job announcements only
intervention type: Behavioral
intervention name: Intervention
description: Participants will receive job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.
arm group label: Intervention
intervention type: Behavioral
intervention name: Control
description: Participants will receive job announcements only.
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Larissa Jennings Mayo-Wilson, PhD MHS
role: Principal Investigator
affiliation: Johns Hopkins Bloomberg School of Public Health
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Yes
ipd description: De-identified individual patient data (IPD) will be shared.
ipd info type: Study Protocol
ipd time frame: The IPD will be posted on a permanent online data repository within 36 months after study completion.
ipd access criteria: There are no access criteria.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: All measures were self-reported and may be subject to reporting biases.
point of contact: 