<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/NCT03237871</url>
  </required_header>
  <id_info>
    <org_study_id>IRB0007563</org_study_id>
    <secondary_id>K01MH107310</secondary_id>
    <nct_id>NCT03237871</nct_id>
  </id_info>
  <brief_title>The EMERGE Project: Feasibility of Assessing Economic and Sexual Risk Behaviors Using Text Messages in Young Adults</brief_title>
  <official_title>The Engaging Microenterprise for Resource Generation and Health Empowerment (EMERGE) Project: Feasibility of Assessing Economic and Sexual Risk Behaviors Using Text Messages in Homeless 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>
      As part of the development of the Engaging Microenterprise for Resource Generation and Health&#xD;
      Empowerment (EMERGE) Project, the study team will conduct a single-group study to examine the&#xD;
      feasibility of assessing economic and sexual risk behaviors using text messages. The team&#xD;
      will enroll approximately 20 young adults, aged 18 to 24, who are African-American, homeless,&#xD;
      out-of-school, and un/under-employed. Participants will complete a text-messaged survey each&#xD;
      week for 5 weeks. The study team will collect information about the number of participants&#xD;
      who respond to the weekly survey, the number of questions to which they respond in each&#xD;
      survey, and the number of hours from sending a survey to participants to receiving their&#xD;
      response. As an exploratory aim, participants will also receive 3 informational text messages&#xD;
      each week for 5 weeks on HIV prevention and economic empowerment. The study team will obtain&#xD;
      qualitative feedback from participants regarding text messages they most and least liked. The&#xD;
      survey is not designed to evaluate the effectiveness of the text message intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As part of the development of the Engaging Microenterprise for Resource Generation and Health&#xD;
      Empowerment (EMERGE) Project, the study team will conduct a single-group study to examine the&#xD;
      feasibility of assessing economic and sexual risk behaviors using text messages. The study&#xD;
      team will enroll approximately 20 young adults, aged 18 to 24, who are African-American,&#xD;
      homeless, out-of-school, and un/under-employed. Participants will complete a text-messaged&#xD;
      survey each week for 5 weeks. The study team will collect information about the number of&#xD;
      participants who respond to the weekly survey, the number of questions to which they respond&#xD;
      in each survey, and the number of hours from sending a survey to participants to receiving&#xD;
      their response. As an exploratory aim, participants will also receive 3 informational text&#xD;
      messages each week for 5 weeks on HIV prevention and economic empowerment. The study team&#xD;
      will obtain qualitative feedback from participants regarding text messages they most and&#xD;
      least liked. The survey is not designed to evaluate the effectiveness of the text message&#xD;
      intervention. The single-group study is anticipated to start in August 2017.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 7, 2017</start_date>
  <completion_date type="Actual">September 19, 2017</completion_date>
  <primary_completion_date type="Actual">September 19, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Respond to the Survey in Week 1</measure>
    <time_frame>Week 1</time_frame>
    <description>Number of enrolled participants who respond to the survey in Week 1. Measure type 'number' was used for small sample size and as described in the original registration protocol.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Number of Questions to Which Participant Respond in Each Survey in Week 1</measure>
    <time_frame>Week 1</time_frame>
    <description>Mean number of questions to which enrolled participant respond in each survey in Week 1.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Number of Hours From Sending a Survey to Participants to Receiving Their Response in Week 1</measure>
    <time_frame>Week 1</time_frame>
    <description>Mean number of hours from sending a survey to enrolled participants to receiving their response in Week 1.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Feasibility</condition>
  <arm_group>
    <arm_group_label>Survey and informational text messages</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Text-message survey and informational text messages</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Text-message survey and informational text messages</intervention_name>
    <description>Participants will complete a text-messaged survey each week for 5 weeks assessing economic and sexual risk behaviors. Participants will also receive 3 informational text messages each week for 5 weeks on HIV prevention and economic empowerment.</description>
    <arm_group_label>Survey and informational text messages</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals will be included in the study if, at the time of enrollment, they are:&#xD;
&#xD;
          -  African American&#xD;
&#xD;
          -  Aged 18-24&#xD;
&#xD;
          -  Living in Baltimore City&#xD;
&#xD;
          -  Experiencing homelessness in the past 12 months&#xD;
&#xD;
          -  Employed fewer than 10 hours per week&#xD;
&#xD;
          -  Not enrolled in school&#xD;
&#xD;
          -  Ownership of a mobile phone with text-messaging capacity&#xD;
&#xD;
          -  Reporting at least one episode of unprotected sex in prior 6 months or one other&#xD;
             personal or sexual partner HIV risk factor within prior 6 months (STI diagnosis, sex&#xD;
             while high or drunk, sex exchange, illicit drug use, alcohol dependence).&#xD;
&#xD;
        Exclusion Criteria:&#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, 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>April 2019</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <results_first_submitted>January 28, 2019</results_first_submitted>
  <results_first_submitted_qc>April 10, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 12, 2019</results_first_posted>
  <last_update_submitted>April 10, 2019</last_update_submitted>
  <last_update_submitted_qc>April 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All de-identified IPD that underlie results in a publication will be shared.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>De-identified individual patient data (IPD) that under results in a publication will become available 12 months after publication and will be available for 24 months.</ipd_time_frame>
    <ipd_access_criteria>Sponsor approval for data sharing will be sought. Only bona fide research groups are eligible to access data as evidenced via curriculum vitae (CV) and the involvement of a qualified statistician or qualitative research scientist. Data access requests should be made via email application to the principal investigator detailing the specific requirements and the proposed research and publication plan. Data access requests will be reviewed against specific criteria by the data custodians. Decisions about requests will be made promptly and no more than 3 months after receipt of request.</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 28, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT03237871/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Survey and Informational Text Messages</title>
          <description>Text-message survey and informational text messages&#xD;
Text-message survey and informational text messages: Participants will complete a text-messaged survey each week for 5 weeks assessing economic and sexual risk behaviors. Participants will also receive 3 informational text messages each week for 5 weeks on HIV prevention and economic empowerment.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Number of participants enrolled in the study</population>
      <group_list>
        <group group_id="B1">
          <title>Survey and Informational Text Messages</title>
          <description>Text-message survey and informational text messages&#xD;
Text-message survey and informational text messages: Participants will complete a text-messaged survey each week for 5 weeks assessing economic and sexual risk behaviors. Participants will also receive 3 informational text messages each week for 5 weeks on HIV prevention and economic empowerment.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="17"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Age</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21.2" 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="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Recruited from community organization</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Respond to the Survey in Week 1</title>
        <description>Number of enrolled participants who respond to the survey in Week 1. Measure type 'number' was used for small sample size and as described in the original registration protocol.</description>
        <time_frame>Week 1</time_frame>
        <population>Number of participants enrolled in the study</population>
        <group_list>
          <group group_id="O1">
            <title>Survey and Informational Text Messages</title>
            <description>Text-message survey and informational text messages&#xD;
Text-message survey and informational text messages: Participants will complete a text-messaged survey each week for 5 weeks assessing economic and sexual risk behaviors. Participants will also receive 3 informational text messages each week for 5 weeks on HIV prevention and economic empowerment.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Respond to the Survey in Week 1</title>
          <description>Number of enrolled participants who respond to the survey in Week 1. Measure type 'number' was used for small sample size and as described in the original registration protocol.</description>
          <population>Number of participants enrolled in the study</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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Number of Questions to Which Participant Respond in Each Survey in Week 1</title>
        <description>Mean number of questions to which enrolled participant respond in each survey in Week 1.</description>
        <time_frame>Week 1</time_frame>
        <population>Mean number of participants enrolled in the study who responded to the survey in week 1</population>
        <group_list>
          <group group_id="O1">
            <title>Survey and Informational Text Messages</title>
            <description>Text-message survey and informational text messages&#xD;
Text-message survey and informational text messages: Participants will complete a text-messaged survey each week for 5 weeks assessing economic and sexual risk behaviors. Participants will also receive 3 informational text messages each week for 5 weeks on HIV prevention and economic empowerment.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Number of Questions to Which Participant Respond in Each Survey in Week 1</title>
          <description>Mean number of questions to which enrolled participant respond in each survey in Week 1.</description>
          <population>Mean number of participants enrolled in the study who responded to the survey in week 1</population>
          <units>Mean number of responded questions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.1" spread="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Number of Hours From Sending a Survey to Participants to Receiving Their Response in Week 1</title>
        <description>Mean number of hours from sending a survey to enrolled participants to receiving their response in Week 1.</description>
        <time_frame>Week 1</time_frame>
        <population>Mean number of participants enrolled in the study who responded to the survey in week 1</population>
        <group_list>
          <group group_id="O1">
            <title>Survey and Informational Text Messages</title>
            <description>Text-message survey and informational text messages&#xD;
Text-message survey and informational text messages: Participants will complete a text-messaged survey each week for 5 weeks assessing economic and sexual risk behaviors. Participants will also receive 3 informational text messages each week for 5 weeks on HIV prevention and economic empowerment.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Number of Hours From Sending a Survey to Participants to Receiving Their Response in Week 1</title>
          <description>Mean number of hours from sending a survey to enrolled participants to receiving their response in Week 1.</description>
          <population>Mean number of participants enrolled in the study who responded to the survey in week 1</population>
          <units>Mean number of hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>5 weeks</time_frame>
      <desc>Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.</desc>
      <group_list>
        <group group_id="E1">
          <title>Survey and Informational Text Messages</title>
          <description>Text-message survey and informational text messages&#xD;
Text-message survey and informational text messages: Participants will complete a text-messaged survey each week for 5 weeks assessing economic and sexual risk behaviors. Participants will also receive 3 informational text messages each week for 5 weeks on HIV prevention and economic empowerment.</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="17"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
              </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="17"/>
              </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>
    <point_of_contact>
      <name_or_title>Principal Investigator</name_or_title>
      <organization>Johns Hopkins Bloomberg School of Public Health</organization>
      <phone>410-955-3537</phone>
      <email>ljennin6@jhu.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03237871
org study id: IRB0007563
secondary id: K01MH107310
nct id: NCT03237871
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
As part of the development of the Engaging Microenterprise for Resource Generation and Health
      Empowerment (EMERGE) Project, the study team will conduct a single-group study to examine the
      feasibility of assessing economic and sexual risk behaviors using text messages. The team
      will enroll approximately 20 young adults, aged 18 to 24, who are African-American, homeless,
      out-of-school, and un/under-employed. Participants will complete a text-messaged survey each
      week for 5 weeks. The study team will collect information about the number of participants
      who respond to the weekly survey, the number of questions to which they respond in each
      survey, and the number of hours from sending a survey to participants to receiving their
      response. As an exploratory aim, participants will also receive 3 informational text messages
      each week for 5 weeks on HIV prevention and economic empowerment. The study team will obtain
      qualitative feedback from participants regarding text messages they most and least liked. The
      survey is not designed to evaluate the effectiveness of the text message intervention.
As part of the development of the Engaging Microenterprise for Resource Generation and Health
      Empowerment (EMERGE) Project, the study team will conduct a single-group study to examine the
      feasibility of assessing economic and sexual risk behaviors using text messages. The study
      team will enroll approximately 20 young adults, aged 18 to 24, who are African-American,
      homeless, out-of-school, and un/under-employed. Participants will complete a text-messaged
      survey each week for 5 weeks. The study team will collect information about the number of
      participants who respond to the weekly survey, the number of questions to which they respond
      in each survey, and the number of hours from sending a survey to participants to receiving
      their response. As an exploratory aim, participants will also receive 3 informational text
      messages each week for 5 weeks on HIV prevention and economic empowerment. The study team
      will obtain qualitative feedback from participants regarding text messages they most and
      least liked. The survey is not designed to evaluate the effectiveness of the text message
      intervention. The single-group study is anticipated to start in August 2017.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Number of Participants Who Respond to the Survey in Week 1
time frame: Week 1
description: Number of enrolled participants who respond to the survey in Week 1. Measure type 'number' was used for small sample size and as described in the original registration protocol.
measure: Mean Number of Questions to Which Participant Respond in Each Survey in Week 1
time frame: Week 1
description: Mean number of questions to which enrolled participant respond in each survey in Week 1.
measure: Mean Number of Hours From Sending a Survey to Participants to Receiving Their Response in Week 1
time frame: Week 1
description: Mean number of hours from sending a survey to enrolled participants to receiving their response in Week 1.
arm group label: Survey and informational text messages
arm group type: Experimental
description: Text-message survey and informational text messages
intervention type: Behavioral
intervention name: Text-message survey and informational text messages
description: Participants will complete a text-messaged survey each week for 5 weeks assessing economic and sexual risk behaviors. Participants will also receive 3 informational text messages each week for 5 weeks on HIV prevention and economic empowerment.
arm group label: Survey and informational text messages
criteria: 
gender: All
minimum age: 18 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Larissa Jennings, 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: All de-identified IPD that underlie results in a publication will be shared.
ipd info type: Study Protocol
ipd time frame: De-identified individual patient data (IPD) that under results in a publication will become available 12 months after publication and will be available for 24 months.
ipd access criteria: Sponsor approval for data sharing will be sought. Only bona fide research groups are eligible to access data as evidenced via curriculum vitae (CV) and the involvement of a qualified statistician or qualitative research scientist. Data access requests should be made via email application to the principal investigator detailing the specific requirements and the proposed research and publication plan. Data access requests will be reviewed against specific criteria by the data custodians. Decisions about requests will be made promptly and no more than 3 months after receipt of request.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 