<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/NCT03308097</url>
  </required_header>
  <id_info>
    <org_study_id>R34MH111342</org_study_id>
    <nct_id>NCT03308097</nct_id>
  </id_info>
  <brief_title>A Mobile Intervention to Improve Uptake of PrEP for Southern Black MSM</brief_title>
  <acronym>MobilePrEP</acronym>
  <official_title>A Mobile Intervention to Improve Uptake of PrEP for Southern Black MSM</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rhode Island Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Mississippi Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rhode Island Hospital</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>
      This study will develop and test an interactive mobile messaging intervention to improve&#xD;
      engagement in care related to Pre-exposure Prophylaxis (PrEP) and decrease HIV risk behaviors&#xD;
      for Black men who have sex with men living in the Southern U.S. The mobile messaging&#xD;
      intervention will include interactive text messaging and free, publicly available links to&#xD;
      websites and YouTube videos. During the intervention participants will gain information about&#xD;
      their health, improve motivation for engagement in PrEP related care, and build skills for&#xD;
      healthy behaviors. Participants will also receive intervention materials to help decrease&#xD;
      frequent barriers to care. If the intervention is found to be effective, it can be tested in&#xD;
      a larger study and then disseminated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The uptake of Pre-Exposure Prophylaxis (PrEP) has been slow for young Black men who have sex&#xD;
      with men (BMSM) living in the Southern United States. This is a significant issue because&#xD;
      eight of the ten states with the highest rates of new HIV infections are located in the&#xD;
      South. Jackson, Mississippi (MS) (the site of this project) has the second highest AIDS&#xD;
      diagnosis rate in the nation, and the highest rate of HIV infection for young urban Black men&#xD;
      who have sex with men. This study will develop and test an engaging, interactive, and cost&#xD;
      effective mobile messaging intervention to improve linkage to PrEP care for BMSM (18-35 yrs)&#xD;
      living in Jackson, MS. BMSM eligible for PrEP, receiving care at the University of&#xD;
      Mississippi Medical Center sexually-transmitted infections (STI)/HIV testing clinics, will be&#xD;
      texted interactive links to publicly available, online content about PrEP and HIV prevention.&#xD;
      Links will be sent to PrEP eligible BMSM by 8-16 interactive text messages over 4 weeks. The&#xD;
      material used in the intervention will be consistent with the Information Motivation Behavior&#xD;
      (IMB) Model and will address cultural and structural barriers to initiating PrEP care. A&#xD;
      small randomized controlled study among 66 new participants in the clinics will examine the&#xD;
      preliminary efficacy of the intervention compared to enhanced standard of care on attendance&#xD;
      at a PrEP Services Appointment (the first step in initiating PrEP care). It is hypothesized&#xD;
      that, compared to BMSM receiving enhanced standard of care, BMSM receiving the PrEP Mobile&#xD;
      Messaging Intervention will show greater attendance at a PrEP Services Appointment and&#xD;
      decreased HIV risk behavior at 4 and 16 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 20, 2018</start_date>
  <completion_date type="Actual">August 12, 2020</completion_date>
  <primary_completion_date type="Actual">August 12, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of PrEP Services Appointments Attended-Full Sample</measure>
    <time_frame>16 weeks</time_frame>
    <description>With participant consent, staff at the STI/HIV testing clinic will abstract from the electronic medical record any PrEP Services Appointment, and any PrEP related care.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of PrEP Services Appointments Attended- Restricted Sample</measure>
    <time_frame>16 weeks</time_frame>
    <description>With participant consent, staff at the STI/HIV testing clinic will abstract from the electronic medical record any PrEP Services Appointment, and any PrEP related care.&#xD;
Restricted Sample is only those who did not receive a PrEP prescription the same day as enrollment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Received a PrEP Prescription-Full Sample</measure>
    <time_frame>16 weeks</time_frame>
    <description>Staff at the testing clinic will abstract any prescription written for PrEP at 16 weeks for the participant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Received a PrEP Prescription-Restricted Sample</measure>
    <time_frame>16 weeks</time_frame>
    <description>Staff at the testing clinic will abstract any prescription written for PrEP at 16 weeks for the participant.&#xD;
Restricted sample is those who did not receive a PrEP prescription the same day as enrollment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in PrEP Knowledge-Full Sample</measure>
    <time_frame>Baseline, 16 weeks</time_frame>
    <description>Change in participants score on the PrEP Knowledge Questionnaire between baseline and 16 weeks follow-up. Scores can range from 0-3, with higher scores indicating greater PrEP knowledge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PrEP Knowledge-Restricted Sample</measure>
    <time_frame>Baseline, 16 weeks</time_frame>
    <description>Change in participants score on the PrEP Knowledge Questionnaire between baseline and 16 weeks follow-up. Scores can range from 0-3, with higher scores indicating greater PrEP knowledge.&#xD;
Restricted sample is those who did not receive a PrEP prescription the same day as enrollment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Social Motivational Readiness for PrEP Care-Full Sample</measure>
    <time_frame>Baseline, 16 weeks</time_frame>
    <description>Change in participants' score on the IMB PrEP Motivation Scale (to assess personal and social motivations for PrEP use) from baseline to16 weeks follow-up. Scores can range from 8 - 32, with higher scores indicating greater motivation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Social Motivational Readiness for PrEP Care-Restricted Sample</measure>
    <time_frame>Baseline, 16 weeks</time_frame>
    <description>Change in participants' score on the IMB PrEP Motivation Scale (to assess personal and social motivations for PrEP use) from baseline to16 weeks follow-up. Scores can range from 8 - 32, with higher scores indicating greater motivation.&#xD;
Restricted sample is those who did not receive a PrEP prescription the same day as enrollment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PrEP Self-efficacy-Full Sample</measure>
    <time_frame>Baseline, 16 weeks</time_frame>
    <description>Change in participants' score on the IMB PrEP Behavioral Skills Scale between baseline and 16 weeks, which assesses self-efficacy for taking PrEP as prescribed and assesses self-efficacy for PrEP related medical appointments. Scores can range from 7 - 28, with higher scores indicating greater self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PrEP Self-efficacy-Restricted Sample</measure>
    <time_frame>Baseline, 16 weeks</time_frame>
    <description>Change in participants' score on the IMB PrEP Behavioral Skills Scale between baseline and 16 weeks, which assesses self-efficacy for taking PrEP as prescribed and assesses self-efficacy for PrEP related medical appointments. Scores can range from 7 - 28, with higher scores indicating greater self-efficacy.&#xD;
Restricted sample is those who did not receive a PrEP prescription the same day as enrollment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Hiv</condition>
  <arm_group>
    <arm_group_label>PrEP Mobile Messaging Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants from the STI/HIV testing clinic will receive Enhanced Standard of Care (described below) plus texted messages with the intervention content and follow-up questions over the next 4 weeks on their cell phones. Participants will receive approximately 8-16 interactive text messages with links to web content. Texts will be sent twice a week over the next 4 weeks. Participants will return for 2 more appointments over the next couple of months to fill out questionnaires.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Standard of Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>As part of the enhanced standard of care, participants seen in the STI/HIV testing clinic are given feedback regarding PrEP eligibility and current risk behaviors. Participants are also given an informational handout about PrEP, shown a brief video, and given contact information for the PrEP Clinic Care Coordinator. Participants will return for 2 more visits over the next couple months to fill out questionnaires.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PrEP Mobile Messaging Intervention</intervention_name>
    <description>See group description</description>
    <arm_group_label>PrEP Mobile Messaging Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced Standard of Care</intervention_name>
    <description>See group description</description>
    <arm_group_label>Enhanced Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Black MSM&#xD;
&#xD;
          -  Eligible for PrEP&#xD;
&#xD;
          -  Visit STI/HIV testing clinics at University of Mississippi Medical Center&#xD;
&#xD;
          -  Able to give consent/assent and not impaired by cognitive or medical limitations as&#xD;
             per clinical assessment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Involved in another PrEP or HIV prevention related study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Study only open to self-identifying male participants.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Larry K. Brown, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rhode Island Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Laura Whiteley, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rhode Island Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Leandro Mena, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>University of Mississippi Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <results_first_submitted>January 18, 2021</results_first_submitted>
  <results_first_submitted_qc>February 15, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 21, 2021</results_first_posted>
  <last_update_submitted>February 15, 2021</last_update_submitted>
  <last_update_submitted_qc>February 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PrEP</keyword>
  <keyword>Uptake</keyword>
  <keyword>MSM</keyword>
  <keyword>Black</keyword>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 5, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/97/NCT03308097/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 8, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/97/NCT03308097/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>In total, 70 individuals completed consent are were enrolled.</recruitment_details>
      <pre_assignment_details>Of the 70 enrolled participants, 68 completed baseline assessment- 1 did not return to the clinic to complete baseline and another seroconverted and was no longer eligible.&#xD;
Of the 68 participants who completed baseline, 65 were randomized- 2 were confirmed HIV+ and no longer eligible, and 1 previously worked at UMMC and was removed from the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>PrEP Mobile Messaging Intervention</title>
          <description>Participants from the STI/HIV testing clinic will receive Enhanced Standard of Care (described below) plus texted messages with the intervention content and follow-up questions over the next 4 weeks on their cell phones. Participants will receive approximately 8-16 interactive text messages with links to web content. Texts will be sent twice a week over the next 4 weeks. Participants will return for 2 more appointments over the next couple of months to fill out questionnaires.&#xD;
PrEP Mobile Messaging Intervention: See group description</description>
        </group>
        <group group_id="P2">
          <title>Enhanced Standard of Care</title>
          <description>As part of the enhanced standard of care, participants seen in the STI/HIV testing clinic are given feedback regarding PrEP eligibility and current risk behaviors. Participants are also given an informational handout about PrEP, shown a brief video, and given contact information for the PrEP Clinic Care Coordinator. Participants will return for 2 more visits over the next couple months to fill out questionnaires.&#xD;
Enhanced Standard of Care: See group description</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>PrEP Mobile Messaging Intervention</title>
          <description>Participants from the STI/HIV testing clinic will receive Enhanced Standard of Care (described below) plus texted messages with the intervention content and follow-up questions over the next 4 weeks on their cell phones. Participants will receive approximately 8-16 interactive text messages with links to web content. Texts will be sent twice a week over the next 4 weeks. Participants will return for 2 more appointments over the next couple of months to fill out questionnaires.&#xD;
PrEP Mobile Messaging Intervention: See group description</description>
        </group>
        <group group_id="B2">
          <title>Enhanced Standard of Care</title>
          <description>As part of the enhanced standard of care, participants seen in the STI/HIV testing clinic are given feedback regarding PrEP eligibility and current risk behaviors. Participants are also given an informational handout about PrEP, shown a brief video, and given contact information for the PrEP Clinic Care Coordinator. Participants will return for 2 more visits over the next couple months to fill out questionnaires.&#xD;
Enhanced Standard of Care: See group description</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="33"/>
            <count group_id="B2" value="32"/>
            <count group_id="B3" value="65"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.9" spread="4.8"/>
                    <measurement group_id="B2" value="23.6" spread="4.8"/>
                    <measurement group_id="B3" value="23.7" spread="4.8"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </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="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </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="28"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="56"/>
                  </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="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sexual Orientation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Heterosexual</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Homosexual</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Bisexual</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asexual</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Undecided</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown/Not reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of PrEP Services Appointments Attended-Full Sample</title>
        <description>With participant consent, staff at the STI/HIV testing clinic will abstract from the electronic medical record any PrEP Services Appointment, and any PrEP related care.</description>
        <time_frame>16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PrEP Mobile Messaging Intervention</title>
            <description>Participants from the STI/HIV testing clinic will receive Enhanced Standard of Care (described below) plus texted messages with the intervention content and follow-up questions over the next 4 weeks on their cell phones. Participants will receive approximately 8-16 interactive text messages with links to web content. Texts will be sent twice a week over the next 4 weeks. Participants will return for 2 more appointments over the next couple of months to fill out questionnaires.&#xD;
PrEP Mobile Messaging Intervention: See group description</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Standard of Care</title>
            <description>As part of the enhanced standard of care, participants seen in the STI/HIV testing clinic are given feedback regarding PrEP eligibility and current risk behaviors. Participants are also given an informational handout about PrEP, shown a brief video, and given contact information for the PrEP Clinic Care Coordinator. Participants will return for 2 more visits over the next couple months to fill out questionnaires.&#xD;
Enhanced Standard of Care: See group description</description>
          </group>
        </group_list>
        <measure>
          <title>Number of PrEP Services Appointments Attended-Full Sample</title>
          <description>With participant consent, staff at the STI/HIV testing clinic will abstract from the electronic medical record any PrEP Services Appointment, and any PrEP related care.</description>
          <units>visits attended</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.58" spread="0.72"/>
                    <measurement group_id="O2" value="0.55" spread="0.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of PrEP Services Appointments Attended- Restricted Sample</title>
        <description>With participant consent, staff at the STI/HIV testing clinic will abstract from the electronic medical record any PrEP Services Appointment, and any PrEP related care.&#xD;
Restricted Sample is only those who did not receive a PrEP prescription the same day as enrollment.</description>
        <time_frame>16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PrEP Mobile Messaging Intervention</title>
            <description>Participants from the STI/HIV testing clinic will receive Enhanced Standard of Care (described below) plus texted messages with the intervention content and follow-up questions over the next 4 weeks on their cell phones. Participants will receive approximately 8-16 interactive text messages with links to web content. Texts will be sent twice a week over the next 4 weeks. Participants will return for 2 more appointments over the next couple of months to fill out questionnaires.&#xD;
PrEP Mobile Messaging Intervention: See group description</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Standard of Care</title>
            <description>As part of the enhanced standard of care, participants seen in the STI/HIV testing clinic are given feedback regarding PrEP eligibility and current risk behaviors. Participants are also given an informational handout about PrEP, shown a brief video, and given contact information for the PrEP Clinic Care Coordinator. Participants will return for 2 more visits over the next couple months to fill out questionnaires.&#xD;
Enhanced Standard of Care: See group description</description>
          </group>
        </group_list>
        <measure>
          <title>Number of PrEP Services Appointments Attended- Restricted Sample</title>
          <description>With participant consent, staff at the STI/HIV testing clinic will abstract from the electronic medical record any PrEP Services Appointment, and any PrEP related care.&#xD;
Restricted Sample is only those who did not receive a PrEP prescription the same day as enrollment.</description>
          <units>visits attended</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.56" spread="0.75"/>
                    <measurement group_id="O2" value="0.50" spread="0.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Received a PrEP Prescription-Full Sample</title>
        <description>Staff at the testing clinic will abstract any prescription written for PrEP at 16 weeks for the participant.</description>
        <time_frame>16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PrEP Mobile Messaging Intervention</title>
            <description>Participants from the STI/HIV testing clinic will receive Enhanced Standard of Care (described below) plus texted messages with the intervention content and follow-up questions over the next 4 weeks on their cell phones. Participants will receive approximately 8-16 interactive text messages with links to web content. Texts will be sent twice a week over the next 4 weeks. Participants will return for 2 more appointments over the next couple of months to fill out questionnaires.&#xD;
PrEP Mobile Messaging Intervention: See group description</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Standard of Care</title>
            <description>As part of the enhanced standard of care, participants seen in the STI/HIV testing clinic are given feedback regarding PrEP eligibility and current risk behaviors. Participants are also given an informational handout about PrEP, shown a brief video, and given contact information for the PrEP Clinic Care Coordinator. Participants will return for 2 more visits over the next couple months to fill out questionnaires.&#xD;
Enhanced Standard of Care: See group description</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Received a PrEP Prescription-Full Sample</title>
          <description>Staff at the testing clinic will abstract any prescription written for PrEP at 16 weeks for the participant.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Did not receive PrEP Prescription</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Received PrEP Prescription</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Received a PrEP Prescription-Restricted Sample</title>
        <description>Staff at the testing clinic will abstract any prescription written for PrEP at 16 weeks for the participant.&#xD;
Restricted sample is those who did not receive a PrEP prescription the same day as enrollment.</description>
        <time_frame>16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PrEP Mobile Messaging Intervention</title>
            <description>Participants from the STI/HIV testing clinic will receive Enhanced Standard of Care (described below) plus texted messages with the intervention content and follow-up questions over the next 4 weeks on their cell phones. Participants will receive approximately 8-16 interactive text messages with links to web content. Texts will be sent twice a week over the next 4 weeks. Participants will return for 2 more appointments over the next couple of months to fill out questionnaires.&#xD;
PrEP Mobile Messaging Intervention: See group description</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Standard of Care</title>
            <description>As part of the enhanced standard of care, participants seen in the STI/HIV testing clinic are given feedback regarding PrEP eligibility and current risk behaviors. Participants are also given an informational handout about PrEP, shown a brief video, and given contact information for the PrEP Clinic Care Coordinator. Participants will return for 2 more visits over the next couple months to fill out questionnaires.&#xD;
Enhanced Standard of Care: See group description</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Received a PrEP Prescription-Restricted Sample</title>
          <description>Staff at the testing clinic will abstract any prescription written for PrEP at 16 weeks for the participant.&#xD;
Restricted sample is those who did not receive a PrEP prescription the same day as enrollment.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Did not receive PrEP Prescription</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Received PrEP Prescription</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in PrEP Knowledge-Full Sample</title>
        <description>Change in participants score on the PrEP Knowledge Questionnaire between baseline and 16 weeks follow-up. Scores can range from 0-3, with higher scores indicating greater PrEP knowledge.</description>
        <time_frame>Baseline, 16 weeks</time_frame>
        <population>Missing data accounts for the discrepancy in the analytic sample for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PrEP Mobile Messaging Intervention</title>
            <description>Participants from the STI/HIV testing clinic will receive Enhanced Standard of Care (described below) plus texted messages with the intervention content and follow-up questions over the next 4 weeks on their cell phones. Participants will receive approximately 8-16 interactive text messages with links to web content. Texts will be sent twice a week over the next 4 weeks. Participants will return for 2 more appointments over the next couple of months to fill out questionnaires.&#xD;
PrEP Mobile Messaging Intervention: See group description</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Standard of Care</title>
            <description>As part of the enhanced standard of care, participants seen in the STI/HIV testing clinic are given feedback regarding PrEP eligibility and current risk behaviors. Participants are also given an informational handout about PrEP, shown a brief video, and given contact information for the PrEP Clinic Care Coordinator. Participants will return for 2 more visits over the next couple months to fill out questionnaires.&#xD;
Enhanced Standard of Care: See group description</description>
          </group>
        </group_list>
        <measure>
          <title>Change in PrEP Knowledge-Full Sample</title>
          <description>Change in participants score on the PrEP Knowledge Questionnaire between baseline and 16 weeks follow-up. Scores can range from 0-3, with higher scores indicating greater PrEP knowledge.</description>
          <population>Missing data accounts for the discrepancy in the analytic sample for this measure.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.50" spread="0.83"/>
                    <measurement group_id="O2" value="1.00" spread="1.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in PrEP Knowledge-Restricted Sample</title>
        <description>Change in participants score on the PrEP Knowledge Questionnaire between baseline and 16 weeks follow-up. Scores can range from 0-3, with higher scores indicating greater PrEP knowledge.&#xD;
Restricted sample is those who did not receive a PrEP prescription the same day as enrollment.</description>
        <time_frame>Baseline, 16 weeks</time_frame>
        <population>Missing data accounts for the discrepancy in the analytic sample for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PrEP Mobile Messaging Intervention</title>
            <description>Participants from the STI/HIV testing clinic will receive Enhanced Standard of Care (described below) plus texted messages with the intervention content and follow-up questions over the next 4 weeks on their cell phones. Participants will receive approximately 8-16 interactive text messages with links to web content. Texts will be sent twice a week over the next 4 weeks. Participants will return for 2 more appointments over the next couple of months to fill out questionnaires.&#xD;
PrEP Mobile Messaging Intervention: See group description</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Standard of Care</title>
            <description>As part of the enhanced standard of care, participants seen in the STI/HIV testing clinic are given feedback regarding PrEP eligibility and current risk behaviors. Participants are also given an informational handout about PrEP, shown a brief video, and given contact information for the PrEP Clinic Care Coordinator. Participants will return for 2 more visits over the next couple months to fill out questionnaires.&#xD;
Enhanced Standard of Care: See group description</description>
          </group>
        </group_list>
        <measure>
          <title>Change in PrEP Knowledge-Restricted Sample</title>
          <description>Change in participants score on the PrEP Knowledge Questionnaire between baseline and 16 weeks follow-up. Scores can range from 0-3, with higher scores indicating greater PrEP knowledge.&#xD;
Restricted sample is those who did not receive a PrEP prescription the same day as enrollment.</description>
          <population>Missing data accounts for the discrepancy in the analytic sample for this measure.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.55" spread="0.86"/>
                    <measurement group_id="O2" value="0.83" spread="1.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Social Motivational Readiness for PrEP Care-Full Sample</title>
        <description>Change in participants' score on the IMB PrEP Motivation Scale (to assess personal and social motivations for PrEP use) from baseline to16 weeks follow-up. Scores can range from 8 - 32, with higher scores indicating greater motivation.</description>
        <time_frame>Baseline, 16 weeks</time_frame>
        <population>Missing data accounts for the discrepancy in the analytic sample for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PrEP Mobile Messaging Intervention</title>
            <description>Participants from the STI/HIV testing clinic will receive Enhanced Standard of Care (described below) plus texted messages with the intervention content and follow-up questions over the next 4 weeks on their cell phones. Participants will receive approximately 8-16 interactive text messages with links to web content. Texts will be sent twice a week over the next 4 weeks. Participants will return for 2 more appointments over the next couple of months to fill out questionnaires.&#xD;
PrEP Mobile Messaging Intervention: See group description</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Standard of Care</title>
            <description>As part of the enhanced standard of care, participants seen in the STI/HIV testing clinic are given feedback regarding PrEP eligibility and current risk behaviors. Participants are also given an informational handout about PrEP, shown a brief video, and given contact information for the PrEP Clinic Care Coordinator. Participants will return for 2 more visits over the next couple months to fill out questionnaires.&#xD;
Enhanced Standard of Care: See group description</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Social Motivational Readiness for PrEP Care-Full Sample</title>
          <description>Change in participants' score on the IMB PrEP Motivation Scale (to assess personal and social motivations for PrEP use) from baseline to16 weeks follow-up. Scores can range from 8 - 32, with higher scores indicating greater motivation.</description>
          <population>Missing data accounts for the discrepancy in the analytic sample for this measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.00" spread="3.59"/>
                    <measurement group_id="O2" value="0.29" spread="4.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Social Motivational Readiness for PrEP Care-Restricted Sample</title>
        <description>Change in participants' score on the IMB PrEP Motivation Scale (to assess personal and social motivations for PrEP use) from baseline to16 weeks follow-up. Scores can range from 8 - 32, with higher scores indicating greater motivation.&#xD;
Restricted sample is those who did not receive a PrEP prescription the same day as enrollment.</description>
        <time_frame>Baseline, 16 weeks</time_frame>
        <population>Missing data accounts for the discrepancy in the analytic sample for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PrEP Mobile Messaging Intervention</title>
            <description>Participants from the STI/HIV testing clinic will receive Enhanced Standard of Care (described below) plus texted messages with the intervention content and follow-up questions over the next 4 weeks on their cell phones. Participants will receive approximately 8-16 interactive text messages with links to web content. Texts will be sent twice a week over the next 4 weeks. Participants will return for 2 more appointments over the next couple of months to fill out questionnaires.&#xD;
PrEP Mobile Messaging Intervention: See group description</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Standard of Care</title>
            <description>As part of the enhanced standard of care, participants seen in the STI/HIV testing clinic are given feedback regarding PrEP eligibility and current risk behaviors. Participants are also given an informational handout about PrEP, shown a brief video, and given contact information for the PrEP Clinic Care Coordinator. Participants will return for 2 more visits over the next couple months to fill out questionnaires.&#xD;
Enhanced Standard of Care: See group description</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Social Motivational Readiness for PrEP Care-Restricted Sample</title>
          <description>Change in participants' score on the IMB PrEP Motivation Scale (to assess personal and social motivations for PrEP use) from baseline to16 weeks follow-up. Scores can range from 8 - 32, with higher scores indicating greater motivation.&#xD;
Restricted sample is those who did not receive a PrEP prescription the same day as enrollment.</description>
          <population>Missing data accounts for the discrepancy in the analytic sample for this measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.35" spread="3.48"/>
                    <measurement group_id="O2" value="0.47" spread="4.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in PrEP Self-efficacy-Full Sample</title>
        <description>Change in participants' score on the IMB PrEP Behavioral Skills Scale between baseline and 16 weeks, which assesses self-efficacy for taking PrEP as prescribed and assesses self-efficacy for PrEP related medical appointments. Scores can range from 7 - 28, with higher scores indicating greater self-efficacy.</description>
        <time_frame>Baseline, 16 weeks</time_frame>
        <population>Missing data accounts for the discrepancy in the analytic sample for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PrEP Mobile Messaging Intervention</title>
            <description>Participants from the STI/HIV testing clinic will receive Enhanced Standard of Care (described below) plus texted messages with the intervention content and follow-up questions over the next 4 weeks on their cell phones. Participants will receive approximately 8-16 interactive text messages with links to web content. Texts will be sent twice a week over the next 4 weeks. Participants will return for 2 more appointments over the next couple of months to fill out questionnaires.&#xD;
PrEP Mobile Messaging Intervention: See group description</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Standard of Care</title>
            <description>As part of the enhanced standard of care, participants seen in the STI/HIV testing clinic are given feedback regarding PrEP eligibility and current risk behaviors. Participants are also given an informational handout about PrEP, shown a brief video, and given contact information for the PrEP Clinic Care Coordinator. Participants will return for 2 more visits over the next couple months to fill out questionnaires.&#xD;
Enhanced Standard of Care: See group description</description>
          </group>
        </group_list>
        <measure>
          <title>Change in PrEP Self-efficacy-Full Sample</title>
          <description>Change in participants' score on the IMB PrEP Behavioral Skills Scale between baseline and 16 weeks, which assesses self-efficacy for taking PrEP as prescribed and assesses self-efficacy for PrEP related medical appointments. Scores can range from 7 - 28, with higher scores indicating greater self-efficacy.</description>
          <population>Missing data accounts for the discrepancy in the analytic sample for this measure.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.33" spread="3.11"/>
                    <measurement group_id="O2" value="-0.37" spread="2.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in PrEP Self-efficacy-Restricted Sample</title>
        <description>Change in participants' score on the IMB PrEP Behavioral Skills Scale between baseline and 16 weeks, which assesses self-efficacy for taking PrEP as prescribed and assesses self-efficacy for PrEP related medical appointments. Scores can range from 7 - 28, with higher scores indicating greater self-efficacy.&#xD;
Restricted sample is those who did not receive a PrEP prescription the same day as enrollment.</description>
        <time_frame>Baseline, 16 weeks</time_frame>
        <population>Missing data accounts for the discrepancy in the analytic sample for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PrEP Mobile Messaging Intervention</title>
            <description>Participants from the STI/HIV testing clinic will receive Enhanced Standard of Care (described below) plus texted messages with the intervention content and follow-up questions over the next 4 weeks on their cell phones. Participants will receive approximately 8-16 interactive text messages with links to web content. Texts will be sent twice a week over the next 4 weeks. Participants will return for 2 more appointments over the next couple of months to fill out questionnaires.&#xD;
PrEP Mobile Messaging Intervention: See group description</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Standard of Care</title>
            <description>As part of the enhanced standard of care, participants seen in the STI/HIV testing clinic are given feedback regarding PrEP eligibility and current risk behaviors. Participants are also given an informational handout about PrEP, shown a brief video, and given contact information for the PrEP Clinic Care Coordinator. Participants will return for 2 more visits over the next couple months to fill out questionnaires.&#xD;
Enhanced Standard of Care: See group description</description>
          </group>
        </group_list>
        <measure>
          <title>Change in PrEP Self-efficacy-Restricted Sample</title>
          <description>Change in participants' score on the IMB PrEP Behavioral Skills Scale between baseline and 16 weeks, which assesses self-efficacy for taking PrEP as prescribed and assesses self-efficacy for PrEP related medical appointments. Scores can range from 7 - 28, with higher scores indicating greater self-efficacy.&#xD;
Restricted sample is those who did not receive a PrEP prescription the same day as enrollment.</description>
          <population>Missing data accounts for the discrepancy in the analytic sample for this measure.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.36" spread="3.23"/>
                    <measurement group_id="O2" value="-0.20" spread="3.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Participants were monitored for adverse events over the duration of the study (4 months).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>PrEP Mobile Messaging Intervention</title>
          <description>Participants from the STI/HIV testing clinic will receive Enhanced Standard of Care (described below) plus texted messages with the intervention content and follow-up questions over the next 4 weeks on their cell phones. Participants will receive approximately 8-16 interactive text messages with links to web content. Texts will be sent twice a week over the next 4 weeks. Participants will return for 2 more appointments over the next couple of months to fill out questionnaires.&#xD;
PrEP Mobile Messaging Intervention: See group description</description>
        </group>
        <group group_id="E2">
          <title>Enhanced Standard of Care</title>
          <description>As part of the enhanced standard of care, participants seen in the STI/HIV testing clinic are given feedback regarding PrEP eligibility and current risk behaviors. Participants are also given an informational handout about PrEP, shown a brief video, and given contact information for the PrEP Clinic Care Coordinator. Participants will return for 2 more visits over the next couple months to fill out questionnaires.&#xD;
Enhanced Standard of Care: See group description</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Larry K. Brown, MD</name_or_title>
      <organization>Rhode Island Hospital</organization>
      <phone>(401) 793 - 8808</phone>
      <email>lkbrown@lifespan.org</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/NCT03308097
org study id: R34MH111342
nct id: NCT03308097
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will develop and test an interactive mobile messaging intervention to improve
      engagement in care related to Pre-exposure Prophylaxis (PrEP) and decrease HIV risk behaviors
      for Black men who have sex with men living in the Southern U.S. The mobile messaging
      intervention will include interactive text messaging and free, publicly available links to
      websites and YouTube videos. During the intervention participants will gain information about
      their health, improve motivation for engagement in PrEP related care, and build skills for
      healthy behaviors. Participants will also receive intervention materials to help decrease
      frequent barriers to care. If the intervention is found to be effective, it can be tested in
      a larger study and then disseminated.
The uptake of Pre-Exposure Prophylaxis (PrEP) has been slow for young Black men who have sex
      with men (BMSM) living in the Southern United States. This is a significant issue because
      eight of the ten states with the highest rates of new HIV infections are located in the
      South. Jackson, Mississippi (MS) (the site of this project) has the second highest AIDS
      diagnosis rate in the nation, and the highest rate of HIV infection for young urban Black men
      who have sex with men. This study will develop and test an engaging, interactive, and cost
      effective mobile messaging intervention to improve linkage to PrEP care for BMSM (18-35 yrs)
      living in Jackson, MS. BMSM eligible for PrEP, receiving care at the University of
      Mississippi Medical Center sexually-transmitted infections (STI)/HIV testing clinics, will be
      texted interactive links to publicly available, online content about PrEP and HIV prevention.
      Links will be sent to PrEP eligible BMSM by 8-16 interactive text messages over 4 weeks. The
      material used in the intervention will be consistent with the Information Motivation Behavior
      (IMB) Model and will address cultural and structural barriers to initiating PrEP care. A
      small randomized controlled study among 66 new participants in the clinics will examine the
      preliminary efficacy of the intervention compared to enhanced standard of care on attendance
      at a PrEP Services Appointment (the first step in initiating PrEP care). It is hypothesized
      that, compared to BMSM receiving enhanced standard of care, BMSM receiving the PrEP Mobile
      Messaging Intervention will show greater attendance at a PrEP Services Appointment and
      decreased HIV risk behavior at 4 and 16 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Number of PrEP Services Appointments Attended-Full Sample
time frame: 16 weeks
description: With participant consent, staff at the STI/HIV testing clinic will abstract from the electronic medical record any PrEP Services Appointment, and any PrEP related care.
measure: Number of PrEP Services Appointments Attended- Restricted Sample
time frame: 16 weeks
description: With participant consent, staff at the STI/HIV testing clinic will abstract from the electronic medical record any PrEP Services Appointment, and any PrEP related care.
Restricted Sample is only those who did not receive a PrEP prescription the same day as enrollment.
measure: Number of Participants Who Received a PrEP Prescription-Full Sample
time frame: 16 weeks
description: Staff at the testing clinic will abstract any prescription written for PrEP at 16 weeks for the participant.
measure: Number of Participants Who Received a PrEP Prescription-Restricted Sample
time frame: 16 weeks
description: Staff at the testing clinic will abstract any prescription written for PrEP at 16 weeks for the participant.
Restricted sample is those who did not receive a PrEP prescription the same day as enrollment.
measure: Change in PrEP Knowledge-Full Sample
time frame: Baseline, 16 weeks
description: Change in participants score on the PrEP Knowledge Questionnaire between baseline and 16 weeks follow-up. Scores can range from 0-3, with higher scores indicating greater PrEP knowledge.
measure: Change in PrEP Knowledge-Restricted Sample
time frame: Baseline, 16 weeks
description: Change in participants score on the PrEP Knowledge Questionnaire between baseline and 16 weeks follow-up. Scores can range from 0-3, with higher scores indicating greater PrEP knowledge.
Restricted sample is those who did not receive a PrEP prescription the same day as enrollment.
measure: Change in Social Motivational Readiness for PrEP Care-Full Sample
time frame: Baseline, 16 weeks
description: Change in participants' score on the IMB PrEP Motivation Scale (to assess personal and social motivations for PrEP use) from baseline to16 weeks follow-up. Scores can range from 8 - 32, with higher scores indicating greater motivation.
measure: Change in Social Motivational Readiness for PrEP Care-Restricted Sample
time frame: Baseline, 16 weeks
description: Change in participants' score on the IMB PrEP Motivation Scale (to assess personal and social motivations for PrEP use) from baseline to16 weeks follow-up. Scores can range from 8 - 32, with higher scores indicating greater motivation.
Restricted sample is those who did not receive a PrEP prescription the same day as enrollment.
measure: Change in PrEP Self-efficacy-Full Sample
time frame: Baseline, 16 weeks
description: Change in participants' score on the IMB PrEP Behavioral Skills Scale between baseline and 16 weeks, which assesses self-efficacy for taking PrEP as prescribed and assesses self-efficacy for PrEP related medical appointments. Scores can range from 7 - 28, with higher scores indicating greater self-efficacy.
measure: Change in PrEP Self-efficacy-Restricted Sample
time frame: Baseline, 16 weeks
description: Change in participants' score on the IMB PrEP Behavioral Skills Scale between baseline and 16 weeks, which assesses self-efficacy for taking PrEP as prescribed and assesses self-efficacy for PrEP related medical appointments. Scores can range from 7 - 28, with higher scores indicating greater self-efficacy.
Restricted sample is those who did not receive a PrEP prescription the same day as enrollment.
arm group label: PrEP Mobile Messaging Intervention
arm group type: Experimental
description: Participants from the STI/HIV testing clinic will receive Enhanced Standard of Care (described below) plus texted messages with the intervention content and follow-up questions over the next 4 weeks on their cell phones. Participants will receive approximately 8-16 interactive text messages with links to web content. Texts will be sent twice a week over the next 4 weeks. Participants will return for 2 more appointments over the next couple of months to fill out questionnaires.
arm group label: Enhanced Standard of Care
arm group type: Active Comparator
description: As part of the enhanced standard of care, participants seen in the STI/HIV testing clinic are given feedback regarding PrEP eligibility and current risk behaviors. Participants are also given an informational handout about PrEP, shown a brief video, and given contact information for the PrEP Clinic Care Coordinator. Participants will return for 2 more visits over the next couple months to fill out questionnaires.
intervention type: Behavioral
intervention name: PrEP Mobile Messaging Intervention
description: See group description
arm group label: PrEP Mobile Messaging Intervention
intervention type: Behavioral
intervention name: Enhanced Standard of Care
description: See group description
arm group label: Enhanced Standard of Care
criteria: 
gender: Male
gender based: Yes
gender description: Study only open to self-identifying male participants.
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Larry K. Brown, M.D.
role: Principal Investigator
affiliation: Rhode Island Hospital
last name: Laura Whiteley, M.D.
role: Principal Investigator
affiliation: Rhode Island Hospital
last name: Leandro Mena, M.D.
role: Study Director
affiliation: University of Mississippi Medical Center
facility: 
country: United States
responsible party type: Sponsor
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 