<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/NCT02994108</url>
  </required_header>
  <id_info>
    <org_study_id>1R21CA208329-01</org_study_id>
    <secondary_id>1R21CA208329-01</secondary_id>
    <nct_id>NCT02994108</nct_id>
  </id_info>
  <brief_title>txt2protect: Using Text Messaging to Increase HPV Vaccination Among Young Sexual Minority Men</brief_title>
  <acronym>t2p</acronym>
  <official_title>Using Text Messaging to Increase HPV Vaccination Among Young Sexual Minority Men</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Human Papillomavirus (HPV) is a common sexually transmitted infection that can cause cancer&#xD;
      (anal, penile, oropharyngeal) and genital warts in men. Due to their sexual practices (e.g.,&#xD;
      receptive anal intercourse), men who have sex with men (MSM) are at particularly high risk&#xD;
      for HPV infection and are disproportionately affected by HPV-related cancers. A safe and&#xD;
      effective vaccine is available to prevent HPV infection, yet HPV vaccination rates in the&#xD;
      U.S. have been low, particularly among males. To remedy this gap, the goal of this study is&#xD;
      to develop and pilot test a text messaging intervention to increase HPV vaccination in young&#xD;
      MSM.&#xD;
&#xD;
      The study has two specific aims:&#xD;
&#xD;
        1. Develop, iteratively refine, and pre-test messages using a formative research procedure&#xD;
           for designing targeted health interventions. The procedure consists of the following&#xD;
           steps: 1) conduct online focus groups, an online survey, and in-depth interviews to&#xD;
           inform message content, 2) draft initial messages based on focus group findings and&#xD;
           pilot data, 3) refine message content and assess acceptability using content advisory&#xD;
           teams, 4) conduct internal alpha testing to ensure software functionality, and 5) beta&#xD;
           test the protocol.&#xD;
&#xD;
        2. Test the feasibility, acceptability, and preliminary efficacy of the txt2protect (t2p)&#xD;
           text messaging intervention in a pilot randomized controlled trial (RCT). To achieve&#xD;
           this aim, 460 unvaccinated MSM (ages 18-25) who live in the Chicago metro area will be&#xD;
           randomly assigned to the treatment (t2p) or control condition. The treatment condition&#xD;
           will receive a culturally appropriate text messaging-based HPV vaccination intervention&#xD;
           based on the Information, Motivation, and Behavioral Skills model, whereas the control&#xD;
           condition will receive a text messaging-based sexual health intervention that includes&#xD;
           basic facts about HPV vaccination readily accessible online.&#xD;
&#xD;
      Primary outcome measures include intervention feasibility (e.g., retention in the trial),&#xD;
      acceptability (satisfaction with the intervention), and preliminary efficacy as determined by&#xD;
      initiation (receipt of the first dose) and completion of the 3-dose HPV vaccine series at the&#xD;
      end of the 9-month trial.&#xD;
&#xD;
      The study team hypothesizes that participants in the t2p condition (vs. control) will report&#xD;
      greater acceptability of the intervention and will be significantly more likely to initiate&#xD;
      and complete the 3-dose HPV vaccine series by the end of the trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2018</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Retention</measure>
    <time_frame>9 Month</time_frame>
    <description>Intervention feasibility will be evaluated by retention in the RCT. The retention rate will be computed at the end of the 9-month trial by dividing the total number of participants who completed the trial (i.e., completed the 9-month assessment) by the total number of participants who were randomized to the treatment or control condition at the beginning of the trial. An 80% 9-month retention rate will be used to indicate a feasible intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention Acceptability for Phase 1</measure>
    <time_frame>3 Weeks</time_frame>
    <description>Intervention acceptability for the first 3 weeks of the intervention (Phase 1) will be assessed at the 3-week assessment. The scale includes both open-ended (&quot;What did you like about the program? What could be improved?&quot;) and 12 closed-ended questions (e.g., &quot;I would recommend a program like this to my friends&quot; 1=strongly disagree to 5=strongly agree). Closed-ended items were combined to compute an average score (minimum value = 1; maximum value = 5). Higher scores indicate greater satisfaction with the program. An average score ≥4 will be used to indicate an acceptable intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention Acceptability for Full Intervention</measure>
    <time_frame>9 Month</time_frame>
    <description>Intervention acceptability for the full intervention will be assessed at the end the 9-month trial. The scale includes both open-ended (&quot;What did you like about the program? What could be improved?&quot;) and 11 closed-ended questions (e.g., &quot;I would recommend a program like this to my friends&quot; 1=strongly disagree to 5=strongly agree). Closed-ended items will be combined to compute an average score (minimum value = 1; maximum value = 5). Higher scores indicate greater satisfaction with the program. An average score ≥4 will be used to indicate an acceptable intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Initiated the HPV Vaccine Series</measure>
    <time_frame>9 Month</time_frame>
    <description>A final confirmatory assessment of HPV vaccination status will be conducted at the 9-month follow-up. Participants will be asked whether they received any doses of HPV vaccine (yes/no) since baseline and if yes, the number of doses and received. Vaccination status will be confirmed by consulting the Illinois Comprehensive Automated Immunization Registry (I-CARE). HPV vaccine initiation was defined as receipt of one or more doses of HPV vaccine by the end of the 9-month trial.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Completed the HPV Vaccine Series</measure>
    <time_frame>9 Month</time_frame>
    <description>A final confirmatory assessment of HPV vaccination status will be conducted at the 9-month follow-up. Participants will be asked whether they received any doses of HPV vaccine (yes/no) since baseline and if yes, the number of doses received. Vaccination status will be confirmed by consulting the Illinois Comprehensive Automated Immunization Registry (I-CARE). HPV vaccine completion was defined as receipt of three doses of HPV vaccine by the end of the 9-month trial.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Information: HPV-related Knowledge</measure>
    <time_frame>3 Weeks</time_frame>
    <description>Assessed with two questions (e.g., &quot;HPV can cause anal cancer.&quot;) interspersed among other true/false questions assessing HIV/STI knowledge. Participants received one point for each correct response and zero points for incorrect and &quot;don't know&quot; responses. Points were summed to create a composite score that ranged from 0 to 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motivation: Attitudes</measure>
    <time_frame>3 Weeks</time_frame>
    <description>Assessed with one item: &quot;My attitude toward getting vaccinated for HPV in the next 9 months is...&quot; 1 = very negative to 5 = very positive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motivation: Subjective Norms</measure>
    <time_frame>3 Weeks</time_frame>
    <description>Assessed with one item: &quot;People who are important to me would want me to get vaccinated for HPV in the next 9 months.&quot; 1 = strongly disagree to 5 = strongly agree.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motivation: Perceived Susceptibility</measure>
    <time_frame>3 Weeks</time_frame>
    <description>Assessed with four items (e.g., &quot;If you don't get the HPV vaccine, what do you think are the chances that you will get HPV?&quot; 1 = very unlikely to 5 = very likely).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motivation: Perceived Severity</measure>
    <time_frame>3 Weeks</time_frame>
    <description>Assessed with four items (e.g., &quot;How serious would each of the following be for you: If you developed warts on your penis or scrotum?&quot; 1 = not at all serious to 5 = very serious).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motivation: Anticipated Regret</measure>
    <time_frame>3 Weeks</time_frame>
    <description>Assessed with two items (e.g., &quot;How much regret would you feel if you decided not to get the HPV vaccine and later developed genital or anal warts?&quot; 1 = none to 5 = quite a lot).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral Skills: Perceived Behavioral Control</measure>
    <time_frame>3 Weeks</time_frame>
    <description>Assessed with one item: &quot;To what extent is whether or not you get vaccinated for HPV in the next 9 months under your control?&quot; 1 = not at all to 5 = completely.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral Skills: Self-efficacy</measure>
    <time_frame>3 Weeks</time_frame>
    <description>Assessed with one item: &quot;Assuming you wanted to, how hard or easy would it be for you to get vaccinated for HPV in the next 9 months?&quot; 1 = very hard to 5 = very easy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral Intentions</measure>
    <time_frame>3 Weeks</time_frame>
    <description>Assessed with one item: &quot;I intend to get vaccinated for HPV in the next 9 months.&quot; 1 = strongly disagree to 5 = strongly agree.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Human Papillomavirus</condition>
  <arm_group>
    <arm_group_label>txt2protect</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules. Module 1 addressed information about HPV infection and HPV vaccination. Module 2 addressed motivation to receive HPV vaccine. Module 3 addressed behavioral skills and self-efficacy for initiating and completing the 3-dose series (e.g., talking with their doctor about the vaccine). Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
txt2protect: Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sexual Health Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules; however, unlike the treatment group, content was topic-based rather than theory-based and focused on general sexual health. Module 1 addressed basic facts about HIV and sexually transmitted infections (STI), including HPV. Module 2 addressed HIV/STI prevention (e.g., condom use, PrEP) and will included basic facts about HPV vaccination currently available online. Module 3 addressed tips for healthy relationships. Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
Sexual Health Control: Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>txt2protect</intervention_name>
    <description>Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination.</description>
    <arm_group_label>txt2protect</arm_group_label>
    <other_name>t2p</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sexual Health Control</intervention_name>
    <description>Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination.</description>
    <arm_group_label>Sexual Health Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
        Participants must:&#xD;
&#xD;
          1. Be male (sex at birth and gender identity)&#xD;
&#xD;
          2. Self-identify as gay, bisexual, or queer; ever had sex with a man; or be physically&#xD;
             attracted to men&#xD;
&#xD;
          3. Be English speaking&#xD;
&#xD;
          4. Live in the Chicago metro area&#xD;
&#xD;
          5. Be the exclusive owner of a cell phone&#xD;
&#xD;
          6. Have used text messaging for at least 6 months&#xD;
&#xD;
          7. Plan to have the same cell phone number for the next 9 months&#xD;
&#xD;
          8. Be enrolled in an unlimited text messaging plan&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Participants must not have been previously vaccinated for HPV.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mary Gerend, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Florida State University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Brian Mustanski, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <results_first_submitted>June 11, 2020</results_first_submitted>
  <results_first_submitted_qc>July 2, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">July 20, 2020</results_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Florida State University</investigator_affiliation>
    <investigator_full_name>Mary Gerend</investigator_full_name>
    <investigator_title>Associate Professor, Behavioral Sciences and Social Medicine, College of Medicine</investigator_title>
  </responsible_party>
  <keyword>Human Papillomavirus</keyword>
  <keyword>Men Who Have Sex with Men</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The PI agrees to develop a de-identified database, codebook, and mechanism by which IPD could be shared with other investigators upon approval of the PI. Data will be available for request approximately 6 months after completion of the project. Interested investigators will be asked to complete a standardized request form stating the specific aims of the analysis, the analytic plans, resources the requestors have to carry out the project, the proposed timeline, and distribution goals (manuscripts and/or grant application). The PI will review these requests to determine whether the proposed analyses constitute an innovative and significant exploration of the data, whether the proposed team has sufficient resources to undertake the request, how data will be protected/managed, and whether there are sufficient resources to honor the request. If any of these issues are problematic, the PI will attempt to negotiate a fair resolution with the interested parties and/or with NIH program staff.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 27, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT02994108/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT02994108/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Study recruitment took place from January through early September 2018 in the Chicago area.</recruitment_details>
      <pre_assignment_details>Although 155 participants completed the baseline survey, only 150 of them were randomized. A double screening protocol was used to ensure participants who had already been vaccinated were not accidentally enrolled. Five participants reported receiving a dose of HPV vaccine on baseline so they were no longer eligible for the RCT.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>txt2protect</title>
          <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules. Module 1 addressed information about HPV infection and HPV vaccination. Module 2 addressed motivation to receive HPV vaccine. Module 3 addressed behavioral skills and self-efficacy for initiating and completing the 3-dose series (e.g., talking with their doctor about the vaccine). Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
txt2protect: Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination.</description>
        </group>
        <group group_id="P2">
          <title>Sexual Health Control</title>
          <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules; however, unlike the treatment group, content was topic-based rather than theory-based and focused on general sexual health. Module 1 addressed basic facts about HIV and sexually transmitted infections (STI), including HPV. Module 2 addressed HIV/STI prevention (e.g., condom use, PrEP) and will included basic facts about HPV vaccination currently available online. Module 3 addressed tips for healthy relationships. Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
Sexual Health Control: Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Intervention Messages</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="74"/>
                <participants group_id="P2" count="76"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="72"/>
                <participants group_id="P2" count="76"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Phase 1 Assessment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="72"/>
                <participants group_id="P2" count="76"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
                <participants group_id="P2" count="73"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Phase 2 Assessment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="72"/>
                <participants group_id="P2" count="76"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="63"/>
                <participants group_id="P2" count="69"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>txt2protect</title>
          <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules. Module 1 addressed information about HPV infection and HPV vaccination. Module 2 addressed motivation to receive HPV vaccine. Module 3 addressed behavioral skills and self-efficacy for initiating and completing the 3-dose series (e.g., talking with their doctor about the vaccine). Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
txt2protect: Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination.</description>
        </group>
        <group group_id="B2">
          <title>Sexual Health Control</title>
          <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules; however, unlike the treatment group, content was topic-based rather than theory-based and focused on general sexual health. Module 1 addressed basic facts about HIV and sexually transmitted infections (STI), including HPV. Module 2 addressed HIV/STI prevention (e.g., condom use, PrEP) and will included basic facts about HPV vaccination currently available online. Module 3 addressed tips for healthy relationships. Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
Sexual Health Knowledge Control: Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination.</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="72"/>
            <count group_id="B2" value="76"/>
            <count group_id="B3" value="148"/>
          </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="148"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22.78" spread="2.03"/>
                    <measurement group_id="B2" value="23.06" spread="2.39"/>
                    <measurement group_id="B3" value="22.92" spread="2.22"/>
                  </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="72"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="148"/>
                  </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="27"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="101"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="11"/>
                  </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="13"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="16"/>
                  </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="72"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="148"/>
                  </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>Gay</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="110"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Bisexual</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other (e.g., queer, pansexual)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Retention</title>
        <description>Intervention feasibility will be evaluated by retention in the RCT. The retention rate will be computed at the end of the 9-month trial by dividing the total number of participants who completed the trial (i.e., completed the 9-month assessment) by the total number of participants who were randomized to the treatment or control condition at the beginning of the trial. An 80% 9-month retention rate will be used to indicate a feasible intervention.</description>
        <time_frame>9 Month</time_frame>
        <population>A total of 150 participants were randomized. Three participants, all of whom were in the txt2protect arm, withdrew from the study. One of the three participants who withdrew provided permission to use include his data up until his withdrawal in month 3 and thus this participant was included in the primary analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>txt2protect</title>
            <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules. Module 1 addressed information about HPV infection and HPV vaccination. Module 2 addressed motivation to receive HPV vaccine. Module 3 addressed behavioral skills and self-efficacy for initiating and completing the 3-dose series (e.g., talking with their doctor about the vaccine). Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
txt2protect: Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination.</description>
          </group>
          <group group_id="O2">
            <title>Sexual Health Control</title>
            <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules; however, unlike the treatment group, content was topic-based rather than theory-based and focused on general sexual health. Module 1 addressed basic facts about HIV and sexually transmitted infections (STI), including HPV. Module 2 addressed HIV/STI prevention (e.g., condom use, PrEP) and will included basic facts about HPV vaccination currently available online. Module 3 addressed tips for healthy relationships. Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
Sexual Health Control: Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Retention</title>
          <description>Intervention feasibility will be evaluated by retention in the RCT. The retention rate will be computed at the end of the 9-month trial by dividing the total number of participants who completed the trial (i.e., completed the 9-month assessment) by the total number of participants who were randomized to the treatment or control condition at the beginning of the trial. An 80% 9-month retention rate will be used to indicate a feasible intervention.</description>
          <population>A total of 150 participants were randomized. Three participants, all of whom were in the txt2protect arm, withdrew from the study. One of the three participants who withdrew provided permission to use include his data up until his withdrawal in month 3 and thus this participant was included in the primary analysis.</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="72"/>
                <count group_id="O2" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.601</p_value>
            <method>Chi-squared</method>
            <param_type>Chi-Square</param_type>
            <param_value>0.415</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Intervention Acceptability for Phase 1</title>
        <description>Intervention acceptability for the first 3 weeks of the intervention (Phase 1) will be assessed at the 3-week assessment. The scale includes both open-ended (&quot;What did you like about the program? What could be improved?&quot;) and 12 closed-ended questions (e.g., &quot;I would recommend a program like this to my friends&quot; 1=strongly disagree to 5=strongly agree). Closed-ended items were combined to compute an average score (minimum value = 1; maximum value = 5). Higher scores indicate greater satisfaction with the program. An average score ≥4 will be used to indicate an acceptable intervention.</description>
        <time_frame>3 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>txt2protect</title>
            <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules. Module 1 addressed information about HPV infection and HPV vaccination. Module 2 addressed motivation to receive HPV vaccine. Module 3 addressed behavioral skills and self-efficacy for initiating and completing the 3-dose series (e.g., talking with their doctor about the vaccine). Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
txt2protect: Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination.</description>
          </group>
          <group group_id="O2">
            <title>Sexual Health Control</title>
            <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules; however, unlike the treatment group, content was topic-based rather than theory-based and focused on general sexual health. Module 1 addressed basic facts about HIV and sexually transmitted infections (STI), including HPV. Module 2 addressed HIV/STI prevention (e.g., condom use, PrEP) and will included basic facts about HPV vaccination currently available online. Module 3 addressed tips for healthy relationships. Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
Sexual Health Knowledge Control: Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Intervention Acceptability for Phase 1</title>
          <description>Intervention acceptability for the first 3 weeks of the intervention (Phase 1) will be assessed at the 3-week assessment. The scale includes both open-ended (&quot;What did you like about the program? What could be improved?&quot;) and 12 closed-ended questions (e.g., &quot;I would recommend a program like this to my friends&quot; 1=strongly disagree to 5=strongly agree). Closed-ended items were combined to compute an average score (minimum value = 1; maximum value = 5). Higher scores indicate greater satisfaction with the program. An average score ≥4 will be used to indicate an acceptable intervention.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.25" spread="0.44"/>
                    <measurement group_id="O2" value="4.16" spread="0.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.249</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.09</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Intervention Acceptability for Full Intervention</title>
        <description>Intervention acceptability for the full intervention will be assessed at the end the 9-month trial. The scale includes both open-ended (&quot;What did you like about the program? What could be improved?&quot;) and 11 closed-ended questions (e.g., &quot;I would recommend a program like this to my friends&quot; 1=strongly disagree to 5=strongly agree). Closed-ended items will be combined to compute an average score (minimum value = 1; maximum value = 5). Higher scores indicate greater satisfaction with the program. An average score ≥4 will be used to indicate an acceptable intervention.</description>
        <time_frame>9 Month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>txt2protect</title>
            <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules. Module 1 addressed information about HPV infection and HPV vaccination. Module 2 addressed motivation to receive HPV vaccine. Module 3 addressed behavioral skills and self-efficacy for initiating and completing the 3-dose series (e.g., talking with their doctor about the vaccine). Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
txt2protect: Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination.</description>
          </group>
          <group group_id="O2">
            <title>Sexual Health Control</title>
            <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules; however, unlike the treatment group, content was topic-based rather than theory-based and focused on general sexual health. Module 1 addressed basic facts about HIV and sexually transmitted infections (STI), including HPV. Module 2 addressed HIV/STI prevention (e.g., condom use, PrEP) and will included basic facts about HPV vaccination currently available online. Module 3 addressed tips for healthy relationships. Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
Sexual Health Knowledge Control: Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Intervention Acceptability for Full Intervention</title>
          <description>Intervention acceptability for the full intervention will be assessed at the end the 9-month trial. The scale includes both open-ended (&quot;What did you like about the program? What could be improved?&quot;) and 11 closed-ended questions (e.g., &quot;I would recommend a program like this to my friends&quot; 1=strongly disagree to 5=strongly agree). Closed-ended items will be combined to compute an average score (minimum value = 1; maximum value = 5). Higher scores indicate greater satisfaction with the program. An average score ≥4 will be used to indicate an acceptable intervention.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.22" spread="0.51"/>
                    <measurement group_id="O2" value="4.18" spread="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.675</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-.04</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Initiated the HPV Vaccine Series</title>
        <description>A final confirmatory assessment of HPV vaccination status will be conducted at the 9-month follow-up. Participants will be asked whether they received any doses of HPV vaccine (yes/no) since baseline and if yes, the number of doses and received. Vaccination status will be confirmed by consulting the Illinois Comprehensive Automated Immunization Registry (I-CARE). HPV vaccine initiation was defined as receipt of one or more doses of HPV vaccine by the end of the 9-month trial.</description>
        <time_frame>9 Month</time_frame>
        <population>A total of 150 participants were randomized. Three participants, all of whom were in the txt2protect arm, withdrew from the study. One of the three participants who withdrew provided permission to use include his data up until his withdrawal in month 3 and thus this participant was included in the primary analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>txt2protect</title>
            <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules. Module 1 addressed information about HPV infection and HPV vaccination. Module 2 addressed motivation to receive HPV vaccine. Module 3 addressed behavioral skills and self-efficacy for initiating and completing the 3-dose series (e.g., talking with their doctor about the vaccine). Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
txt2protect: Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination.</description>
          </group>
          <group group_id="O2">
            <title>Sexual Health Control</title>
            <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules; however, unlike the treatment group, content was topic-based rather than theory-based and focused on general sexual health. Module 1 addressed basic facts about HIV and sexually transmitted infections (STI), including HPV. Module 2 addressed HIV/STI prevention (e.g., condom use, PrEP) and will included basic facts about HPV vaccination currently available online. Module 3 addressed tips for healthy relationships. Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
Sexual Health Knowledge Control: Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Initiated the HPV Vaccine Series</title>
          <description>A final confirmatory assessment of HPV vaccination status will be conducted at the 9-month follow-up. Participants will be asked whether they received any doses of HPV vaccine (yes/no) since baseline and if yes, the number of doses and received. Vaccination status will be confirmed by consulting the Illinois Comprehensive Automated Immunization Registry (I-CARE). HPV vaccine initiation was defined as receipt of one or more doses of HPV vaccine by the end of the 9-month trial.</description>
          <population>A total of 150 participants were randomized. Three participants, all of whom were in the txt2protect arm, withdrew from the study. One of the three participants who withdrew provided permission to use include his data up until his withdrawal in month 3 and thus this participant was included in the primary analysis.</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="72"/>
                <count group_id="O2" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.025</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.43</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.17</ci_lower_limit>
            <ci_upper_limit>10.08</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Completed the HPV Vaccine Series</title>
        <description>A final confirmatory assessment of HPV vaccination status will be conducted at the 9-month follow-up. Participants will be asked whether they received any doses of HPV vaccine (yes/no) since baseline and if yes, the number of doses received. Vaccination status will be confirmed by consulting the Illinois Comprehensive Automated Immunization Registry (I-CARE). HPV vaccine completion was defined as receipt of three doses of HPV vaccine by the end of the 9-month trial.</description>
        <time_frame>9 Month</time_frame>
        <population>A total of 150 participants were randomized. Three participants, all of whom were in the txt2protect arm, withdrew from the study. One of the three participants who withdrew provided permission to use include his data up until his withdrawal in month 3 and thus this participant was included in the primary analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>txt2protect</title>
            <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules. Module 1 addressed information about HPV infection and HPV vaccination. Module 2 addressed motivation to receive HPV vaccine. Module 3 addressed behavioral skills and self-efficacy for initiating and completing the 3-dose series (e.g., talking with their doctor about the vaccine). Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
txt2protect: Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination.</description>
          </group>
          <group group_id="O2">
            <title>Sexual Health Control</title>
            <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules; however, unlike the treatment group, content was topic-based rather than theory-based and focused on general sexual health. Module 1 addressed basic facts about HIV and sexually transmitted infections (STI), including HPV. Module 2 addressed HIV/STI prevention (e.g., condom use, PrEP) and will included basic facts about HPV vaccination currently available online. Module 3 addressed tips for healthy relationships. Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
Sexual Health Control: Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Completed the HPV Vaccine Series</title>
          <description>A final confirmatory assessment of HPV vaccination status will be conducted at the 9-month follow-up. Participants will be asked whether they received any doses of HPV vaccine (yes/no) since baseline and if yes, the number of doses received. Vaccination status will be confirmed by consulting the Illinois Comprehensive Automated Immunization Registry (I-CARE). HPV vaccine completion was defined as receipt of three doses of HPV vaccine by the end of the 9-month trial.</description>
          <population>A total of 150 participants were randomized. Three participants, all of whom were in the txt2protect arm, withdrew from the study. One of the three participants who withdrew provided permission to use include his data up until his withdrawal in month 3 and thus this participant was included in the primary analysis.</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="72"/>
                <count group_id="O2" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.923</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.08</ci_lower_limit>
            <ci_upper_limit>16.95</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Information: HPV-related Knowledge</title>
        <description>Assessed with two questions (e.g., &quot;HPV can cause anal cancer.&quot;) interspersed among other true/false questions assessing HIV/STI knowledge. Participants received one point for each correct response and zero points for incorrect and &quot;don't know&quot; responses. Points were summed to create a composite score that ranged from 0 to 2.</description>
        <time_frame>3 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>txt2protect</title>
            <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules. Module 1 addressed information about HPV infection and HPV vaccination. Module 2 addressed motivation to receive HPV vaccine. Module 3 addressed behavioral skills and self-efficacy for initiating and completing the 3-dose series (e.g., talking with their doctor about the vaccine). Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
txt2protect: Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination.</description>
          </group>
          <group group_id="O2">
            <title>Sexual Health Control</title>
            <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules; however, unlike the treatment group, content was topic-based rather than theory-based and focused on general sexual health. Module 1 addressed basic facts about HIV and sexually transmitted infections (STI), including HPV. Module 2 addressed HIV/STI prevention (e.g., condom use, PrEP) and will included basic facts about HPV vaccination currently available online. Module 3 addressed tips for healthy relationships. Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
Sexual Health Control: Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Information: HPV-related Knowledge</title>
          <description>Assessed with two questions (e.g., &quot;HPV can cause anal cancer.&quot;) interspersed among other true/false questions assessing HIV/STI knowledge. Participants received one point for each correct response and zero points for incorrect and &quot;don't know&quot; responses. Points were summed to create a composite score that ranged from 0 to 2.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.11" spread="0.40"/>
                    <measurement group_id="O2" value="1.00" spread="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.174</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.11</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Motivation: Attitudes</title>
        <description>Assessed with one item: &quot;My attitude toward getting vaccinated for HPV in the next 9 months is...&quot; 1 = very negative to 5 = very positive.</description>
        <time_frame>3 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>txt2protect</title>
            <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules. Module 1 addressed information about HPV infection and HPV vaccination. Module 2 addressed motivation to receive HPV vaccine. Module 3 addressed behavioral skills and self-efficacy for initiating and completing the 3-dose series (e.g., talking with their doctor about the vaccine). Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
txt2protect: Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination.</description>
          </group>
          <group group_id="O2">
            <title>Sexual Health Control</title>
            <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules; however, unlike the treatment group, content was topic-based rather than theory-based and focused on general sexual health. Module 1 addressed basic facts about HIV and sexually transmitted infections (STI), including HPV. Module 2 addressed HIV/STI prevention (e.g., condom use, PrEP) and will included basic facts about HPV vaccination currently available online. Module 3 addressed tips for healthy relationships. Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
Sexual Health Control: Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Motivation: Attitudes</title>
          <description>Assessed with one item: &quot;My attitude toward getting vaccinated for HPV in the next 9 months is...&quot; 1 = very negative to 5 = very positive.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.51" spread="0.61"/>
                    <measurement group_id="O2" value="4.11" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.002</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.40</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Motivation: Subjective Norms</title>
        <description>Assessed with one item: &quot;People who are important to me would want me to get vaccinated for HPV in the next 9 months.&quot; 1 = strongly disagree to 5 = strongly agree.</description>
        <time_frame>3 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>txt2protect</title>
            <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules. Module 1 addressed information about HPV infection and HPV vaccination. Module 2 addressed motivation to receive HPV vaccine. Module 3 addressed behavioral skills and self-efficacy for initiating and completing the 3-dose series (e.g., talking with their doctor about the vaccine). Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
txt2protect: Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination.</description>
          </group>
          <group group_id="O2">
            <title>Sexual Health Control</title>
            <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules; however, unlike the treatment group, content was topic-based rather than theory-based and focused on general sexual health. Module 1 addressed basic facts about HIV and sexually transmitted infections (STI), including HPV. Module 2 addressed HIV/STI prevention (e.g., condom use, PrEP) and will included basic facts about HPV vaccination currently available online. Module 3 addressed tips for healthy relationships. Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
Sexual Health Control: Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Motivation: Subjective Norms</title>
          <description>Assessed with one item: &quot;People who are important to me would want me to get vaccinated for HPV in the next 9 months.&quot; 1 = strongly disagree to 5 = strongly agree.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.10" spread="0.78"/>
                    <measurement group_id="O2" value="4.11" spread="0.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.964</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.01</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Motivation: Perceived Susceptibility</title>
        <description>Assessed with four items (e.g., &quot;If you don't get the HPV vaccine, what do you think are the chances that you will get HPV?&quot; 1 = very unlikely to 5 = very likely).</description>
        <time_frame>3 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>txt2protect</title>
            <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules. Module 1 addressed information about HPV infection and HPV vaccination. Module 2 addressed motivation to receive HPV vaccine. Module 3 addressed behavioral skills and self-efficacy for initiating and completing the 3-dose series (e.g., talking with their doctor about the vaccine). Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
txt2protect: Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination.</description>
          </group>
          <group group_id="O2">
            <title>Sexual Health Control</title>
            <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules; however, unlike the treatment group, content was topic-based rather than theory-based and focused on general sexual health. Module 1 addressed basic facts about HIV and sexually transmitted infections (STI), including HPV. Module 2 addressed HIV/STI prevention (e.g., condom use, PrEP) and will included basic facts about HPV vaccination currently available online. Module 3 addressed tips for healthy relationships. Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
Sexual Health Control: Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Motivation: Perceived Susceptibility</title>
          <description>Assessed with four items (e.g., &quot;If you don't get the HPV vaccine, what do you think are the chances that you will get HPV?&quot; 1 = very unlikely to 5 = very likely).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.12" spread="1.00"/>
                    <measurement group_id="O2" value="2.78" spread="1.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.053</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.34</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Motivation: Perceived Severity</title>
        <description>Assessed with four items (e.g., &quot;How serious would each of the following be for you: If you developed warts on your penis or scrotum?&quot; 1 = not at all serious to 5 = very serious).</description>
        <time_frame>3 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>txt2protect</title>
            <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules. Module 1 addressed information about HPV infection and HPV vaccination. Module 2 addressed motivation to receive HPV vaccine. Module 3 addressed behavioral skills and self-efficacy for initiating and completing the 3-dose series (e.g., talking with their doctor about the vaccine). Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
txt2protect: Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination.</description>
          </group>
          <group group_id="O2">
            <title>Sexual Health Control</title>
            <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules; however, unlike the treatment group, content was topic-based rather than theory-based and focused on general sexual health. Module 1 addressed basic facts about HIV and sexually transmitted infections (STI), including HPV. Module 2 addressed HIV/STI prevention (e.g., condom use, PrEP) and will included basic facts about HPV vaccination currently available online. Module 3 addressed tips for healthy relationships. Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
Sexual Health Control: Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Motivation: Perceived Severity</title>
          <description>Assessed with four items (e.g., &quot;How serious would each of the following be for you: If you developed warts on your penis or scrotum?&quot; 1 = not at all serious to 5 = very serious).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.56" spread="0.49"/>
                    <measurement group_id="O2" value="4.66" spread="0.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.183</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.10</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Motivation: Anticipated Regret</title>
        <description>Assessed with two items (e.g., &quot;How much regret would you feel if you decided not to get the HPV vaccine and later developed genital or anal warts?&quot; 1 = none to 5 = quite a lot).</description>
        <time_frame>3 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>txt2protect</title>
            <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules. Module 1 addressed information about HPV infection and HPV vaccination. Module 2 addressed motivation to receive HPV vaccine. Module 3 addressed behavioral skills and self-efficacy for initiating and completing the 3-dose series (e.g., talking with their doctor about the vaccine). Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
txt2protect: Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination.</description>
          </group>
          <group group_id="O2">
            <title>Sexual Health Control</title>
            <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules; however, unlike the treatment group, content was topic-based rather than theory-based and focused on general sexual health. Module 1 addressed basic facts about HIV and sexually transmitted infections (STI), including HPV. Module 2 addressed HIV/STI prevention (e.g., condom use, PrEP) and will included basic facts about HPV vaccination currently available online. Module 3 addressed tips for healthy relationships. Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
Sexual Health Control: Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Motivation: Anticipated Regret</title>
          <description>Assessed with two items (e.g., &quot;How much regret would you feel if you decided not to get the HPV vaccine and later developed genital or anal warts?&quot; 1 = none to 5 = quite a lot).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.76" spread="0.60"/>
                    <measurement group_id="O2" value="4.50" spread="0.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.064</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.26</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Behavioral Skills: Perceived Behavioral Control</title>
        <description>Assessed with one item: &quot;To what extent is whether or not you get vaccinated for HPV in the next 9 months under your control?&quot; 1 = not at all to 5 = completely.</description>
        <time_frame>3 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>txt2protect</title>
            <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules. Module 1 addressed information about HPV infection and HPV vaccination. Module 2 addressed motivation to receive HPV vaccine. Module 3 addressed behavioral skills and self-efficacy for initiating and completing the 3-dose series (e.g., talking with their doctor about the vaccine). Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
txt2protect: Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination.</description>
          </group>
          <group group_id="O2">
            <title>Sexual Health Control</title>
            <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules; however, unlike the treatment group, content was topic-based rather than theory-based and focused on general sexual health. Module 1 addressed basic facts about HIV and sexually transmitted infections (STI), including HPV. Module 2 addressed HIV/STI prevention (e.g., condom use, PrEP) and will included basic facts about HPV vaccination currently available online. Module 3 addressed tips for healthy relationships. Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
Sexual Health Control: Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Behavioral Skills: Perceived Behavioral Control</title>
          <description>Assessed with one item: &quot;To what extent is whether or not you get vaccinated for HPV in the next 9 months under your control?&quot; 1 = not at all to 5 = completely.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.42" spread="0.68"/>
                    <measurement group_id="O2" value="4.19" spread="1.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.147</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.22</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Behavioral Skills: Self-efficacy</title>
        <description>Assessed with one item: &quot;Assuming you wanted to, how hard or easy would it be for you to get vaccinated for HPV in the next 9 months?&quot; 1 = very hard to 5 = very easy.</description>
        <time_frame>3 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>txt2protect</title>
            <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules. Module 1 addressed information about HPV infection and HPV vaccination. Module 2 addressed motivation to receive HPV vaccine. Module 3 addressed behavioral skills and self-efficacy for initiating and completing the 3-dose series (e.g., talking with their doctor about the vaccine). Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
txt2protect: Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination.</description>
          </group>
          <group group_id="O2">
            <title>Sexual Health Control</title>
            <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules; however, unlike the treatment group, content was topic-based rather than theory-based and focused on general sexual health. Module 1 addressed basic facts about HIV and sexually transmitted infections (STI), including HPV. Module 2 addressed HIV/STI prevention (e.g., condom use, PrEP) and will included basic facts about HPV vaccination currently available online. Module 3 addressed tips for healthy relationships. Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
Sexual Health Control: Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Behavioral Skills: Self-efficacy</title>
          <description>Assessed with one item: &quot;Assuming you wanted to, how hard or easy would it be for you to get vaccinated for HPV in the next 9 months?&quot; 1 = very hard to 5 = very easy.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.96" spread="0.98"/>
                    <measurement group_id="O2" value="3.67" spread="1.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.096</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.29</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Behavioral Intentions</title>
        <description>Assessed with one item: &quot;I intend to get vaccinated for HPV in the next 9 months.&quot; 1 = strongly disagree to 5 = strongly agree.</description>
        <time_frame>3 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>txt2protect</title>
            <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules. Module 1 addressed information about HPV infection and HPV vaccination. Module 2 addressed motivation to receive HPV vaccine. Module 3 addressed behavioral skills and self-efficacy for initiating and completing the 3-dose series (e.g., talking with their doctor about the vaccine). Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
txt2protect: Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination.</description>
          </group>
          <group group_id="O2">
            <title>Sexual Health Control</title>
            <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules; however, unlike the treatment group, content was topic-based rather than theory-based and focused on general sexual health. Module 1 addressed basic facts about HIV and sexually transmitted infections (STI), including HPV. Module 2 addressed HIV/STI prevention (e.g., condom use, PrEP) and will included basic facts about HPV vaccination currently available online. Module 3 addressed tips for healthy relationships. Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
Sexual Health Control: Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Behavioral Intentions</title>
          <description>Assessed with one item: &quot;I intend to get vaccinated for HPV in the next 9 months.&quot; 1 = strongly disagree to 5 = strongly agree.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.16" spread="0.86"/>
                    <measurement group_id="O2" value="3.75" spread="1.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.013</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.41</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>9 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>txt2protect</title>
          <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules. Module 1 addressed information about HPV infection and HPV vaccination. Module 2 addressed motivation to receive HPV vaccine. Module 3 addressed behavioral skills and self-efficacy for initiating and completing the 3-dose series (e.g., talking with their doctor about the vaccine). Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
txt2protect: Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination.</description>
        </group>
        <group group_id="E2">
          <title>Sexual Health Control</title>
          <description>Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules; however, unlike the treatment group, content was topic-based rather than theory-based and focused on general sexual health. Module 1 addressed basic facts about HIV and sexually transmitted infections (STI), including HPV. Module 2 addressed HIV/STI prevention (e.g., condom use, PrEP) and will included basic facts about HPV vaccination currently available online. Module 3 addressed tips for healthy relationships. Phase 2 &quot;booster&quot; messages largely reinforced Phase 1 content to foster continued engagement with the program.&#xD;
Sexual Health Knowledge Control: Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination.</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="72"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="76"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="76"/>
              </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="72"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="76"/>
              </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>Mary Gerend</name_or_title>
      <organization>Florida State University College of Medicine</organization>
      <phone>8506451541</phone>
      <email>mary.gerend@med.fsu.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/NCT02994108
org study id: 1R21CA208329-01
secondary id: 1R21CA208329-01
nct id: NCT02994108
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Human Papillomavirus (HPV) is a common sexually transmitted infection that can cause cancer
      (anal, penile, oropharyngeal) and genital warts in men. Due to their sexual practices (e.g.,
      receptive anal intercourse), men who have sex with men (MSM) are at particularly high risk
      for HPV infection and are disproportionately affected by HPV-related cancers. A safe and
      effective vaccine is available to prevent HPV infection, yet HPV vaccination rates in the
      U.S. have been low, particularly among males. To remedy this gap, the goal of this study is
      to develop and pilot test a text messaging intervention to increase HPV vaccination in young
      MSM.

      The study has two specific aims:

        1. Develop, iteratively refine, and pre-test messages using a formative research procedure
           for designing targeted health interventions. The procedure consists of the following
           steps: 1) conduct online focus groups, an online survey, and in-depth interviews to
           inform message content, 2) draft initial messages based on focus group findings and
           pilot data, 3) refine message content and assess acceptability using content advisory
           teams, 4) conduct internal alpha testing to ensure software functionality, and 5) beta
           test the protocol.

        2. Test the feasibility, acceptability, and preliminary efficacy of the txt2protect (t2p)
           text messaging intervention in a pilot randomized controlled trial (RCT). To achieve
           this aim, 460 unvaccinated MSM (ages 18-25) who live in the Chicago metro area will be
           randomly assigned to the treatment (t2p) or control condition. The treatment condition
           will receive a culturally appropriate text messaging-based HPV vaccination intervention
           based on the Information, Motivation, and Behavioral Skills model, whereas the control
           condition will receive a text messaging-based sexual health intervention that includes
           basic facts about HPV vaccination readily accessible online.

      Primary outcome measures include intervention feasibility (e.g., retention in the trial),
      acceptability (satisfaction with the intervention), and preliminary efficacy as determined by
      initiation (receipt of the first dose) and completion of the 3-dose HPV vaccine series at the
      end of the 9-month trial.

      The study team hypothesizes that participants in the t2p condition (vs. control) will report
      greater acceptability of the intervention and will be significantly more likely to initiate
      and complete the 3-dose HPV vaccine series by the end of the trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Retention
time frame: 9 Month
description: Intervention feasibility will be evaluated by retention in the RCT. The retention rate will be computed at the end of the 9-month trial by dividing the total number of participants who completed the trial (i.e., completed the 9-month assessment) by the total number of participants who were randomized to the treatment or control condition at the beginning of the trial. An 80% 9-month retention rate will be used to indicate a feasible intervention.
measure: Intervention Acceptability for Phase 1
time frame: 3 Weeks
description: Intervention acceptability for the first 3 weeks of the intervention (Phase 1) will be assessed at the 3-week assessment. The scale includes both open-ended ("What did you like about the program? What could be improved?") and 12 closed-ended questions (e.g., "I would recommend a program like this to my friends" 1=strongly disagree to 5=strongly agree). Closed-ended items were combined to compute an average score (minimum value = 1; maximum value = 5). Higher scores indicate greater satisfaction with the program. An average score ≥4 will be used to indicate an acceptable intervention.
measure: Intervention Acceptability for Full Intervention
time frame: 9 Month
description: Intervention acceptability for the full intervention will be assessed at the end the 9-month trial. The scale includes both open-ended ("What did you like about the program? What could be improved?") and 11 closed-ended questions (e.g., "I would recommend a program like this to my friends" 1=strongly disagree to 5=strongly agree). Closed-ended items will be combined to compute an average score (minimum value = 1; maximum value = 5). Higher scores indicate greater satisfaction with the program. An average score ≥4 will be used to indicate an acceptable intervention.
measure: Number of Participants Who Initiated the HPV Vaccine Series
time frame: 9 Month
description: A final confirmatory assessment of HPV vaccination status will be conducted at the 9-month follow-up. Participants will be asked whether they received any doses of HPV vaccine (yes/no) since baseline and if yes, the number of doses and received. Vaccination status will be confirmed by consulting the Illinois Comprehensive Automated Immunization Registry (I-CARE). HPV vaccine initiation was defined as receipt of one or more doses of HPV vaccine by the end of the 9-month trial.
measure: Number of Participants Who Completed the HPV Vaccine Series
time frame: 9 Month
description: A final confirmatory assessment of HPV vaccination status will be conducted at the 9-month follow-up. Participants will be asked whether they received any doses of HPV vaccine (yes/no) since baseline and if yes, the number of doses received. Vaccination status will be confirmed by consulting the Illinois Comprehensive Automated Immunization Registry (I-CARE). HPV vaccine completion was defined as receipt of three doses of HPV vaccine by the end of the 9-month trial.
measure: Information: HPV-related Knowledge
time frame: 3 Weeks
description: Assessed with two questions (e.g., "HPV can cause anal cancer.") interspersed among other true/false questions assessing HIV/STI knowledge. Participants received one point for each correct response and zero points for incorrect and "don't know" responses. Points were summed to create a composite score that ranged from 0 to 2.
measure: Motivation: Attitudes
time frame: 3 Weeks
description: Assessed with one item: "My attitude toward getting vaccinated for HPV in the next 9 months is..." 1 = very negative to 5 = very positive.
measure: Motivation: Subjective Norms
time frame: 3 Weeks
description: Assessed with one item: "People who are important to me would want me to get vaccinated for HPV in the next 9 months." 1 = strongly disagree to 5 = strongly agree.
measure: Motivation: Perceived Susceptibility
time frame: 3 Weeks
description: Assessed with four items (e.g., "If you don't get the HPV vaccine, what do you think are the chances that you will get HPV?" 1 = very unlikely to 5 = very likely).
measure: Motivation: Perceived Severity
time frame: 3 Weeks
description: Assessed with four items (e.g., "How serious would each of the following be for you: If you developed warts on your penis or scrotum?" 1 = not at all serious to 5 = very serious).
measure: Motivation: Anticipated Regret
time frame: 3 Weeks
description: Assessed with two items (e.g., "How much regret would you feel if you decided not to get the HPV vaccine and later developed genital or anal warts?" 1 = none to 5 = quite a lot).
measure: Behavioral Skills: Perceived Behavioral Control
time frame: 3 Weeks
description: Assessed with one item: "To what extent is whether or not you get vaccinated for HPV in the next 9 months under your control?" 1 = not at all to 5 = completely.
measure: Behavioral Skills: Self-efficacy
time frame: 3 Weeks
description: Assessed with one item: "Assuming you wanted to, how hard or easy would it be for you to get vaccinated for HPV in the next 9 months?" 1 = very hard to 5 = very easy.
measure: Behavioral Intentions
time frame: 3 Weeks
description: Assessed with one item: "I intend to get vaccinated for HPV in the next 9 months." 1 = strongly disagree to 5 = strongly agree.
arm group label: txt2protect
arm group type: Experimental
description: Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules. Module 1 addressed information about HPV infection and HPV vaccination. Module 2 addressed motivation to receive HPV vaccine. Module 3 addressed behavioral skills and self-efficacy for initiating and completing the 3-dose series (e.g., talking with their doctor about the vaccine). Phase 2 "booster" messages largely reinforced Phase 1 content to foster continued engagement with the program.
txt2protect: Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination.
arm group label: Sexual Health Control
arm group type: Active Comparator
description: Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules; however, unlike the treatment group, content was topic-based rather than theory-based and focused on general sexual health. Module 1 addressed basic facts about HIV and sexually transmitted infections (STI), including HPV. Module 2 addressed HIV/STI prevention (e.g., condom use, PrEP) and will included basic facts about HPV vaccination currently available online. Module 3 addressed tips for healthy relationships. Phase 2 "booster" messages largely reinforced Phase 1 content to foster continued engagement with the program.
Sexual Health Control: Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination.
intervention type: Behavioral
intervention name: txt2protect
description: Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination.
arm group label: txt2protect
other name: t2p
intervention type: Behavioral
intervention name: Sexual Health Control
description: Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination.
arm group label: Sexual Health Control
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mary Gerend, PhD
role: Principal Investigator
affiliation: Florida State University
last name: Brian Mustanski, PhD
role: Principal Investigator
affiliation: Northwestern University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Florida State University
investigator full name: Mary Gerend
investigator title: Associate Professor, Behavioral Sciences and Social Medicine, College of Medicine
sharing ipd: Yes
ipd description: The PI agrees to develop a de-identified database, codebook, and mechanism by which IPD could be shared with other investigators upon approval of the PI. Data will be available for request approximately 6 months after completion of the project. Interested investigators will be asked to complete a standardized request form stating the specific aims of the analysis, the analytic plans, resources the requestors have to carry out the project, the proposed timeline, and distribution goals (manuscripts and/or grant application). The PI will review these requests to determine whether the proposed analyses constitute an innovative and significant exploration of the data, whether the proposed team has sufficient resources to undertake the request, how data will be protected/managed, and whether there are sufficient resources to honor the request. If any of these issues are problematic, the PI will attempt to negotiate a fair resolution with the interested parties and/or with NIH program staff.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 