<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/NCT03755661</url>
  </required_header>
  <id_info>
    <org_study_id>3468a</org_study_id>
    <secondary_id>3R01AA022301-02S1</secondary_id>
    <nct_id>NCT03755661</nct_id>
  </id_info>
  <brief_title>MI With Text Messaging to Reduce Sexual Risk and Hazardous Drinking Among MSM</brief_title>
  <acronym>MI&amp;TXT4MSM</acronym>
  <official_title>Alcohol and Implicit Process in Sexual Risk Behavior in MSM Supplement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston University Charles River Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston University Charles River Campus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a small pilot study to provide effect size estimates for a brief intervention&#xD;
      designed to reduce hazardous drinking and sexual risk behavior among men who have sex with&#xD;
      men. The intervention consists of an &quot;in-person&quot; brief motivational intervention followed by&#xD;
      a series of text messages related to alcohol and sexual risk reduction. The primary outcome&#xD;
      is heavy drinking episodes and frequency of condomless anal intercourse at 3 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a pilot study designed to provide initial effect size estimates for an intervention&#xD;
      addressing hazardous drinking and sexual risk behavior among men who have sex with men. In&#xD;
      this study, 24 participants initially recruited through advertisements in the community will&#xD;
      be randomly assigned to either Assessment Only or Intervention Condition. Those in the&#xD;
      Assessment Only condition will complete baseline, 6-week, 3-month and 6-month assessments.&#xD;
      Those in the intervention condition will receive a 50-min brief intervention in person&#xD;
      followed by 6 weeks of tailored app-based messaging to support the intervention content, then&#xD;
      another 6-weeks of goal setting text-based messages. Data will be analyzed to determine&#xD;
      effect sizes of the intervention on key alcohol use and sex risk outcomes. The primary&#xD;
      outcome will be 3-month outcomes, controlling for corresponding baseline outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 9, 2018</start_date>
  <completion_date type="Actual">March 9, 2020</completion_date>
  <primary_completion_date type="Actual">March 9, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants are randomly assigned to one of two groups</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The outcomes assessor is not provided with randomization information for the subjects</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Heavy Drinking Episodes NIAAA Criteria (5 or More Drinks on a Single Occasion)</measure>
    <time_frame>30 days</time_frame>
    <description>Number of heavy drinking episodes in the past 30 days. This question is an open ended question that asks the participant to report the number of times in the past 30 days that he has consumed 5 or more drinks on a single occasion [no scale]. Higher score is a worse outcome, range 0-30</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Condomless Anal Intercourse Episodes (CAI) From the Sexual Behaviors Survey (Gordon et al., 2007) is Used to Measure Sexual Risk [Main Time Point at 3 Month Follow-up]</measure>
    <time_frame>90 days</time_frame>
    <description>Frequency of CAI in past 90 days. This is an open ended question where the Participant report the frequency of condomless anal intercourse episodes over a period of 90 days [no scale] Range from 0-90</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified Daily Drinking Questionnaire- Typical Number of Standard Drinks Per Week Over the Past Month</measure>
    <time_frame>30 days</time_frame>
    <description>Average quantity of alcohol use per week in the past 30 days. Participants complete a seven day calendar which reflects the typical number of standard drinks that they have consumed for each day of the week over the past 30 days. The number of drinks can range from 0 to an unlimited high number. A higher number of drinks listed in the week is reflective of a worse outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Young Adult Alcohol Consequences Questionnaire [Alcohol]</measure>
    <time_frame>30 days</time_frame>
    <description>Number of alcohol-related consequences in the past month. This is the 48-item Yes/No version of the YAACQ. The range for the score is 0-48. Higher score is a worse outcome</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of CAI Past 6 Weeks From the Sexual Behaviors Survey Item Described Above.</measure>
    <time_frame>6 -weeks</time_frame>
    <description>The number of condomless anal intercourse episodes (CAI) in the 6 weeks following the baseline as an additional outcome</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Alcohol; Harmful Use</condition>
  <condition>Sex, Unsafe</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This intervention arm is a combined in-person text messaging intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Assessment Only Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The is the assessment only comparison condition</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MI&amp;TXT4MSM</intervention_name>
    <description>brief in-person intervention followed by text messaging</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 1 heavy drinking episode or consumption of more than 14 drinks per week over&#xD;
             the past month&#xD;
&#xD;
          -  At least 1 condomless anal sex episode in past 3 months&#xD;
&#xD;
          -  Score of 3 or greater on the Kinsey Scale (Kinsey et al., 1948) indicating at least&#xD;
             &quot;equally heterosexual and homosexual&quot;. Scale ranges from 0 (exclusively heterosexual)&#xD;
             to 6 (exclusively homosexual)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Alcohol treatment currently or in past 3 years&#xD;
&#xD;
          -  Bipolar disorder or schizophrenia treatment&#xD;
&#xD;
          -  Exclusive monogamous relationship&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>identify as male</gender_description>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Boston University Department of Psychological and Brain Science</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <results_first_submitted>March 7, 2021</results_first_submitted>
  <results_first_submitted_qc>April 8, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 6, 2021</results_first_posted>
  <last_update_submitted>April 8, 2021</last_update_submitted>
  <last_update_submitted_qc>April 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston University Charles River Campus</investigator_affiliation>
    <investigator_full_name>Tibor Palfai</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data will be shared following release within one year of the trial end to investigators who make specific requests in writing regarding analysis plans. Plans will be reviewed with co-investigators to ensure that there is no overlap with planned analyses. Specific de-identified data set will be provided to other researchers after this review</ipd_description>
    <ipd_time_frame>Data will be available one year after the trial end. They will be available for investigators to request up to 5 years following their release</ipd_time_frame>
    <ipd_access_criteria>Researcher with specified analytic request.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 17, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT03755661/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited through social media ads and the study was conducted at a university laboratory that is affiliated with a psychological services clinic</recruitment_details>
      <pre_assignment_details>Eligibility was confirmed at the in-person session. Randomization occurred following baseline assessment</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>This intervention arm is a combined in-person text messaging intervention&#xD;
MI&amp;TXT4MSM: brief in-person intervention followed by text messaging</description>
        </group>
        <group group_id="P2">
          <title>Assessment Only Control</title>
          <description>This condition includes only assessment measures. It is used as the comparison condition to the intervention under study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </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="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>Intervention</title>
          <description>This intervention arm is a combined in-person text messaging intervention&#xD;
MI&amp;TXT4MSM: brief in-person intervention followed by text messaging</description>
        </group>
        <group group_id="B2">
          <title>Assessment Only Control</title>
          <description>The is the assessment only comparison condition</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="12"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="24"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.18" spread="7.26"/>
                    <measurement group_id="B2" value="30.75" spread="7.79"/>
                    <measurement group_id="B3" value="30.48" spread="7.36"/>
                  </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="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="24"/>
                  </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="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="19"/>
                  </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="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Heavy Drinking Episodes NIAAA Criteria (5 or More Drinks on a Single Occasion)</title>
        <description>Number of heavy drinking episodes in the past 30 days. This question is an open ended question that asks the participant to report the number of times in the past 30 days that he has consumed 5 or more drinks on a single occasion [no scale]. Higher score is a worse outcome, range 0-30</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>This intervention arm is a combined in-person text messaging intervention&#xD;
MI&amp;TXT4MSM: brief in-person intervention followed by text messaging</description>
          </group>
          <group group_id="O2">
            <title>Assessment Only Control</title>
            <description>The is the assessment only comparison condition</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Heavy Drinking Episodes NIAAA Criteria (5 or More Drinks on a Single Occasion)</title>
          <description>Number of heavy drinking episodes in the past 30 days. This question is an open ended question that asks the participant to report the number of times in the past 30 days that he has consumed 5 or more drinks on a single occasion [no scale]. Higher score is a worse outcome, range 0-30</description>
          <units>heavy drinking episodes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.09" spread="3.62"/>
                    <measurement group_id="O2" value="5.33" spread="3.42"/>
                  </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>
            <groups_desc>pilot study to calculate effect size, study is not powered to detect significant group differences</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>pilot data to estimate effect size f-squared as the parameter as primary outcome</non_inferiority_desc>
            <p_value>.048</p_value>
            <p_value_desc>provide inferential statistics for data completion. Study is not designed to detect significant differences between groups</p_value_desc>
            <method>Regression, Linear</method>
            <method_desc>R-square change = .12; F-change (1, 20) = 4.44</method_desc>
            <other_analysis_desc>Computed f-squared as effect size estimate where baseline value of heavy drinking episodes entered in step 1 and condition in step 2&#xD;
f- squared = .22</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Condomless Anal Intercourse Episodes (CAI) From the Sexual Behaviors Survey (Gordon et al., 2007) is Used to Measure Sexual Risk [Main Time Point at 3 Month Follow-up]</title>
        <description>Frequency of CAI in past 90 days. This is an open ended question where the Participant report the frequency of condomless anal intercourse episodes over a period of 90 days [no scale] Range from 0-90</description>
        <time_frame>90 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>This intervention arm is a combined in-person text messaging intervention&#xD;
MI&amp;TXT4MSM: brief in-person intervention followed by text messaging</description>
          </group>
          <group group_id="O2">
            <title>Assessment Only Control</title>
            <description>The is the assessment only comparison condition</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Condomless Anal Intercourse Episodes (CAI) From the Sexual Behaviors Survey (Gordon et al., 2007) is Used to Measure Sexual Risk [Main Time Point at 3 Month Follow-up]</title>
          <description>Frequency of CAI in past 90 days. This is an open ended question where the Participant report the frequency of condomless anal intercourse episodes over a period of 90 days [no scale] Range from 0-90</description>
          <units>condomless anal intercourse episodes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.54" spread="2.46"/>
                    <measurement group_id="O2" value="4.33" spread="6.12"/>
                  </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>
            <groups_desc>pilot trial to compute effect size estimate</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The main outcome variable is f-squared as an estimate of differences between conditions controlling for baseline value.&#xD;
A statistical test is provided only for completeness as this study is not powered to detect significant effects</non_inferiority_desc>
            <p_value>.34</p_value>
            <p_value_desc>F-change (1, 20) = 0.97</p_value_desc>
            <method>Regression, Linear</method>
            <other_analysis_desc>Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .05, r-squared change = .04</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Modified Daily Drinking Questionnaire- Typical Number of Standard Drinks Per Week Over the Past Month</title>
        <description>Average quantity of alcohol use per week in the past 30 days. Participants complete a seven day calendar which reflects the typical number of standard drinks that they have consumed for each day of the week over the past 30 days. The number of drinks can range from 0 to an unlimited high number. A higher number of drinks listed in the week is reflective of a worse outcome</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>This intervention arm is a combined in-person text messaging intervention&#xD;
MI&amp;TXT4MSM: brief in-person intervention followed by text messaging</description>
          </group>
          <group group_id="O2">
            <title>Assessment Only Control</title>
            <description>The is the assessment only comparison condition</description>
          </group>
        </group_list>
        <measure>
          <title>Modified Daily Drinking Questionnaire- Typical Number of Standard Drinks Per Week Over the Past Month</title>
          <description>Average quantity of alcohol use per week in the past 30 days. Participants complete a seven day calendar which reflects the typical number of standard drinks that they have consumed for each day of the week over the past 30 days. The number of drinks can range from 0 to an unlimited high number. A higher number of drinks listed in the week is reflective of a worse outcome</description>
          <units>Average number of drinks per week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.45" spread="6.57"/>
                    <measurement group_id="O2" value="11.58" spread="6.14"/>
                  </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>
            <non_inferiority_desc>This is a pilot trial to estimate effect sizes and not powered to detect significant differences</non_inferiority_desc>
            <p_value>.20</p_value>
            <p_value_desc>data provided for completeness, not powered to test differences</p_value_desc>
            <method>Regression, Linear</method>
            <method_desc>F-change (1, 20) = 1.80</method_desc>
            <other_analysis_desc>Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .09, r-squared change = .058</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Young Adult Alcohol Consequences Questionnaire [Alcohol]</title>
        <description>Number of alcohol-related consequences in the past month. This is the 48-item Yes/No version of the YAACQ. The range for the score is 0-48. Higher score is a worse outcome</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>This intervention arm is a combined in-person text messaging intervention&#xD;
MI&amp;TXT4MSM: brief in-person intervention followed by text messaging</description>
          </group>
          <group group_id="O2">
            <title>Assessment Only Control</title>
            <description>The is the assessment only comparison condition</description>
          </group>
        </group_list>
        <measure>
          <title>Young Adult Alcohol Consequences Questionnaire [Alcohol]</title>
          <description>Number of alcohol-related consequences in the past month. This is the 48-item Yes/No version of the YAACQ. The range for the score is 0-48. Higher score is a worse outcome</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="11"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.45" spread="6.62"/>
                    <measurement group_id="O2" value="9.41" spread="7.41"/>
                  </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>
            <groups_desc>Pilot trial not powered to detect significant group differences</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Pilot trial not powered to detect significant group differences. Data from analyses presented for completeness. Primary outcome is effect size estimates</non_inferiority_desc>
            <p_value>.19</p_value>
            <method>Regression, Linear</method>
            <method_desc>F-change (1, 20) = 1.83</method_desc>
            <other_analysis_desc>Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .09, r-squared change = .048</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of CAI Past 6 Weeks From the Sexual Behaviors Survey Item Described Above.</title>
        <description>The number of condomless anal intercourse episodes (CAI) in the 6 weeks following the baseline as an additional outcome</description>
        <time_frame>6 -weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>This intervention arm is a combined in-person text messaging intervention&#xD;
MI&amp;TXT4MSM: brief in-person intervention followed by text messaging</description>
          </group>
          <group group_id="O2">
            <title>Assessment Only Control</title>
            <description>The is the assessment only comparison condition</description>
          </group>
        </group_list>
        <measure>
          <title>Number of CAI Past 6 Weeks From the Sexual Behaviors Survey Item Described Above.</title>
          <description>The number of condomless anal intercourse episodes (CAI) in the 6 weeks following the baseline as an additional outcome</description>
          <units>condomless anal intercourse episodes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.91" spread="0.94"/>
                    <measurement group_id="O2" value="1.63" spread="1.56"/>
                  </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>
            <groups_desc>Not powered to test significant differences. provide data on effect size estimate below</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.26</p_value>
            <p_value_desc>F-change (1, 19) = 1.34</p_value_desc>
            <method>Regression, Linear</method>
            <other_analysis_desc>Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .05, r-squared change = .04</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected up to the 6 month outcome following enrollment. This corresponds to the time period from initial enrollment to study completion</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>This intervention arm is a combined in-person text messaging intervention&#xD;
MI&amp;TXT4MSM: brief in-person intervention followed by text messaging&#xD;
No adverse events</description>
        </group>
        <group group_id="E2">
          <title>Assessment Only Control</title>
          <description>The is the assessment only comparison condition&#xD;
No adverse events</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="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </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="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </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>LaNeia Thomas</name_or_title>
      <organization>Boston University</organization>
      <phone>617-358-6346</phone>
      <email>laneia@bu.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/NCT03755661
org study id: 3468a
secondary id: 3R01AA022301-02S1
nct id: NCT03755661
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a small pilot study to provide effect size estimates for a brief intervention
      designed to reduce hazardous drinking and sexual risk behavior among men who have sex with
      men. The intervention consists of an "in-person" brief motivational intervention followed by
      a series of text messages related to alcohol and sexual risk reduction. The primary outcome
      is heavy drinking episodes and frequency of condomless anal intercourse at 3 months.
This is a pilot study designed to provide initial effect size estimates for an intervention
      addressing hazardous drinking and sexual risk behavior among men who have sex with men. In
      this study, 24 participants initially recruited through advertisements in the community will
      be randomly assigned to either Assessment Only or Intervention Condition. Those in the
      Assessment Only condition will complete baseline, 6-week, 3-month and 6-month assessments.
      Those in the intervention condition will receive a 50-min brief intervention in person
      followed by 6 weeks of tailored app-based messaging to support the intervention content, then
      another 6-weeks of goal setting text-based messages. Data will be analyzed to determine
      effect sizes of the intervention on key alcohol use and sex risk outcomes. The primary
      outcome will be 3-month outcomes, controlling for corresponding baseline outcomes.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants are randomly assigned to one of two groups
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: The outcomes assessor is not provided with randomization information for the subjects
measure: Number of Heavy Drinking Episodes NIAAA Criteria (5 or More Drinks on a Single Occasion)
time frame: 30 days
description: Number of heavy drinking episodes in the past 30 days. This question is an open ended question that asks the participant to report the number of times in the past 30 days that he has consumed 5 or more drinks on a single occasion [no scale]. Higher score is a worse outcome, range 0-30
measure: Number of Condomless Anal Intercourse Episodes (CAI) From the Sexual Behaviors Survey (Gordon et al., 2007) is Used to Measure Sexual Risk [Main Time Point at 3 Month Follow-up]
time frame: 90 days
description: Frequency of CAI in past 90 days. This is an open ended question where the Participant report the frequency of condomless anal intercourse episodes over a period of 90 days [no scale] Range from 0-90
measure: Modified Daily Drinking Questionnaire- Typical Number of Standard Drinks Per Week Over the Past Month
time frame: 30 days
description: Average quantity of alcohol use per week in the past 30 days. Participants complete a seven day calendar which reflects the typical number of standard drinks that they have consumed for each day of the week over the past 30 days. The number of drinks can range from 0 to an unlimited high number. A higher number of drinks listed in the week is reflective of a worse outcome
measure: Young Adult Alcohol Consequences Questionnaire [Alcohol]
time frame: 30 days
description: Number of alcohol-related consequences in the past month. This is the 48-item Yes/No version of the YAACQ. The range for the score is 0-48. Higher score is a worse outcome
measure: Number of CAI Past 6 Weeks From the Sexual Behaviors Survey Item Described Above.
time frame: 6 -weeks
description: The number of condomless anal intercourse episodes (CAI) in the 6 weeks following the baseline as an additional outcome
arm group label: Intervention
arm group type: Experimental
description: This intervention arm is a combined in-person text messaging intervention
arm group label: Assessment Only Control
arm group type: No Intervention
description: The is the assessment only comparison condition
intervention type: Behavioral
intervention name: MI&TXT4MSM
description: brief in-person intervention followed by text messaging
arm group label: Intervention
criteria: 
gender: Male
gender based: Yes
gender description: identify as male
minimum age: 21 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston University Charles River Campus
investigator full name: Tibor Palfai
investigator title: Professor
sharing ipd: Yes
ipd description: Data will be shared following release within one year of the trial end to investigators who make specific requests in writing regarding analysis plans. Plans will be reviewed with co-investigators to ensure that there is no overlap with planned analyses. Specific de-identified data set will be provided to other researchers after this review
ipd time frame: Data will be available one year after the trial end. They will be available for investigators to request up to 5 years following their release
ipd access criteria: Researcher with specified analytic request.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 