<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/NCT03826342</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00143896</org_study_id>
    <secondary_id>1R01HD093611-01A1</secondary_id>
    <nct_id>NCT03826342</nct_id>
  </id_info>
  <brief_title>Technology-Based Intervention for Reducing Sexually Transmitted Infections and Substance Use During Pregnancy</brief_title>
  <official_title>Technology-Based Intervention for Reducing Sexually Transmitted Infections and Substance Use During Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>Yes</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 proposed study is to test whether Health Check-up for Expectant Moms (HCEM), a&#xD;
      computer-delivered screening and brief intervention (SBI) that simultaneously targets&#xD;
      sexually transmitted infection (STI) risk and alcohol/drug use during pregnancy, reduces&#xD;
      antenatal and postpartum risk more than an attention, time, and information matched control&#xD;
      condition among pregnant women seeking prenatal care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 16, 2019</start_date>
  <completion_date type="Anticipated">February 2024</completion_date>
  <primary_completion_date type="Anticipated">February 2024</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of unprotected sexual occasions (USOs)</measure>
    <time_frame>Baseline</time_frame>
    <description>Timeline Follow-Back (TLFB) is used to assess USOs which are sex-risk behaviors . The TLFB is a calendar assisted structured interview that provides a way to cue memory so that accurate recall is enhanced for event-level data; it has been used to assess sexual risk-taking. USOs will be assessed in the 90 days prior to the baseline, as well as the 8-week follow-up assessments.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of days of alcohol use measured by Timeline Follow-Back (TLFB)</measure>
    <time_frame>8 week follow-up</time_frame>
    <description>Number of days of alcohol use will be measured by the TLFB by using the variable of percent days abstinent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days of illicit drug use measured by Timeline Follow-Back (TLFB)</measure>
    <time_frame>8 week follow-up</time_frame>
    <description>Illicit drug use will also be collected from the TLFB, and measured by using the &quot;yes/no&quot; variable for each day.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Sexually Transmitted Infection</condition>
  <condition>Alcohol Use Complicating the Puerperium</condition>
  <condition>Alcohol Use Complicating Pregnancy, Unspecified Trimester</condition>
  <condition>Drug Use</condition>
  <arm_group>
    <arm_group_label>Health Check-up for Expectant Moms</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Theory-driven and derived from empirical support</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Time, attention, and information-matched control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Well-validated</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health Check-up for Expectant Moms</intervention_name>
    <description>A brief intervention (one session plus two booster sessions)</description>
    <arm_group_label>Health Check-up for Expectant Moms</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Time, attention, and information-matched control</intervention_name>
    <description>We will include facts about alcohol/drug use and risky sex during pregnancy, along with informational brochures that provide face validity.</description>
    <arm_group_label>Time, attention, and information-matched control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least one unprotected vaginal (or anal) sex occasion in the past 30 days&#xD;
&#xD;
          -  Having more than one male sex partner in the last 6 months and/or having uncertainty&#xD;
             about current partner's monogamy.&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Current alcohol/drug use risk.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to understand English&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Golfo Tzilos Wernette</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>West Ann Arbor Health Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>September 12, 2023</last_update_submitted>
  <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Golfo Tzilos</investigator_full_name>
    <investigator_title>Assistant Professor of Family Medicine and Assistant Professor of Psychiatry</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Sexually Transmitted Diseases</mesh_term>
    <mesh_term>Pregnancy Complications</mesh_term>
    <mesh_term>Substance-Related Disorders</mesh_term>
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The study team does not currently have a plan to share data. However, the team is currently in discussion about sharing data and will update the registration as needed.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03826342
org study id: HUM00143896
secondary id: 1R01HD093611-01A1
nct id: NCT03826342
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This proposed study is to test whether Health Check-up for Expectant Moms (HCEM), a
      computer-delivered screening and brief intervention (SBI) that simultaneously targets
      sexually transmitted infection (STI) risk and alcohol/drug use during pregnancy, reduces
      antenatal and postpartum risk more than an attention, time, and information matched control
      condition among pregnant women seeking prenatal care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Number of unprotected sexual occasions (USOs)
time frame: Baseline
description: Timeline Follow-Back (TLFB) is used to assess USOs which are sex-risk behaviors . The TLFB is a calendar assisted structured interview that provides a way to cue memory so that accurate recall is enhanced for event-level data; it has been used to assess sexual risk-taking. USOs will be assessed in the 90 days prior to the baseline, as well as the 8-week follow-up assessments.
measure: Number of days of alcohol use measured by Timeline Follow-Back (TLFB)
time frame: 8 week follow-up
description: Number of days of alcohol use will be measured by the TLFB by using the variable of percent days abstinent.
measure: Number of days of illicit drug use measured by Timeline Follow-Back (TLFB)
time frame: 8 week follow-up
description: Illicit drug use will also be collected from the TLFB, and measured by using the "yes/no" variable for each day.
arm group label: Health Check-up for Expectant Moms
arm group type: Experimental
description: Theory-driven and derived from empirical support
arm group label: Time, attention, and information-matched control
arm group type: Active Comparator
description: Well-validated
intervention type: Behavioral
intervention name: Health Check-up for Expectant Moms
description: A brief intervention (one session plus two booster sessions)
arm group label: Health Check-up for Expectant Moms
intervention type: Behavioral
intervention name: Time, attention, and information-matched control
description: We will include facts about alcohol/drug use and risky sex during pregnancy, along with informational brochures that provide face validity.
arm group label: Time, attention, and information-matched control
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Golfo Tzilos Wernette
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Golfo Tzilos
investigator title: Assistant Professor of Family Medicine and Assistant Professor of Psychiatry
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Sexually Transmitted Diseases
mesh term: Pregnancy Complications
mesh term: Substance-Related Disorders
mesh term: Alcohol Drinking
sharing ipd: No
ipd description: The study team does not currently have a plan to share data. However, the team is currently in discussion about sharing data and will update the registration as needed.