<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/NCT01695694</url>
  </required_header>
  <id_info>
    <org_study_id>RSRB00040309</org_study_id>
    <secondary_id>7K01MH080660</secondary_id>
    <nct_id>NCT01695694</nct_id>
  </id_info>
  <brief_title>Violence and HIV Risk Among Women</brief_title>
  <acronym>VHRW</acronym>
  <official_title>HIV Risk Reduction for Women Reporting Intimate Partner Violence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Rochester</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to test the feasibility, acceptability, and efficacy of an&#xD;
      adapted intervention that is theoretically and empirically guided by the&#xD;
      Information-Motivation-Behavioral skills model (IMB) and aims at reducing sexual risk&#xD;
      behavior among women who have experienced Intimate Partner Violence (IPV), as well as such an&#xD;
      intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The two foremost health problems impacting young adult women are STDs/HIV infection and&#xD;
      intimate partner violence (IPV). STDs pose a significant public health issue in the US,&#xD;
      particularly among women. The consequences of some STDs are more severe for women, and&#xD;
      include infertility, pelvic inflammatory disease, and brain, cardiovascular, and organ&#xD;
      damage. Women with STDs are at increased risk for HIV. The proportion of AIDS cases among US&#xD;
      adult and adolescent women has more than tripled since 1985. Approximately 12,000 US women&#xD;
      are infected with HIV annually, primarily through heterosexual contact. Also, in the US HIV&#xD;
      is particularly affecting women of color and those in low-income urban areas.&#xD;
&#xD;
      IPV also affects many women. While the causal links between IPV and HIV risk or infection&#xD;
      have not yet been established, emerging empirical evidence has drawn connections between IPV&#xD;
      with HIV risk. Several researchers have highlighted the importance of developing sexual risk&#xD;
      reduction interventions that address the growing concern of gender-based violence against&#xD;
      women. Also, scholars are calling for HIV prevention programs aimed at women to be more&#xD;
      comprehensive; for example, by combining them with STD screening or with programs designed to&#xD;
      reduce violence against women. Despite this call, there are very few empirically tested&#xD;
      interventions for prevention and treatment targeting women who are at risk for STDs/HIV and&#xD;
      experience IPV in their intimate relationships. To address high risk sexual behaviors among&#xD;
      women who experience gender-based violence in their intimate relationships, I have adapted an&#xD;
      existing information-motivation-behavioral skills (IMB) STD/HIV prevention intervention for&#xD;
      reducing high sexual risk-taking behaviors. The STD/HIV and IPV comprehensive intervention&#xD;
      will address both sexual risk reduction and IPV risk; the intention is to help women to&#xD;
      acquire knowledge, skills, and strategies that will reduce their risk for both STDs/HIV and&#xD;
      IPV.&#xD;
&#xD;
      Aim 1: To assess the feasibility and acceptability of the adapted IMB STD/HIV prevention&#xD;
      intervention by implementing the intervention with a sample of women who are at risk for&#xD;
      HIV/STDs and experience IPV. To achieve this aim:&#xD;
&#xD;
        1. 120 women who are at risk for HIV/STDs and have experienced IPV will be randomized&#xD;
           either to receive the experimental prevention intervention or to attend a structurally&#xD;
           similar drop-in enhanced support group at a domestic violence agency.&#xD;
&#xD;
        2. Enrollment, attendance, and attrition data will be used to determine the feasibility of&#xD;
           the intervention.&#xD;
&#xD;
        3. The acceptability of the intervention will be appraised by analyzing pre- and&#xD;
           post-intervention acceptability ratings completed by subjects and interventionists.&#xD;
&#xD;
      Aim 2: To gather preliminary evidence of the efficacy of the theoretically guided&#xD;
      intervention using a controlled design. To achieve this aim:&#xD;
&#xD;
        1. Women in the experimental and control groups will be assessed at baseline,&#xD;
           post-intervention, and at a 3-month follow-up.&#xD;
&#xD;
        2. Outcome analyses to calculate effect sizes for use in future power analyses for a larger&#xD;
           RCT of the proposed intervention will include measures on primary variables of&#xD;
           hypothesized risk antecedents, standard measures of protected and unprotected sex, and&#xD;
           secondary variables such as mental health, self esteem, and IPV experiences.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</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>Change from Baseline in sexual risk behavior at 3 months</measure>
    <time_frame>at the completion of 3 months after the intervention</time_frame>
    <description>Sexual risk behavior is assessed by self-reported number sexual partners in the last three months and number of episodes of unprotected sex with each partner</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in experience of violence at 3 months</measure>
    <time_frame>At the end 3-months after the end of the intervention</time_frame>
    <description>Participant's experiences of violence as well as the frequency and intensity of thse experiences will be assessed using established measures of intimate partner violence</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>HIV Risk Reduction</condition>
  <arm_group>
    <arm_group_label>community support group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>supporting positive and healthy relationships</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>supporting positive and healthy relationships</intervention_name>
    <arm_group_label>supporting positive and healthy relationships</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>community support group</intervention_name>
    <arm_group_label>community support group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Women will be eligible to participate in the research study if they meet the following&#xD;
        criteria:&#xD;
&#xD;
          -  between ages 18 and 49;&#xD;
&#xD;
          -  heterosexually active;&#xD;
&#xD;
          -  have experienced intimate partner violence in the last three months;&#xD;
&#xD;
          -  have engaged in risky sexual behavior in the past three months;&#xD;
&#xD;
          -  not currently pregnant or trying to become pregnant; and&#xD;
&#xD;
          -  physically and psychologically capable of providing informed consent. All subjects&#xD;
             will be required to provide written informed consent prior to enrolling in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Persons who meet one or more of the following criteria will be excluded from the study:&#xD;
&#xD;
          -  men;&#xD;
&#xD;
          -  women who have active psychosis or impaired mental status (confirmed with a&#xD;
             Mini-Mental Status Exam);&#xD;
&#xD;
          -  are unable to understand spoken English;&#xD;
&#xD;
          -  are less than 18 years old or greater than 49 years old;&#xD;
&#xD;
          -  are currently pregnant or trying to become pregnant&#xD;
&#xD;
          -  women who are exclusively in same-sex relationships.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mona Mittal, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rochester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>July 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>February 17, 2014</last_update_submitted>
  <last_update_submitted_qc>February 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01695694
org study id: RSRB00040309
secondary id: 7K01MH080660
nct id: NCT01695694
lead sponsor: 
collaborator: 
has dmc: No
The purpose of the study is to test the feasibility, acceptability, and efficacy of an
      adapted intervention that is theoretically and empirically guided by the
      Information-Motivation-Behavioral skills model (IMB) and aims at reducing sexual risk
      behavior among women who have experienced Intimate Partner Violence (IPV), as well as such an
      intervention.
The two foremost health problems impacting young adult women are STDs/HIV infection and
      intimate partner violence (IPV). STDs pose a significant public health issue in the US,
      particularly among women. The consequences of some STDs are more severe for women, and
      include infertility, pelvic inflammatory disease, and brain, cardiovascular, and organ
      damage. Women with STDs are at increased risk for HIV. The proportion of AIDS cases among US
      adult and adolescent women has more than tripled since 1985. Approximately 12,000 US women
      are infected with HIV annually, primarily through heterosexual contact. Also, in the US HIV
      is particularly affecting women of color and those in low-income urban areas.

      IPV also affects many women. While the causal links between IPV and HIV risk or infection
      have not yet been established, emerging empirical evidence has drawn connections between IPV
      with HIV risk. Several researchers have highlighted the importance of developing sexual risk
      reduction interventions that address the growing concern of gender-based violence against
      women. Also, scholars are calling for HIV prevention programs aimed at women to be more
      comprehensive; for example, by combining them with STD screening or with programs designed to
      reduce violence against women. Despite this call, there are very few empirically tested
      interventions for prevention and treatment targeting women who are at risk for STDs/HIV and
      experience IPV in their intimate relationships. To address high risk sexual behaviors among
      women who experience gender-based violence in their intimate relationships, I have adapted an
      existing information-motivation-behavioral skills (IMB) STD/HIV prevention intervention for
      reducing high sexual risk-taking behaviors. The STD/HIV and IPV comprehensive intervention
      will address both sexual risk reduction and IPV risk; the intention is to help women to
      acquire knowledge, skills, and strategies that will reduce their risk for both STDs/HIV and
      IPV.

      Aim 1: To assess the feasibility and acceptability of the adapted IMB STD/HIV prevention
      intervention by implementing the intervention with a sample of women who are at risk for
      HIV/STDs and experience IPV. To achieve this aim:

        1. 120 women who are at risk for HIV/STDs and have experienced IPV will be randomized
           either to receive the experimental prevention intervention or to attend a structurally
           similar drop-in enhanced support group at a domestic violence agency.

        2. Enrollment, attendance, and attrition data will be used to determine the feasibility of
           the intervention.

        3. The acceptability of the intervention will be appraised by analyzing pre- and
           post-intervention acceptability ratings completed by subjects and interventionists.

      Aim 2: To gather preliminary evidence of the efficacy of the theoretically guided
      intervention using a controlled design. To achieve this aim:

        1. Women in the experimental and control groups will be assessed at baseline,
           post-intervention, and at a 3-month follow-up.

        2. Outcome analyses to calculate effect sizes for use in future power analyses for a larger
           RCT of the proposed intervention will include measures on primary variables of
           hypothesized risk antecedents, standard measures of protected and unprotected sex, and
           secondary variables such as mental health, self esteem, and IPV experiences.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Change from Baseline in sexual risk behavior at 3 months
time frame: at the completion of 3 months after the intervention
description: Sexual risk behavior is assessed by self-reported number sexual partners in the last three months and number of episodes of unprotected sex with each partner
measure: Change from Baseline in experience of violence at 3 months
time frame: At the end 3-months after the end of the intervention
description: Participant's experiences of violence as well as the frequency and intensity of thse experiences will be assessed using established measures of intimate partner violence
arm group label: community support group
arm group type: Active Comparator
arm group label: supporting positive and healthy relationships
arm group type: Experimental
intervention type: Behavioral
intervention name: supporting positive and healthy relationships
arm group label: supporting positive and healthy relationships
intervention type: Behavioral
intervention name: community support group
arm group label: community support group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: No
last name: Mona Mittal, PhD
role: Principal Investigator
affiliation: University of Rochester
facility: 
country: United States
responsible party type: Sponsor