<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/NCT02189876</url>
  </required_header>
  <id_info>
    <org_study_id>MD-13-010</org_study_id>
    <secondary_id>P20MD000182</secondary_id>
    <nct_id>NCT02189876</nct_id>
  </id_info>
  <brief_title>Females of African American Legacy Empowering Self (FemAALES)</brief_title>
  <acronym>FemAALES</acronym>
  <official_title>Reducing HIV/STD Risk in African American Women With At-Risk Male Partners</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charles Drew University of Medicine and Science</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Minority Health and Health Disparities (NIMHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>St. John's Well Child &amp; Family Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Charles Drew University of Medicine and Science</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The FemAALES Project is a community collaborative two-arm intervention designed to prevent&#xD;
      HIV (human immunodeficiency) and STD (sexually transmitted disease) infection and&#xD;
      transmission among African American women and men by reducing sexual risk factors and&#xD;
      enhancing sexual negotiation skills. The team of investigators is a collaboration of&#xD;
      researchers and community service providers who are committed to developing prevention&#xD;
      interventions that employ holistic and culturally relevant approaches. This includes&#xD;
      recognizing the impact of forces such as racism, sexism, and gender expectations on&#xD;
      individual behavior and relationship dynamics in African American communities. Specifically,&#xD;
      the investigators hypothesis is that compared to the control condition the FemAALES&#xD;
      intervention arm will reduce risky sexual behavior and STI (sexually transmitted infection)&#xD;
      incidence and will increase condom self-efficacy and risk behavior communication with sexual&#xD;
      partners.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Two thirds of female HIV/AIDS cases occur in Black women and an estimated 76% of these are&#xD;
      attributed to heterosexual contact. HIV is the third-leading killer of Black women ages&#xD;
      25-44, and STI associated morbidity may contribute to racial disparities in cervical cancer,&#xD;
      adverse pregnancy outcomes, and infant mortality.&#xD;
&#xD;
      The investigators propose to test the efficacy of the FemAALES of African American Legacy&#xD;
      Empowering Self Intervention in a population of adult Black/African American women who have&#xD;
      either no health insurance or a public/subsidized form of health insurance against a Control&#xD;
      or &quot;Standard of Care&quot; arm involving family planning and STI counseling.&#xD;
&#xD;
      In addition, the investigators will explore the impact of the FemAALES intervention on the&#xD;
      use of new media for social support and networking, obtaining health information, and&#xD;
      identifying resources and services. FemAALES incorporates cultural contextual, and&#xD;
      partnership issues and promotes access to resources not readily available to this population.&#xD;
      FemAALES curriculum is guided by the Theory of Reasoned Action and Planning and Critical&#xD;
      Thinking and Cultural Affirmation Model developed by a collaborating community-based&#xD;
      organization.&#xD;
&#xD;
      The primary specific aims are to:&#xD;
&#xD;
        1. Determine the impact of the FemAALES of African American Legacy Empowering Self&#xD;
           (FemAALES II) on HIV risk factors including:&#xD;
&#xD;
             1. number of sex partners&#xD;
&#xD;
             2. unprotected anal/vaginal sex&#xD;
&#xD;
             3. incidence of bacterial STIs&#xD;
&#xD;
        2. Determine the impact of the FemAALES interventions on psychosocial outcomes, including&#xD;
           self-efficacy for safer sex negotiation and discussions with partners regarding HIV/STI&#xD;
           testing and risk&#xD;
&#xD;
             -  Hypothesis 1: Compared to the control, FemAALES will reduce the number of&#xD;
                vaginal/anal sex partners and number of episodes of unprotected intercourse at&#xD;
                3months and 9 months post intervention&#xD;
&#xD;
             -  Hypothesis 2: Compared to the control, FemAALES will reduce the incidence of&#xD;
                gonorrhea and chlamydia&#xD;
&#xD;
             -  Hypothesis 3: Compared to the control, FemAALES will improve self-efficacy for&#xD;
                condom negotiation&#xD;
&#xD;
             -  Hypothesis 4: Compared to the control. FemAALES will increase the proportion of&#xD;
                women who have discussions regarding sexual and drug use risk factors with their&#xD;
                sexual partners.&#xD;
&#xD;
      A third, exploratory aim, is to assess the impact of the FemAALES intervention on the use of&#xD;
      new social media for social support and networking, obtaining health information and&#xD;
      identifying resources and services.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2013</start_date>
  <completion_date type="Actual">April 2018</completion_date>
  <primary_completion_date type="Actual">April 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in number of sex partners from baseline</measure>
    <time_frame>3 and 9 months</time_frame>
    <description>Determine the impact of the FemAALES intervention compared to the control condition on the number of vaginal and anal sex partners in the prior 90 days .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in frequency of unprotected sex from baseline.</measure>
    <time_frame>3 and 9 months</time_frame>
    <description>Determine the impact of the FemAALES interventions compared to the control condition on the number of vaginal or anal sex acts reported without condoms in the prior 90 days.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in bacterial STDs from baseline</measure>
    <time_frame>9 months</time_frame>
    <description>Examine the impact of the FemAALES interventions compared to the control condition on the incidence of gonorrhea and chlamydia.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Safer Sex Negotiation Skills and Behaviors</measure>
    <time_frame>3 and 9 months</time_frame>
    <description>Determine the impact of the FemAALES conditions compared to the control condition on psychosocial outcomes, including self-efficacy for safer sex negotiation and discussions regarding HIV/STI risk with sexual partners.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Intervention Effect on Use of New Media</measure>
    <time_frame>9 months</time_frame>
    <description>Determine the impact of the FemAALES intervention on the frequency and types of use of new media for social support, health information, and identifying resources.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">256</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>FemAALES</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Females of African American Legacy Empowering Self Intervention. A nine session, theoretically grounded small group intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A one-time STD/family planning testing and counseling session provided to all study participants.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>All participants will be provided a STD/HIV pre-test counseling session. This session will be provided by either certified project staff or clinical staff at a Los Angeles clinic that conduct State of CA Fam Pact services for patients who are of child bearing age, including our current study partner St. John's Well Child and Family Center and our former study partner, JWCH (John Wesley Community Health) Institute-Wesley Health Center Clinics. Following the counseling session, the participant will be asked to provide a sample of urine to test for Chlamydia and Gonorrhea.</description>
    <arm_group_label>FemAALES</arm_group_label>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>FemAALES</intervention_name>
    <description>Women will attend 9 small group sessions over 4 weeks. Three of these sessions will focus specifically on participants learning to use a computer, set up an email account, communicate with the team and the group using the Internet, and developing a prevention message for display on project website and social media accounts. The other 6 sessions will include discussions on the following topics: being a Black woman in American, Black history, assessing personal health, changing current behaviors, HIV/AIDS information, and education, self-empowerment, communication skills, reasons to change, and goal setting.</description>
    <arm_group_label>FemAALES</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female sex&#xD;
&#xD;
          -  self-identifies as Black/African American&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  has had unprotected vaginal or anal sex in the last 90 days&#xD;
&#xD;
          -  any male partner in the last 90 days has done one or more of the following: had sex&#xD;
             with a man; had sex with a male-to-female transgender; used crack cocaine, heroin, or&#xD;
             methamphetamines; been incarcerated for more than 6 months; had sex with other female&#xD;
             partners during the relationship; OR - a male partner in the last 90 days has an&#xD;
             unknown sexual history&#xD;
&#xD;
          -  publicly funded or public subsidized health insurance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  participated in a small group HIV prevention program in the past 12 months,&#xD;
             participated in HARRP program in the past 12 months, has private insurance, refuses&#xD;
             chlamydia or gonorrhea test at baseline,&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>54 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nina T Harawa, Ph.D, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charles Drew University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Martin Shapiro, MD Ph.D MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Samuel Gonzalez, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. John's Well Child and Family Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. John's Well Child and Family Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charles Drew University of Medicine and Science</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90059</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>June 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>August 1, 2018</last_update_submitted>
  <last_update_submitted_qc>August 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV Prevention</keyword>
  <keyword>Behavioral Intervention</keyword>
  <keyword>Condom Use</keyword>
  <keyword>African American</keyword>
  <keyword>Sexually Transmitted Disease</keyword>
  <keyword>Sexually Transmitted Infection</keyword>
  <keyword>Internet</keyword>
  <!-- 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/NCT02189876
org study id: MD-13-010
secondary id: P20MD000182
nct id: NCT02189876
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The FemAALES Project is a community collaborative two-arm intervention designed to prevent
      HIV (human immunodeficiency) and STD (sexually transmitted disease) infection and
      transmission among African American women and men by reducing sexual risk factors and
      enhancing sexual negotiation skills. The team of investigators is a collaboration of
      researchers and community service providers who are committed to developing prevention
      interventions that employ holistic and culturally relevant approaches. This includes
      recognizing the impact of forces such as racism, sexism, and gender expectations on
      individual behavior and relationship dynamics in African American communities. Specifically,
      the investigators hypothesis is that compared to the control condition the FemAALES
      intervention arm will reduce risky sexual behavior and STI (sexually transmitted infection)
      incidence and will increase condom self-efficacy and risk behavior communication with sexual
      partners.
Two thirds of female HIV/AIDS cases occur in Black women and an estimated 76% of these are
      attributed to heterosexual contact. HIV is the third-leading killer of Black women ages
      25-44, and STI associated morbidity may contribute to racial disparities in cervical cancer,
      adverse pregnancy outcomes, and infant mortality.

      The investigators propose to test the efficacy of the FemAALES of African American Legacy
      Empowering Self Intervention in a population of adult Black/African American women who have
      either no health insurance or a public/subsidized form of health insurance against a Control
      or "Standard of Care" arm involving family planning and STI counseling.

      In addition, the investigators will explore the impact of the FemAALES intervention on the
      use of new media for social support and networking, obtaining health information, and
      identifying resources and services. FemAALES incorporates cultural contextual, and
      partnership issues and promotes access to resources not readily available to this population.
      FemAALES curriculum is guided by the Theory of Reasoned Action and Planning and Critical
      Thinking and Cultural Affirmation Model developed by a collaborating community-based
      organization.

      The primary specific aims are to:

        1. Determine the impact of the FemAALES of African American Legacy Empowering Self
           (FemAALES II) on HIV risk factors including:

             1. number of sex partners

             2. unprotected anal/vaginal sex

             3. incidence of bacterial STIs

        2. Determine the impact of the FemAALES interventions on psychosocial outcomes, including
           self-efficacy for safer sex negotiation and discussions with partners regarding HIV/STI
           testing and risk

             -  Hypothesis 1: Compared to the control, FemAALES will reduce the number of
                vaginal/anal sex partners and number of episodes of unprotected intercourse at
                3months and 9 months post intervention

             -  Hypothesis 2: Compared to the control, FemAALES will reduce the incidence of
                gonorrhea and chlamydia

             -  Hypothesis 3: Compared to the control, FemAALES will improve self-efficacy for
                condom negotiation

             -  Hypothesis 4: Compared to the control. FemAALES will increase the proportion of
                women who have discussions regarding sexual and drug use risk factors with their
                sexual partners.

      A third, exploratory aim, is to assess the impact of the FemAALES intervention on the use of
      new social media for social support and networking, obtaining health information and
      identifying resources and services.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in number of sex partners from baseline
time frame: 3 and 9 months
description: Determine the impact of the FemAALES intervention compared to the control condition on the number of vaginal and anal sex partners in the prior 90 days .
measure: Change in frequency of unprotected sex from baseline.
time frame: 3 and 9 months
description: Determine the impact of the FemAALES interventions compared to the control condition on the number of vaginal or anal sex acts reported without condoms in the prior 90 days.
measure: Change in bacterial STDs from baseline
time frame: 9 months
description: Examine the impact of the FemAALES interventions compared to the control condition on the incidence of gonorrhea and chlamydia.
measure: Change in Safer Sex Negotiation Skills and Behaviors
time frame: 3 and 9 months
description: Determine the impact of the FemAALES conditions compared to the control condition on psychosocial outcomes, including self-efficacy for safer sex negotiation and discussions regarding HIV/STI risk with sexual partners.
measure: Intervention Effect on Use of New Media
time frame: 9 months
description: Determine the impact of the FemAALES intervention on the frequency and types of use of new media for social support, health information, and identifying resources.
arm group label: FemAALES
arm group type: Experimental
description: Females of African American Legacy Empowering Self Intervention. A nine session, theoretically grounded small group intervention.
arm group label: Standard of Care
arm group type: Active Comparator
description: A one-time STD/family planning testing and counseling session provided to all study participants.
intervention type: Behavioral
intervention name: Standard of Care
description: All participants will be provided a STD/HIV pre-test counseling session. This session will be provided by either certified project staff or clinical staff at a Los Angeles clinic that conduct State of CA Fam Pact services for patients who are of child bearing age, including our current study partner St. John's Well Child and Family Center and our former study partner, JWCH (John Wesley Community Health) Institute-Wesley Health Center Clinics. Following the counseling session, the participant will be asked to provide a sample of urine to test for Chlamydia and Gonorrhea.
arm group label: FemAALES
arm group label: Standard of Care
intervention type: Behavioral
intervention name: FemAALES
description: Women will attend 9 small group sessions over 4 weeks. Three of these sessions will focus specifically on participants learning to use a computer, set up an email account, communicate with the team and the group using the Internet, and developing a prevention message for display on project website and social media accounts. The other 6 sessions will include discussions on the following topics: being a Black woman in American, Black history, assessing personal health, changing current behaviors, HIV/AIDS information, and education, self-empowerment, communication skills, reasons to change, and goal setting.
arm group label: FemAALES
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 54 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nina T Harawa, Ph.D, MPH
role: Principal Investigator
affiliation: Charles Drew University
last name: Martin Shapiro, MD Ph.D MPH
role: Principal Investigator
affiliation: University of California, Los Angeles
last name: Samuel Gonzalez, MS
role: Principal Investigator
affiliation: St. John's Well Child and Family Center
facility: 
facility: 
country: United States
responsible party type: Sponsor