Females of African American Legacy Empowering Self (FemAALES)
Condition: HIV
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Standard of Care; FemAALES
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV Prevention; Behavioral Intervention; Condom Use; African American; Sexually Transmitted Disease; Sexually Transmitted Infection; Internet