Females of African American Legacy Empowering Self (FemAALES)
NCT02189876 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 256
Last updated 2018-08-03
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.
Conditions
Interventions
- BEHAVIORAL
-
Standard of Care
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.
- BEHAVIORAL
-
FemAALES
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.
Sponsors & Collaborators
-
National Institute on Minority Health and Health Disparities (NIMHD)
collaborator NIH -
University of California, Los Angeles
collaborator OTHER -
St. John's Well Child & Family Center
collaborator UNKNOWN -
Charles Drew University of Medicine and Science
lead OTHER
Principal Investigators
-
Nina T Harawa, Ph.D, MPH · Charles Drew University
-
Martin Shapiro, MD Ph.D MPH · University of California, Los Angeles
-
Samuel Gonzalez, MS · St. John's Well Child and Family Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 54 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-07-31
- Primary Completion
- 2018-04-30
- Completion
- 2018-04-30
Countries
- United States
Study Locations
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