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Females of African American Legacy Empowering Self (FemAALES) (FemAALES)

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ClinicalTrials.gov Identifier: NCT02189876
Recruitment Status : Completed
First Posted : July 15, 2014
Last Update Posted : August 3, 2018
Sponsor:
Collaborators:
National Institute on Minority Health and Health Disparities (NIMHD)
University of California, Los Angeles
St. John's Well Child & Family Center
Information provided by (Responsible Party):
Charles Drew University of Medicine and Science

Tracking Information
First Submitted Date  ICMJE June 11, 2014
First Posted Date  ICMJE July 15, 2014
Last Update Posted Date August 3, 2018
Actual Study Start Date  ICMJE July 2013
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2016)
  • Change in number of sex partners from baseline [ Time Frame: 3 and 9 months ]
    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 .
  • Change in frequency of unprotected sex from baseline. [ Time Frame: 3 and 9 months ]
    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.
  • Change in bacterial STDs from baseline [ Time Frame: 9 months ]
    Examine the impact of the FemAALES interventions compared to the control condition on the incidence of gonorrhea and chlamydia.
Original Primary Outcome Measures  ICMJE
 (submitted: July 11, 2014)
  • Change in number of sex partners from baseline [ Time Frame: 3 and 9 months ]
    Determine the impact of the FemAALES and HARRP intervention compared to the control condition on the number of vaginal and anal sex partners in the prior 90 days .
  • Change in frequency of unprotected sex from baseline. [ Time Frame: 3 and 9 months ]
    Determine the impact of the FemAALES and HARRP interventions compared to the control condition on the number of vaginal or anal sex acts reported without condoms in the prior 90 days.
  • Change in bacterial STDs from baseline [ Time Frame: 9 months ]
    Examine the impact of the FemAALES and HARRP interventions compared to the control condition on the incidence of gonorrhea and chlamydia.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2016)
Change in Safer Sex Negotiation Skills and Behaviors [ Time Frame: 3 and 9 months ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2014)
Change in Safer Sex Negotiation Skills and Behaviors [ Time Frame: 3 and 9 months ]
Determine the impact of the FemAALES and HARRP 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.
Current Other Pre-specified Outcome Measures
 (submitted: July 11, 2014)
Intervention Effect on Use of New Media [ Time Frame: 9 months ]
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Females of African American Legacy Empowering Self (FemAALES)
Official Title  ICMJE Reducing HIV/STD Risk in African American Women With At-Risk Male Partners
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE HIV
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: FemAALES
    Females of African American Legacy Empowering Self Intervention. A nine session, theoretically grounded small group intervention.
    Interventions:
    • Behavioral: Standard of Care
    • Behavioral: FemAALES
  • Active Comparator: Standard of Care
    A one-time STD/family planning testing and counseling session provided to all study participants.
    Intervention: Behavioral: Standard of Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 1, 2018)
256
Original Estimated Enrollment  ICMJE
 (submitted: July 11, 2014)
540
Actual Study Completion Date  ICMJE April 2018
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • female sex
  • self-identifies as Black/African American
  • 18 years of age or older
  • English speaking
  • has had unprotected vaginal or anal sex in the last 90 days
  • any male partner in the last 90 days has done one or more of the following: had sex with a man; had sex with a male-to-female transgender; used crack cocaine, heroin, or methamphetamines; been incarcerated for more than 6 months; had sex with other female partners during the relationship; OR - a male partner in the last 90 days has an unknown sexual history
  • publicly funded or public subsidized health insurance

Exclusion Criteria:

  • participated in a small group HIV prevention program in the past 12 months, participated in HARRP program in the past 12 months, has private insurance, refuses chlamydia or gonorrhea test at baseline,
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 54 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02189876
Other Study ID Numbers  ICMJE MD-13-010
P20MD000182 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Charles Drew University of Medicine and Science
Study Sponsor  ICMJE Charles Drew University of Medicine and Science
Collaborators  ICMJE
  • National Institute on Minority Health and Health Disparities (NIMHD)
  • University of California, Los Angeles
  • St. John's Well Child & Family Center
Investigators  ICMJE
Principal Investigator: Nina T Harawa, Ph.D, MPH Charles Drew University
Principal Investigator: Martin Shapiro, MD Ph.D MPH University of California, Los Angeles
Principal Investigator: Samuel Gonzalez, MS St. John's Well Child and Family Center
PRS Account Charles Drew University of Medicine and Science
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP