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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Charles Drew University of Medicine and Science
Sponsor:
Collaborators:
National Institute on Minority Health and Health Disparities (NIMHD)
University of California, Los Angeles
St. John's Well Child and Family Center
Information provided by (Responsible Party):
Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier:
NCT02189876
First received: June 11, 2014
Last updated: March 30, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
HIV
Behavioral: Standard of Care
Behavioral: FemAALES
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Reducing HIV/STD Risk in African American Women With At-Risk Male Partners

Resource links provided by NLM:


Further study details as provided by Charles Drew University of Medicine and Science:

Primary Outcome Measures:
  • Change in number of sex partners from baseline [ Time Frame: 3 and 9 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Examine the impact of the FemAALES interventions compared to the control condition on the incidence of gonorrhea and chlamydia.


Secondary Outcome Measures:
  • Change in Safer Sex Negotiation Skills and Behaviors [ Time Frame: 3 and 9 months ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Intervention Effect on Use of New Media [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 325
Study Start Date: July 2013
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FemAALES
Females of African American Legacy Empowering Self Intervention. A nine session, theoretically grounded small group intervention.
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.
Active Comparator: Standard of Care
A one-time STD/family planning testing and counseling session provided to all study participants.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 54 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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,
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02189876

Contacts
Contact: Qiana Montazeri 323-357-3645 qianamontazeri@cdrewu.edu
Contact: Nina T Harawa, Ph.D, MPH 323-563-5899 ninaharawa@cdrewu.edu

Locations
United States, California
St. John's Well Child and Family Center Recruiting
Los Angeles, California, United States, 90037
Contact: Samuel Gonzalez, MS    323-541-1600 ext 1079    sgonzalez@wellchild.org   
Contact: Qiana Montazeri    3233573645    qianamontazeri@cdrewu.edu   
Charles Drew University of Medicine and Science Recruiting
Los Angeles, California, United States, 90059
Sponsors and Collaborators
Charles Drew University of Medicine and Science
National Institute on Minority Health and Health Disparities (NIMHD)
University of California, Los Angeles
St. John's Well Child and Family Center
Investigators
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
  More Information

Additional Information:
Responsible Party: Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier: NCT02189876     History of Changes
Other Study ID Numbers: MD-13-010  P20MD000182 
Study First Received: June 11, 2014
Last Updated: March 30, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Charles Drew University of Medicine and Science:
HIV Prevention
Behavioral Intervention
Condom Use
African American
Sexually Transmitted Disease
Sexually Transmitted Infection
Internet

ClinicalTrials.gov processed this record on May 04, 2016