Females of African American Legacy Empowering Self (FemAALES)

Charles Drew University of Medicine and Science

Status: Completed

Conditions: HIV

Treatments: Behavioral: Standard of Care; Behavioral: FemAALES

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02189876

MD-13-010

P20MD000182 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 256 patients

Sex: Female

Ages: 18 to 54 years old

Volunteers: Accepts Healthy Volunteers

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,

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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256 participants in 2 patient groups

FemAALES

Experimental group

Description:

Females of African American Legacy Empowering Self Intervention. A nine session, theoretically grounded small group intervention.

Treatment:

Behavioral: Standard of Care

Behavioral: FemAALES

Standard of Care

Active Comparator group

Description:

A one-time STD/family planning testing and counseling session provided to all study participants.

Treatment:

Behavioral: Standard of Care