Clinical trial NCT02189876: Females of African American Legacy Empowering Self (FemAALES)
Official title: Reducing HIV/STD Risk in African American Women With At-Risk Male Partners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV Prevention
Behavioral Intervention
Condom Use
African American
Sexually Transmitted Disease
Sexually Transmitted Infection
Internet
Lead sponsor: Charles Drew University of Medicine and Science
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: University of California, Los Angeles
name: St. John's Well Child & Family Center
First posted: 2014-07-15
Enrollment: 256
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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,

Primary outcomes:
measure: Change in number of sex partners from baseline
timeFrame: 3 and 9 months
measure: Change in frequency of unprotected sex from baseline.
timeFrame: 3 and 9 months
measure: Change in bacterial STDs from baseline
timeFrame: 9 months
Secondary outcomes:
measure: Change in Safer Sex Negotiation Skills and Behaviors
timeFrame: 3 and 9 months
Other outcomes:
measure: Intervention Effect on Use of New Media
timeFrame: 9 months
Locations:
city: Los Angeles
country: United States
facility: St. John's Well Child and Family Center
state: California
city: Los Angeles
country: United States
facility: Charles Drew University of Medicine and Science
state: California
Study officials:
affiliation: Charles Drew University
name: Nina T Harawa, Ph.D, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Martin Shapiro, MD Ph.D MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: St. John's Well Child and Family Center
name: Samuel Gonzalez, MS
role: PRINCIPAL_INVESTIGATOR
References: