Females of African American Legacy Empowering Self (FemAALES)
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 54 |
| Updated: | 8/5/2018 |
| Start Date: | July 2013 |
| End Date: | April 2018 |
Reducing HIV/STD Risk in African American Women With At-Risk Male Partners
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.
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.
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.
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.
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,
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