Females of African American Legacy Empowering Self (FemAALES) (FemAALES)
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| ClinicalTrials.gov Identifier: NCT02189876 |
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Recruitment Status :
Completed
First Posted : July 15, 2014
Last Update Posted : August 3, 2018
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Sponsor:
Charles Drew University of Medicine and Science
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 | ||||||||||
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| 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 |
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| Original Primary Outcome Measures ICMJE |
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| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE |
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.
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| Original Secondary Outcome Measures ICMJE |
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.
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| Current Other Pre-specified Outcome Measures |
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.
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| 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:
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. |
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| 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 |
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| Condition ICMJE | HIV | |||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Completed | |||||||||
| Actual Enrollment ICMJE |
256 | |||||||||
| Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| 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 ) |
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| 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 |
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| Investigators ICMJE |
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| PRS Account | Charles Drew University of Medicine and Science | |||||||||
| Verification Date | August 2018 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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