Sexually Transmitted Infections Among African American Women Who Have Sex With Women (WSHP)
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| First Received Date ICMJE | March 2, 2012 | ||||||||
| Last Updated Date | March 11, 2013 | ||||||||
| Start Date ICMJE | August 2011 | ||||||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Sexually Transmitted Infection Diagnosis [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01546714 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Sexually Transmitted Infections Among African American Women Who Have Sex With Women | ||||||||
| Official Title ICMJE | Sexually Transmitted Infections Among African American Women Who Have Sex With Women | ||||||||
| Brief Summary | The purpose of this study is to determine rates of sexually transmitted infections (STIs) among African American women who have sex with women (AAWSW). In addition, the study is interested in better understanding the types of risk behaviors that place AAWSW at risk for STIs. The investigators hypothesis is that AAWSW experience high rates of STIs, similar to heterosexual African American women. Knowledge gained from this study will guide development of interventions to reduce women's risk for these types of infections and will improve how AAWSW are screened for STIs. |
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| Detailed Description | The objectives of this study are (1) To determine the prevalence of bacterial vaginosis, trichomoniasis, Chlamydia, gonorrhea, Mycoplasma genitalium, HIV, genital herpes, and syphilis and associated risk behaviors in a cohort of African American women who have sex with women (AAWSW) in Birmingham, Alabama; (2) To compare exclusive AAWSW (during the past 12 months) to African American women who have sex with women and men (AAWSWM) in terms of socio-demographic characteristics, sexual risk behavior characteristics, and STI prevalence; and(3) To perform an exploratory prospective study of an age-matched (± 2 years) sub-group of exclusive AAWSW and AAWSWM over a 12 month time period to obtain data on differences in STI risk behaviors and STI incidence rates. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: One vaginal swab and one endocervical swab to be stored for future studies. |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | African American women, aged 16 years or older, living in Birmingham, Alabama |
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| Condition ICMJE | Sexually Transmitted Infections | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | AAWSW/AAWSWM
African American Women Who Have Sex with Women/African American Women Who Have Sex with Women and Men |
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| Publications * |
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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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 370 | ||||||||
| Estimated Completion Date | October 2013 | ||||||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 16 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01546714 | ||||||||
| Other Study ID Numbers ICMJE | ASTDA WSHP, American STD Association | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Dr. Christina Muzny, University of Alabama at Birmingham | ||||||||
| Study Sponsor ICMJE | University of Alabama at Birmingham | ||||||||
| Collaborators ICMJE | University of Mississippi Medical Center | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Alabama at Birmingham | ||||||||
| Verification Date | March 2013 | ||||||||
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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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