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Sexually Transmitted Infections Among African American Women Who Have Sex With Women (WSHP)

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ClinicalTrials.gov Identifier: NCT01546714
Recruitment Status : Completed
First Posted : March 7, 2012
Last Update Posted : February 8, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Sexually Transmitted Infections

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.

Study Design

Study Type : Observational
Actual Enrollment : 165 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sexually Transmitted Infections Among African American Women Who Have Sex With Women
Study Start Date : August 2011
Primary Completion Date : October 2013
Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
AAWSW/AAWSWM
African American Women Who Have Sex with Women/African American Women Who Have Sex with Women and Men


Outcome Measures

Primary Outcome Measures :
  1. Sexually Transmitted Infection Diagnosis [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
One vaginal swab and one endocervical swab to be stored for future studies.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
African American women, aged 16 years or older, living in Birmingham, Alabama
Criteria

Inclusion Criteria:

  • Female gender, self-identification as African American
  • Age of 16 years or older, self report of sexual contact (oral, vaginal, or anal) with another female within the past 12 months
  • English speaking
  • The ability to give written informed consent.
  • For the sub-groups of women being followed prospectively, they have to have at least one active female sexual partner (AAWSW group) or at least one active female and male sexual partner (AAWSWM group) at the time of enrollment into the study.

Exclusion Criteria:

  • Pregnant or nursing and the inability or unwillingness to give written informed consent.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01546714


Locations
United States, Alabama
Jefferson County Health Department
Birmingham, Alabama, United States, 35233
UAB Personal Health Clinic
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
University of Mississippi Medical Center
Harvard University
Investigators
Principal Investigator: Christina A Muzny, MD University of Alabama at Birmingham
More Information

Publications:

Responsible Party: Dr. Christina Muzny, Assistant Professor of Medicine, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01546714     History of Changes
Other Study ID Numbers: ASTDA WSHP
American STD Association ( Other Grant/Funding Number: 2009283 )
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be shared with investigators at the Harvard School of Public Health for secondary data analysis.

Additional relevant MeSH terms:
Infection
Communicable Diseases
Sexually Transmitted Diseases
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female