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

This study has been completed.
Sponsor:
Collaborator:
University of Mississippi Medical Center
Information provided by (Responsible Party):
Dr. Christina Muzny, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01546714
First received: March 2, 2012
Last updated: October 2, 2014
Last verified: October 2014

March 2, 2012
October 2, 2014
August 2011
October 2013   (final data collection date for primary outcome measure)
Sexually Transmitted Infection Diagnosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01546714 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Sexually Transmitted Infections Among African American Women Who Have Sex With Women
Sexually Transmitted Infections Among African American Women Who Have Sex With Women

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

One vaginal swab and one endocervical swab to be stored for future studies.

Non-Probability Sample

African American women, aged 16 years or older, living in Birmingham, Alabama

Sexually Transmitted Infections
Not Provided
AAWSW/AAWSWM
African American Women Who Have Sex with Women/African American Women Who Have Sex with Women and Men

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
165
October 2013
October 2013   (final data collection date for primary outcome measure)

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.
Female
16 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01546714
ASTDA WSHP, American STD Association
No
Dr. Christina Muzny, University of Alabama at Birmingham
University of Alabama at Birmingham
University of Mississippi Medical Center
Principal Investigator: Christina A Muzny, MD University of Alabama at Birmingham
University of Alabama at Birmingham
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP