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: March 23, 2014
Last verified: March 2014
  Purpose

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
Sexually Transmitted Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sexually Transmitted Infections Among African American Women Who Have Sex With Women

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Sexually Transmitted Infection Diagnosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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


Enrollment: 165
Study Start Date: August 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
AAWSW/AAWSWM
African American Women Who Have Sex with Women/African American Women Who Have Sex with Women and Men

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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
Study First Received: March 2, 2012
Last Updated: March 23, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 31, 2014