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

This study is currently recruiting participants.
Verified March 2013 by University of Alabama at Birmingham
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 11, 2013
Last verified: March 2013
History of Changes
  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:

U.S. FDA Resources

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.


Estimated Enrollment: 370
Study Start Date: August 2011
Estimated Study Completion Date: October 2013
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546714

Contacts
Contact: Christina A Muzny, MD 205-975-3298 cmuzny@uab.edu
Contact: Jane Schwebke, MD 205-975-5665 schwebke@uab.edu

Locations
United States, Alabama
Jefferson County Health Department Recruiting
Birmingham, Alabama, United States, 35233
Contact: Hanne Harbison, CFNP     205-930-1151     hanne@uab.edu    
Contact: Allison Whittington, RN     205-930-1548     allie493@uab.edu    
Principal Investigator: Christina A Muzny, MD            
Sub-Investigator: Jane Schwebke, MD            
Sub-Investigator: Edward Hook, III, MD            
UAB Personal Health Clinic Recruiting
Birmingham, Alabama, United States, 35294
Contact: Joy Lewis     205-975-5665     joybrown@uab.edu    
Contact: Jane Schwebke, MD     205-975-5665     schwebke@uab.edu    
Principal Investigator: Christina A Muzny, MD            
Sub-Investigator: Jane Schwebke, MD            
Sub-Investigator: Edward Hook, III, MD            
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 11, 2013
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 May 22, 2013