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

This study has been completed.
Sponsor:
Collaborators:
Mississippi State Department of Health
University of Alabama at Birmingham
Information provided by (Responsible Party):
Leandro A. Mena, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT01043081
First received: January 4, 2010
Last updated: May 10, 2016
Last verified: May 2016

January 4, 2010
May 10, 2016
February 2009
December 2011   (final data collection date for primary outcome measure)
Prevalence rates of sexually transmitted infections [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01043081 on ClinicalTrials.gov Archive Site
Associated sexual risk behaviors [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Sexually Transmitted Infections Among African American Women Who Have Sex With Women
Prevalence Rates of Sexually Transmitted Infections and Sexual Risk Behaviors Among African American Women Who Have Sex With Women
The purpose of this study is to determine the rates of sexually transmitted infections (STI) among a group of African American women who have sex with women (AA WSW). The first study hypothesis is that AA WSW are at risk for acquiring and transmitting STI, including the human immunodeficiency virus (HIV). The second study hypothesis is that AA WSW participate in multiple high-risk sexual activities that may facilitate transmission of STIs, including HIV.

Historically, women who have sex with women (WSW) have been thought to be at low risk for acquiring sexually transmitted infections (STI), presumably due to the absence of genital mucosal contact present during vaginal-penile sex or due to the assumption that the vaginal mucosa experiences a lesser degree of trauma during female sex than during heterosexual sex. This assumption has been challenged and debated over the past two decades. In addition, the sexual health risks of WSW are only beginning to be understood.

To date the majority of research regarding STI in women has occurred in heterosexuals. National and local surveillance data that estimate the risk for STI transmission between WSW are limited, especially among African Americans. This is a group of women that may exhibit distinctive behavioral characteristics that may put them at higher risk for sexually transmitted infections STI and HIV than their Caucasian counterparts. This group of women has traditionally been reluctant to discuss their sexual orientation with physicians for fear of being stigmatized. The burden of STIs, including HIV, experienced by this group of women is largely unknown.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:
Endocervical and vaginal secretion specimens are being retained for future research studies in this field of sexually transmitted diseases.
Non-Probability Sample
The study population is African American women, aged 18 or above, who present to the Crossroads Clinic (STD Clinic) in the Jackson, MS metropolitan area for STI screening/evaluation who have engaged in sexual contact with another woman within the past 6 months.
  • Sexually Transmitted Infections
  • HIV Infections
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
June 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female
  • Age 18 years or older
  • African American race
  • Sexual contact with another female within the past 6 months
  • Ability to give written informed consent

Exclusion Criteria:

  • Male
  • Age less than 18 years old
  • Race other than African American
  • No sexual contact with another woman within the past 6 months
  • Pregnant
  • Prior enrollment in this study
  • Participants who, for any reason, in the opinion of the investigator, do not have the ability to give written informed consent or may not be expected to comply with the requirements of the protocol
Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01043081
2008-0143
No
No
Data will only be shared with investigators
Leandro A. Mena, University of Mississippi Medical Center
University of Mississippi Medical Center
  • Mississippi State Department of Health
  • University of Alabama at Birmingham
Principal Investigator: Leandro A Mena, MD, MPH University of Mississippi Medical Center
University of Mississippi Medical Center
May 2016

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