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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01043081
Recruitment Status : Completed
First Posted : January 6, 2010
Last Update Posted : May 11, 2016
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

Study Description
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Brief Summary:
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.

Condition or disease
Sexually Transmitted Infections HIV Infections

Detailed Description:

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.

Study Design
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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Prevalence Rates of Sexually Transmitted Infections and Sexual Risk Behaviors Among African American Women Who Have Sex With Women
Study Start Date : February 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Prevalence rates of sexually transmitted infections [ Time Frame: 18 Months ]

Secondary Outcome Measures :
  1. Associated sexual risk behaviors [ Time Frame: 18 Months ]

Biospecimen Retention:   Samples With DNA
Endocervical and vaginal secretion specimens are being retained for future research studies in this field of sexually transmitted diseases.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
Contacts and Locations
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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): NCT01043081


Locations
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United States, Mississippi
Crossroads Clinic
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
Mississippi State Department of Health
University of Alabama at Birmingham
Investigators
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Principal Investigator: Leandro A Mena, MD, MPH University of Mississippi Medical Center
More Information
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Publications of Results:

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Responsible Party: Leandro A. Mena, Associate Professor of Medicine, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT01043081    
Other Study ID Numbers: 2008-0143
First Posted: January 6, 2010    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will only be shared with investigators
Keywords provided by Leandro A. Mena, University of Mississippi Medical Center:
African American women who have sex with women
Sexually transmitted infections
Homosexuality
Human papillomavirus
Cervical intraepithelial neoplasia
Herpes simplex virus types 1 and 2
 Chlamydia
Gonorrhea
Trichomoniasis
Bacterial vaginosis
Syphilis
Human immunodeficiency virus
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Sexually Transmitted Diseases
Disease Attributes
Pathologic Processes