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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01043081
Other study ID # 2008-0143
Secondary ID
Status Completed
Phase N/A
First received January 4, 2010
Last updated May 10, 2016
Start date February 2009
Est. completion date June 2012

Study information

Verified date May 2016
Source University of Mississippi Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date June 2012
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Locations

Country Name City State
United States Crossroads Clinic Jackson Mississippi

Sponsors (3)

Lead Sponsor Collaborator
University of Mississippi Medical Center Mississippi State Department of Health, University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (5)

Muzny CA, Rivers CA, Parker CJ, Mena LA, Austin EL, Schwebke JR. Lack of evidence for sexual transmission of genital Candida species among women who have sex with women: a mixed methods study. Sex Transm Infect. 2014 Mar;90(2):165-70. doi: 10.1136/sextran — View Citation

Muzny CA, Sunesara IR, Austin EL, Mena LA, Schwebke JR. Bacterial vaginosis among African American women who have sex with women. Sex Transm Dis. 2013 Sep;40(9):751-5. doi: 10.1097/OLQ.0000000000000004. — View Citation

Muzny CA, Sunesara IR, Griswold ME, Kumar R, Lefkowitz EJ, Mena LA, Schwebke JR, Martin DH, Swiatlo E. Association between BVAB1 and high Nugent scores among women with bacterial vaginosis. Diagn Microbiol Infect Dis. 2014 Dec;80(4):321-3. doi: 10.1016/j. — View Citation

Muzny CA, Sunesara IR, Kumar R, Mena LA, Griswold ME, Martin DH, Lefkowitz EJ, Schwebke JR, Swiatlo E. Characterization of the vaginal microbiota among sexual risk behavior groups of women with bacterial vaginosis. PLoS One. 2013 Nov 13;8(11):e80254. doi: — View Citation

Muzny CA, Sunesara IR, Martin DH, Mena LA. Sexually transmitted infections and risk behaviors among African American women who have sex with women: does sex with men make a difference? Sex Transm Dis. 2011 Dec;38(12):1118-25. doi: 10.1097/OLQ.0b013e31822e — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence rates of sexually transmitted infections 18 Months No
Secondary Associated sexual risk behaviors 18 Months No
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