NCT01546714

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2011

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

February 8, 2017

Status Verified

February 1, 2017

Enrollment Period

2.2 years

First QC Date

March 2, 2012

Last Update Submit

February 6, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sexually Transmitted Infection Diagnosis

    1 year

Study Arms (1)

AAWSW/AAWSWM

African American Women Who Have Sex with Women/African American Women Who Have Sex with Women and Men

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

African American women, aged 16 years or older, living in Birmingham, Alabama

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnant or nursing and the inability or unwillingness to give written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jefferson County Health Department

Birmingham, Alabama, 35233, United States

Location

UAB Personal Health Clinic

Birmingham, Alabama, 35294, United States

Location

Related Publications (12)

  • 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.0b013e31822e6179.

    PMID: 22082722BACKGROUND
  • Muzny CA, Harbison HS, Pembleton ES, Hook EW, Austin EL. Misperceptions regarding protective barrier method use for safer sex among African-American women who have sex with women. Sex Health. 2013 May;10(2):138-41. doi: 10.1071/SH12106.

    PMID: 23369280BACKGROUND
  • Muzny CA, Rivers CA, Mena LA, Schwebke JR. Genotypic characterization of Trichomonas vaginalis isolates among women who have sex with women in sexual partnerships. Sex Transm Dis. 2012 Jul;39(7):556-8. doi: 10.1097/OLQ.0b013e31824f1c49.

    PMID: 22706219BACKGROUND
  • Cornelius DC, Robinson DA, Muzny CA, Mena LA, Aanensen DM, Lushbaugh WB, Meade JC. Genetic characterization of Trichomonas vaginalis isolates by use of multilocus sequence typing. J Clin Microbiol. 2012 Oct;50(10):3293-300. doi: 10.1128/JCM.00643-12. Epub 2012 Aug 1.

    PMID: 22855512BACKGROUND
  • Muzny CA, Harbison HS, Pembleton ES, Austin EL. Sexual behaviors, perception of sexually transmitted infection risk, and practice of safe sex among southern African American women who have sex with women. Sex Transm Dis. 2013 May;40(5):395-400. doi: 10.1097/OLQ.0b013e31828caf34.

    PMID: 23588129BACKGROUND
  • 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.

    PMID: 23949590BACKGROUND
  • 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/sextrans-2013-051361. Epub 2014 Jan 15.

    PMID: 24431188BACKGROUND
  • Austin EL, Lindley LL, Mena LA, Crosby RA, Muzny CA. Families of choice and noncollegiate sororities and fraternities among lesbian and bisexual African-American women in a southern community: implications for sexual and reproductive health research. Sex Health. 2014 Mar;11(1):24-30. doi: 10.1071/SH13145.

    PMID: 24438825BACKGROUND
  • Muzny CA, Kapil R, Austin EL, Brown L, Hook EW 3rd, Geisler WM. Chlamydia trachomatis infection in African American women who exclusively have sex with women. Int J STD AIDS. 2016 Oct;27(11):978-83. doi: 10.1177/0956462415604092. Epub 2015 Sep 18.

    PMID: 26384942BACKGROUND
  • Agenor M, Austin SB, Kort D, Austin EL, Muzny CA. Sexual Orientation and Sexual and Reproductive Health among African American Sexual Minority Women in the U.S. South. Womens Health Issues. 2016 Nov-Dec;26(6):612-621. doi: 10.1016/j.whi.2016.07.004. Epub 2016 Aug 18.

    PMID: 27546567BACKGROUND
  • Muzny CA, Austin EL, Harbison HS, Hook EW 3rd. Sexual partnership characteristics of African American women who have sex with women; impact on sexually transmitted infection risk. Sex Transm Dis. 2014 Oct;41(10):611-7. doi: 10.1097/OLQ.0000000000000194.

  • Muzny CA, Kapil R, Austin EL, Hook EW, Geisler WM. Lower sexually transmissible infection prevalence among lifetime exclusive women who have sex with women compared with women who have sex with women and men. Sex Health. 2014 Dec;11(6):592-3. doi: 10.1071/SH14181.

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christina A Muzny, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

March 2, 2012

First Posted

March 7, 2012

Study Start

August 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

February 8, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will share

De-identified data will be shared with investigators at the Harvard School of Public Health for secondary data analysis.

Locations