Sexually Transmitted InfectionsWSHPNCT01546714
Sexually Transmitted Infections Among African American Women Who Have Sex With Women
An observational study of Sexually Transmitted Infections, run by University of Alabama at Birmingham at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Infections
- How many people
- 165 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2011to Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: African American women, aged 16 years or older, living in Birmingham, Alabama
Who may be able to join
- 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.
Who cannot join
- Pregnant or nursing and the inability or unwillingness to give written informed consent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Jefferson County Health Department
Birmingham, Alabama, 35233
UAB Personal Health Clinic
Birmingham, Alabama, 35294
About this study
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.
Read the 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.
- Conditions
- Sexually Transmitted Infections
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AAWSW/AAWSWM | African American Women Who Have Sex with Women/African American Women Who Have Sex with Women and Men |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexually Transmitted Infection Diagnosis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startAug 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Sexually Transmitted InfectionsStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of Mississippi Medical Center, Harvard University
- Responsible party
- Principal investigator, Dr. Christina Muzny, University of Alabama at Birmingham
- Investigators
- Christina A Muzny, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546714
- Sponsor's protocol ID
- ASTDA WSHP
- Other IDs
- American STD Association
- Acronym
- WSHP
- Status last verified
- Feb 2017
- First submitted
- 2 Mar 2012
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified data will be shared with investigators at the Harvard School of Public Health for secondary data analysis.
Publications
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.
PubMed 22082722Muzny 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.
PubMed 23369280Muzny 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.
PubMed 22706219Cornelius 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.
PubMed 22855512Muzny 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.
PubMed 23588129Muzny 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.
PubMed 23949590Muzny 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.
PubMed 24431188Austin 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.
PubMed 24438825Muzny 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.
PubMed 26384942Agenor 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.
PubMed 27546567Muzny 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.
PubMed 25211257Muzny 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.
PubMed 25435197
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexually Transmitted Infections Among African American Women Who Have Sex With Women
- ClinicalTrials.gov ID
- NCT01546714
- Acronym / sponsor ID
- WSHP / ASTDA WSHP
- Conditions
- Sexually Transmitted Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- University of Mississippi Medical Center, Harvard University
- Study start
- Aug 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AAWSW/AAWSWM | – | –African American Women Who Have Sex with Women/African American Women Who Have Sex with Women and Men |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- African American women, aged 16 years or older, living in Birmingham, Alabama
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Pregnant or nursing and the inability or unwillingness to give written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sexually Transmitted Infection Diagnosis
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
- Background: PubMed 22082722Muzny 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.
- Background: PubMed 23369280Muzny 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.
- Background: PubMed 22706219Muzny 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.
- Background: PubMed 22855512Cornelius 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.
- Background: PubMed 23588129Muzny 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.
- Background: PubMed 23949590Muzny 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.
- Background: PubMed 24431188Muzny 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.
- Background: PubMed 24438825Austin 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.
- Background: PubMed 26384942Muzny 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.
- Background: PubMed 27546567Agenor 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.
- Results publication: PubMed 25211257Muzny 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.
- Results publication: PubMed 25435197Muzny 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.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with investigators at the Harvard School of Public Health for secondary data analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina A Muzny, MD principal investigator
University of Alabama at Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexually Transmitted Infections, run by University of Alabama at Birmingham at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexually Transmitted Infection Diagnosis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01546714, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2017.