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

February 6, 2017 updated by: Dr. Christina Muzny, University of Alabama at Birmingham
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

165

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • UAB Personal Health Clinic
      • Birmingham, Alabama, United States, 35233
        • Jefferson County Health Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
AAWSW/AAWSWM
African American Women Who Have Sex with Women/African American Women Who Have Sex with Women and Men

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sexually Transmitted Infection Diagnosis
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

Harvard University
University of Mississippi Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

March 2, 2012

First Submitted That Met QC Criteria

March 6, 2012

First Posted (Estimate)

March 7, 2012

Study Record Updates

Last Update Posted (Estimate)

February 8, 2017

Last Update Submitted That Met QC Criteria

February 6, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASTDA WSHP
  • American STD Association (Other Grant/Funding Number: 2009283)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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