NCT01043081

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

February 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

May 11, 2016

Status Verified

May 1, 2016

Enrollment Period

2.8 years

First QC Date

January 4, 2010

Last Update Submit

May 10, 2016

Conditions

Keywords

African American women who have sex with womenSexually transmitted infectionsHomosexualityHuman papillomavirusCervical intraepithelial neoplasiaHerpes simplex virus types 1 and 2ChlamydiaGonorrheaTrichomoniasisBacterial vaginosisSyphilisHuman immunodeficiency virus

Outcome Measures

Primary Outcomes (1)

  • Prevalence rates of sexually transmitted infections

    18 Months

Secondary Outcomes (1)

  • Associated sexual risk behaviors

    18 Months

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Crossroads Clinic

Jackson, Mississippi, 39216, United States

Location

Related Publications (5)

  • 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.diagmicrobio.2014.09.008. Epub 2014 Sep 16.

  • 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.

  • 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: 10.1371/journal.pone.0080254. eCollection 2013.

  • 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.

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

Endocervical and vaginal secretion specimens are being retained for future research studies in this field of sexually transmitted diseases.

MeSH Terms

Conditions

Sexually Transmitted DiseasesHIV InfectionsHomosexualityUterine Cervical DysplasiaChlamydia InfectionsGonorrheaTrichomonas InfectionsVaginosis, BacterialSyphilisAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBlood-Borne InfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSexualitySexual BehaviorBehaviorPrecancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsChlamydiaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesSexually Transmitted Diseases, BacterialNeisseriaceae InfectionsProtozoan InfectionsParasitic DiseasesVaginitisVaginal DiseasesTreponemal InfectionsSpirochaetales InfectionsSlow Virus Diseases

Study Officials

  • Leandro A Mena, MD, MPH

    University of Mississippi Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

January 4, 2010

First Posted

January 6, 2010

Study Start

February 1, 2009

Primary Completion

December 1, 2011

Study Completion

June 1, 2012

Last Updated

May 11, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Data will only be shared with investigators

Locations