Pathogenesis of Bacterial Vaginosis in Women Who Have Sex With Women

NCT02272231 | Completed

• 1 other identifier: F131127001
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study are to: (1) use cultivation-independent molecular methods to determine the sequence of microbiological events culminating in bacterial vaginosis (BV) among sexually active African American women who have sex with women (AAWSW) and (2) determine if specific Gardnerella vaginalis oligotypes are associated with the development of BV among sexually active AAWSW.

Conditions

Vaginosis, Bacterial

Keywords

women's health; vaginosis, bacterial; african americans

Outcome Measures

Primary Outcomes (1)

• Development of incident BV

  Based on 3 consecutive days of Nugent score readings of 7-10 (vaginal Gram stain result)

  90 days

Secondary Outcomes (1)

• Development of vaginal symptoms

  90 days

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Sexually active African American women who have sex with women with normal vaginal flora at baseline (determined based on 0/4 Amsel criteria and a normal Nugent score of 0-3 with no Gardnerella vaginalis morphotypes noted on vaginal Gram stain) will be followed prospectively over a 90 day time period for the development of incident BV.

You may qualify if:

• African American race
• Female Gender
• Age 18-45 years
• History of sexual activity (oral, vaginal, and/or anal) with a female sexual partner during the past 12 months
• Current female sexual partner
• English speaking
• Ability to give written informed consent

You may not qualify if:

• Use of antimicrobials (oral and/or vaginal) within the past 14 days
• Known HIV
• Known pregnancy
• Currently on menstrual period
• No Amsel criteria (i.e. patient currently asymptomatic from vaginal discharge standpoint, has normal vaginal pH, negative whiff test, and no clue cells on saline microscopy)
• Nugent score of 0-3 with no Gardnerella vaginalis morphotypes noted on Gram stain
• Presence of current vaginal infections (i.e. trichomoniasis or symptomatic vaginal yeast infection)
• Pregnancy
• Reasons for Subsequent Participant Discontinuation after Initial Enrollment\*\*:
• (1) Duplicate Nugent score reading \> 3 (2) Concurrent trichomonas diagnosis - as determined by nucleic acid amplification testing results

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• University of Mississippi Medical Center: collaborator
• Louisiana State University Health Sciences Center in New Orleans: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (12)

• Schwebke JR, Muzny CA, Josey WE. Role of Gardnerella vaginalis in the pathogenesis of bacterial vaginosis: a conceptual model. J Infect Dis. 2014 Aug 1;210(3):338-43. doi: 10.1093/infdis/jiu089. Epub 2014 Feb 7.

  PMID: 24511102 BACKGROUND

• Muzny CA, Schwebke JR. Gardnerella vaginalis: Still a Prime Suspect in the Pathogenesis of Bacterial Vaginosis. Curr Infect Dis Rep. 2013 Apr;15(2):130-5. doi: 10.1007/s11908-013-0318-4.

  PMID: 23371405 BACKGROUND

• 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.

  PMID: 24236175 BACKGROUND

• 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.

  PMID: 25262105 BACKGROUND

• Schwebke JR, Muzny CA, Josey WE. Reply to Hickey and Forney. J Infect Dis. 2014 Nov 15;210(10):1683-4. doi: 10.1093/infdis/jiu304. Epub 2014 May 22. No abstract available.

  PMID: 24855685 BACKGROUND

• 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: 23949590 BACKGROUND

• Muzny CA, Schwebke JR. Editorial commentary: women who have sex with women: a unique population for studying the pathogenesis of bacterial vaginosis. Clin Infect Dis. 2015 Apr 1;60(7):1054-6. doi: 10.1093/cid/ciu1132. Epub 2014 Dec 16. No abstract available.

  PMID: 25516182 BACKGROUND

• Muzny CA, Schwebke JR. Biofilms: An Underappreciated Mechanism of Treatment Failure and Recurrence in Vaginal Infections. Clin Infect Dis. 2015 Aug 15;61(4):601-6. doi: 10.1093/cid/civ353. Epub 2015 May 1.

  PMID: 25935553 BACKGROUND

• Muzny CA, Schwebke JR. Accuracy of Self-Report of Sexual Activity among Adolescent Girls: Implications for Interpretation of Vaginal Flora Patterns. mBio. 2015 Jun 23;6(3):e00819. doi: 10.1128/mBio.00819-15. No abstract available.

  PMID: 26106081 BACKGROUND

• Muzny CA, Blanchard E, Taylor CM, Aaron KJ, Talluri R, Griswold ME, Redden DT, Luo M, Welsh DA, Van Der Pol WJ, Lefkowitz EJ, Martin DH, Schwebke JR. Identification of Key Bacteria Involved in the Induction of Incident Bacterial Vaginosis: A Prospective Study. J Infect Dis. 2018 Aug 14;218(6):966-978. doi: 10.1093/infdis/jiy243.

  PMID: 29718358 BACKGROUND

• Van Der Pol WJ, Kumar R, Morrow CD, Blanchard EE, Taylor CM, Martin DH, Lefkowitz EJ, Muzny CA. In Silico and Experimental Evaluation of Primer Sets for Species-Level Resolution of the Vaginal Microbiota Using 16S Ribosomal RNA Gene Sequencing. J Infect Dis. 2019 Jan 7;219(2):305-314. doi: 10.1093/infdis/jiy508.

  PMID: 30535155 BACKGROUND

• Olson KM, Boohaker LJ, Schwebke JR, Aslibekyan S, Muzny CA. Comparisons of vaginal flora patterns among sexual behaviour groups of women: implications for the pathogenesis of bacterial vaginosis. Sex Health. 2018 Feb;15(1):61-67. doi: 10.1071/SH17087.

  PMID: 29212588 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Self-collected vaginal swabs from women participating in this study will be stored for future research purposes related to the study of the vaginal microbiome.

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

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: Associate Professor - Med-Infectious Disease

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: October 22, 2014
• Study Start: September 1, 2014
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: January 7, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)