Bacterial Vaginosis Home Screening to Prevent STDs

NCT00667368 | Completed Phase 3 Results

• 2 other identifiers: 05-0131HHSN272201300012I
• Study Type: interventional
• Target: 1,370
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to determine whether regular screening (every 2 months) and treatment for bacterial vaginosis (BV \[infection of the vagina\]) will reduce the number of incidences of chlamydia and gonorrhea (sexually transmitted diseases) over the course of a year. Chlamydial and gonococcal infections will be determined by vaginal swab testing at 4, 8, and 12 months after enrollment. Subjects will include 1500 women aged 15-25 years who have clinical evidence of BV, with no symptoms. Subjects will be randomly assigned to 1 of 2 possible study groups: the intervention group (treatment of BV) or the control group (no BV treatment). Every 2 months, subjects will complete a home self-testing kit for screening of BV using a swab. If BV is detected by self-test, the subjects in the interventional group will receive a 7 day course of the antibiotic metronidazole. Participants will be involved in study related procedures for up to 12 months.

Conditions

Bacterial Vaginosis

Keywords

bacterial vaginosis; children; chlamydia; gonorrhea; mentronidazole; vaginal; women

Outcome Measures

Primary Outcomes (1)

• One-year Incidence of Chlamydial and Gonococcal Infections in Women Who Receive Screening (Every 2 Months) and Treatment for Asymptomatic Bacterial Vaginosis as Compared to a Control Group With Regular Monitoring (Every 2 Months) But no Treatment

  Chlamydia and gonococcal infections were determined by vaginal swab testing collected at 4, 8, and 12 months after enrollment. Specimens were evaluated using the BD ProbeTec Amplified DNA AssayTM (Becton-Dickson, Inc. Sparks, MD). The primary outcome measure is the combined number of chlamydia and gonococcal infections.

  At 4, 8, and 12 months after enrollment.

Secondary Outcomes (1)

• Percentage of Women Testing Positive for Bacterial Vaginosis (BV) Through 12 Months

  2, 4, 6, 8, 10, 12 months after enrollment

Study Arms (2)

Control

NO INTERVENTION

Bi-monthly testing for BV without treatment.

Intervention

EXPERIMENTAL

Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection

Drug: Metronidazole

Interventions

Metronidazole DRUG

Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days.

Intervention

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subject provides written informed consent, or if subject is under age 18, parent signs informed consent and subject signs assent. -Female age 15-25 years (age at last birthday). -Vaginal intercourse within the past 3 months. -Asymptomatic bacterial vaginosis (BV) a. Vaginal pH \> 4.5 b. Clue cells on wet prep microscopy, \>20 percent c. Woman denies unusual or abnormal vaginal odor and discharge. -Two or more risk factors for sexually transmitted diseases (STDs): a. Age less than or equal to 20 b. African-American race c. Hispanic ethnicity d. Regular douching (at least one time per month) e. Two or more sex partners (past 12 months) f. Current or past STD (past 12 months). -Be able to understand study procedures . -Be able to comply with the study procedures for the entire length of the study.

You may not qualify if:

• Self-reported pregnancy, or no menstrual period in past 4 weeks and positive urine pregnancy test Note: We will exclude women who are pregnant at the time of enrollment because some guidelines recommend screening and treatment for bacterial vaginosis (BV) in high-risk women during pregnancy. -Regular use of antibiotics: use at least once daily for 2 of the past six months ( e.g., for acne). Note: Women taking antibiotics on a regular basis will be excluded because antibiotic use could affect both BV and chlamydia/gonorrhea infections. -Self-reported currently married/partnered and living with husband/partner of over 1 year. This does not include married women who are separated. Note: We will exclude women who are married and who are in established long term relationships because our goal is to enroll a sample of women at high-risk for sexually transmitted diseases (STDs). Although these women are at risk for STDs, they are at lower risk overall than women who are single, separated, or divorced. -Homeless Note: We will exclude women who are homeless because they are likely to be difficult to track. -Excessive alcohol use (consumes more than 14 alcoholic drinks per week, or is not willing to abstain from alcohol for one week in order to take medication). Note: We will exclude persons who do not think they could avoid drinking alcohol for one week to take an antibiotic (because metronidazole plus alcohol can lead to nausea and vomiting). -Allergy to metronidazole. -Current or history of seizure disorder. -Current or history of any kind of neuropathy. -Use of warfarin sodium (Coumadin ®). -Use of cimetidine (Tagamet ®). -Known liver disease. Note: we will exclude women with current seizure disorders, women taking warfarin (Coumadin), women taking cimetidine, and women with known liver disease; as such women may be at greater risk of adverse consequences from taking metronidazole. -History of hysterectomy. Note: we will exclude women who have had a hysterectomy because most chlamydial and gonococcal infections target the cervix. -Trichomonas vaginalis detected via wet mount during eligibility assessment. Note: we will also exclude women with a trichomonas infection identified during eligibility assessment through wet mount evaluation because we will treat them with a single dose of metronidazole. Such treatment would affect BV among women in the study. Women treated with metronidazole during eligibility assessment will have to wait for one month post treatment to become eligible for the study. -Unable to swallow pills. -Has an active uncontrolled medical condition, such as cancer, or per the judgment of the principal investigator should not participate in the study. -Women who are in the menstrual phase of the menstrual cycle. -Current participation in another research study of an investigational drug. -For women younger than age 18 years (19 in Alabama), a parent or guardian they live with is unaware that she is sexually active.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (7)

University of Alabama Hospital - Infectious Diseases

Birmingham, Alabama, 35249-0001, United States

Location

San Francisco Department of Public Health - San Francisco City Clinic

San Francisco, California, 94103-4030, United States

Location

RTI International - Women's Global Health Imperative

San Francisco, California, 94104-3812, United States

Location

Johns Hopkins Bayview Medical Center - Infectious Diseases

Baltimore, Maryland, 21224-2735, United States

Location

University of North Carolina School of Medicine - Center for Infectious Diseases

Chapel Hill, North Carolina, 27599-7030, United States

Location

Durham County Health Department

Durham, North Carolina, 27701-3720, United States

Location

Magee Women's Hospital of UPMC - Reproductive Infectious Disease Research

Pittsburgh, Pennsylvania, 15213-3108, United States

Location

Related Publications (1)

• Schwebke JR, Lee JY, Lensing S, Philip SS, Wiesenfeld HC, Sena AC, Trainor N, Acevado N, Saylor L, Rompalo AM, Cook RL. Home Screening for Bacterial Vaginosis to Prevent Sexually Transmitted Diseases. Clin Infect Dis. 2016 Mar 1;62(5):531-6. doi: 10.1093/cid/civ975. Epub 2015 Nov 26.

  PMID: 26611782 DERIVED

MeSH Terms

Conditions

Vaginosis, Bacterial; Chlamydia Infections; Gonorrhea

Interventions

Metronidazole

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; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Neisseriaceae Infections

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Jane Schwebke
• Organization: University of Alabama at Birmingham

schwebke@uab.edu

205-975-5665

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 28, 2008
• Study Start: July 28, 2008
• Primary Completion: December 31, 2014
• Study Completion: December 31, 2014
• Last Updated: February 18, 2020
• Results First Posted: October 29, 2015

Record last verified: 2015-08-20

Locations

US (7)