Bacterial Vaginosis Home Screening to Prevent STDs

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00667368
First received: April 24, 2008
Last updated: October 16, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Bacterial Vaginosis
Drug: Metronidazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Home Screening for Bacterial Vaginosis to Prevent STDs

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • The outcome of incident chlamydial and gonococcal infections determined by vaginal swab testing. [ Time Frame: At 4, 8, and 12 months after enrollment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in bacterial vaginosis (BV) status. [ Time Frame: Over 12 months. ] [ Designated as safety issue: No ]

Enrollment: 1370
Study Start Date: July 2008
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Bi-monthly testing for BV without treatment.
Experimental: Intervention
Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection
Drug: Metronidazole
Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days.

Detailed Description:

Bacterial vaginosis (BV) is characterized by an imbalance in the normal vaginal bacterial flora. In the United States (US), BV is very common, and the most common cause of vaginitis, affecting approximately 1 in 10 sexually active young women. Because BV is so common, interventions targeting BV could have a tremendous public health impact. This is a phase III randomized controlled trial, in which the primary objective is to determine whether regular screening (every two months) and treatment for asymptomatic BV can reduce the one-year incidence of chlamydial and gonococcal infections, compared to a control group of women who receive regular monitoring (every two months) for BV but no treatment. The secondary study objective is to determine demographic and behavioral factors associated with the acquisition of BV, its persistence among women who are not treated for this condition, its spontaneous resolution, and its recurrence in women who are treated for this condition. This study protocol will enroll 1500 sexually active females, aged 15 - 25 years, from 6 US cities involved in the Sexually Transmitted Infections Clinical Trials Group network (Birmingham, Durham, Raleigh, Pittsburgh, Baltimore and San Francisco). To be eligible, women must have 2 or more risk factors for sexually transmitted diseases (STDs) and must have clinical evidence of asymptomatic BV at enrollment. For the purposes of this study, women with a vaginal pH>4.5 with >20 percent clue cells detected by microscopy to have asymptomatic BV. In addition, women must deny the presence of unusual or abnormal vaginal discharge or odor. Subjects will receive bi-monthly (every two months) home self-testing kits for BV using a vaginal swab. If BV is detected by self-test, the subjects in the intervention group will receive antibiotic treatment consisting of metronidazole 500mg twice daily for 7 days. Subjects will be randomized to either an intervention group (screening and treatment for BV) or a control group (monitoring for BV without treatment). Subjects in both the intervention group and the control group will complete bi-monthly (every 2 months) follow-up assessments for BV at months 2, 4, 6, 8, 10, and 12 (the final follow-up). In addition, subjects will provide sample collections for Chlamydia trachomatis and Neisseria gonorrhoeae at 4, 8, and 12 months after study entry.

  Eligibility

Ages Eligible for Study:   15 Years to 25 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

    1. Vaginal pH > 4.5
    2. Clue cells on wet prep microscopy, >20 percent
    3. Woman denies unusual or abnormal vaginal odor and discharge.
  • Two or more risk factors for sexually transmitted diseases (STDs):

    1. Age less than or equal to 20
    2. African-American race
    3. Hispanic ethnicity
    4. Regular douching (at least one time per month)
    5. Two or more sex partners (past 12 months)
    6. 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667368

Locations
United States, Alabama
University of Alabama Hospital - Infectious Diseases
Birmingham, Alabama, United States, 35249-0001
United States, California
San Francisco Department of Public Health - San Francisco City Clinic
San Francisco, California, United States, 94103-4030
United States, Maryland
Johns Hopkins Bayview Medical Center - Infectious Diseases
Baltimore, Maryland, United States, 21224-2735
United States, North Carolina
University of North Carolina School of Medicine - Center for Infectious Diseases
Chapel Hill, North Carolina, United States, 27599-7030
Durham County Health Department
Durham, North Carolina, United States, 27701-3720
United States, Pennsylvania
Magee Women's Hospital of UPMC - Reproductive Infectious Disease Research
Pittsburgh, Pennsylvania, United States, 15213-3108
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00667368     History of Changes
Other Study ID Numbers: 05-0131, N01AI40073
Study First Received: April 24, 2008
Last Updated: October 16, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
bacterial vaginosis, women, chlamydia, gonorrhea, mentronidazole, vaginal, children

Additional relevant MeSH terms:
Vaginosis, Bacterial
Bacterial Infections
Genital Diseases, Female
Vaginal Diseases
Vaginitis
Metronidazole
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014