Bacterial Vaginosis Home Screening to Prevent STDs
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Intervention: Metronidazole
Intervention description: Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days.
Intervention MeSH terms: Metronidazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 1370.0
Sex: Female
Minimum age: 15 Years
Maximum age: 25 Years
Healthy volunteers: No
Keywords: bacterial vaginosis; children; chlamydia; gonorrhea; mentronidazole; vaginal; women

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.
    

Eligibility 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) 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.

        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.