Bacterial Vaginosis Home Screening to Prevent STDs

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.

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.