BV Home Screening to Prevent STDs

Condition(s) targeted: Bacterial Vaginosis

Intervention: Metronidazole (Drug); No Intervention (Other)

Phase: Phase 3

Status: Recruiting

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Overall contact:
Jane R Schwebke, Phone: (205) 975-5665, Email: schwebke@uab.edu

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 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: intervention group (treatment of BV) or 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.

Official title: Home Screening for Bacterial Vaginosis to Prevent STDs

Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Primary outcome: The outcome of incident chlamydial and gonococcal infections determined by vaginal swab testing.

Secondary outcome: Change in bacterial vaginosis (BV) status.

Detailed description: Bacterial vaginosis (BV) is characterized by an imbalance in the normal vaginal bacterial flora. In the United States, 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. The study will

include 1500 sexually active females, aged 1 - 25 years, from 5 U. S. cities involved in the

Sexually Transmitted Infections Clinical Trials Group (STI CTG) network (Birmingham, Durham, Raleigh, San Francisco and Pittsburgh). 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, asymptomatic BV is defined by the presence of a pH greater than 4. 5, the presence clue cells (greater than 20%), and the absence of subject reported unusual/abnormal vaginal odor or discharge. After the informed consent is obtained, eligible women will be randomized to either an intervention group (screening and treatment for asymptomatic BV) or a control group (monitoring for BV without treatment). All 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 interventional group will receive metronidazole 500mg twice daily for 7 days. 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. The primary study outcome is incident chlamydial and gonococcal infections, which will be determined by laboratory testing every 4 months during follow up. Secondary study outcomes are changes in BV status over 12 months.

Minimum age: 15 Years. Maximum age: 25 Years. Gender(s): Female.

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)

- Vaginal pH > 4. 5

- Clue cells on wet prep microscopy, >20%

- 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.

- Used any antibiotics in the last 30 days and/or regularly uses antibiotics: use at

least once daily for 2 of 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.

- For women younger than age 18 years (19 in Alabama), a parent or guardian they live

with is unaware that she is sexually active.

Jane R Schwebke, Phone: (205) 975-5665, Email: schwebke@uab.edu

University of Alabama at Birmingham, Birmingham, Alabama 35294-0007, United States; Recruiting

RTI International, San Francisco, California 94104, United States; Not yet recruiting

San Francisco Department of Public Health, San Francisco, California 94103, United States; Not yet recruiting

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599-7030, United States; Recruiting

Durham County Health Department, Durham, North Carolina 27701, United States; Recruiting

University of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States; Recruiting

Starting date: July 2008
Ending date: March 2012
Last updated: October 1, 2009