BV Home Screening to Prevent STDs

Condition(s) targeted: Bacterial Vaginosis

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

Phase: Phase 3

Status: Recruiting

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

Overall contact:
Robert L Cook, Phone: (352) 227-5869

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 1800 women aged 15-25 years who have clinical evidence of BV. 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, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Incident STDs (chlamydial and gonococcal infections) determined by vaginal swab testing.

Secondary outcome: Change in 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. This trial will

recruit 1,800 women, ages 15 - 25 years, from 6 sites within the Sexually Transmitted

Infections Clinical Trials Group (STI CTG) network. 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 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 detected during one year of follow-up. For this outcome, researchers will consider two measures: cumulative STD incidence rate at one year and the cumulative proportion of participants who acquire at least one chlamydial or gonococcal infection by one year. The secondary study outcome is BV at any assessment point, as defined by microbiologic assessment of a gram-stained vaginal swab specimen.

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 BV.

- Vaginal pH greater than 4. 5.

- Clue cells on wet prep microscopy, greater than 20%.

- Woman denies unusual or abnormal vaginal odor and discharge.

- Two or more risk factors for STDs:

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

- Regular use of antibiotics: use at least once daily for 2 of past six months ( e. g.,

for acne).

- Self-reported currently married/partnered and living with husband/partner. This does

not include married women who are separated.

- Homeless.

- 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).

- Allergy to metronidazole.

- Current seizure disorder.

- Use of warfarin sodium (Coumadin ®).

- Use of cimetidine (Tagamet ®).

- Known liver disease. disease; as such women may be at greater risk of adverse

consequences from taking metronidazole.

- History of hysterectomy.

- Trichomonas vaginalis detected via wet mount during eligibility assessment.

- 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.

Robert L Cook, Phone: (352) 227-5869

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

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

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

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599-7030, United States; Not yet recruiting

Durham County Health Department, Durham, North Carolina 27701, United States; Not yet recruiting

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

Starting date: July 2008
Ending date: March 2012
Last updated: October 23, 2008