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BV Home Screening to Prevent STDs
This study is currently recruiting participants.
Verified by National Institute of Allergy and Infectious Diseases (NIAID), February 2009
First Received: April 24, 2008   Last Updated: May 7, 2009   History of Changes
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00667368
  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 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.


Condition Intervention Phase
Bacterial Vaginosis
Drug: Metronizadole
Other: No Intervention
Phase III

MedlinePlus related topics: Gonorrhea
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title: Home Screening for Bacterial Vaginosis to Prevent STDs

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

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

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

Estimated Enrollment: 1800
Study Start Date: July 2008
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Intervention: Experimental
Bi-monthly screening and treatment for BV with Metronizadole.
Drug: Metronizadole
Metronidazole 500mg twice daily for 7 days.
Control: No Intervention
Bi-monthly monitoring for BV without treatment.
Other: No Intervention
Subjects receive no treatment.

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.

  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 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.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00667368

Contacts
Contact: Robert L Cook (352) 227-5869

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294-0007
United States, California
RTI International Not yet recruiting
San Francisco, California, United States, 94104
San Francisco Department of Public Health Not yet recruiting
San Francisco, California, United States, 94103
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7030
Durham County Health Department Recruiting
Durham, North Carolina, United States, 27701
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: HHS/NIAID/DMID ( Robert Johnson )
Study ID Numbers: 05-0131
Study First Received: April 24, 2008
Last Updated: May 7, 2009
ClinicalTrials.gov Identifier: NCT00667368     History of Changes
Health Authority: United States: Institutional Review Board;   United States: Federal Government;   United States: Food and Drug Administration

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

Study placed in the following topic categories:
Genital Diseases, Female
Bacterial Infections
Metronidazole
Vaginosis, Bacterial
Vaginitis
Chlamydia Infections
Vaginal Diseases
Gonorrhea

Additional relevant MeSH terms:
Genital Diseases, Female
Bacterial Infections
Vaginosis, Bacterial
Vaginitis
Vaginal Diseases

ClinicalTrials.gov processed this record on May 07, 2009