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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00667368 |
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 |
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Bacterial Vaginosis |
Drug: Metronizadole Other: No Intervention |
Phase III |
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 |
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 |
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Intervention: Experimental
Bi-monthly screening and treatment for BV with Metronizadole.
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Drug: Metronizadole
Metronidazole 500mg twice daily for 7 days.
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Control: No Intervention
Bi-monthly monitoring for BV without treatment.
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Other: No Intervention
Subjects receive no treatment.
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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.
Ages Eligible for Study: | 15 Years to 25 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Vaginal pH greater than 4.5 Clue cells on wet prep microscopy, greater than 20% Woman denies unusual or abnormal vaginal odor and discharge
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)
Exclusion Criteria:
Contact: Robert L Cook | (352) 227-5869 |
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 |
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 |
bacterial vaginosis, women, chlamydia, gonorrhea |
Genital Diseases, Female Bacterial Infections Metronidazole Vaginosis, Bacterial |
Vaginitis Chlamydia Infections Vaginal Diseases Gonorrhea |
Genital Diseases, Female Bacterial Infections Vaginosis, Bacterial Vaginitis Vaginal Diseases |