Trial Outcomes & Findings for Bacterial Vaginosis Home Screening to Prevent STDs (NCT NCT00667368)
NCT ID: NCT00667368
Last Updated: 2020-02-18
Results Overview
Chlamydia and gonococcal infections were determined by vaginal swab testing collected at 4, 8, and 12 months after enrollment. Specimens were evaluated using the BD ProbeTec Amplified DNA AssayTM (Becton-Dickson, Inc. Sparks, MD). The primary outcome measure is the combined number of chlamydia and gonococcal infections.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1370 participants
Primary outcome timeframe
At 4, 8, and 12 months after enrollment.
Results posted on
2020-02-18
Participant Flow
The target enrollment was 1370 and 1370 participants were randomized, but 5 participants were later found to be enrolled twice. The second enrollment of these participants were removed; therefore, the total enrolled was 1365.
Participant milestones
| Measure |
Control
Bi-monthly testing for BV without treatment.
|
Intervention
Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection
Metronidazole: Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days.
|
|---|---|---|
|
Overall Study
STARTED
|
682
|
683
|
|
Overall Study
COMPLETED
|
482
|
511
|
|
Overall Study
NOT COMPLETED
|
200
|
172
|
Reasons for withdrawal
| Measure |
Control
Bi-monthly testing for BV without treatment.
|
Intervention
Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection
Metronidazole: Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
176
|
155
|
|
Overall Study
Discontinued early
|
24
|
17
|
Baseline Characteristics
Bacterial Vaginosis Home Screening to Prevent STDs
Baseline characteristics by cohort
| Measure |
Control
n=682 Participants
Bi-monthly testing for BV without treatment.
|
Intervention
n=683 Participants
Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection
Metronidazole: Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days.
|
Total
n=1365 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21 years
STANDARD_DEVIATION 2 • n=5 Participants
|
21 years
STANDARD_DEVIATION 2 • n=7 Participants
|
21 years
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
682 Participants
n=5 Participants
|
683 Participants
n=7 Participants
|
1365 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
62 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
620 Participants
n=5 Participants
|
623 Participants
n=7 Participants
|
1243 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
535 Participants
n=5 Participants
|
530 Participants
n=7 Participants
|
1065 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
54 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
682 participants
n=5 Participants
|
683 participants
n=7 Participants
|
1365 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 4, 8, and 12 months after enrollment.Chlamydia and gonococcal infections were determined by vaginal swab testing collected at 4, 8, and 12 months after enrollment. Specimens were evaluated using the BD ProbeTec Amplified DNA AssayTM (Becton-Dickson, Inc. Sparks, MD). The primary outcome measure is the combined number of chlamydia and gonococcal infections.
Outcome measures
| Measure |
Control
n=682 Participants
Bi-monthly testing for BV without treatment.
|
Intervention
n=683 Participants
Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection
Metronidazole: Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days.
|
|---|---|---|
|
One-year Incidence of Chlamydial and Gonococcal Infections in Women Who Receive Screening (Every 2 Months) and Treatment for Asymptomatic Bacterial Vaginosis as Compared to a Control Group With Regular Monitoring (Every 2 Months) But no Treatment
|
19.2 Number infections per 100 person-years
Interval 15.9 to 23.2
|
18.3 Number infections per 100 person-years
Interval 15.1 to 22.1
|
SECONDARY outcome
Timeframe: 2, 4, 6, 8, 10, 12 months after enrollmentPopulation: All randomized participants
Percentage of women testing positive for BV at any follow-up visit. The outcome of BV status was determined by self-collected vaginal swab specimens that were evaluated by the Nugent criteria. A Nugent score of 7-10 indicates positive for BV.
Outcome measures
| Measure |
Control
n=682 Participants
Bi-monthly testing for BV without treatment.
|
Intervention
n=683 Participants
Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection
Metronidazole: Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days.
|
|---|---|---|
|
Percentage of Women Testing Positive for Bacterial Vaginosis (BV) Through 12 Months
|
92.5 percentage of participants
|
82.6 percentage of participants
|
Adverse Events
Control
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control
n=682 participants at risk
Bi-monthly testing for BV without treatment.
|
Intervention
n=683 participants at risk
Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection
Metronidazole: Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days.
|
|---|---|---|
|
Infections and infestations
Wound Infection
|
0.00%
0/682 • 12 months after enrollment
|
0.15%
1/683 • Number of events 1 • 12 months after enrollment
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disk Protrusion
|
0.00%
0/682 • 12 months after enrollment
|
0.15%
1/683 • Number of events 1 • 12 months after enrollment
|
|
Reproductive system and breast disorders
Turbo-Ovarian Abscess
|
0.00%
0/682 • 12 months after enrollment
|
0.15%
1/683 • Number of events 1 • 12 months after enrollment
|
|
Nervous system disorders
Demyelination
|
0.00%
0/682 • 12 months after enrollment
|
0.15%
1/683 • Number of events 1 • 12 months after enrollment
|
|
Nervous system disorders
Optic Neuritis
|
0.00%
0/682 • 12 months after enrollment
|
0.15%
1/683 • Number of events 1 • 12 months after enrollment
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/682 • 12 months after enrollment
|
0.15%
1/683 • Number of events 2 • 12 months after enrollment
|
|
Nervous system disorders
Convulsion
|
0.00%
0/682 • 12 months after enrollment
|
0.15%
1/683 • Number of events 1 • 12 months after enrollment
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum Haemorrhage
|
0.15%
1/682 • Number of events 1 • 12 months after enrollment
|
0.15%
1/683 • Number of events 1 • 12 months after enrollment
|
|
Pregnancy, puerperium and perinatal conditions
Premature Labour
|
0.15%
1/682 • Number of events 1 • 12 months after enrollment
|
0.00%
0/683 • 12 months after enrollment
|
|
Infections and infestations
Abscess Limb
|
0.15%
1/682 • Number of events 1 • 12 months after enrollment
|
0.00%
0/683 • 12 months after enrollment
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place