Bacterial Vaginosis Home Screening to Prevent STDs
Study Details
Study Description
Brief Summary
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 (sexually transmitted diseases) 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: the intervention group (treatment of BV) or the 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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
Bacterial vaginosis (BV) is characterized by an imbalance in the normal vaginal bacterial flora. In the United States (US), 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 study protocol will enroll 1500 sexually active females, aged 15 - 25 years, from 6 US cities involved in the Sexually Transmitted Infections Clinical Trials Group network (Birmingham, Durham, Raleigh, Pittsburgh, Baltimore and San Francisco). 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, women with a vaginal pH>4.5 with >20 percent clue cells detected by microscopy to have asymptomatic BV. In addition, women must deny the presence of unusual or abnormal vaginal discharge or odor. 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 intervention group will receive antibiotic treatment consisting of metronidazole 500mg twice daily for 7 days. Subjects will be randomized to either an intervention group (screening and treatment for BV) or a control group (monitoring for BV without treatment). 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Control Bi-monthly testing for BV without treatment. |
|
| Experimental: Intervention Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection |
Drug: Metronidazole
Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days.
|
Outcome Measures
Primary Outcome Measures
- 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 [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.
Secondary Outcome Measures
- Percentage of Women Testing Positive for Bacterial Vaginosis (BV) Through 12 Months [2, 4, 6, 8, 10, 12 months after enrollment]
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.
Eligibility Criteria
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) a. Vaginal pH > 4.5 b. Clue cells on wet prep microscopy, >20 percent c. Woman denies unusual or abnormal vaginal odor and discharge. -Two or more risk factors for sexually transmitted diseases (STDs): a. Age less than or equal to 20 b. African-American race c. Hispanic ethnicity d. Regular douching (at least one time per month) e. Two or more sex partners (past 12 months) f. 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. -Regular use of antibiotics: use at least once daily for 2 of the 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 of an investigational drug. -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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama Hospital - Infectious Diseases | Birmingham | Alabama | United States | 35249-0001 |
| 2 | San Francisco Department of Public Health - San Francisco City Clinic | San Francisco | California | United States | 94103-4030 |
| 3 | RTI International - Women's Global Health Imperative | San Francisco | California | United States | 94104-3812 |
| 4 | Johns Hopkins Bayview Medical Center - Infectious Diseases | Baltimore | Maryland | United States | 21224-2735 |
| 5 | University of North Carolina School of Medicine - Center for Infectious Diseases | Chapel Hill | North Carolina | United States | 27599-7030 |
| 6 | Durham County Health Department | Durham | North Carolina | United States | 27701-3720 |
| 7 | Magee Women's Hospital of UPMC - Reproductive Infectious Disease Research | Pittsburgh | Pennsylvania | United States | 15213-3108 |
Sponsors and Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 05-0131
- HHSN272201300012I
Study Results
Participant Flow
| Recruitment Details | 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. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Control | Intervention |
|---|---|---|
| Arm/Group Description | Bi-monthly testing for BV without treatment. | 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. |
| Period Title: Overall Study | ||
| STARTED | 682 | 683 |
| COMPLETED | 482 | 511 |
| NOT COMPLETED | 200 | 172 |
Baseline Characteristics
| Arm/Group Title | Control | Intervention | Total |
|---|---|---|---|
| Arm/Group Description | Bi-monthly testing for BV without treatment. | 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 of all reporting groups |
| Overall Participants | 682 | 683 | 1365 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
21
(2)
|
21
(2)
|
21
(2)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
682
100%
|
683
100%
|
1365
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
62
9.1%
|
60
8.8%
|
122
8.9%
|
| Not Hispanic or Latino |
620
90.9%
|
623
91.2%
|
1243
91.1%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
2
0.3%
|
2
0.3%
|
4
0.3%
|
| Asian |
11
1.6%
|
5
0.7%
|
16
1.2%
|
| Native Hawaiian or Other Pacific Islander |
9
1.3%
|
4
0.6%
|
13
1%
|
| Black or African American |
535
78.4%
|
530
77.6%
|
1065
78%
|
| White |
45
6.6%
|
65
9.5%
|
110
8.1%
|
| More than one race |
54
7.9%
|
48
7%
|
102
7.5%
|
| Unknown or Not Reported |
26
3.8%
|
29
4.2%
|
55
4%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
682
100%
|
683
100%
|
1365
100%
|
Outcome Measures
| Title | 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 |
|---|---|
| Description | 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. |
| Time Frame | At 4, 8, and 12 months after enrollment. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | Intervention |
|---|---|---|
| Arm/Group Description | Bi-monthly testing for BV without treatment. | 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. |
| Measure Participants | 682 | 683 |
| Number (95% Confidence Interval) [Number infections per 100 person-years] |
19.2
|
18.3
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Control, Intervention |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.754 |
| Comments | ||
| Method | Two-sample test, Poisson | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | -0.9 | |
| Confidence Interval |
(2-Sided) 95% -12.0 to 10.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The risk difference reflects the treatment arm minus the control arm. The units are the number of positive tests for chlamydia and gonorrhea per 100 person-years. | |
| Title | Percentage of Women Testing Positive for Bacterial Vaginosis (BV) Through 12 Months |
|---|---|
| Description | 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. |
| Time Frame | 2, 4, 6, 8, 10, 12 months after enrollment |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants |
| Arm/Group Title | Control | Intervention |
|---|---|---|
| Arm/Group Description | Bi-monthly testing for BV without treatment. | 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. |
| Measure Participants | 682 | 683 |
| Number [percentage of participants] |
92.5
13.6%
|
82.6
12.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Control, Intervention |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Adverse Events
| Time Frame | 12 months after enrollment | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Control | Intervention | ||
| Arm/Group Description | Bi-monthly testing for BV without treatment. | 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. | ||
All Cause Mortality |
||||
| Control | Intervention | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Control | Intervention | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/682 (0.4%) | 7/683 (1%) | ||
| Gastrointestinal disorders | ||||
| Vomiting | 0/682 (0%) | 0 | 1/683 (0.1%) | 2 |
| Infections and infestations | ||||
| Wound Infection | 0/682 (0%) | 0 | 1/683 (0.1%) | 1 |
| Abscess Limb | 1/682 (0.1%) | 1 | 0/683 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Intervertebral Disk Protrusion | 0/682 (0%) | 0 | 1/683 (0.1%) | 1 |
| Nervous system disorders | ||||
| Demyelination | 0/682 (0%) | 0 | 1/683 (0.1%) | 1 |
| Optic Neuritis | 0/682 (0%) | 0 | 1/683 (0.1%) | 1 |
| Convulsion | 0/682 (0%) | 0 | 1/683 (0.1%) | 1 |
| Pregnancy, puerperium and perinatal conditions | ||||
| Postpartum Haemorrhage | 1/682 (0.1%) | 1 | 1/683 (0.1%) | 1 |
| Premature Labour | 1/682 (0.1%) | 1 | 0/683 (0%) | 0 |
| Reproductive system and breast disorders | ||||
| Turbo-Ovarian Abscess | 0/682 (0%) | 0 | 1/683 (0.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Control | Intervention | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/682 (0%) | 0/683 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Jane Schwebke |
|---|---|
| Organization | University of Alabama at Birmingham |
| Phone | 205-975-5665 |
| schwebke@uab.edu |
- 05-0131
- HHSN272201300012I