Sexually Transmitted Diseases
Conditions
Keywords
Gonorrhea, Syphilis, Chlamydia, Listerine, STI
Brief summary
The study involves a randomized placebo controlled trial that aims to assess if a mouthwash (Listerine cool mint, LCM) is able to reduce the cumulative incidence of gonorrhoea (Ng), chlamydia (Ct) and syphilis in men who have sex with men and receiving preexposure prophylaxis (PrEP) at the Institute of Tropical Medicine (ITM).
Detailed description
The study aims to assess if there is a difference in the incidence rate of gonorrhea, chlamydia and syphilis detected at any site whilst individuals are on daily and pre/post sex Listerine cool mint (LCM) vs. placebo mouthwash. The study has a double-blind, cross-over design, in which subjects will be screened at the ITM and, if eligible, will be enrolled and randomized to group 1 (LCM) or group 2 (placebo). After 3 months, a crossover will occur and subjects will switch to the other intervention. Each participant will therefore be enrolled for 6 months (2 x 3 months, no wash out period). Subjects will be recruited from the existing PrEP cohort at the Institute of Tropical Medicine Antwerp. A total of 320 subjects will be recruited (160 in each arm).
Interventions
OTHERMouthwash with LCM
Subjects will mouthwash daily with LCM and before/after sex
OTHERMouthwash with placebo
Subjects will mouthwash daily with placebo and before/after sex
Sponsors
Institute of Tropical Medicine, Belgium
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Men aged 18 or more * Enrolled in Belgian PrEP program at ITM * Has had sex with another man in the previous year * Has had a symptomatic or asymptomatic STI (Ct/Ng/syphilis) in the previous 2 years * Willing to be enrolled in the cohort for 6 months and attend 3 monthly follow up visits * Willing to comply with the mouthwash study schema and willing to ask their casual partners to mouthwash pre- and post-sex * Prepared to fill out the online diary once a week * Able and willing to provide written informed consent
Exclusion criteria
* Currently using a mouthwash and unwilling to cease use of this mouthwash * Enrolment in another interventional trial * Tests HIV positive at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period | 3-month period following each intervention | The sum of new diagnoses of Gonnorhea (Ng), Chlamydia (Ct) and syphilis in a 3 month period on LCM/placebo. Each participant can only contribute one diagnosis of Ct and one diagnosis of Ng per visit - regardless of number of sites infected. Thus each participant can contribute up to 3 diagnoses (Ct/Ng/syphilis) at each visit. The diagnosis of Ng and Ct will be made via molecular testing and syphilis via Rapid Plasma Reagin test (RPR) and Treponema Pallidum Antibodies tests (TPA) according to currently used European case definitions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Incidence Rate of Ct (Combined Pharyngeal, Urethral and Rectal) Between Each Study Arm for Each Period | 3-month period following each intervention | Incidence rate of new Ct cases in each allocation arm (LCM and placebo) for each study period of 3 months. |
| Difference in Incidence Rate of Syphilis Between Periods on LCM vs. Placebo | 3-month period following each intervention | Incidence rate of new syphilis cases in each allocation arm (LCM and placebo) for each study period of 3 months. |
| Difference in Incidence Rate of Pharyngeal Ng Between Each Study Arm for Each Period | 3-month period following each intervention | Incidence rate of new pharyngeal Ng cases in each allocation arm for each study period of 3 months. |
| Difference in Incidence Rate of Ng Plus Ct Plus Syphilis Between LCM and Placebo After Controlling for Adherence With Daily and Pre/Post Sex Mouthwash | 3-month period following each intervention | Incidence rate of Ng, Ct and syphilis between both groups (LCM and placebo) post controlling for adherence to mouthwash |
| Difference in Cumulative Numbers of Antibiotics Used Between Periods on LCM vs. Placebo | 3-month period following each intervention | Cumulative number of antibiotics used between both groups (LCM and placebo) for each period |
| Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | 6-month period | Daily: Proportion of days in study used mouthwash at least daily Post sex: Proportion of casual sexual contacts in study when mouthwash used post sex. Pre sex: proportion of casual sexual contacts in study when mouthwash used pre sex |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LCM (Intervention), Then Placebo Mouthwash with Listerine Cool Mint: Subjects will mouthwash daily with LCM and before/after sex for 3 months and then switch to placebo mouthwash for 3 months. | 172 |
| Placebo, Then LCM Mouthwash with placebo: Subjects will mouthwash daily with placebo and before/after sex for 3 months and then switch to LCM mouthwash for 3 months. | 171 |
| Total | 343 |
Baseline characteristics
| Characteristic | Placebo, Then LCM | Total | LCM (Intervention), Then Placebo |
|---|---|---|---|
| Age, Continuous | 40 years | 40 years | 39 years |
| Antibiotics use (last 6 months) Any antibiotics | 136 Participants | 276 Participants | 140 Participants |
| Antibiotics use (last 6 months) Beta-lactam | 121 Participants | 232 Participants | 111 Participants |
| Antibiotics use (last 6 months) Fluoroquinolones | 3 Participants | 7 Participants | 4 Participants |
| Antibiotics use (last 6 months) Macrolides | 86 Participants | 157 Participants | 71 Participants |
| Antibiotics use (last 6 months) Other | 2 Participants | 2 Participants | 0 Participants |
| Antibiotics use (last 6 months) Tetracyclines | 30 Participants | 77 Participants | 47 Participants |
| Condom use with casual partners 0-24% | 62 Participants | 112 Participants | 50 Participants |
| Condom use with casual partners 25-49% | 34 Participants | 76 Participants | 42 Participants |
| Condom use with casual partners 50-74% | 26 Participants | 57 Participants | 31 Participants |
| Condom use with casual partners 75-100% | 42 Participants | 86 Participants | 44 Participants |
| Number of casual partners (last 3 months) | 10 casual partners | 10 casual partners | 10 casual partners |
| Number of main partners (last 3 months) | 1 Main partners | 1 Main partners | 1 Main partners |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 171 Participants | 343 Participants | 172 Participants |
| Sexually Transmitted Infection (STI) history (last 24 months) Any STI | 171 Participants | 343 Participants | 172 Participants |
| Sexually Transmitted Infection (STI) history (last 24 months) Chlamydia | 82 Participants | 171 Participants | 89 Participants |
| Sexually Transmitted Infection (STI) history (last 24 months) Gonorrhea | 117 Participants | 217 Participants | 100 Participants |
| Sexually Transmitted Infection (STI) history (last 24 months) Other | 21 Participants | 36 Participants | 15 Participants |
| Sexually Transmitted Infection (STI) history (last 24 months) Syphilis | 66 Participants | 141 Participants | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 195 | 0 / 196 |
| other Total, other adverse events | 45 / 195 | 30 / 196 |
| serious Total, serious adverse events | 1 / 195 | 3 / 196 |
Outcome results
Primary
Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period
The sum of new diagnoses of Gonnorhea (Ng), Chlamydia (Ct) and syphilis in a 3 month period on LCM/placebo. Each participant can only contribute one diagnosis of Ct and one diagnosis of Ng per visit - regardless of number of sites infected. Thus each participant can contribute up to 3 diagnoses (Ct/Ng/syphilis) at each visit. The diagnosis of Ng and Ct will be made via molecular testing and syphilis via Rapid Plasma Reagin test (RPR) and Treponema Pallidum Antibodies tests (TPA) according to currently used European case definitions.
Time frame: 3-month period following each intervention
Population: Intention-to-treat population. LCM (intervention) has a total of 195 participants (121 during the first 3 months and 74 during the last 3 months). The placebo arm had a total of 196 participants (119 during the first 3 months and 77 during the last 3 months).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LCM (Intervention) | Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period | First 3 months : Any STI | 36 Participants |
| LCM (Intervention) | Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period | First 3 months : Chlamydia | 19 Participants |
| LCM (Intervention) | Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period | First 3 months : Gonorrhea | 19 Participants |
| LCM (Intervention) | Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period | First 3 months : Syphilis | 2 Participants |
| LCM (Intervention) | Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period | Last 3 months : Any STI | 27 Participants |
| LCM (Intervention) | Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period | Last 3 months : Chlamydia | 11 Participants |
| LCM (Intervention) | Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period | Last 3 months : Gonorrhea | 14 Participants |
| LCM (Intervention) | Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period | Last 3 months : Syphilis | 4 Participants |
| Placebo | Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period | Last 3 months : Syphilis | 4 Participants |
| Placebo | Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period | First 3 months : Any STI | 33 Participants |
| Placebo | Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period | Last 3 months : Any STI | 21 Participants |
| Placebo | Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period | First 3 months : Chlamydia | 18 Participants |
| Placebo | Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period | Last 3 months : Gonorrhea | 8 Participants |
| Placebo | Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period | First 3 months : Gonorrhea | 17 Participants |
| Placebo | Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period | Last 3 months : Chlamydia | 10 Participants |
| Placebo | Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period | First 3 months : Syphilis | 6 Participants |
p-value: 0.35995% CI: [0.84, 1.64]Mixed Models Analysis
Secondary
Difference in Cumulative Numbers of Antibiotics Used Between Periods on LCM vs. Placebo
Cumulative number of antibiotics used between both groups (LCM and placebo) for each period
Time frame: 3-month period following each intervention
Population: The overall number of participants analyzed is for both study periods. The number analyzed per row is the number of participants analyzed per period. LCM (intervention) has a total of 195 participants (121 during the first 3 months and 74 during the last 3 months). The placebo arm had a total of 196 participants (119 during the first 3 months and 77 during the last 3 months).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LCM (Intervention) | Difference in Cumulative Numbers of Antibiotics Used Between Periods on LCM vs. Placebo | Month 3 | 49 Participants |
| LCM (Intervention) | Difference in Cumulative Numbers of Antibiotics Used Between Periods on LCM vs. Placebo | Month 6 | 39 Participants |
| Placebo | Difference in Cumulative Numbers of Antibiotics Used Between Periods on LCM vs. Placebo | Month 3 | 55 Participants |
| Placebo | Difference in Cumulative Numbers of Antibiotics Used Between Periods on LCM vs. Placebo | Month 6 | 35 Participants |
Secondary
Difference in Incidence Rate of Ct (Combined Pharyngeal, Urethral and Rectal) Between Each Study Arm for Each Period
Incidence rate of new Ct cases in each allocation arm (LCM and placebo) for each study period of 3 months.
Time frame: 3-month period following each intervention
Population: Intention-to-treat population. LCM (intervention) has a total of 195 participants (121 during the first 3 months and 74 during the last 3 months). The placebo arm had a total of 196 participants (119 during the first 3 months and 77 during the last 3 months).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LCM (Intervention) | Difference in Incidence Rate of Ct (Combined Pharyngeal, Urethral and Rectal) Between Each Study Arm for Each Period | First 3 months | 19 diagnoses |
| LCM (Intervention) | Difference in Incidence Rate of Ct (Combined Pharyngeal, Urethral and Rectal) Between Each Study Arm for Each Period | Last 3 months | 11 diagnoses |
| Placebo | Difference in Incidence Rate of Ct (Combined Pharyngeal, Urethral and Rectal) Between Each Study Arm for Each Period | First 3 months | 18 diagnoses |
| Placebo | Difference in Incidence Rate of Ct (Combined Pharyngeal, Urethral and Rectal) Between Each Study Arm for Each Period | Last 3 months | 10 diagnoses |
p-value: 0.77495% CI: [0.61, 1.95]Mixed Models Analysis
Secondary
Difference in Incidence Rate of Ng Plus Ct Plus Syphilis Between LCM and Placebo After Controlling for Adherence With Daily and Pre/Post Sex Mouthwash
Incidence rate of Ng, Ct and syphilis between both groups (LCM and placebo) post controlling for adherence to mouthwash
Time frame: 3-month period following each intervention
Population: Intention-to-treat population. LCM (intervention) has a total of 195 participants (121 during the first 3 months and 74 during the last 3 months). The placebo arm had a total of 196 participants (119 during the first 3 months and 77 during the last 3 months).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LCM (Intervention) | Difference in Incidence Rate of Ng Plus Ct Plus Syphilis Between LCM and Placebo After Controlling for Adherence With Daily and Pre/Post Sex Mouthwash | First 3 months: Any STIs | 36 Participants |
| LCM (Intervention) | Difference in Incidence Rate of Ng Plus Ct Plus Syphilis Between LCM and Placebo After Controlling for Adherence With Daily and Pre/Post Sex Mouthwash | First 3 months: Chlamydia | 19 Participants |
| LCM (Intervention) | Difference in Incidence Rate of Ng Plus Ct Plus Syphilis Between LCM and Placebo After Controlling for Adherence With Daily and Pre/Post Sex Mouthwash | First 3 months: Gonorrhea | 19 Participants |
| LCM (Intervention) | Difference in Incidence Rate of Ng Plus Ct Plus Syphilis Between LCM and Placebo After Controlling for Adherence With Daily and Pre/Post Sex Mouthwash | First 3 months: Syphilis | 2 Participants |
| LCM (Intervention) | Difference in Incidence Rate of Ng Plus Ct Plus Syphilis Between LCM and Placebo After Controlling for Adherence With Daily and Pre/Post Sex Mouthwash | Last 3 months: Any STI | 27 Participants |
| LCM (Intervention) | Difference in Incidence Rate of Ng Plus Ct Plus Syphilis Between LCM and Placebo After Controlling for Adherence With Daily and Pre/Post Sex Mouthwash | Last 3 months: Chlamydia | 11 Participants |
| LCM (Intervention) | Difference in Incidence Rate of Ng Plus Ct Plus Syphilis Between LCM and Placebo After Controlling for Adherence With Daily and Pre/Post Sex Mouthwash | Last 3 months: Gonorrhea | 14 Participants |
| LCM (Intervention) | Difference in Incidence Rate of Ng Plus Ct Plus Syphilis Between LCM and Placebo After Controlling for Adherence With Daily and Pre/Post Sex Mouthwash | Last 3 months: Syphilis | 4 Participants |
| Placebo | Difference in Incidence Rate of Ng Plus Ct Plus Syphilis Between LCM and Placebo After Controlling for Adherence With Daily and Pre/Post Sex Mouthwash | Last 3 months: Syphilis | 4 Participants |
| Placebo | Difference in Incidence Rate of Ng Plus Ct Plus Syphilis Between LCM and Placebo After Controlling for Adherence With Daily and Pre/Post Sex Mouthwash | First 3 months: Any STIs | 33 Participants |
| Placebo | Difference in Incidence Rate of Ng Plus Ct Plus Syphilis Between LCM and Placebo After Controlling for Adherence With Daily and Pre/Post Sex Mouthwash | Last 3 months: Any STI | 21 Participants |
| Placebo | Difference in Incidence Rate of Ng Plus Ct Plus Syphilis Between LCM and Placebo After Controlling for Adherence With Daily and Pre/Post Sex Mouthwash | First 3 months: Chlamydia | 18 Participants |
| Placebo | Difference in Incidence Rate of Ng Plus Ct Plus Syphilis Between LCM and Placebo After Controlling for Adherence With Daily and Pre/Post Sex Mouthwash | Last 3 months: Gonorrhea | 8 Participants |
| Placebo | Difference in Incidence Rate of Ng Plus Ct Plus Syphilis Between LCM and Placebo After Controlling for Adherence With Daily and Pre/Post Sex Mouthwash | First 3 months: Gonorrhea | 17 Participants |
| Placebo | Difference in Incidence Rate of Ng Plus Ct Plus Syphilis Between LCM and Placebo After Controlling for Adherence With Daily and Pre/Post Sex Mouthwash | Last 3 months: Chlamydia | 10 Participants |
| Placebo | Difference in Incidence Rate of Ng Plus Ct Plus Syphilis Between LCM and Placebo After Controlling for Adherence With Daily and Pre/Post Sex Mouthwash | First 3 months: Syphilis | 6 Participants |
p-value: 0.27995% CI: [0.86, 1.72]Mixed Models Analysis
Secondary
Difference in Incidence Rate of Pharyngeal Ng Between Each Study Arm for Each Period
Incidence rate of new pharyngeal Ng cases in each allocation arm for each study period of 3 months.
Time frame: 3-month period following each intervention
Population: Intention-to-treat population. LCM (intervention) has a total of 195 participants (121 during the first 3 months and 74 during the last 3 months). The placebo arm had a total of 196 participants (119 during the first 3 months and 77 during the last 3 months).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LCM (Intervention) | Difference in Incidence Rate of Pharyngeal Ng Between Each Study Arm for Each Period | First 3 months | 8 diagnoses |
| LCM (Intervention) | Difference in Incidence Rate of Pharyngeal Ng Between Each Study Arm for Each Period | Last 3 months | 3 diagnoses |
| Placebo | Difference in Incidence Rate of Pharyngeal Ng Between Each Study Arm for Each Period | First 3 months | 2 diagnoses |
| Placebo | Difference in Incidence Rate of Pharyngeal Ng Between Each Study Arm for Each Period | Last 3 months | 0 diagnoses |
p-value: 0.02495% CI: [1.52, 136.56]Mixed Models Analysis
Secondary
Difference in Incidence Rate of Syphilis Between Periods on LCM vs. Placebo
Incidence rate of new syphilis cases in each allocation arm (LCM and placebo) for each study period of 3 months.
Time frame: 3-month period following each intervention
Population: Intention-to-treat population. LCM (intervention) has a total of 195 participants (121 during the first 3 months and 74 during the last 3 months). The placebo arm had a total of 196 participants (119 during the first 3 months and 77 during the last 3 months).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LCM (Intervention) | Difference in Incidence Rate of Syphilis Between Periods on LCM vs. Placebo | First 3 months | 2 diagnoses |
| LCM (Intervention) | Difference in Incidence Rate of Syphilis Between Periods on LCM vs. Placebo | Last 3 months | 4 diagnoses |
| Placebo | Difference in Incidence Rate of Syphilis Between Periods on LCM vs. Placebo | First 3 months | 6 diagnoses |
| Placebo | Difference in Incidence Rate of Syphilis Between Periods on LCM vs. Placebo | Last 3 months | 4 diagnoses |
p-value: 0.32395% CI: [0.2, 1.63]Mixed Models Analysis
Secondary
Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex
Daily: Proportion of days in study used mouthwash at least daily Post sex: Proportion of casual sexual contacts in study when mouthwash used post sex. Pre sex: proportion of casual sexual contacts in study when mouthwash used pre sex
Time frame: 6-month period
Population: Intention-to-treat population.LCM (intervention) has a total of 195 participants (121 during the first 3 months and 74 during the last 3 months). The placebo arm had a total of 196 participants (119 during the first 3 months and 77 during the last 3 months).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LCM (Intervention) | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 6 pre-sex | 0-24% | 19 Participants |
| LCM (Intervention) | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 6 daily use | 75-100% | 15 Participants |
| LCM (Intervention) | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 6 pre-sex | 25-49% | 13 Participants |
| LCM (Intervention) | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 3 daily use | 25-49% | 8 Participants |
| LCM (Intervention) | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 6 pre-sex | 50-74% | 13 Participants |
| LCM (Intervention) | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 6 daily use | Missing | 40 Participants |
| LCM (Intervention) | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 6 pre-sex | 75-100% | 25 Participants |
| LCM (Intervention) | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 6 daily use | 0-24% | 6 Participants |
| LCM (Intervention) | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 6 pre-sex | Missing | 4 Participants |
| LCM (Intervention) | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 3 pre-sex | 0-24% | 30 Participants |
| LCM (Intervention) | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 3 post-sex | 0-24% | 31 Participants |
| LCM (Intervention) | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 3 daily use | 75-100% | 80 Participants |
| LCM (Intervention) | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 3 post-sex | 25-49% | 16 Participants |
| LCM (Intervention) | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 3 pre-sex | 25-49% | 15 Participants |
| LCM (Intervention) | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 3 post-sex | 50-74% | 22 Participants |
| LCM (Intervention) | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 6 daily use | 25-49% | 4 Participants |
| LCM (Intervention) | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 3 post-sex | 75-100% | 45 Participants |
| LCM (Intervention) | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 3 pre-sex | 50-74% | 20 Participants |
| LCM (Intervention) | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 3 post-sex | Missing | 7 Participants |
| LCM (Intervention) | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 3 daily use | 50-74% | 17 Participants |
| LCM (Intervention) | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 6 post-sex | 0-24% | 22 Participants |
| LCM (Intervention) | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 3 pre-sex | 75-100% | 49 Participants |
| LCM (Intervention) | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 6 post-sex | 25-49% | 13 Participants |
| LCM (Intervention) | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 6 daily use | 50-74% | 9 Participants |
| LCM (Intervention) | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 6 post-sex | 50-74% | 14 Participants |
| LCM (Intervention) | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 3 pre-sex | Missing | 7 Participants |
| LCM (Intervention) | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 6 post-sex | 75-100% | 21 Participants |
| LCM (Intervention) | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 3 daily use | Missing | 5 Participants |
| LCM (Intervention) | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 6 post-sex | Missing | 4 Participants |
| LCM (Intervention) | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 3 daily use | 0-24% | 11 Participants |
| Placebo | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 6 post-sex | Missing | 7 Participants |
| Placebo | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 3 daily use | 0-24% | 14 Participants |
| Placebo | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 3 daily use | 25-49% | 9 Participants |
| Placebo | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 3 daily use | 50-74% | 14 Participants |
| Placebo | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 3 daily use | 75-100% | 79 Participants |
| Placebo | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 3 daily use | Missing | 3 Participants |
| Placebo | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 6 daily use | 0-24% | 6 Participants |
| Placebo | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 6 daily use | 25-49% | 5 Participants |
| Placebo | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 6 daily use | 50-74% | 11 Participants |
| Placebo | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 6 daily use | 75-100% | 9 Participants |
| Placebo | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 6 daily use | Missing | 46 Participants |
| Placebo | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 3 pre-sex | 0-24% | 36 Participants |
| Placebo | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 3 pre-sex | 25-49% | 18 Participants |
| Placebo | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 3 pre-sex | 50-74% | 19 Participants |
| Placebo | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 3 pre-sex | 75-100% | 41 Participants |
| Placebo | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 3 pre-sex | Missing | 5 Participants |
| Placebo | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 6 pre-sex | 0-24% | 13 Participants |
| Placebo | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 6 pre-sex | 25-49% | 15 Participants |
| Placebo | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 6 pre-sex | 50-74% | 18 Participants |
| Placebo | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 6 pre-sex | 75-100% | 24 Participants |
| Placebo | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 6 pre-sex | Missing | 7 Participants |
| Placebo | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 3 post-sex | 0-24% | 38 Participants |
| Placebo | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 3 post-sex | 25-49% | 16 Participants |
| Placebo | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 3 post-sex | 50-74% | 26 Participants |
| Placebo | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 3 post-sex | 75-100% | 34 Participants |
| Placebo | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 3 post-sex | Missing | 5 Participants |
| Placebo | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 6 post-sex | 0-24% | 14 Participants |
| Placebo | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 6 post-sex | 25-49% | 17 Participants |
| Placebo | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 6 post-sex | 50-74% | 18 Participants |
| Placebo | Proportion of Days That Mouthwash is Used on a Daily Basis and Proportion of Casual Sex Contacts When Mouthwash is Used Pre or Post Sex | Month 6 post-sex | 75-100% | 21 Participants |