Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R21AI147969 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
Not provided
Not provided
Not provided
This study aims to determine acceptability and preliminary efficacy of daily use of an antibacterial mouthwash as compared to a placebo mouthwash in reducing the incidence of pharyngeal gonorrhea among a cohort of HIV-positive and high risk HIV-negative men.
Investigators plan to test the following hypotheses:
The proposed study will build on the NIH/NIDA funded mSTUDY (U01 DA036267 PIs Gorbach and Shoptaw), which is a longitudinal study designed to assess the impact of substance use and HIV on minority MSM. Participants in the proposed study will be those enrolled in the mSTUDY and the objectives of this study are to measure the preliminary efficacy and acceptability of antibacterial mouthwash use for the prevention of pharyngeal gonorrhea among a cohort of high risk HIV-negative and HIV-positive MSM. In order to achieve this goal the investigators propose to conduct a double-blind, randomized, crossover trial of daily antibacterial mouthwash use as compared to a placebo mouthwash among mSTUDY participants at high risk for pharyngeal gonorrhea (i.e. previously diagnosed with pharyngeal gonorrhea). Participants will be followed for a total of 24 weeks, with each participant receiving 12-weeks of antibacterial mouthwash and 12-weeks of placebo mouthwash.
After providing written informed consent, participants will complete a computer-based questionnaire, provide biological specimen, and will be randomly allocated to their study group. The study survey will include questions that are collected as part of mSTUDY as well as questions relevant to the proposed study. Following the questionnaire, participants will provide a bio-specimen for STI testing including: (1) urine, for chlamydia and gonorrhea testing; (2) rectal and pharyngeal swabs for gonorrhea and chlamydia testing; and (3) blood, which is used for syphilis and HIV testing, and HIV-1 RNA levels (for HIV-positive).
Participants will be randomly allocated to either first receive a 12-week antibacterial mouthwash followed by 12-weeks of placebo mouthwash or start with 12-weeks of placebo mouthwash and crossover to 12-weeks of antibacterial mouthwash. The antibacterial mouthwash and placebo are commercially available products (Cool Mint Listerine® Antiseptic mouthwash and Biotene® Oral Rinse respectively) and are selected based on evidence demonstrating inhibitory effects of the antibacterial mouthwash (Cool Mint Listerine® Antiseptic mouthwash) against N. gonorrhoeae. In order to ensure concealment of study allocation and to allow for blinding, the following procedures will be instituted:
When participants return for the 12-week visit, they will receive another 12-week supply, which will be the crossover condition to what was assigned at baseline. Participants will be instructed to stop using any other mouthwash they may have been using prior to study enrollment. All participants will be asked to return to the study site for a 12-week follow-up visit. This visit is a study specific visit and is the only visit of the three study visits that does not overlap with an mSTUDY follow-up visit. Participants will be asked to complete a computer-based survey to collect information comparable to what was collected at baseline including information on sexual behaviors, substance use, and oral hygiene practices. Additionally, participants will be asked to complete questions regarding study mouthwash us including frequency and timing of mouthwash use (i.e., intervention fidelity) and acceptability of mouthwash. Pharyngeal swabs will be collected in order to test for gonorrhea including nucleic acid amplification testing (NAAT) and culture testing. All participants will be asked to return in 12-weeks (i.e., 24-weeks from baseline) which will coincide with an mSTUDY visit and data collection procedures from baseline will be repeated including laboratory testing for STIs and survey administration.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Listerine Cool Mint Antiseptic Mouthwash | Active Comparator | Daily use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash) during the 12-week follow-up period. |
|
| Biotene Oral Rinse | Placebo Comparator | Daily use of a placebo mouthwash with no known antibacterial qualities (Biotene Oral Rinse) during the 12-week follow-up period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Listerine Antiseptic Mouthwash Product | Drug | COOL MINT LISTERINE® Antiseptic Mouthwash will be used as the 'active' study drug condition. This is a commercially available, over the counter mouthwash product. Active ingredients for this product include Eucalyptol 0.092%, Menthol 0.042%, Methyl salicylate 0.060%, Thymol 0.064%. This product also contains 21% alcohol. Participants will be asked to rinse and gargle their mouth with 20mL of mouthwash daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Mouthwash Adherence - Percent of Days Mouthwash Used | This outcome was assessed using self-reported questionnaire data asking participants to report "In the past 3 months, what proportion of days did you use the mouthwash?" | This outcome will be measured over each 12-week intervention period |
| Mouthwash Acceptability - Number of Participants Who Reported it Was Hard to Gargle/Rinse With Mouthwash | This outcome will be assessed using self-reported questionnaire and is intended to measure acceptability of mouthwash as prevention strategy for pharyngeal gonnorrhea. Participants were asked "Did you experience any of the following difficulties using the mouthwash?" with answer choices including: It was hard to gargle/rinse I didn't like the mouthwash flavor/taste It was uncomfortable Amount of liquid was too much Amount of gargling time was too long | This outcome will be measured at 12-weeks post intervention. |
| Mouthwash Acceptability - Number of Participants Who Did Not Like Mouthwash Flavor/Taste | This outcome will be assessed using self-reported questionnaire and is intended to measure acceptability of mouthwash as prevention strategy for pharyngeal gonnorrhea. Participants were asked "Did you experience any of the following difficulties using the mouthwash?" with answer choices including: It was hard to gargle/rinse I didn't like the mouthwash flavor/taste It was uncomfortable Amount of liquid was too much Amount of gargling time was too long | This outcome will be measured at 12-weeks post intervention. |
| Mouthwash Acceptability - Number of Participants Who Said Mouthwash Use Was Uncomfortable | This outcome will be assessed using self-reported questionnaire and is intended to measure acceptability of mouthwash as prevention strategy for pharyngeal gonnorrhea. Participants were asked "Did you experience any of the following difficulties using the mouthwash?" with answer choices including: It was hard to gargle/rinse I didn't like the mouthwash flavor/taste It was uncomfortable Amount of liquid was too much Amount of gargling time was too long |
| Measure | Description | Time Frame |
|---|---|---|
| Pharyngeal Gonorrhea - Laboratory Testing Results | Laboratory confirmed pharyngeal gonorrhea | Past 12 weeks |
Not provided
This study will only include participants recruited as part an NIH/NIDA funded study (U01 DA036267 PIs Gorbach and Shoptaw) - the mSTUDY. By design, half of the participants are HIV-positive and half are HIV-negative and other inclusion criteria for the mSTUDY are as follows:
At least 18 but not older than 45 years of age on day of consent
Identified biologically male at birth
Willing to return for follow-up study visits every 6 months as long as the study is ongoing and be available to return for all study visits, barring unforeseen circumstances
Willing and able to provide written informed consent to take part in the study
Willing and able to provide adequate information for locator purposes
STI testing at each study visit (with reporting and treatment referral when indicated)
Understands and agrees to local STI reporting requirements
If HIV-negative at screening, report unprotected anal intercourse with a male in the past 6 months
Additional inclusion criteria specific to this study are:
Currently enrolled in mSTUDY
mSTUDY participants who have turned 45 since enrollment in mSTUDY continue to be eligible for inclusion in this study.
Previously diagnosed with pharyngeal gonorrhea (while an mSTUDY participant)
Participants will be excluded from the study if:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marjan Javanbakht | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles LGBT Center | Los Angeles | California | 90028 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants in this study were drawn from mSTUDY, an NIH/NIDA-funded longitudinal cohort study (U01 DA036267) designed to examine the impact of substance use and HIV among men. Participants in mSTUDY were recruited from two sites: a community-based organization providing sexual health services and a university-affiliated research clinic. Recruitment for this study began in February 2022 and concluded in August 2024.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Listerine Cool Mint Antiseptic Mouthwash, Then Biotene Oral Rinse | Daily use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash) for 12-weeks, followed by daily use of a placebo mouthwash (Biotene Oral Rinse) for 12-weeks. |
| FG001 | Biotene Oral Rinse, Then Listerine Cool Mint Antiseptic Mouthwash | Daily use of a placebo mouthwash (Biotene Oral Rinse) for 12-weeks, followed by 12-weeks of dialy use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: First Intervention (12 weeks) |
| |||||||||||||
| Period 2: Second Intervention (12 weeks) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Listerine Cool Mint Antiseptic Mouthwash, Then Biotene Oral Rinse | Daily use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash) for 12-weeks, followed by daily use of a placebo mouthwash (Biotene Oral Rinse) for 12-weeks. |
| BG001 | Biotene Oral Rinse, Then Listerine Cool Mint Antiseptic Mouthwash |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | This is a cross over with the same 89 participants completing both study arms |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mouthwash Adherence - Percent of Days Mouthwash Used | This outcome was assessed using self-reported questionnaire data asking participants to report "In the past 3 months, what proportion of days did you use the mouthwash?" | Among the 45 participants assigned to the active-to-placebo sequence and the 44 participants assigned to the placebo-to-active sequence, 32 participants in each sequence completed the first 12-week follow-up assessment. Among the 32 participants in active-to-placebo sequence that completed the 12-week assessment, 31 completed the 24-week assess. Among the 32 participants in placebo-to-active sequence that completed the 12-week assessment, 28 completed the 24-week assess. | Posted | Count of Participants | Participants | This outcome will be measured over each 12-week intervention period |
|
From enrollment until end of follow-up at 24 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1. Listerine Cool Mint Antiseptic Mouthwash | Daily use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash) during the 12-week follow-up period. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marjan Javanbakht | University of California Los Angeles | 310-825-3234 | javan@ucla.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2021 | May 13, 2026 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006069 | Gonorrhea |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Biotene Mouthwash | Drug | Biotène Rinse is designed with a moisturizing formula to help relieve dry mouth symptoms and is specifically designed to have a pH similar to saliva. This is a commercially available, over the counter mouthwash product. Biotène Mouthwash Ingredients include: Purified Water, Propylene Glycol, Hydrogenated Starch Hydrolysate, Poloxamer 407, Hydroxyethylcellulose, Sodium Benzoate, Flavor (Peppermint Oil), Benzoic Acid, Disodium Phosphate, Zinc Gluconate, Lactoferrin, Lysozyme, Lactoperoxidase, Potassium Thiocyanate, Aloe Vera Gel, Calcium Lactate, Glucose Oxidase. Participants will be asked to rinse and gargle their mouth with 20mL of mouthwash daily. |
|
|
| This outcome will be measured at 12-weeks post intervention. |
| Mouthwash Acceptability - Number of Participants Who Said Amount of Liquid Was Too Much | This outcome will be assessed using self-reported questionnaire and is intended to measure acceptability of mouthwash as prevention strategy for pharyngeal gonnorrhea. Participants were asked "Did you experience any of the following difficulties using the mouthwash?" with answer choices including: It was hard to gargle/rinse I didn't like the mouthwash flavor/taste It was uncomfortable Amount of liquid was too much Amount of gargling time was too long | This outcome will be measured at 12-weeks post intervention. |
| Mouthwash Acceptability - Number of Participants Who Said Gargling Time Was Too Long | This outcome will be assessed using self-reported questionnaire and is intended to measure acceptability of mouthwash as prevention strategy for pharyngeal gonnorrhea. Participants were asked "Did you experience any of the following difficulties using the mouthwash?" with answer choices including: It was hard to gargle/rinse I didn't like the mouthwash flavor/taste It was uncomfortable Amount of liquid was too much Amount of gargling time was too long | This outcome will be measured at 12-weeks post intervention. |
| NOT COMPLETED |
|
Daily use of a placebo mouthwash (Biotene Oral Rinse) for 12-weeks, followed by 12-weeks of dialy use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash) |
| BG002 | Total | Total of all reporting groups |
| Median |
| Inter-Quartile Range |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Daily use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash) for 12-weeks, followed by daily use of a placebo mouthwash (Biotene Oral Rinse) for 12-weeks.
| OG001 | Biotene Oral Rinse, Then Listerine Cool Mint Antiseptic Mouthwash | Daily use of a placebo mouthwash (Biotene Oral Rinse) for 12-weeks, followed by 12-weeks of dialy use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash) |
|
|
| Secondary | Pharyngeal Gonorrhea - Laboratory Testing Results | Laboratory confirmed pharyngeal gonorrhea | Among the 45 participants assigned to the active-to-placebo sequence and the 44 participants assigned to the placebo-to-active sequence, 32 participants in each sequence completed the first 12-week follow-up assessment. Among the 32 participants in active-to-placebo sequence that completed the 12-week assessment, 31 completed the 24-week assess. Among the 32 participants in placebo-to-active sequence that completed the 12-week assessment, 28 completed the 24-week assess. | Posted | Count of Participants | Participants | No | Past 12 weeks |
|
|
|
| Primary | Mouthwash Acceptability - Number of Participants Who Reported it Was Hard to Gargle/Rinse With Mouthwash | This outcome will be assessed using self-reported questionnaire and is intended to measure acceptability of mouthwash as prevention strategy for pharyngeal gonnorrhea. Participants were asked "Did you experience any of the following difficulties using the mouthwash?" with answer choices including: It was hard to gargle/rinse I didn't like the mouthwash flavor/taste It was uncomfortable Amount of liquid was too much Amount of gargling time was too long | Among the 45 participants assigned to the active-to-placebo sequence and the 44 participants assigned to the placebo-to-active sequence, 32 participants in each sequence completed the first 12-week follow-up assessment. Among the 32 participants in active-to-placebo sequence that completed the 12-week assessment, 31 completed the 24-week assess. Among the 32 participants in placebo-to-active sequence that completed the 12-week assessment, 28 completed the 24-week assess. | Posted | Count of Participants | Participants | This outcome will be measured at 12-weeks post intervention. |
|
|
|
| Primary | Mouthwash Acceptability - Number of Participants Who Did Not Like Mouthwash Flavor/Taste | This outcome will be assessed using self-reported questionnaire and is intended to measure acceptability of mouthwash as prevention strategy for pharyngeal gonnorrhea. Participants were asked "Did you experience any of the following difficulties using the mouthwash?" with answer choices including: It was hard to gargle/rinse I didn't like the mouthwash flavor/taste It was uncomfortable Amount of liquid was too much Amount of gargling time was too long | Among the 45 participants assigned to the active-to-placebo sequence and the 44 participants assigned to the placebo-to-active sequence, 32 participants in each sequence completed the first 12-week follow-up assessment. Among the 32 participants in active-to-placebo sequence that completed the 12-week assessment, 31 completed the 24-week assess. Among the 32 participants in placebo-to-active sequence that completed the 12-week assessment, 28 completed the 24-week assess. | Posted | Count of Participants | Participants | This outcome will be measured at 12-weeks post intervention. |
|
|
|
| Primary | Mouthwash Acceptability - Number of Participants Who Said Mouthwash Use Was Uncomfortable | This outcome will be assessed using self-reported questionnaire and is intended to measure acceptability of mouthwash as prevention strategy for pharyngeal gonnorrhea. Participants were asked "Did you experience any of the following difficulties using the mouthwash?" with answer choices including: It was hard to gargle/rinse I didn't like the mouthwash flavor/taste It was uncomfortable Amount of liquid was too much Amount of gargling time was too long | Among the 45 participants assigned to the active-to-placebo sequence and the 44 participants assigned to the placebo-to-active sequence, 32 participants in each sequence completed the first 12-week follow-up assessment. Among the 32 participants in active-to-placebo sequence that completed the 12-week assessment, 31 completed the 24-week assess. Among the 32 participants in placebo-to-active sequence that completed the 12-week assessment, 28 completed the 24-week assess. | Posted | Count of Participants | Participants | No | This outcome will be measured at 12-weeks post intervention. |
|
|
|
| Primary | Mouthwash Acceptability - Number of Participants Who Said Amount of Liquid Was Too Much | This outcome will be assessed using self-reported questionnaire and is intended to measure acceptability of mouthwash as prevention strategy for pharyngeal gonnorrhea. Participants were asked "Did you experience any of the following difficulties using the mouthwash?" with answer choices including: It was hard to gargle/rinse I didn't like the mouthwash flavor/taste It was uncomfortable Amount of liquid was too much Amount of gargling time was too long | Among the 45 participants assigned to the active-to-placebo sequence and the 44 participants assigned to the placebo-to-active sequence, 32 participants in each sequence completed the first 12-week follow-up assessment. Among the 32 participants in active-to-placebo sequence that completed the 12-week assessment, 31 completed the 24-week assess. Among the 32 participants in placebo-to-active sequence that completed the 12-week assessment, 28 completed the 24-week assess. | Posted | Count of Participants | Participants | This outcome will be measured at 12-weeks post intervention. |
|
|
|
| Primary | Mouthwash Acceptability - Number of Participants Who Said Gargling Time Was Too Long | This outcome will be assessed using self-reported questionnaire and is intended to measure acceptability of mouthwash as prevention strategy for pharyngeal gonnorrhea. Participants were asked "Did you experience any of the following difficulties using the mouthwash?" with answer choices including: It was hard to gargle/rinse I didn't like the mouthwash flavor/taste It was uncomfortable Amount of liquid was too much Amount of gargling time was too long | Among the 45 participants assigned to the active-to-placebo sequence and the 44 participants assigned to the placebo-to-active sequence, 32 participants in each sequence completed the first 12-week follow-up assessment. Among the 32 participants in active-to-placebo sequence that completed the 12-week assessment, 31 completed the 24-week assess. Among the 32 participants in placebo-to-active sequence that completed the 12-week assessment, 28 completed the 24-week assess. | Posted | Count of Participants | Participants | This outcome will be measured at 12-weeks post intervention. |
|
|
|
| 0 |
| 89 |
| 0 |
| 89 |
| 0 |
| 89 |
| EG001 | Biotene Oral Rinse | Daily use of a placebo mouthwash with no known antibacterial qualities (Biotene Oral Rinse) during the 12-week follow-up period. | 0 | 89 | 0 | 89 | 0 | 89 |
Not provided
Not provided
| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| 25%-49% of days |
|
| 0%-24% of days |
|
| Lost to follow-up |
|
| Not Done |
|
| Pharyngeal gonorrhea laboratory results, period 2 (second 12-weeks after crossover) |
|
| Lost to follow-up |
|
| Period 2 (second 12-weeks after crossover) |
|
| Lost to follow-up |
|
| Period 2 (second 12-weeks after crossover) |
|
| Lost to follow-up |
|
| Period 2 (second 12-weeks after crossover) |
|
| Lost to follow-up |
|
| Period 2 (second 12-weeks after crossover) |
|
| Lost to follow-up |
|
| Period 2 (second 12-weeks after crossover) |
|