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:
Condition or disease | Intervention/treatment | Phase |
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Gonorrhea | Drug: Listerine Antiseptic Mouthwash Product Drug: Biotene Mouthwash | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | A Randomized Crossover Study to Evaluate the Efficacy of Antibacterial Mouthwash in Preventing Pharyngeal Gonorrhea Among a High Risk Population |
Estimated Study Start Date : | August 2021 |
Estimated Primary Completion Date : | August 2022 |
Estimated Study Completion Date : | December 2022 |
Arm | Intervention/treatment |
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Active Comparator: Listerine Cool Mint Antiseptic Mouthwash
Daily use of an antibacterial mouthwash (Listerine Cool Mint Antiseptic Mouthwash) during the 12-week follow-up period.
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Drug: Listerine Antiseptic Mouthwash Product
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.
Other Name: Active Mouthwash
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Placebo Comparator: Biotene Oral Rinse
Daily use of a placebo mouthwash with no known antibacterial qualities (Biotene Oral Rinse) during the 12-week follow-up period.
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Drug: Biotene Mouthwash
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.
Other Name: Placebo Mouthwash
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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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:
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:
Participants will be excluded from the study if:
Contact: Marjan Javanbakht, PhD | 310-739-8107 | javan@ucla.edu |
United States, California | |
Los Angeles LGBT Center | |
Los Angeles, California, United States, 90028 | |
Contact: Risa Flynn, PhD |
Principal Investigator: | Marjan Javanbakht | University of California, Los Angeles |
Tracking Information | |||||||
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First Submitted Date ICMJE | May 26, 2021 | ||||||
First Posted Date ICMJE | July 19, 2021 | ||||||
Last Update Posted Date | July 19, 2021 | ||||||
Estimated Study Start Date ICMJE | August 2021 | ||||||
Estimated Primary Completion Date | August 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | No Changes Posted | ||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Antibacterial Mouthwash for Pharyngeal Gonorrhea Prevention | ||||||
Official Title ICMJE | A Randomized Crossover Study to Evaluate the Efficacy of Antibacterial Mouthwash in Preventing Pharyngeal Gonorrhea Among a High Risk Population | ||||||
Brief Summary |
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:
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Detailed Description |
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. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE | Gonorrhea | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||
Estimated Enrollment ICMJE |
100 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | December 2022 | ||||||
Estimated Primary Completion Date | August 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
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:
Participants will be excluded from the study if:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 45 Years (Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04966507 | ||||||
Other Study ID Numbers ICMJE | R21AI147969( U.S. NIH Grant/Contract ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Marjan Javanbakht, MPH, PhD, University of California, Los Angeles | ||||||
Study Sponsor ICMJE | University of California, Los Angeles | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | University of California, Los Angeles | ||||||
Verification Date | July 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |