CompletedPhase 2

Antibacterial Mouthwash for Pharyngeal Gonorrhea Prevention

United States89 participantsStarted 2022-02-17

Plain-language 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: 1. Participants will maintain a high level of adherence and satisfaction with daily mouthwash use. Furthermore, the investigators hypothesize that barriers to adherence will include structural factors such as unstable housing and individual level factors such as substance use. 2. Participants receiving the antibacterial mouthwash will have a lower incidence of pharyngeal gonorrhea as compared to participants receiving the placebo mouthwash. Furthermore, the investigators hypothesize that these reductions will remain even after adjusting for other factors such as HIV-status and substance use.

Who can participate

Age range

18 Years – 45 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mouthwash Adherence - Percent of Days Mouthwash Used

Timeframe: 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

Timeframe: This outcome will be measured at 12-weeks post intervention.

Mouthwash Acceptability - Number of Participants Who Did Not Like Mouthwash Flavor/Taste

Timeframe: This outcome will be measured at 12-weeks post intervention.

Mouthwash Acceptability - Number of Participants Who Said Mouthwash Use Was Uncomfortable

Timeframe: This outcome will be measured at 12-weeks post intervention.

Mouthwash Acceptability - Number of Participants Who Said Amount of Liquid Was Too Much

Timeframe: This outcome will be measured at 12-weeks post intervention.

Mouthwash Acceptability - Number of Participants Who Said Gargling Time Was Too Long

Timeframe: This outcome will be measured at 12-weeks post intervention.

Trial details

NCT IDNCT04966507

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-16

Results submitted2026-05-13

View on ClinicalTrials.gov More Gonorrhea trials

Plain-language summary

Who can participate

Age range

18 Years – 45 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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