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A Trial to Compare Antibacterial vs. Placebo Mouthwash to Reduce the Incidence of Sexually Transmitted Infections (STIs) in Men Who Have Sex With Men (MSM) Taking HIV Pre-Exposure Prophylaxis (PrEP) (PReGo)

Primary Purpose

Sexually Transmitted Diseases

Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Mouthwash with LCM
Mouthwash with placebo
Sponsored by
Institute of Tropical Medicine, Belgium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexually Transmitted Diseases focused on measuring Gonorrhea, Syphilis, Chlamydia, Listerine, STI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Institute of Tropical Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

LCM, then placebo

Placebo, then LCM

Arm Description

Mouthwash with LCM for 3 months followed by mouthwash with placebo for 3 months.

Mouthwash with placebo for 3 months followed by mouthwash with LCM for 3 months

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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
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
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

Full Information

First Posted
March 13, 2019
Last Updated
April 12, 2021
Sponsor
Institute of Tropical Medicine, Belgium
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1. Study Identification

Unique Protocol Identification Number
NCT03881007
Brief Title
A Trial to Compare Antibacterial vs. Placebo Mouthwash to Reduce the Incidence of Sexually Transmitted Infections (STIs) in Men Who Have Sex With Men (MSM) Taking HIV Pre-Exposure Prophylaxis (PrEP)
Acronym
PReGo
Official Title
A Double-blind Single Center, Crossover, Randomized Controlled Trial of Antibacterial vs. Placebo Mouthwash to Reduce the Incidence of Gonorrhea/Chlamydia/Syphilis in MSM Taking HIV Pre-exposure Prophylaxis (PrEP)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
An interim analysis, planned because of the influence of the COVID-lockdown, showed the LCM mouthwash did not affect the incidence of Ng, Ct and syphilis.
Study Start Date
April 3, 2019 (Actual)
Primary Completion Date
June 15, 2020 (Actual)
Study Completion Date
June 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Tropical Medicine, Belgium

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Diseases
Keywords
Gonorrhea, Syphilis, Chlamydia, Listerine, STI

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
343 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LCM, then placebo
Arm Type
Experimental
Arm Description
Mouthwash with LCM for 3 months followed by mouthwash with placebo for 3 months.
Arm Title
Placebo, then LCM
Arm Type
Experimental
Arm Description
Mouthwash with placebo for 3 months followed by mouthwash with LCM for 3 months
Intervention Type
Other
Intervention Name(s)
Mouthwash with LCM
Intervention Description
Subjects will mouthwash daily with LCM and before/after sex
Intervention Type
Other
Intervention Name(s)
Mouthwash with placebo
Intervention Description
Subjects will mouthwash daily with placebo and before/after sex
Primary Outcome Measure Information:
Title
Patient Counts of Ng Plus Ct Plus Syphilis in Each Study Arm for Each Period
Description
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
Secondary Outcome Measure Information:
Title
Difference in Incidence Rate of Pharyngeal Ng Between Each Study Arm for Each Period
Description
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
Title
Difference in Incidence Rate of Ct (Combined Pharyngeal, Urethral and Rectal) Between Each Study Arm for Each Period
Description
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
Title
Difference in Incidence Rate of Syphilis Between Periods on LCM vs. Placebo
Description
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
Title
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
Description
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
Title
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
Description
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
Title
Difference in Cumulative Numbers of Antibiotics Used Between Periods on LCM vs. Placebo
Description
Cumulative number of antibiotics used between both groups (LCM and placebo) for each period
Time Frame
3-month period following each intervention

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Kenyon, MD
Organizational Affiliation
Institute of Tropical Medicine Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Tropical Medicine
City
Antwerp
ZIP/Postal Code
2000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data sharing for the PreGo trial will comply with ITMs Data Sharing Policy. Study data might be made available for secondary research and analyses to external researchers by means of a managed access procedure within 12 months of publication date. Because of privacy concerns, access requests will be reviewed and approved prior to release by ITMs Data Access Committee. Requests for access can be made centrally through: https://www.itg.be/E/data-sharing-open-access The possibility of sharing (anonymized) study data is also mentioned in the Informed Consent Form and approved by the Ethics Committees that approved the initial PreGo clinical trial protocol.
IPD Sharing Time Frame
Available in clinicaltrials.gov
Citations:
PubMed Identifier
33676596
Citation
Van Dijck C, Tsoumanis A, Rotsaert A, Vuylsteke B, Van den Bossche D, Paeleman E, De Baetselier I, Brosius I, Laumen J, Buyze J, Wouters K, Lynen L, Van Esbroeck M, Herssens N, Abdellati S, Declercq S, Reyniers T, Van Herrewege Y, Florence E, Kenyon C. Antibacterial mouthwash to prevent sexually transmitted infections in men who have sex with men taking HIV pre-exposure prophylaxis (PReGo): a randomised, placebo-controlled, crossover trial. Lancet Infect Dis. 2021 May;21(5):657-667. doi: 10.1016/S1473-3099(20)30778-7. Epub 2021 Mar 4.
Results Reference
derived

Learn more about this trial

A Trial to Compare Antibacterial vs. Placebo Mouthwash to Reduce the Incidence of Sexually Transmitted Infections (STIs) in Men Who Have Sex With Men (MSM) Taking HIV Pre-Exposure Prophylaxis (PrEP)

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