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A Trial to Compare Antibacterial vs. Placebo Mouthwash to Reduce the Incidence of STIs in MSM Taking HIV PrEP (PReGo)

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ClinicalTrials.gov Identifier: NCT03881007
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Institute of Tropical Medicine, Belgium

Tracking Information
First Submitted Date  ICMJE March 13, 2019
First Posted Date  ICMJE March 19, 2019
Last Update Posted Date April 8, 2019
Actual Study Start Date  ICMJE April 3, 2019
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
Incidence rate of NG plus Ct plus Syphilis in each study arm for each period [ Time Frame: 3-month period ]
The sum of new diagnoses of Ng, 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 RPR and TPA tests according to currently used European case definitions
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03881007 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
  • Difference in Incidence rate of pharyngeal Ng between each study arm for each period [ Time Frame: 3-month 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 [ Time Frame: 3-month 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 [ Time Frame: 3-month period ]
    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 [ Time Frame: 6-month period ]
    Daily: Proportion of days in study used mouthwash at least daily Pre/post sex: Proportion of casual sexual contacts in study when mouthwash used pre and 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 [ Time Frame: 3-month period ]
    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 [ Time Frame: 3-month period ]
    Cumulative number of antibiotics used between both groups (LCM and placebo) for each period
  • Assess if resistance to LCM in Ng and N. flavescens can be induced (time to induction of LCM resistance) in the NGmorbidostat and if so which mutations are associated with resistance [ Time Frame: 6-month period ]
    Ng: Time to induction of LCM resistance N. flavescens: Time to induction of LCM resistance
  • Assess if LCM-resistance-associated mutations are more prevalent (1) in those receiving LCM vs. placebo (Inter-individual comparison) (2) after 3 months on LCM than before receiving LCM (Intra-individual comparison) [ Time Frame: 3-month period ]
    Prevalence of LCM-resistance-associated mutations in the pharyngeal and rectal microbiome of the LCM group vs placebo-group. Prevalence of LCM-resistance-associated mutations in those receiving LCM after 3 months vs before receiving LCM.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial to Compare Antibacterial vs. Placebo Mouthwash to Reduce the Incidence of STIs in MSM Taking HIV PrEP
Official Title  ICMJE 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)
Brief Summary The study involves a randomized placebo controlled trial that aims to assess if a mouthwash (Listerine cool mint) is able to reduce the cumulative incidence of gonorrhoea, chlamydia and syphilis in men who have sex with men and receiving preexposure prophylaxis at the Institute of Tropical Medicine.
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Sexually Transmitted Diseases
Intervention  ICMJE
  • Other: Mouthwash with LCM
    Subjects will mouthwash daily with LCM and before/after sex
  • Other: Mouthwash with placebo
    Subjects will mouthwash daily with placebo and before/after sex
Study Arms  ICMJE
  • Experimental: LCM
    Mouthwash with LCM
    Intervention: Other: Mouthwash with LCM
  • Placebo Comparator: Placebo
    Mouthwash with placebo
    Intervention: Other: Mouthwash with placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 18, 2019)
320
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2020
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Natacha Herssens, MSc 003232470778 nherssens@itgb.be
Contact: Chris Kenyon, MD 003232470786 ckenyon@itg.be
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03881007
Other Study ID Numbers  ICMJE ITM201801
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Institute of Tropical Medicine, Belgium
Study Sponsor  ICMJE Institute of Tropical Medicine, Belgium
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chris Kenyon, MD Institute of Tropical Medicine Antwerp
PRS Account Institute of Tropical Medicine, Belgium
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP