A Trial to Compare Antibacterial vs. Placebo Mouthwash to Reduce the Incidence of STIs in MSM Taking HIV PrEP (PReGo)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03881007|
Recruitment Status : Terminated (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.)
First Posted : March 19, 2019
Last Update Posted : July 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Sexually Transmitted Diseases||Other: Mouthwash with LCM Other: Mouthwash with placebo||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||343 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|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)|
|Actual Study Start Date :||April 3, 2019|
|Actual Primary Completion Date :||June 15, 2020|
|Actual Study Completion Date :||June 15, 2020|
Mouthwash with LCM
Other: Mouthwash with LCM
Subjects will mouthwash daily with LCM and before/after sex
Placebo Comparator: Placebo
Mouthwash with placebo
Other: Mouthwash with placebo
Subjects will mouthwash daily with placebo and before/after sex
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881007
|Institute of Tropical Medicine|
|Antwerp, Belgium, 2000|
|Principal Investigator:||Chris Kenyon, MD||Institute of Tropical Medicine Antwerp|