- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06793605
Community Burden of MG Infection
Community Burden of Mycoplasma Genitalium Infection and Its Implications for Test-and-treat Strategies
Objective: To assess the burden and the transmission dynamics of Mycoplasma genitalium (MG) infection in men who have sex with men in Hong Kong.
Design and setting: involving a) a cross-sectional study (completion of an online self-administered survey, followed by self-sampling for testing in the laboratory, and performance of HIV self-test); b) a mathematical modelling study to simulate the transmission dynamics of MG infection and resistant MG infection and compare the impacts of test-and-treat strategies.
Participants: Around 920 men who have sex with men would be recruited
Study Overview
Status
Detailed Description
Cross-sectional study: A total of 920 men who have sex with men aged 18 or above and normally living in Hong Kong would be recruited. Eligible participants would be asked to complete a self-administered online survey, submit self-collected urine specimen and rectal swabs for Chlamydia trachomatis, Neisseria gonorrhoeae, and Mycoplasma genitalium testing in the laboratory, and submit HIV self-test results.
Mathematical modelling study: A compartmental model would be constructed to simulate the transmission dynamics of MG infection and resistant MG infection, and analyse the impact of different test-and-treat strategies.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Hong Kong, Hong Kong, 0000
- Recruiting
- The Chinese University of Hong Kong
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Contact:
- Ngai Sze Wong, PhD
- Phone Number: 22528862
- Email: candy_wong@cuhk.edu.hk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- men who have sex with men aged 18 or above, normally living in Hong Kong, and could communicate in written and spoken English or Chinese
Exclusion Criteria:
- cannot provide consent
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
prevalence of MG infection
Time Frame: 1 year
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detection of MG infections in self-collected samples divided by the total number of samples collected
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1 year
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prevalence of MG resistance mutations
Time Frame: 1 year
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detection of MG resistance mutations macrolide/fluoroquinolone in MG positive samples divided by the total number of MG positive samples
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
prevalence of CT infection
Time Frame: 1 year
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detection of CT infections in self-collected samples divided by the total number of samples collected
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1 year
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prevalence of NG infection
Time Frame: 1 year
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detection of NG infections in self-collected samples divided by the total number of samples collected
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1 year
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co-infection of STIs
Time Frame: 1 year
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number of co-infection of HIV, CT, NG, and/or MG
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1 year
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history of STI and HIV testing
Time Frame: ever
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number of self-reported history of STI and/or HIV testing at survey
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ever
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Pathologic Processes
- Disease Attributes
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Negative Bacterial Infections
- Pleural Diseases
- Pleurisy
- Mycoplasmatales Infections
- Infections
- Communicable Diseases
- Sexually Transmitted Diseases
- Pleuropneumonia
- Mycoplasma Infections
Other Study ID Numbers
- MGMSM1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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