Sexually Transmitted Infection (STI)NCT06793605
Community Burden of MG Infection
An observational study of Sexually Transmitted Infection (STI) and Mycoplasma Genitalium Infection, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Infection (STI), Mycoplasma Genitalium Infection
- How many people
- 920 participants
- Where
- 1 siteHong Kong
- Study dates
- 18 Feb 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: men who have sex with men in Hong Kong
Who may be able to join
- 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
Who cannot join
- cannot provide consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong, 0000
Ngai Sze Wong, PhD, 22528862, candy_wong@cuhk.edu.hk
About this study
Official title: 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
Read the 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.
- Keywords
- Mycoplasma genitalium, Chlamydia trachomatis, Neisseria gonorrhoeae, men who have sex with men
- Medical subject headings
- Sexually Transmitted Diseases, Homosexuality
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of MG infection
detection of MG infections in self-collected samples divided by the total number of samples collected
Measured: 1 year
prevalence of MG resistance mutations
detection of MG resistance mutations macrolide/fluoroquinolone in MG positive samples divided by the total number of MG positive samples
Measured: 1 year
Secondary outcomes (4)
prevalence of CT infection
detection of CT infections in self-collected samples divided by the total number of samples collected
Measured: 1 year
prevalence of NG infection
detection of NG infections in self-collected samples divided by the total number of samples collected
Measured: 1 year
co-infection of STIs
number of co-infection of HIV, CT, NG, and/or MG
Measured: 1 year
history of STI and HIV testing
number of self-reported history of STI and/or HIV testing at survey
Measured: ever
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start18 Feb 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexually Transmitted Infection (STI)Studies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 920 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ngai Sze WONG, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793605
- Sponsor's protocol ID
- MGMSM1
- Status last verified
- Mar 2025
- First submitted
- 21 Jan 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Burden of Mycoplasma Genitalium Infection and Its Implications for Test-and-treat Strategies
- ClinicalTrials.gov ID
- NCT06793605
- Acronym / sponsor ID
- MGMSM1
- Keywords
- Mycoplasma genitalium, Chlamydia trachomatis, Neisseria gonorrhoeae, men who have sex with men
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 920 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- men who have sex with men in Hong Kong
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- cannot provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence of MG infection
Time frame: 1 year
detection of MG infections in self-collected samples divided by the total number of samples collected
prevalence of MG resistance mutations
Time frame: 1 year
detection of MG resistance mutations macrolide/fluoroquinolone in MG positive samples divided by the total number of MG positive samples
4 secondary outcomes
prevalence of CT infection
Time frame: 1 year
prevalence of NG infection
Time frame: 1 year
co-infection of STIs
Time frame: 1 year
history of STI and HIV testing
Time frame: ever
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexually Transmitted Infection (STI) and Mycoplasma Genitalium Infection, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of MG infection (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.