STINCT05789134
Mycoplasma Genitalium Infection and Associated Antimicrobial Resistance Among HIV-infected Male in Hong Kong
An observational study of STI and Mycoplasma Genitalium Infection, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Worldwide, Mycoplasma genitalium (MG) is increasingly reported as an emerging cause of sexually transmitted infections. Internationally, the prevalence of MG is higher in male with urethritis and community groups especially among people living with HIV (PLHIV). 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
- STI, Mycoplasma Genitalium Infection
- What is being tested?
- self-sampling kits for STI testing in the laboratory
- How many people
- 573 participants
- Where
- 1 siteHong Kong
- Study dates
- 24 Jul 2023to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: HIV-infected male who are attending the HIV specialist clinic in Hong Kong
Who may be able to join
- aged 18 or older, male, HIV-infected, and are attendees of the HIV specialist clinic, and can communicate in written and spoken English or Chinese
Who cannot join
- not able to provide consent
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The Chinese University of Hong Kong
Hong Kong, Hong Kong, China, 0000
About this study
Worldwide, Mycoplasma genitalium (MG) is increasingly reported as an emerging cause of sexually transmitted infections. Internationally, the prevalence of MG is higher in male with urethritis and community groups especially among people living with HIV (PLHIV). While MG is treatable, antimicrobial resistance is a rising concern. This cross-sectional study aims to determine the prevalence of MG infection and the antimicrobial resistance pattern in HIV-infected male in Hong Kong.
A total of 750 HIV-infected male attending HIV specialist clinic in Hong Kong would be recruited. The main outcome measures include prevalence of MG and resistance mutations to macrolide/fluoroquinolone in HIV-infected male; prevalence of MG/STI co-infections, as defined by concurrent detection of MG and one or more other bacterial STI.
Read the detailed description
A total of 750 HIV-infected male attending HIV specialist clinic in Hong Kong would be recruited. An online questionnaire would be self-administered. The participants would self-collect urine sample, rectal and pharyngeal swabs for MG, Chlamydia trachomatis (CT) and Neisseria Gonorrhoeae (NG) screening by nucleic acid amplification tests, and MG genotypic resistance mutations detection. Clinical data would be transcribed from medical records of recruited subjects.
- Conditions
- STI, Mycoplasma Genitalium Infection
- Being tested
- self-sampling kits for STI testing in the laboratory
- Keywords
- chlamydia trachomatis, Mycoplasma Genitalium Infection, Neisseria gonorrhoeae, men who have sex with men, heterosexual men, people living with HIV
- Medical subject headings
- Sexually Transmitted Diseases, Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-sampling kits for STI testing in the laboratoryOther
Participants will receive the self-sampling kits and their submitted samples would be sent to laboratory for testing
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
- detection of MG resistance mutations macrolide/fluoroquinolone in MG positive samples divided by the total number of samples collected
Measured: 1 year
Secondary outcomes (5)
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
prevalence of syphilis
total number of reported syphilis diagnosis divided by total number of participants tested for syphilis in the clinic
Measured: 1 year
prevalence of HCV infection
total number of reported HCV diagnosis divided by total number of participants tested for HCV in the clinic
Measured: 1 year
prevalence of overall STI
total number of reported STI diagnosis divided by total number of participants tested for STI in the clinic
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start24 Jul 2023
- Primary completion27 Jun 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STIStudies 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
- 573 participants (actual)
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
- NCT05789134
- Sponsor's protocol ID
- 22210282
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2023
- Last updated
- 18 Mar 2026
- 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 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mycoplasma Genitalium Infection and Associated Antimicrobial Resistance Among HIV-infected Male in Hong Kong
- ClinicalTrials.gov ID
- NCT05789134
- Acronym / sponsor ID
- 22210282
- Conditions
- STI, Mycoplasma Genitalium Infection
- Keywords
- chlamydia trachomatis, Mycoplasma Genitalium Infection, Neisseria gonorrhoeae, men who have sex with men, heterosexual men, people living with HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 573 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 29 Mar 2023 (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.
Worldwide, Mycoplasma genitalium (MG) is increasingly reported as an emerging cause of sexually transmitted infections. Internationally, the prevalence of MG is higher in male with urethritis and community groups especially among people living with HIV (PLHIV). While MG is treatable, antimicrobial resistance is a rising concern. This cross-sectional study aims to determine the prevalence of MG infection and the antimicrobial resistance pattern in HIV-infected male in Hong Kong.
A total of 750 HIV-infected male attending HIV specialist clinic in Hong Kong would be recruited. The main outcome measures include prevalence of MG and resistance mutations to macrolide/fluoroquinolone in HIV-infected male; prevalence of MG/STI co-infections, as defined by concurrent detection of MG and one or more other bacterial STI.
Detailed description
A total of 750 HIV-infected male attending HIV specialist clinic in Hong Kong would be recruited. An online questionnaire would be self-administered. The participants would self-collect urine sample, rectal and pharyngeal swabs for MG, Chlamydia trachomatis (CT) and Neisseria Gonorrhoeae (NG) screening by nucleic acid amplification tests, and MG genotypic resistance mutations detection. Clinical data would be transcribed from medical records of recruited subjects.
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
- HIV-infected male who are attending the HIV specialist clinic in Hong Kong
Key inclusion criteria (1 listed)
- aged 18 or older, male, HIV-infected, and are attendees of the HIV specialist clinic, and can communicate in written and spoken English or Chinese
Key exclusion criteria (1 listed)
- not able to 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-sampling kits for STI testing in the laboratoryParticipants will receive the self-sampling kits and their submitted samples would be sent to laboratory for testing | Other | – |
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 * detection of MG resistance mutations macrolide/fluoroquinolone in MG positive samples divided by the total number of samples collected
5 secondary outcomes
prevalence of CT infection
Time frame: 1 year
prevalence of NG infection
Time frame: 1 year
prevalence of syphilis
Time frame: 1 year
prevalence of HCV infection
Time frame: 1 year
prevalence of overall STI
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 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: finished, as of the sponsor's last update on 18 Mar 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 2026.