Community Burden of MG Infection

Recruiting

• Conditions: Sexually Transmitted Infection (STI); Mycoplasma Genitalium Infection

• Registration Number: NCT06793605
• Lead Sponsor: Chinese University of Hong Kong

Brief 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 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 Timeline

• Study First Submitted: 2025-01-21
• Study First Submitted QC: 2025-01-21
• Study First Posted: 2025-01-27
• Study Start: 2025-02-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-18
• Primary Completion: 2026-06-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 920

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
prevalence of MG infection	1 year	detection of MG infections in self-collected samples divided by the total number of samples collected
prevalence of MG resistance mutations	1 year	detection of MG resistance mutations macrolide/fluoroquinolone in MG positive samples divided by the total number of MG positive samples

Secondary Outcome Measures

Name	Time	Method
prevalence of CT infection	1 year	detection of CT infections in self-collected samples divided by the total number of samples collected
prevalence of NG infection	1 year	detection of NG infections in self-collected samples divided by the total number of samples collected
co-infection of STIs	1 year	number of co-infection of HIV, CT, NG, and/or MG
history of STI and HIV testing	ever	number of self-reported history of STI and/or HIV testing at survey

Trial Locations

Locations (1)

The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong