Mycoplasma Genitalium Infection and Associated Antimicrobial Resistance Among HIV-infected Male in Hong Kong

Recruiting

• Conditions: STI; Mycoplasma Genitalium Infection

• Registration Number: NCT05789134
• Lead Sponsor: Chinese University of Hong Kong

Brief 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). 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 Timeline

• Study First Submitted: 2023-03-16
• Study First Submitted QC: 2023-03-16
• Study First Posted: 2023-03-29
• Study Start: 2023-07-24
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-04
• Last Update Posted: 2023-09-06
• Primary Completion: 2024-12-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 750

Inclusion Criteria

• 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

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Exclusion Criteria

• not able to provide consent

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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; * detection of MG resistance mutations macrolide/fluoroquinolone in MG positive samples divided by the total number of samples collected

Secondary Outcome Measures

Name	Time	Method
prevalence of overall STI	1 year	total number of reported STI diagnosis divided by total number of participants tested for STI in the clinic
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
prevalence of syphilis	1 year	total number of reported syphilis diagnosis divided by total number of participants tested for syphilis in the clinic
prevalence of HCV infection	1 year	total number of reported HCV diagnosis divided by total number of participants tested for HCV in the clinic

Trial Locations

Locations (1)

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