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

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05789134

Collaborator

(none)

750

Enrollment

Location

Anticipated Duration (Months)

28.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
STI Mycoplasma Genitalium Infection	Other: self-sampling kits for STI testing in the laboratory

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

Study Type:

Observational

Anticipated Enrollment :

750 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

May 31, 2025

Outcome Measures

Primary Outcome Measures

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

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
prevalence of overall STI [1 year]
total number of reported STI diagnosis divided by total number of participants tested for STI in the clinic