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NCT Number: NCT05789134

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

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.

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Key information

Conditions

STI Behavior Communicable Diseases Disease Attributes Genital Diseases Homosexuality Infections Mycoplasma Genitalium Infection Pathologic Processes Pathological Conditions, Signs and Symptoms Sexual Behavior Sexuality Sexually Transmitted Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

The Chinese University of Hong Kong

Hong Kong, Hong Kong, China, 0000

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • not able to provide consent

Treatment and study plan

self-sampling kits for STI testing in the laboratory

Other

Participants will receive the self-sampling kits and their submitted samples would be sent to laboratory for testing

Primary outcomes

  1. prevalence of MG infection

    Time frame: 1 year

    detection of MG infections in self-collected samples divided by the total number of samples collected

  2. 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

Secondary outcomes

  1. prevalence of CT infection

    Time frame: 1 year

    detection of CT infections in self-collected samples divided by the total number of samples collected

  2. prevalence of NG infection

    Time frame: 1 year

    detection of NG infections in self-collected samples divided by the total number of samples collected

  3. prevalence of syphilis

    Time frame: 1 year

    total number of reported syphilis diagnosis divided by total number of participants tested for syphilis in the clinic

  4. prevalence of HCV infection

    Time frame: 1 year

    total number of reported HCV diagnosis divided by total number of participants tested for HCV in the clinic

  5. prevalence of overall STI

    Time frame: 1 year

    total number of reported STI diagnosis divided by total number of participants tested for STI in the clinic

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 29, 2023
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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