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.

Study Overview

• Status: Recruiting
• Conditions: STI; Mycoplasma Genitalium Infection
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 750

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, China
    • Hong Kong, Hong Kong, China, Hong Kong, 0000
      • Recruiting
      • The Chinese University of Hong Kong
      • Contact: Ngai Sze Wong, PhD; Phone Number: 22528862; Email: candy_wong@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

HIV-infected male who are attending the HIV specialist clinic in Hong Kong

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevalence of MG infection	detection of MG infections in self-collected samples divided by the total number of samples collected	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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevalence of CT infection	detection of CT infections in self-collected samples divided by the total number of samples collected	1 year
prevalence of NG infection	detection of NG infections in self-collected samples divided by the total number of samples collected	1 year
prevalence of syphilis	total number of reported syphilis diagnosis divided by total number of participants tested for syphilis in the clinic	1 year
prevalence of HCV infection	total number of reported HCV diagnosis divided by total number of participants tested for HCV in the clinic	1 year
prevalence of overall STI	total number of reported STI diagnosis divided by total number of participants tested for STI in the clinic	1 year

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: March 16, 2023
• First Submitted That Met QC Criteria: March 16, 2023
• First Posted (Actual): March 29, 2023

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 4, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: men who have sex with men; chlamydia trachomatis; Neisseria gonorrhoeae; people living with HIV; heterosexual men; Mycoplasma Genitalium Infection
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Disease Attributes; Pleural Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Pleurisy; Mycoplasmatales Infections; Infections; Communicable Diseases; Pleuropneumonia; Mycoplasma Infections
• Other Study ID Numbers: 22210282

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No