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

NCT05789134 | Completed

• 1 other identifier: 22210282
• Study Type: observational
• Target: 573
• Locations: 1 country
• Sites: 1

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.

Conditions

Mycoplasma Genitalium Infection; STI

Keywords

chlamydia trachomatis; Mycoplasma Genitalium Infection; Neisseria gonorrhoeae; men who have sex with men; heterosexual men; people living with HIV

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• prevalence of CT infection

  1 year

• prevalence of NG infection

  1 year

• prevalence of syphilis

  1 year

• prevalence of HCV infection

  1 year

• prevalence of overall STI

  1 year

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• not able to provide consent

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong, China, 0000, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITH DNA

urine specimen, rectal swab, pharyngeal swab

MeSH Terms

Conditions

Sexually Transmitted Diseases; Homosexuality

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sexuality; Sexual Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 29, 2023
• Study Start: July 24, 2023
• Primary Completion: June 27, 2025
• Study Completion: September 30, 2025
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)