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

STI Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05789134
• Other study ID #: 22210282
• Status: Recruiting
• Start date: July 24, 2023
• Est. completion date: May 31, 2025

Study information

• Verified date: September 2023
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: May 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Mycoplasma Genitalium Infection
• Mycoplasma Infections
• Pleuropneumonia
• STI

Intervention

Other:
• self-sampling kits for STI testing in the laboratory
Participants will receive the self-sampling kits and their submitted samples would be sent to laboratory for testing

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Hong Kong	Hong Kong, China

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of MG infection	detection of MG infections in self-collected samples divided by the total number of samples collected	1 year
Primary	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	prevalence of CT infection	detection of CT infections in self-collected samples divided by the total number of samples collected	1 year
Secondary	prevalence of NG infection	detection of NG infections in self-collected samples divided by the total number of samples collected	1 year
Secondary	prevalence of syphilis	total number of reported syphilis diagnosis divided by total number of participants tested for syphilis in the clinic	1 year
Secondary	prevalence of HCV infection	total number of reported HCV diagnosis divided by total number of participants tested for HCV in the clinic	1 year
Secondary	prevalence of overall STI	total number of reported STI diagnosis divided by total number of participants tested for STI in the clinic	1 year