Community Burden of MG Infection | NCT06793605

Studies
Community Burden of MG Infection

NCT06793605

Sponsor

Chinese University of Hong Kong

Status

Recruiting

Last Update Posted

Mar 18, 2025Actual

Enrollment

920Estimated

Phase

Not provided

Conditions

Sexually Transmitted Infection (STI)
Mycoplasma Genitalium Infection

Interventions

Not provided

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 18, 2025Actual

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Jan 21, 2025

First Submission Date that Met QC Criteria

Jan 21, 2025

First Posted Date

Jan 27, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2025

Last Update Posted Date

Mar 18, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ngai Sze WONG, Assistant Professor, Chinese University of Hong KongPrincipal Investigator

Lead Sponsor

Chinese University of Hong KongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Objective: To assess the burden and the transmission dynamics of Mycoplasma genitalium (MG) infection in men who have sex with men in Hong Kong.

Design and setting: involving a) a cross-sectional study (completion of an online self-administered survey, followed by self-sampling for testing in the laboratory, and performance of HIV self-test); b) a mathematical modelling study to simulate the transmission dynamics of MG infection and resistant MG infection and compare the impacts of test-and-treat strategies.

Participants: Around 920 men who have sex with men would be recruited

Detailed Description

Cross-sectional study: A total of 920 men who have sex with men aged 18 or above and normally living in Hong Kong would be recruited. Eligible participants would be asked to complete a self-administered online survey, submit self-collected urine specimen and rectal swabs for Chlamydia trachomatis, Neisseria gonorrhoeae, and Mycoplasma genitalium testing in the laboratory, and submit HIV self-test results.

Mathematical modelling study: A compartmental model would be constructed to simulate the transmission dynamics of MG infection and resistant MG infection, and analyse the impact of different test-and-treat strategies.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

920Estimated

Outcomes Module

Primary Outcomes

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	1 year

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

men who have sex with men aged 18 or above, normally living in Hong Kong, and could communicate in written and spoken English or Chinese

Exclusion Criteria:

cannot provide consent

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

men who have sex with men in Hong Kong

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Chinese University of Hong Kong	Recruiting	Hong Kong		0000	Hong Kong

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012749	Sexually Transmitted Diseases
D006716	Homosexuality

Ancestor Terms

ID	Term
D003141	Communicable Diseases
D007239	Infections
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

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Browse Branches

Not provided