NCT06793605

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
920

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Feb 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress42%
Feb 2025Dec 2027

First Submitted

Initial submission to the registry

January 21, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

February 18, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

1.4 years

First QC Date

January 21, 2025

Last Update Submit

March 14, 2025

Conditions

Sexually Transmitted Infection (STI)Mycoplasma Genitalium Infection

Keywords

Mycoplasma genitaliumChlamydia trachomatisNeisseria gonorrhoeaemen who have sex with men

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

    1 year

Secondary Outcomes (4)

  • prevalence of CT infection

    1 year

  • prevalence of NG infection

    1 year

  • co-infection of STIs

    1 year

  • history of STI and HIV testing

    ever

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

men who have sex with men in Hong Kong

You may qualify if:

  • 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

You may not qualify if:

  • cannot provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, 0000, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

urine specimen, rectal swab

MeSH Terms

Conditions

Sexually Transmitted DiseasesHomosexuality

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSexualitySexual BehaviorBehavior

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

January 21, 2025

First Posted

January 27, 2025

Study Start

February 18, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

March 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)