NCT04793841

Brief Summary

This is a 5-year cross-disciplinary sexually transmitted infection (STI) project involving a) territory-wide and community-based studies (survey and specimen collection); b) simulation of STI transmission dynamics and comparison of STI intervention strategies through mathematical modelling and cost-effectiveness analysis. The aim of this project is to assess the burden and the transmission dynamics of STIs in the general population and men who have sex with men (MSM) in Hong Kong. Around 1300 sexually experienced adults and 900 MSM would be recruited, 100 participants would be invited for individual in-depth interviews. Main outcome measures include STI history and service preference, effectiveness as measured by the proportion of new STI infections (chlamydia, gonorrhoea and human papillomavirus infections) averted above base-case scenario, and incremental cost-effectiveness ratio.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,977

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 1, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 13, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

3.6 years

First QC Date

February 1, 2021

Last Update Submit

March 14, 2025

Conditions

Keywords

chlamydia trachomatisNeisseria gonorrhoeaehuman papillomavirusmen who have sex with mengeneral population

Outcome Measures

Primary Outcomes (2)

  • self-reported STI diagnosis in questionnaire

    number of STI diagnosis

    up to 2 years

  • effectiveness of STI intervention strategies

    incremental cost-effectiveness ratio

    10 years

Secondary Outcomes (3)

  • STI symptom reported in questionnaire

    12 months

  • willingness to pay for STI testing reported in questionnaire

    12 months

  • prevalence of STI estimated through laboratory testing

    12 months

Study Arms (2)

General population

sexually experienced adults (aged 18 or above) of the randomly selected household

Other: self-sampling kits for STI testing in laboratory

men who have sex with men

men who have sex with men aged 18 or above and normally living in Hong Kong

Other: self-sampling kits for STI testing in laboratory

Interventions

participants in both groups will receive self-sampling kits and deliver the collected samples to laboratory for testing

General populationmen who have sex with men

Eligibility Criteria

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

sexually experienced adults

You may qualify if:

  • aged 18 or above
  • ever having sex
  • normally living in Hong Kong
  • can communicate in English or Chinese

You may not qualify if:

  • failed to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

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

Location

Biospecimen

Retention: SAMPLES WITH DNA

urine, penile swab, cervical swab, rectal swab, pharyngeal swab

MeSH Terms

Conditions

Sexually Transmitted DiseasesHomosexuality

Interventions

Laboratories

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private FacilitiesHealth FacilitiesHealth Care Facilities Workforce and Services

Study Officials

  • Ngai Sze Wong, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 1, 2021

First Posted

March 11, 2021

Study Start

May 13, 2021

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 17, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations