- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04793841
Population Burden of STI and Implication for Intervention in Hong Kong
March 14, 2025 updated by: Ngai Sze WONG, Chinese University of Hong Kong
Population Burden of Sexually Transmitted Infections and Implication for Intervention in Hong Kong
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
After completion of baseline questionnaire, the participants are invitied for STI self-sampling.
If agree, a package of self-sampling kits, instructions, and packaging materials for return post would be delivered to their selected collection points.
The second round of self-sampling would be offered at least one year from the first round of self-sampled specimens collected.
Study Type
Observational
Enrollment (Actual)
1977
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hong Kong, China
-
Hong Kong, Hong Kong, China, Hong Kong, 0000
- The Chinese University of Hong Kong
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
sexually experienced adults
Description
Inclusion Criteria:
- aged 18 or above
- ever having sex
- normally living in Hong Kong
- can communicate in English or Chinese
Exclusion Criteria:
- failed to provide consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
General population
sexually experienced adults (aged 18 or above) of the randomly selected household
|
participants in both groups will receive self-sampling kits and deliver the collected samples to laboratory for testing
|
|
men who have sex with men
men who have sex with men aged 18 or above and normally living in Hong Kong
|
participants in both groups will receive self-sampling kits and deliver the collected samples to laboratory for testing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
self-reported STI diagnosis in questionnaire
Time Frame: up to 2 years
|
number of STI diagnosis
|
up to 2 years
|
|
effectiveness of STI intervention strategies
Time Frame: 10 years
|
incremental cost-effectiveness ratio
|
10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
STI symptom reported in questionnaire
Time Frame: 12 months
|
types of symptom presentations
|
12 months
|
|
willingness to pay for STI testing reported in questionnaire
Time Frame: 12 months
|
willingness to pay (HKD)
|
12 months
|
|
prevalence of STI estimated through laboratory testing
Time Frame: 12 months
|
prevalence of chlamydia trachomatis, Neisseria gonorrhoeae and human papillomavirus infections from self-collected samples
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ngai Sze Wong, PhD, Chinese University of Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 13, 2021
Primary Completion (Actual)
December 31, 2024
Study Completion (Actual)
December 31, 2024
Study Registration Dates
First Submitted
February 1, 2021
First Submitted That Met QC Criteria
March 9, 2021
First Posted (Actual)
March 11, 2021
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 14, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CID-CUHK-E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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