STINCT04793841
Population Burden of STI and Implication for Intervention in Hong Kong
An observational study of STI, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- STI
- What is being tested?
- self-sampling kits for STI testing in laboratory
- How many people
- 1,977 participants
- Where
- 1 siteHong Kong
- Study dates
- 13 May 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: sexually experienced adults
Who may be able to join
- aged 18 or above
- ever having sex
- normally living in Hong Kong
- can communicate in English or Chinese
Who cannot join
- failed to provide consent
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The Chinese University of Hong Kong
Hong Kong, Hong Kong, China, 0000
About this study
Official title: 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.
Read the 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.
- Conditions
- STI
- Being tested
- self-sampling kits for STI testing in laboratory
- Keywords
- chlamydia trachomatis, Neisseria gonorrhoeae, human papillomavirus, men who have sex with men, general population
- Medical subject headings
- Sexually Transmitted Diseases, Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-sampling kits for STI testing in laboratoryOther
participants in both groups will receive self-sampling kits and deliver the collected samples to laboratory for testing
| Study group | Role | What they receive |
|---|---|---|
| General population | sexually experienced adults (aged 18 or above) of the randomly selected household Receives: 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 Receives: Other: self-sampling kits for STI testing in laboratory |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-reported STI diagnosis in questionnaire
number of STI diagnosis
Measured: up to 2 years
effectiveness of STI intervention strategies
incremental cost-effectiveness ratio
Measured: 10 years
Secondary outcomes (3)
STI symptom reported in questionnaire
types of symptom presentations
Measured: 12 months
willingness to pay for STI testing reported in questionnaire
willingness to pay (HKD)
Measured: 12 months
prevalence of STI estimated through laboratory testing
prevalence of chlamydia trachomatis, Neisseria gonorrhoeae and human papillomavirus infections from self-collected samples
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start13 May 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STIStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,977 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ngai Sze WONG, Chinese University of Hong Kong
- Investigators
- Ngai Sze Wong, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793841
- Sponsor's protocol ID
- CID-CUHK-E
- Status last verified
- Mar 2025
- First submitted
- 1 Feb 2021
- Last updated
- 17 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Burden of Sexually Transmitted Infections and Implication for Intervention in Hong Kong
- ClinicalTrials.gov ID
- NCT04793841
- Acronym / sponsor ID
- CID-CUHK-E
- Conditions
- STI
- Keywords
- chlamydia trachomatis, Neisseria gonorrhoeae, human papillomavirus, men who have sex with men, general population
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,977 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 13 May 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General population | – | Other: self-sampling kits for STI testing in laboratorysexually experienced adults (aged 18 or above) of the randomly selected household |
| men who have sex with men | – | Other: self-sampling kits for STI testing in laboratorymen who have sex with men aged 18 or above and normally living in Hong Kong |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- sexually experienced adults
Key inclusion criteria (4 listed)
- aged 18 or above
- ever having sex
- normally living in Hong Kong
- can communicate in English or Chinese
Key exclusion criteria (1 listed)
- failed to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-sampling kits for STI testing in laboratoryparticipants in both groups will receive self-sampling kits and deliver the collected samples to laboratory for testing | Other | General population, men who have sex with men |
Primary outcome
self-reported STI diagnosis in questionnaire
Time frame: up to 2 years
number of STI diagnosis
effectiveness of STI intervention strategies
Time frame: 10 years
incremental cost-effectiveness ratio
3 secondary outcomes
STI symptom reported in questionnaire
Time frame: 12 months
willingness to pay for STI testing reported in questionnaire
Time frame: 12 months
prevalence of STI estimated through laboratory testing
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ngai Sze Wong, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of STI, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self-reported STI diagnosis in questionnaire (time frame: up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.