Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Population Burden of STI and Implication for Intervention in Hong Kong

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04793841
Recruitment Status : Recruiting
First Posted : March 11, 2021
Last Update Posted : August 4, 2021
Sponsor:
Information provided by (Responsible Party):
Ngai Sze WONG, Chinese University of Hong Kong

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
STI Other: self-sampling kits for STI testing in laboratory

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 2200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Population Burden of Sexually Transmitted Infections and Implication for Intervention in Hong Kong
Actual Study Start Date : May 13, 2021
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : September 30, 2025
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
General population
sexually experienced adults (aged 18 or above) of the randomly selected household
 Other: self-sampling kits for STI testing in laboratory
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
 Other: self-sampling kits for STI testing in laboratory
participants in both groups will receive self-sampling kits and deliver the collected samples to laboratory for testing


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. self-reported STI diagnosis in questionnaire [ Time Frame: up to 2 years ]
    number of STI diagnosis

  2. effectiveness of STI intervention strategies [ Time Frame: 10 years ]
    incremental cost-effectiveness ratio


Secondary Outcome Measures :
  1. STI symptom reported in questionnaire [ Time Frame: 12 months ]
    types of symptom presentations

  2. willingness to pay for STI testing reported in questionnaire [ Time Frame: 12 months ]
    willingness to pay (HKD)

  3. 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


Biospecimen Retention:   Samples With DNA
urine, penile swab, cervical swab, rectal swab, pharyngeal swab

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
sexually experienced adults
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04793841


Contacts
Layout table for location contacts
Contact: Ngai Sze Wong, PhD (852)22528862 candy_wong@cuhk.edu.hk

Locations
Layout table for location information
Hong Kong
The Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong, China, Hong Kong, 0000
Contact: Ngai Sze Wong, PhD    22528862    candy_wong@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Layout table for investigator information
Principal Investigator: Ngai Sze Wong, PhD Chinese University of Hong Kong
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Ngai Sze WONG, Research Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04793841    
Other Study ID Numbers: CID-CUHK-E
First Posted: March 11, 2021    Key Record Dates
Last Update Posted: August 4, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ngai Sze WONG, Chinese University of Hong Kong:
chlamydia trachomatis
Neisseria gonorrhoeae
human papillomavirus
men who have sex with men
general population