Population Burden of STI and Implication for Intervention in Hong Kong

STI Clinical Trial

Official title:

Population Burden of Sexually Transmitted Infections and Implication for Intervention in Hong Kong

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04793841
• Other study ID #: CID-CUHK-E
• Status: Recruiting
• Start date: May 13, 2021
• Est. completion date: September 30, 2025

Study information

• Verified date: February 2024
• Source: Chinese University of Hong Kong
• Contact: Ngai Sze Wong, PhD
• Phone: (852)22528862
• Email: candy_wong[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1860
• Est. completion date: September 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• STI

Intervention

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

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Hong Kong	Hong Kong, China

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	self-reported STI diagnosis in questionnaire	number of STI diagnosis	up to 2 years
Primary	effectiveness of STI intervention strategies	incremental cost-effectiveness ratio	10 years
Secondary	STI symptom reported in questionnaire	types of symptom presentations	12 months
Secondary	willingness to pay for STI testing reported in questionnaire	willingness to pay (HKD)	12 months
Secondary	prevalence of STI estimated through laboratory testing	prevalence of chlamydia trachomatis, Neisseria gonorrhoeae and human papillomavirus infections from self-collected samples	12 months