Analyses of Newly Diagnosed HIV Infection in Hong Kong

Combined Epidemiologic and Molecular Network Analyses of Newly Diagnosed HIV Infection in Hong Kong

The goal of the project is to determine the epidemiologic status and changing patterns of HIV infection in Hong Kong. The main question it aims to answer is:

- what is the molecular pattern and burden of HIV-1 infections over the years

Study Overview

• Status: Recruiting
• Conditions: HIV -1 Infection

Detailed Description

With the aim of determining the epidemiologic status and changing patterns of HIV infection in Hong Kong, a prospective cohort study is conducted with the objectives of: (a) describing the distribution of HIV-1 subtypes of newly diagnosed infection and their association with transmission routes; (b) characterising the transmission clusters of HIV infection and their dynamicity; and (c) evaluating the community burden of HIV and its changes over time. An epidemiologic cohort database would be established from newly diagnosed HIV infections reported in Hong Kong over a 4-year period. People living with HIV infections are invited to complete a self-administered questionnaire survey to capture data on their behavioural and network profiles prior to infection, supplemented by transcription of relevant clinical record data including CD4/CD8 and viral load measures. Blood sampling would be performed for supporting RNA sequencing. The main outcome measures are the prevalent and temporal changes of epidemiologic profile, molecular network patterns and population viral loads

• Study Type: Observational
• Enrollment (Estimated): 720

Contacts and Locations

• Study Contact: Name: Shui Shan Lee, MD; Phone Number: +85261703177; Email: sslee@cuhk.edu.hk
• Study Contact Backup: Name: Ngai Sze Wong, PhD; Phone Number: +85222528812; Email: candy_wong@cuhk.edu.hk

Study Locations

• Hong Kong
  • North Point, Hong Kong, 0000
    • Recruiting
    • S.H. Ho Research Centre for Infectious Diseases
    • Principal Investigator: Shui Shan Lee, MD
    • Contact: Ngai Sze Wong, PhD; Phone Number: +85222528812; Email: candy_wong@cuhk.edu.hk
    • Contact: Shui Shan Lee, MD; Phone Number: +85222528812; Email: sslee@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All adult people living with HIV attending a public clinical service in Hong Kong where HIV diagnosis has recently been made

Description

Inclusion Criteria:

• adult of age 18 or above, who are
• people living with HIV, and
• attending the service of an HIV specialist clinic in the public service in Hong Kong

Exclusion Criteria:

• travelers or visitors who are temporarily staying in Hong Kong
• prisoners
• patients with mental illnesses who are unable to make informed decision
• patients whose HIV diagnosis was made outside Hong Kong and whose treatment have already started.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
people with newly diagnosed HIV infection; adults newly diagnosed with HIV infection who are of age 18 or above and attending the service of HIV specialist clinics in Hong Kong

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
main molecular HIV-1 subtype	Proportion of patients infection with HIV-1 subtype B	from enrollment to the end of the study at 4 years
main HIV transmission mode	Proportion of patients who are men who have sex with men	from enrollment to end of study at 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in HIV molecular pattern	Percentage difference in the proportion of patients with HIV-1 subtype B between the last 2 years versus the first 2 years	from enrolment to end of study at 4 years
Change in transmission mode	Percentage difference in the proportion of patients who are men who have sex with men in the last 2 years versus the first 2 years	from enrolment to end of study at 4 years

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Shui Shan S Lee, MD, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: HIV; epidemiology; Hong Kong; people living with HIV; molecular analyses; community burden
• Other Study ID Numbers: HK HIV newly diagnosed

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD restricted to investigators as stipulated in the institutional approval

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No