HIV -1 InfectionNCT07725042
Analyses of Newly Diagnosed HIV Infection in Hong Kong
An observational study of HIV -1 Infection, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV -1 Infection
- How many people
- 720 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Aug 2024to Oct 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: All adult people living with HIV attending a public clinical service in Hong Kong where HIV diagnosis has recently been made
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
S.H. Ho Research Centre for Infectious Diseases
North Point, 0000
Shui Shan Lee, MD, +85222528812, sslee@cuhk.edu.hk
Ngai Sze Wong, PhD, +85222528812, candy_wong@cuhk.edu.hk
About this study
Official title: 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
Read the 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
- Conditions
- HIV -1 Infection
- Keywords
- HIV, people living with HIV, molecular analyses, community burden, epidemiology, Hong Kong
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
main molecular HIV-1 subtype
Proportion of patients infection with HIV-1 subtype B
Measured: 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
Measured: from enrollment to end of study at 4 years
Secondary outcomes (2)
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
Measured: 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
Measured: from enrolment to end of study at 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Aug 2024
- Primary completionJul 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV -1 InfectionStudies 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
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shui-Shan Lee, MD, Chinese University of Hong Kong
- Investigators
- Shui Shan S Lee, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725042
- Sponsor's protocol ID
- HK HIV newly diagnosed
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD restricted to investigators as stipulated in the institutional approval
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Epidemiologic and Molecular Network Analyses of Newly Diagnosed HIV Infection in Hong Kong
- ClinicalTrials.gov ID
- NCT07725042
- Acronym / sponsor ID
- HK HIV newly diagnosed
- Conditions
- HIV -1 Infection
- Keywords
- HIV, people living with HIV, molecular analyses, community burden, epidemiology, Hong Kong
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 24 Jul 2026 (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.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult people living with HIV attending a public clinical service in Hong Kong where HIV diagnosis has recently been made
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
main molecular HIV-1 subtype
Time frame: from enrollment to the end of the study at 4 years
Proportion of patients infection with HIV-1 subtype B
main HIV transmission mode
Time frame: from enrollment to end of study at 4 years
Proportion of patients who are men who have sex with men
2 secondary outcomes
changes in HIV molecular pattern
Time frame: from enrolment to end of study at 4 years
Change in transmission mode
Time frame: from enrolment to end of study at 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No. IPD restricted to investigators as stipulated in the institutional approval
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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.
Shui Shan S Lee, MD 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 HIV -1 Infection, 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 24 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shui Shan Lee, MD (+85261703177, sslee@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
main molecular HIV-1 subtype (time frame: from enrollment to the end of the study at 4 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 24 Jul 2026.