Recreational Drug UseNCT05031832
Chemsex Engagement and HIV Biomedical Prevention in MSM
An observational study of Recreational Drug Use, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
HIV biomedical prevention through treatment-as-prevention (TasP) and pre-exposure prophylaxis (PrEP) is highly efficacious for reducing HIV transmission risk. The benefits could be undermined by the rising HIV transmission risks in men who have sex with men (MSM) who engaged in chemsex. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Recreational Drug Use
- What is being tested?
- HIV test
- How many people
- 733 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: sexually active adult men who have sex with men living in Hong Kong, and able to complete the questionnaire
Who may be able to join
- aged 18 or above
- male
- have had sex with men since 2019
- could be communicated 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, 0000
About this study
Official title: The Interrelationship Between Chemsex Engagement and HIV Biomedical Prevention in MSM
HIV biomedical prevention through treatment-as-prevention (TasP) and pre-exposure prophylaxis (PrEP) is highly efficacious for reducing HIV transmission risk. The benefits could be undermined by the rising HIV transmission risks in men who have sex with men (MSM) who engaged in chemsex. This project aims to assess the impacts of chemsex on the growth of the HIV epidemic by exploring the complex relationships between chemsex engagement and usage of HIV biomedical prevention in MSM in Hong Kong. Participants would be recruited from the community and clinics in 2 cross-sectional studies (500 HIV-negative and 500 HIV-positive MSM), for HIV self-testing and completing an electronic questionnaire. The association of chemsex would be examined between PrEP-naïve and PrEP experienced HIV-negative MSM, and between good and poor adherence to antiretroviral therapy (ART) among HIV-positive subjects in case-control analyses using logistic regression and multilevel models. The main outcomes include coverage of biomedical prevention in MSM, and their drug use patterns.
- Conditions
- Recreational Drug Use
- Being tested
- HIV test
- Keywords
- Chemsex engagement, Pre-exposure prophylaxis, Antiretroviral therapy, men who have sex with men
- Medical subject headings
- Recreational Drug Use, Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV testDiagnostic test
HIV test would be offered to self-reported HIV-negative / unknown HIV status MSM to confirm their HIV status
| Study group | Role | What they receive |
|---|---|---|
| HIV-negative | Not described Receives: Diagnostic Test: HIV test | |
| HIV-positive | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
pre-exposure prophylaxis coverage
proportion of HIV-negative MSM taking pre-exposure prophylaxis; based on self-reported data in questionnaire
Measured: 6 months
Good antiretroviral therapy adherence
proportion of HIV-positive MSM with good antiretroviral therapy adherence; based on self-reported data (CD4 count, viral load level, history of stoppoing ART / missing doses) in questionnaire
Measured: 2 years
Drug use pattern
types of drugs taken for chemsex engagement (taking before or during sex); based on self-reported data in questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start1 Jun 2021
- Primary completion2 Oct 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 Recreational Drug UseStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 733 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031832
- Sponsor's protocol ID
- MSS344R
- Status last verified
- Jan 2025
- First submitted
- 30 Aug 2021
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- 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 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interrelationship Between Chemsex Engagement and HIV Biomedical Prevention in MSM
- ClinicalTrials.gov ID
- NCT05031832
- Acronym / sponsor ID
- MSS344R
- Conditions
- Recreational Drug Use
- Keywords
- Chemsex engagement, Pre-exposure prophylaxis, Antiretroviral therapy, men who have sex with men
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 733 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 2 Oct 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 2 Sep 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.
HIV biomedical prevention through treatment-as-prevention (TasP) and pre-exposure prophylaxis (PrEP) is highly efficacious for reducing HIV transmission risk. The benefits could be undermined by the rising HIV transmission risks in men who have sex with men (MSM) who engaged in chemsex. This project aims to assess the impacts of chemsex on the growth of the HIV epidemic by exploring the complex relationships between chemsex engagement and usage of HIV biomedical prevention in MSM in Hong Kong. Participants would be recruited from the community and clinics in 2 cross-sectional studies (500 HIV-negative and 500 HIV-positive MSM), for HIV self-testing and completing an electronic questionnaire. The association of chemsex would be examined between PrEP-naïve and PrEP experienced HIV-negative MSM, and between good and poor adherence to antiretroviral therapy (ART) among HIV-positive subjects in case-control analyses using logistic regression and multilevel models. The main outcomes include coverage of biomedical prevention in MSM, and their drug use patterns.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV-negative | – | Diagnostic Test: HIV test |
| HIV-positive | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- sexually active adult men who have sex with men living in Hong Kong, and able to complete the questionnaire
Key inclusion criteria (4 listed)
- aged 18 or above
- male
- have had sex with men since 2019
- could be communicated 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 |
|---|---|---|
| HIV testHIV test would be offered to self-reported HIV-negative / unknown HIV status MSM to confirm their HIV status | Diagnostic test | HIV-negative |
Primary outcome
pre-exposure prophylaxis coverage
Time frame: 6 months
proportion of HIV-negative MSM taking pre-exposure prophylaxis; based on self-reported data in questionnaire
Good antiretroviral therapy adherence
Time frame: 2 years
proportion of HIV-positive MSM with good antiretroviral therapy adherence; based on self-reported data (CD4 count, viral load level, history of stoppoing ART / missing doses) in questionnaire
Drug use pattern
Time frame: 6 months
types of drugs taken for chemsex engagement (taking before or during sex); based on self-reported data in questionnaire
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 23 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Recreational Drug Use, 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 23 Jan 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?
pre-exposure prophylaxis coverage (time frame: 6 months). The study lists 3 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 23 Jan 2025.