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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05031832
Other study ID # MSS344R
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date December 31, 2024

Study information

Verified date September 2023
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 31, 2024
Est. primary completion date May 4, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - aged 18 or above - male - have had sex with men since 2019 - could be communicated in English or Chinese Exclusion Criteria: - failed to provide consent

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
HIV test
HIV test would be offered to self-reported HIV-negative / unknown HIV status MSM to confirm their HIV status

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 pre-exposure prophylaxis coverage proportion of HIV-negative MSM taking pre-exposure prophylaxis; based on self-reported data in questionnaire 6 months
Primary 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 2 years
Primary Drug use pattern types of drugs taken for chemsex engagement (taking before or during sex); based on self-reported data in questionnaire 6 months
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