NCT05031832

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
733

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 23, 2025

Status Verified

January 1, 2025

Enrollment Period

3.3 years

First QC Date

August 30, 2021

Last Update Submit

January 21, 2025

Conditions

Keywords

Chemsex engagementPre-exposure prophylaxisAntiretroviral therapymen who have sex with men

Outcome Measures

Primary Outcomes (3)

  • pre-exposure prophylaxis coverage

    proportion of HIV-negative MSM taking pre-exposure prophylaxis; based on self-reported data in questionnaire

    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

    2 years

  • Drug use pattern

    types of drugs taken for chemsex engagement (taking before or during sex); based on self-reported data in questionnaire

    6 months

Study Arms (2)

HIV-negative

Diagnostic Test: HIV test

HIV-positive

Interventions

HIV testDIAGNOSTIC_TEST

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

HIV-negative

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

sexually active adult men who have sex with men living in Hong Kong, and able to complete the questionnaire

You may qualify if:

  • aged 18 or above
  • male
  • have had sex with men since 2019
  • could be communicated in English or Chinese

You may not qualify if:

  • failed to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong, 0000, Hong Kong

Location

MeSH Terms

Conditions

Recreational Drug UseHomosexuality

Interventions

HIV Testing

Condition Hierarchy (Ancestors)

BehaviorSexualitySexual Behavior

Intervention Hierarchy (Ancestors)

Microbiological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 30, 2021

First Posted

September 2, 2021

Study Start

June 1, 2021

Primary Completion

October 2, 2024

Study Completion

December 31, 2024

Last Updated

January 23, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations