HIV Pre-exposure Prophylaxis Implementation Hong Kong Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

339 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2024-01-31

Brief Summary

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While pre-exposure prophylaxis (PrEP) is widely recommended and a number of pilot studies are on-going worldwide, progress of its implementation in the real world setting has been slow, especially in Asia. This study aims to develop a service model for PrEP delivery and test its operability in the real world setting. In this implementation study, 400 individuals with high sexual risk of HIV infection who fulfil eligibility criteria would be recruited. Eligible participants would receive one year of daily tenofovir disoproxil fumarate 300mg / emtricitabine 200mg (TDF/FTC) for free. A client-initiated approach would be adopted, requiring participants to self-arrange for regular HIV/sexually transmitted infections (STI) testing. An online system would be developed to facilitate participants to plan for testing and consultation for accessing PrEP. Questionnaire at baseline and subsequent monthly follow-up would be administered to assess behaviour, monitor adverse effects and drug adherence, the latter coupled with the completion of an online diary. Testing of HIV and creatinine would be performed using point-of-care test or by phlebotomy during clinical visits. Blood samples would be collected for archiving. Around 40 participants would be invited to join an in-depth interview in the later part of the study to evaluate the service model. The main outcome measures are: PrEP service adherence, PrEP drug adherence, prevalence of drug intolerance, prevalence of unprotected sex in the study period, incidence of HIV and STI

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Tenofovir Disoproxil Fumarate 300 mg / emtricitabine 200 mg

daily use for PrEP

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Can communicate in written and spoken English or Chinese
* Is normally resident in Hong Kong
* Has tested HIV antibody negative in the past 3 months
* Has more than 1 episode of unprotected sex (especially anal sex) in the preceding 6 months
* Has any one of the following experiences in the past 6 months: chemsex engagement, group sex, multiple sex partners, STI diagnosis, having sex partner(s) with HIV+ve status
* Is inclined to engage in high risk sexual activities

Exclusion Criteria

* Chronic HBV infection (HBsAg +ve)
* Impaired renal function, defined as estimated glomerular filtration rate (eGFR) \< 60mL/min/1.73m2
* Having any form of mental illnesses
* Inability or refusal to give consent
* Prisoners or any institutionalised persons
* Pregnant or planning to get pregnant (for female)
* Injection drug user

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes