NCT04367688Completed
HIV Pre-exposure Prophylaxis Implementation Hong Kong Study
Delivery of Pre-exposure Prophylaxis to Individuals With High Sexual Risk of HIV Infection in Hong Kong - an Implementation Study
Source: ClinicalTrials.gov · Last updated 7 Feb 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 339 (actual)
- First submitted
- 26 Apr 2020
- Start date
- 1 Mar 2020
- Primary completion date
- 30 Sept 2023
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- HIV
- NCT number
- NCT04367688
What you commit to
- Study type: Observational
- Participants enrolled: 339
- From 1 Mar 2020 to the primary completion date, 30 Sept 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Injection drug user
Other illness
- Chronic HBV infection (HBsAg +ve)
- Having any form of mental illnesses
Lab values
- Impaired renal function, defined as estimated glomerular filtration rate (eGFR) \< 60mL/min/1.73m2
Other
- Inability or refusal to give consent
- Prisoners or any institutionalised persons
- Pregnant or planning to get pregnant (for female)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.