HIV Pre-exposure Prophylaxis Implementation Hong Kong Study

HIV Infections Clinical Trial

Official title:

Delivery of Pre-exposure Prophylaxis to Individuals With High Sexual Risk of HIV Infection in Hong Kong - an Implementation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04367688
• Other study ID #: MSS325R
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: January 31, 2024

Study information

• Verified date: February 2024
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 339
• Est. completion date: January 31, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infections

Intervention

Drug:
• Tenofovir Disoproxil Fumarate 300 mg / emtricitabine 200 mg
daily use for PrEP

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong

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	adherence to PrEP service	attending the PrEP service with prescription and HIV tests regularly in accordance with protocol	12 months
Primary	adherence to PrEP regimen	proportion adherent to daily TDF/FTC	12 months