HIV Pre-exposure Prophylaxis Implementation Hong Kong Study

NCT04367688 | Completed FDA Drug

• 1 other identifier: MSS325R
• Study Type: observational
• Target: 339
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

HIV Infections

Keywords

HIV; pre-exposure prophylaxis; adherence; antiretroviral

Outcome Measures

Primary Outcomes (2)

• adherence to PrEP service

  attending the PrEP service with prescription and HIV tests regularly in accordance with protocol

  12 months

• adherence to PrEP regimen

  proportion adherent to daily TDF/FTC

  12 months

Interventions

Tenofovir Disoproxil Fumarate 300 mg / emtricitabine 200 mg DRUG

daily use for PrEP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with high risk sexual behaviours for HIV transmission who are referred by government/public service or non-government service in Hong Kong or self-referred for enrolment in a PrEP program

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

HIV Infections

Interventions

Tenofovir; Emtricitabine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Shui Shan Lee, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 26, 2020
• First Posted: April 29, 2020
• Study Start: March 1, 2020
• Primary Completion: September 30, 2023
• Study Completion: January 31, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)