Clinical Trials

MainTitle

HIV Pre-exposure Prophylaxis Implementation Hong Kong Study

This study is currently recruiting participants. (see Contacts and Locations)

Verified April 2020 by Shui-Shan Lee, MD, Chinese University of Hong Kong

Sponsor
Chinese University of Hong Kong


Information provided by (Responsible Party)
Shui-Shan Lee, MD, Chinese University of Hong Kong

ClinicalTrials.gov Identifier
NCT04367688

First received: April 26, 2020
Last updated: April 29, 2020
Last Verified: April 2020
History of Changes
Purpose

Purpose

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

Condition Intervention
HIV Infections

Drug : Tenofovir Disoproxil Fumarate 300 mg / emtricitabine 200 mg

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Delivery of Pre-exposure Prophylaxis to Individuals With High Sexual Risk of HIV Infection in Hong Kong - an Implementation Study

Further study details as provided by Shui-Shan Lee, MD, Chinese University of Hong Kong:

Primary Outcome Measures

  • adherence to PrEP service [ Time Frame: 12 months ]
    attending the PrEP service with prescription and HIV tests regularly in accordance with protocol
  • adherence to PrEP regimen [ Time Frame: 12 months ]
    proportion adherent to daily TDF/FTC

Biospecimen Retention: Samples With DNA
blood samples

Estimated Enrollment: 400
Study Start Date: January 11, 2020
Estimated Study Completion Date: March 31, 2023
Estimated Primary Completion Date: September 30, 2022 (Final data collection date for primary outcome measure)

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  
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

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT04367688

Contacts

Contact:   Shui Shan Lee, MD 852 22528812 sslee@cuhk.edu.hk
Contact:   Ngai Sze Wong, PhD 852 22528860 candy_wong@cuhk.edu.hk

Locations

Hong Kong
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Shui Shan Lee, MD    852 22528812    sslee@cuhk.edu.hk
Contact: Ngai Sze Wong, PhD    852 22528860    candy_wong@cuhk.edu.hk

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

Principal Investigator: Shui Shan Lee, MD Chinese University of Hong Kong
More Information

More Information


Responsible Party: Shui-Shan Lee, MD, Professor, Chinese University of Hong Kong  
ClinicalTrials.gov Identifier: NCT04367688   History of Changes  
Other Study ID Numbers: MSS325R  
Study First Received: April 26, 2020  
Last Updated: April 29, 2020  
Individual Participant Data    
Plan to Share IPD: No  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  
Product Manufactured in and Exported from the U.S.: Yes  

Keywords provided by Shui-Shan Lee, MD, Chinese University of Hong Kong:

HIV
pre-exposure prophylaxis
adherence
antiretroviral

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Tenofovir
Emtricitabine

ClinicalTrials.gov processed this data on August 07, 2020
This information is provided by ClinicalTrials.gov.