The efficacy of pre-exposure prophylaxis for Human Immunodeficiency Virus (HIV) in high-risk individuals in Victoria, Australia

Phase 4

Recruiting

• Conditions: HIV; Anxiety; Infection - Acquired immune deficiency syndrome (AIDS / HIV); Mental Health - Anxiety

• Registration Number: ACTRN12616001215415
• Lead Sponsor: The Alfred

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 2600

Inclusion Criteria

Age greater than or equal to 18 years old
Willing and able to provide informed consent
Documentation of an HIV negative test performed at enrolment
Have a creatinine clearance of > 60mL per minute eGFR
Will to provide an email address
Have a high risk of HIV infection as per the Australian PrEP Guidelines

Exclusion Criteria

HIV infection confirmed by HIV antibody and western blot testing
Signs and symptoms of acute HIV infection
Unwilling to provide consent for follow up
An eGFR of <60 Mls per minute
Ues of any investigational agents which may interact or affect PrEP medication
use of any nephrotoxic agents
Concomitant participation in another clinical trial using investigational agents, including placebo-controlled agents
At enrolment an individual that has any other condition that, based on the opinion of the treating physician, would make participation in the project unsafe

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of the study is the number of new HIV infections in Victoria during the 36 months from the time that the PrEPX study opens, as reported by the Victorian HIV Surveillance registry.<br><br>Study participants who are attending clinics that participate in the ACCESS surveillance system will have their results collected by ACCESS, using the software GRHANITE. GRHANITE is able to access the clinics' patient management systems to retrieve study participants' HIV and STI test results.<br>Study participants who are not attending clinics that participate in the ACCESS surveillance system will have their test result data collected manually.[We will monitor new HIV infections in Victoria from July 2016 until July 2019.<br>This outcome is not for study participants only: the outcome reflects new infections across all populations in Victoria.]