The Victorian Pre-Exposure Prophylaxis Demonstration Project- VicPrEP HIV prevention trial for people at risk of HIV

The Victorian HIV Pre-Exposure Prophylaxis Demonstration Project- To determine in HIV negative individuals at risk of HIV infection whether the uptake of PrEP is associated with decreased HIV risk behaviour and a decreased likelihood of future HIV and STI infections.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617000196347

Acronym

VicPrEP

Enrollment

115

Registered

2017-02-06

Start date

2014-06-19

Completion date

2015-08-28

Last updated

2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

VicPrEP is a demonstration project investigating the adherence, behavioural change, acceptability, safety, and feasibility of the use of HIV PrEP in the Victorian community. The nature of a demonstration study is to study patients who can feasibly be recruited. Based on Australian research undertaken by members of our study team regarding the likelihood of PrEP use in HIV negative gay or bisexual men and the likely uptake of healthy, fertile HIV serodiscordant couples we have estimated that approximately 100 patients willing to accept PrEP could feasibly be recruited into the study over a two year period. This number of patients may reasonably allow us to undertake regression analyses to determine whether a number of baseline covariables are associated with PrEP adherence, behavioural change and acceptability. However the study sample size was necessarily chosen based on feasibility of recruitment and not based upon power calculations.

Interventions

This is a multi-site, prospective, open-label PrEP demonstration project that aims to assess the uptake, acceptability, safety, and feasibility of a single tablet of emtricitabine 200mg and tenofovir disoproxil fumarate 300mg as PrEP, administered orally, once daily to enrolled participants who engage in high risk sexual practices over a period of 30 months. Refill based assessment and dried blood spot testing will be utilised to monitor adherence.

Study design

Allocation

Non-randomised trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

HIV negative people at risk of HIV infection, including MSM and HIV serodiscordant couples. 1. Age 18 years and older 2. Willing and able to provide written informed consent 3. Documentation of an HIV negative test performed at both screening visit and enrolment 4. Have a creatinine clearance of > 60mL per minute (via Cockroft-Gault formula) 5. Evidence of risk for acquiring HIV-1 infection including any one of the following: a. Unprotected receptive or insertive intercourse (anal and/or vaginal) with an HIV seropositive partner and/or b. RUAI with casual partners whose HIV status is unknown (MSM and transgender) c. Uncircumcised male and IUAI with casual partners whose HIV status is unknown (MSM only) d. HIV serodiscordant couples wishing to conceive without the use of assisted reproduction 6. Able to provide street address and/or telephone number and/or email address to be contacted during the period of the demonstration project

Exclusion criteria

1. HIV as confirmed by HIV antibody and western blot testing 2. Signs of symptoms of acute HIV infection 3. Signs of intercurrent sexually transmitted infection 4. Unable to attend scheduled follow-up assessments 5. Unwilling to provide consent to follow-up 6. A creatinine clearance of < 60 mL per minute (via Cockroft-Gault formula) 7. Active, clinically significant medical problems including active tuberculosis, poorly controlled cardiac disease, previous or currently diagnosed malignancy requiring further treatment 8. Hepatitis B surface antigen (HBsAg) positive 9. Current use of any of the following: ART, including nucleoside analogs, non nucleoside reverse transcriptase inhibitors, protease inhibitors or investigational antiretroviral agents, interferon (alpha, beta or gamma) or interleukin (e.g. IL-2) therapy, any investigational agents which may interact or affect PrEP medication and any nephrotoxic agents 10. Severe inter-current illness 11. Concomitant participation in another clinical trial using investigational agents, including placebo-controlled agents, with the exception of The Pre Exposure Prophylaxis Expanded Study- The PrEPX Study [Alfred Ethics Approved Project 100/16]. Participants may be allowed to transfer from The VicPrEP Study to The PrEPX Study. 12. At enrolment, has any other condition that, based on the opinion of the treating physician, would make participation in the project unsafe; complicate interpretation of outcome data; or otherwise interfere with achieving the project objectives.

Outcome results