Significant increases in HIV diagnoses among gay and other homosexually active men, in
Australia and internationally, have been observed since the late 1990s. The levels of high
HIV risk sexual practices among gay men have also increased, particularly unprotected anal
intercourse (UAI). Nationally, over three quarters of the new HIV infections diagnosed
annually are among men who have sex with men (MSM). The proportion of heterosexual men and
women among those diagnosed with HIV annually has also increased in recent years. Despite
successes in some situations, HIV transmission has not been adequately reduced by the
prevention methods available to those at risk, such as education, condoms, and treatment of
sexually transmitted infections (STIs).
The effectiveness of daily oral antiretroviral medications (ARVs) as preexposure prophylaxis
of HIV (PrEP) has now been established by clinical trials in both heterosexual adults and
homosexual men. Whether PrEP confers high rates of protection in real life situations and is
a feasible strategy to implement still requires further investigation. Through its "HIV
prevention strategy 2015: New era," NSW Health committed to consider how to most
appropriately and efficiently implement PrEP in line with evidence. This commitment
translated in the support to this PrEP demonstration project.
This demonstration project is designed to evaluate the off-label provision of daily
combination of tenofovir disoproxil fumarate and emtricitabine (TDF/FTC, known as TRUVADA) as
PrEP to a sample of sero-negative individuals at high risk for HIV infection in clinical
settings in New South Wales. The project will inform policy development regarding primary HIV
prevention with PrEP.
This is an open-label, single-arm treatment evaluation study. All consenting and eligible HIV
negative participants will receive TRUVADA prescribed for daily administration orally. At
each followup visit, the following procedures will be conducted: clinical evaluations/
procedures, laboratory evaluations/ procedures, testing for HIV, STIs, hepatic and renal
function, assessment for adherence to the prescribed medication, side effects, eligibility
for next TRUVADA prescription, and willingness to continue on PrEP.
As a study requirement, participants will be offered a self-administered assessment of
behaviour, lifestyle and attitudes which will be conducted ideally within two and no more
than seven days of the clinic visit in the participant's private space.
Analyses will include: the feasibility of PrEP delivery, adherence to the study medication,
safety and tolerability, the effects of PrEP use on behavior, and statistical analyses of the
risk of HIV seroconversion.
Phase:
Phase 4
Details
Lead Sponsor:
Kirby Institute
Treatments:
Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Tenofovir