PrEP Demonstration Project (PRELUDE Study) (PRELUDE)
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|ClinicalTrials.gov Identifier: NCT02206555|
Recruitment Status : Completed
First Posted : August 1, 2014
Last Update Posted : December 2, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV||Drug: emtricitabine/tenofovir disoproxil fumarate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||327 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Implementation of HIV Preexposure Prophylaxis With Antiretroviral Medications Among People at High Risk for HIV Infection: A Demonstration Project|
|Actual Study Start Date :||November 14, 2014|
|Actual Primary Completion Date :||November 28, 2016|
|Actual Study Completion Date :||December 20, 2017|
Experimental: Treatment group (TRUVADA)
Homosexual men and heterosexual men and women at high risk of HIV infection
Drug: emtricitabine/tenofovir disoproxil fumarate
- Time to accrual [ Time Frame: Approximately 18 months ]Time to accrual of 300 person-years of follow-up on TRUVADA. Each participant will receive TRUVADA for a maximum of 12 months, and will be followed for an additional three months after discontinuation. (Primary endpoint: feasibility of the process of PrEP delivery in health care settings in NSW)
- Seroconversion-free time on PrEP [ Time Frame: Approximately 18 months ]Seroconversion-free time on PrEP (Primary endpoint: feasibility of the process of PrEP delivery in health care settings in NSW)
- Time to TRUVADA discontinuation [ Time Frame: Approximately 18 months ]Time to TRUVADA discontinuation (primary endpoint: adherence)
- Prescribed doses taken [ Time Frame: Approximately 18 months ]Percentage of prescribed doses taken orally in the prescribed period (primary endpoint: adherence)
- Incidents of HIV seroconversion [ Time Frame: Approximately 24 months ]Incidence of HIV seroconversion among study participants during the course of their study participation and in six months following PrEP discontinuation (primary endpoint: safety and side effects)
- Incidents of rectal gonorrhea and chlamydia [ Time Frame: Approximately 18 months ]New rectal gonorrhoea and chlamydia infections (primary endpoint: behavioral effects of PrEP use)
- Serious adverse reactions [ Time Frame: Approximately 18 months ](primary endpoint: safety and side effects)
- Adverse events [ Time Frame: Approximately 18 months ]Any adverse events leading to interruption or discontinuation of the study product (TRUVADA) (primary endpoint: safety and side effects)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02206555
|Australia, New South Wales|
|RPA Sexual Health|
|Camperdown, New South Wales, Australia, 2050|
|Holdsworth House Medical Practice|
|Darlinghurst, New South Wales, Australia, 2010|
|St Vincent's Hospital HIV, Immunology and Infectious Disease Unit|
|Darlinghurst, New South Wales, Australia, 2010|
|Western Sydney Sexual Health Centre|
|Parramatta, New South Wales, Australia, 2150|
|Sydney Sexual Health Centre|
|Sydney, New South Wales, Australia, 2000|
|Study Chair:||Iryna Zablotska, MD, MPH, PhD||The Kirby Institute for Infection and Immunity in Society|