Expanded PrEP Implementation in Communities in NSW (EPIC-NSW)
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|ClinicalTrials.gov Identifier: NCT02870790|
Recruitment Status : Active, not recruiting
First Posted : August 17, 2016
Last Update Posted : January 13, 2020
A new NSW Ministry of Health HIV Strategy released on 1 December 2015 aims for the virtual elimination of HIV transmission in NSW by 2020. Critical to the new strategy's success is the population-based, targeted roll-out of HIV PrEP. PrEP involves taking one pill daily of co-formulated tenofovir disoproxil fumarate (TDF)/ emtricitabine (FTC). This large-scale study aims for the rapid roll-out of TDF/FTC to individuals at high risk of HIV, who will comprise mostly gay and bisexual men (GBM) but will also include small numbers of heterosexuals, injecting drug users, and transgender men and women. The drug will be used according to existing NSW Ministry of Health Guidelines. By rapidly rolling out this new intervention over a 12 month period, and following participants for two years on treatments, a reduction of about 50% in new HIV diagnoses in NSW is expected.
The study aims to assess the incidence of HIV among PrEP study participants and measure the population-level impact of the rapid roll-out of PrEP on HIV diagnoses among GBM in NSW over a two-year period.
It will also evaluate the rate of PrEP uptake among high risk GBM in NSW, assess the incidence of STI (gonorrhoea, chlamydia and infectious syphilis) among people prescribed PrEP and measure the effect of the rapid roll-out of PrEP on the overall number of notifications of gonorrhoea, chlamydia and infectious syphilis in NSW, describe patterns of PrEP use and medication adherence, and monitor behavioural risk practices among PrEP users.
The main population group will be more than 3700 gay men at high risk of HIV infection. All procedures of this study are guided by the NSW Guidelines on PrEP.
Protocol Co-Chairs Professor David Cooper, Professor Andrew Grulich. Project Manager: Barbara Yeung
|Condition or disease||Intervention/treatment||Phase|
|HIV STI||Drug: TDF/FTC||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9733 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of the Rapid Expansion of Pre-exposure Prophylaxis (PrEP) on HIV Incidence, in a Setting With High HIV Testing and Antiretroviral Treatment Coverage, to Achieve the Virtual Elimination of HIV Transmission by 2020: a NSW HIV Strategy Implementation Project|
|Actual Study Start Date :||March 2016|
|Actual Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||October 2020|
A single open-label arm. All participants receive daily oral pill containing TDF/FTC
one pill daily
- Incidence of HIV infection per 100 person years among study participants [ Time Frame: 24 months of follow-up ]
- Number of HIV diagnoses among gay and bisexual men notified to the NSW Ministry of Health. [ Time Frame: 24 months of follow-up ]
- Incidence of STI (gonorrhoea, chlamydia and infectious syphilis) per 100 person years among study participants [ Time Frame: 24 months of follow-up ]
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): NCT02870790
|Study Chair:||David Cooper, MD, PhD||The Kirby Institute, UNSW Sydney|
|Study Chair:||Andrew Grulich, MD, PhD||The Kirby Institute, UNSW Sydney|