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Abstract #3398 - Biomedical prevention
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Session: 13.1: Biomedical prevention (Oral poster discussion) on Wednesday @ 13.30-14.30 in Poster room 2 Chaired by Catherine Hankins, Sara Paparini
Authors: Presenting Author: Mrs Elske Hoornenborg - GGD Amsterdam, Netherlands
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Additional Authors:
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Aim: The HIV epidemic in the Netherlands is concentrated in men who have sex with men (MSM). Amsterdam is the epicentre of the Dutch HIV epidemic among MSM, illustrated by the fact that 45% (4,885/10,753) of HIV-positive MSM are registered at HIV treatment centres in the city of Amsterdam. In spite of intensive prevention efforts, the HIV incidence rate among MSM is not declining. Clearly current prevention methods are not effective in curbing the epidemic. Recent European studies show a high PrEP efficacy of 86%. Additional interventions such as integrative and innovative HIV prevention with PrEP are needed to reach the aim set by UNAIDS for 2030 to reduce new HIV infections by 90%.
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Method / Issue: PrEP efficacy has a sound and reproducible evidence base. However, several aspects of PrEP warrant further research. GGD Amsterdam will start the AMPrEP demonstration project to provide PrEP for MSM in Amsterdam and to answer, in a real-life setting where PrEP is newly introduced, the following research questions.
(1) What is the uptake, acceptability, usability and cost-effectiveness of a comprehensive HIV infection prevention program for MSM at risk for HIV, through two intervention modalities: (a) daily PrEP and (b) intermittent, event-driven PrEP.
(2) Does risk compensation (i.e. increases in condomless anal sex and in incidence rates of other STIs) occur among PrEP users, and what are its determinants.
(3) What are determinants (behavioral, cognitive and demographic) of modality choice.
(4) What is the rate of, and are reasons for switching between PrEP.
(5) What are adherence levels to PrEP and their determinants.
(6) What is the frequency of serious adverse events.
(7) What is the frequency of HIV resistance mutations among those who, in spite of the intervention, acquire an HIV infection.
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Results / Comments: Over the course of 26 months we aim to include 370 HIV-negative MSM, who are at high risk for HIV infection. Men will be screened for eligibility, if eligible, and after providing informed consent, they will be enrolled and be able to choose between daily PrEP and intermittent, event-driven PrEP. Participants will visit the clinic every three months to test for HIV and other STIs, to assess serum creatinine and proteinuria. Adherence will be measured by pill count, self-report, and an online diary (through an app for mobile phone). Participants may switch between the two PrEP modalities at every visit. PrEP will be provided until June 2018, subsequently participants will be invited for two additional follow-up visits.
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Discussion: Although tenofovir/emtricitabine (Truvada) has been approved and licensed for use as PrEP in the USA, PrEP provision and guidance is lagging behind in Europe. This project will provide much-needed data necessary for clinical guidance and decision making regarding PrEP implementation at national and international level.
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