title: Pre-Exposure Prophylaxis (PrEP) as an Additional Tool for HIV Prevention Among Men Who Have Sex With Men in Belgium: The Be-PrEP-ared Study Protocol.
abstract: BACKGROUND
  Pre-exposure prophylaxis (PrEP) is a promising and effective tool to prevent HIV. With the approval of Truvada as daily PrEP by the European Commission in August 2016, individual European Member states prepare themselves for PrEP implementation following the examples of France and Norway. However, context-specific data to guide optimal implementation is currently lacking.
  
  
  OBJECTIVE
  With this demonstration project we evaluate whether daily and event-driven PrEP, provided within a comprehensive prevention package, is a feasible and acceptable additional prevention tool for men who have sex with men (MSM) at high risk of acquiring HIV in Belgium. The study's primary objective is to document the uptake, acceptability, and adherence to both daily and event-driven PrEP, while several secondary objectives have been formulated including impact of PrEP use on sexual behavior.
  
  
  METHODS
  The Be-PrEP-ared study is a phase 3, single-site, open-label prospective cohort study with a large social science component embedded in the trial. A total of 200 participants choose between daily or event-driven PrEP use and may switch, discontinue, or restart their regimen at the 3-monthly visits for a duration of 18 months. Data are collected on several platforms: an electronic case report form, a Web-based tool where participants register their sexual behavior and pill use, a more detailed electronic self-administered questionnaire completed during study visits on a tablet computer, and in-depth interviews among a selected sample of participants. To answer the primary objective, the recruitment rate, (un)safe sex behavior during the last 6 months, percentage of reported intention to use PrEP in the future, retention rates in different regimens, and attitudes towards PrEP use will be analyzed. Adherence will be monitored using self-reported adherence, pill count, tenofovir drug levels in blood samples, and the perceived skills to adhere.
  
  
  RESULTS
  All participants are currently enrolled, and the last study visit is planned to take place around Q3 2018.
  
  
  CONCLUSIONS
  As PrEP is not yet available in Belgium for use, this study will provide insights into how to optimally implement PrEP within the current health care provision and will shape national and European guidelines with regard to the place of PrEP in HIV prevention strategies.
  
  
  BACKGROUND
  EU Clinical Trial 2015-000054-37; https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-000054-37/BE (Archived by WebCite at http://www.webcitation.org/6nacjSdmM).
authors.affiliation: Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
authors.forename: Irith
authors.identifier: http://orcid.org/0000-0002-1804-252X
authors.initials: I
authors.lastname: De Baetselier
authors.affiliation: HIV and Sexual Health Unit, Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium.
authors.forename: Thijs
authors.identifier: http://orcid.org/0000-0002-2086-3124
authors.initials: T
authors.lastname: Reyniers
authors.affiliation: HIV and Sexual Health Unit, Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium.
authors.forename: Christiana
authors.identifier: http://orcid.org/0000-0001-9031-8503
authors.initials: C
authors.lastname: Nöstlinger
authors.affiliation: HIV/Sexually Transmitted Infection Clinic, Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
authors.forename: Kristien
authors.identifier: http://orcid.org/0000-0002-8056-138X
authors.initials: K
authors.lastname: Wouters
authors.affiliation: Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
authors.forename: Katrien
authors.identifier: http://orcid.org/0000-0003-2127-4599
authors.initials: K
authors.lastname: Fransen
authors.affiliation: Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
authors.forename: Tania
authors.identifier: http://orcid.org/0000-0002-2235-6038
authors.initials: T
authors.lastname: Crucitti
authors.affiliation: HIV/Sexually Transmitted Infection Clinic, Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.|Department of Medicine, University of Cape Town, Cape Town, South Africa.
authors.forename: Chris
authors.identifier: http://orcid.org/0000-0002-2557-8998
authors.initials: C
authors.lastname: Kenyon
authors.affiliation: Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
authors.forename: Jozefien
authors.identifier: http://orcid.org/0000-0001-6780-380X
authors.initials: J
authors.lastname: Buyze
authors.affiliation: Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
authors.forename: Céline
authors.identifier: http://orcid.org/0000-0002-5427-3974
authors.initials: C
authors.lastname: Schurmans
authors.affiliation: HIV and Sexual Health Unit, Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium.
authors.forename: Marie
authors.identifier: http://orcid.org/0000-0002-3567-000X
authors.initials: M
authors.lastname: Laga
authors.affiliation: HIV and Sexual Health Unit, Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium.
authors.forename: Bea
authors.identifier: http://orcid.org/0000-0003-0514-4372
authors.initials: B
authors.lastname: Vuylsteke
authors.affiliation: Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.|See Authors' Contributions section for collaborators/group members, .
keywords: Belgium; HIV prevention; MSM; acceptability; adherence; daily; demonstration project; event-driven; pre-exposure prophylaxis