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@article{b321271142d7461fa3788d848aee5c9e,
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.CLINICALTRIAL: 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).",
author = "{De Baetselier}, Irith and Thijs Reyniers and Christiana N{\"o}stlinger and Kristien Wouters and Katrien Fransen and Tania Crucitti and Chris Kenyon and Jozefien Buyze and C{\'e}line Schurmans and Marie Laga and Bea Vuylsteke and {Be-PrEP-Ared Study Group}",
year = "2017",
doi = "10.2196/resprot.6767",
language = "English",
volume = "6",
pages = "e11",
journal = "JMIR Research Protocols",
issn = "1929-0748",
publisher = "JMIR Publications Inc.",
number = "1",

}

RIS

TY - JOUR

T1 - Pre-Exposure Prophylaxis (PrEP) as an additional tool for HIV prevention among men who have sex with men in Belgium

T2 - the Be-PrEP-ared study protocol

AU - De Baetselier, Irith

AU - Reyniers, Thijs

AU - Nöstlinger, Christiana

AU - Wouters, Kristien

AU - Fransen, Katrien

AU - Crucitti, Tania

AU - Kenyon, Chris

AU - Buyze, Jozefien

AU - Schurmans, Céline

AU - Laga, Marie

AU - Vuylsteke, Bea

AU - Be-PrEP-Ared Study Group

PY - 2017

Y1 - 2017

N2 - 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.CLINICALTRIAL: 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).

AB - 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.CLINICALTRIAL: 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).

U2 - 10.2196/resprot.6767

DO - 10.2196/resprot.6767

M3 - A2: International peer reviewed article (not A1-type)

C2 - 28135199

VL - 6

SP - e11

JO - JMIR Research Protocols

JF - JMIR Research Protocols

SN - 1929-0748

IS - 1

ER -

ID: 1874499