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- Essais cliniques sur Infections à VIH - Registre des essais cliniques - ICH GCP
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As noted earlier, a unique barcode was attached to the questionnaire and to the biological sample for each individual allowing anonymous linkage between the two kinds of information for later analysis. Finally, the result of the tests was made available to the study participants through the same barcode attached to a card given to individuals during the sample collection. Participants enrolled in the study were asked to provide informed consent.
Individuals were given the possibility to withdraw from the study at any time without explanation. In case of a confirmed positive test, participants were offered a confirmation test on a different biological sample and encouraged to get a referral to local care for further checks and treatment in line both with the international guidelines and local standard pathways of care. In order to ensure no harm for the respondents enrolled in the Sialon II surveys and to harmonise all the data collection procedures, a specific training manual for data collectors has been developed.
The coordinators were also in charge of monitoring the local data collection and coaching the data collectors during activities. On-going monitoring activities were carried out so that any potential difficulty or issue in preserving privacy and confidentiality was supervised. The Sialon II protocols have been submitted to the relevant ethics committee in each participating city, where official approval was obtained prior to any data collection.
As a consequence of this, periodical monitoring reports on the status of the survey implementation have been prepared and submitted to the WHO-ERC committee for review and approval. Data analysis will be carried out in line with the sampling method adopted in each study site. Data management will be carried out using DataEntry, R v3. In line with the sampling approach adopted, estimates will be weighted. Handcock, Ian E. Fellows, Krista J. Data will be analysed as part of the protocol in and results will be available in A second generation surveillance approach to monitoring and controlling the HIV epidemic is a critical tool for state-of-the art public health.
Specifically, implementation of the Sialon II protocols, which take into account the most recent GARPR indicators [ 11 ], offer a unique opportunity to pilot a large-scale bio-behavioural survey in line with the SGSS approach in a substantial number of EU countries.
The Sialon II protocol and findings that will be available on the project website as well as in additional scientific publications from are likely to contribute significantly to increasing the comparability of data in EU countries through the use of common indicators and in implementing effective public health strategies and policies in areas of high need.
In addition to this, data collected through the former Sialon project and through the Sialon II survey could represent the basis for implementing additional surveys — in line with the SGSS — in order to develop trend analysis to monitor the HIV-STI epidemic over time. In terms of limitations, the use of two different sampling strategies could represent a limitation for the study, as it has been shown in other studies that through TLS and RDS methods different segments of the total MSM population can be enrolled and this can result in different sample characteristics, and the differences may persist also after applying weighting corrections to the result estimates: this might limit the results from the Sialon II survey.
Finally, the Sialon protocols may provide a useful and feasible model for community-based organisations to conduct decentralised and de-medicalised HIV testing in the future, as such protocols were tested across highly heterogeneous settings. Moreover, by involving the MSM community in all aspects of the study through both the partnership itself and collaborations with local gay NGOs in the participating countries, as well as working intersectorally with public health institutions and universities, it is possible to increase the capacity of all stakeholders in using innovative sampling methods for collecting bio- behavioural data among MSM in future second generation surveys.
Authors would like to thank the Sialon II colleagues from Associated and Collaborating partners for the constant support, commitment and enthusiasm in the project implementation. UMA and SDV participated in the formative research component, in the conception and design of the protocol and in drafting the manuscript. NSH participated in the conception and design of the protocol and in drafting the manuscript. MFU participated in the early stages of development of the protocols and in drafting the manuscript.
MBR participated in the data collectors training component and data collection, in the early stages of development of the protocols, in the conception and design of the protocol and in drafting the manuscript. CNO and WVB participated in the prevention component, in the conception and design of the protocol and in drafting the manuscript. SDI participated in the conception and design of the protocol, in the protocols adaptation to the country specific context, in data collectors training and in drafting the manuscript. DST and IAL participated in the laboratory component, in the conception and design of the protocol and in drafting the manuscript.
All authors read, amended and approved the final manuscript. Lorenzo Gios, Email: moc. Massimo Mirandola, Email: ti. Igor Toskin, Email: tni. Ulrich Marcus, Email: ed. Sandra Dudareva-Vizule, Email: ed. Nigel Sherriff, Email: ku. Michele Breveglieri, Email: ti. Martina Furegato, Email: ti. Cinta Folch, Email: ten. Laia Ferrer, Email: ten. Alexandra Montoliu, Email: ten. Wim Vanden Berghe, Email: eb. Inga Velicko, Email: es.
Barbara Suligoi, Email: ti. Vincenza Regine, Email: ti. Danica Stanekova, Email: ks. Saulius Caplinskas, Email: tl. Irena Klavs, Email: is. Ivailo Alexiev, Email: moc. Read article at publisher's site DOI : J Public Health Oxf , 42 2 :ee, 01 May Viruses , 12 4 , 14 Apr Euro Surveill , 23 49 , 01 Dec PLoS One , 13 12 :e, 06 Dec Coronavirus: Find the latest articles and preprints.
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Dudareva-VizuleS rki. Dudareva-Vizule S 4 ,. Sherriff N 5 ,. Breveglieri M 1 ,. Furegato M 1 ,. Folch C 6 ,. Ferrer L 6 ,. Montoliu A 6 ,. Wvandenberghe itg.
Essais cliniques sur Infections à VIH - Registre des essais cliniques - ICH GCP
Vanden Berghe W 7 ,. Velicko I 8 ,. Dias S 9 ,. Suligoi B 10 ,. Regine V 10 ,. Stanekova D 11 ,. Caplinskas S 13 ,. Klavs I 14 ,. Alexiev I 15 ,. Matei Bals, Bucharest, Romania. Search articles by 'Alexandru Rafila'. Rafila A Show less. Affiliations 3 authors 1. From mid-January for a month, Igloo Fest takes over the Old Port of Montreal for a large electro-music festival each weekend. This is a large outdoor electronic music festival that takes place every Sunday afternoon from May to September at the Parc Jean-Drapeau. Like Igloo Fest, it's not exclusively gay, but all our local gay Montreal friends raved about this one as well.
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As it takes place during the summer months, the outfits are a lot skimpier compared to Igloo Fest… just sayin'.. With workshops, debates and performances galore, you'll find plenty to enjoy if you're in the city at the right time. There are usually around 25 different performances taking place in more than 15 venues throughout Montreal, including outdoor spaces, so check their website for all the details. This is the largest international comedy festival in the world, held every July for 1 week.
Attracting more than 2 million people to Montreal, there are often huge comedy stars performing along with undiscovered talent. If you like a good laugh and seriously, who doesn't?
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For when you just need a quick bite, breakfast or cup of Joe, Montreal has some wonderful gay cafes to check out. These are our favourite gay owned and gay friendly cafes we loved in the city:. It's been around for over 20 years and is a great place to come for lunch or coffee during the day. They specialise in home-style classics, big sandwiches and antipasto.