University College London is running the AURAH2 study in partnership with 56 Dean Street, the Mortimer Market Clinic, London and the Claude Nicol Centre, Brighton.
The aim of the AURAH2 study is to study the incidence and predictors of new infections among HIV negative MSM at risk of acquiring HIV, and to assess changes over time in risk behaviour and HIV testing practices within individuals.
Study participants will be approached for participation when they attend any of the 3 sexual health centres that are recruiting for the AURAH2 study.
56 Dean Street and Dean Street Express: http://www.chelwest.nhs.uk/services/hiv-sexual-health/clinics/56-dean-street
The Mortimer Market Centre: http://www.cnwl.nhs.uk/service/mortimer-market-centre/
Claude Nicol Centre: http://www.brightonsexualhealth.com/
Joining the study and what it entails:
Participants will be invited to read an information sheet during their attendance at any of the 3 AURAH2 sites.
If a participant agrees to join the study he will be invited to complete a consent form and the baseline questionnaire for the study. On the consent form he will be asked to write his email address that the study team will be able to email him with as well as his name and date of birth.
After 4 months the participant will receive an email from the study team that contains a link to the study registration page. He will be asked to register, create a password and be directed to his first questionnaire.
Every 4 months the participant will receive an email from the study team containing the link to the AURAH2 website where he can log-in using his email address and the password he created at registration. He will then be directed to his questionnaire to complete.
Each short questionnaire will take around 5 minutes to complete.
On an annual basis the questionnaire will be more in depth and take longer to complete than the twice yearly short questionnaire – the annual questionnaire will take around 20 minutes to complete.
At the end of each questionnaire there is a text box where participants can write comments or suggestions for the study team.
There will be a total of 9 questionnaires over a 3 year period to complete.
Participants will not need to return to the clinic to complete the questionnaires, these can be done online using a mobile, laptop or PC device.
If a participant has an HIV test whilst he is in the study and receives a positive HIV test result he can remain in the study and will continue to receive emails containing the link to log-in and complete his questionnaire on a 4 monthly basis.
On an annual basis each participant that has completed a year of the study will be entered in to a prize draw for a £1000 prize. The winner will be notified by email.
At the end of the study participant’s names and dates of birth will be compared with Public Health England’s HIV and AIDS surveillance system to confirm any new HIV diagnoses that occurred during the course of the study.
The online questionnaire web pages will be hosted on a secure web server. All procedures and processes for online data collection and storage will be assessed against the requirements of the NHS Information Governance Toolkit and any recommendations will be acted on.
The study result datasets will be held on IT facilities at University College London and will be securely stored on centrally managed servers or on encrypted PC and laptop drives. Paper forms (including questionaires and copies of the study log) will be stored securely in locked cabinets. Any participant personal identifable details will be securely stored in encrypted form or within a secure environment for handling personally identifiable data in a manner compliant with the Data Protection Act and only used for the consented purposes . Once the personally identifiable information has been used for the consented purposes, and after the period of 6 months as indicated on the consent form has expired, the personal details will be permanently deleted.