What should I do in order to participate in this study?
If you would like to participate in this study, register at a study site near you (you can find the contact details of the sites here). There you must sign the consent form before any further tests or procedures can be performed. After signing the informed consent you will be asked to fill out a questionnaire if you are infected with HIV. You will also be physically examined and have blood drawn to see if you are eligible.
Does it cost money to participate?
All treatments and examinations performed during the study are free of charge for you.
Will my time and travel expenses be compensated?
Your travel expenses and time spent on the study will be paid for. For each scheduled visit, you will receive, 25€ at the conclusion of each visit.
How many volunteers are taking part in this study?
We intend to include up to 320 participants in this study. These will consist of up to 100 participants with acute HIV infection, up to 120 uninfected participants at risk for HIV infection, and up to 100 participants with chronic HIV infection.
How long will I participate in this study?
You will be observed for up to 24 months. However, if you become infected with HIV during the course of the study, you will be given the opportunity to re-consent and participate in the study for an additional 24 months. If you do not want to be monitored for another 24 months, your participation in the study will end.
Will I benefit from participating in this study?
While you may benefit from the clinical tests and physical examinations, you may not benefit directly from participating in the study.
The study will educate and advise you on HIV and risk reduction so you can better protect yourself from HIV. From the insights gained in this study, you and others may benefit in the future.
Will I receive medication for HIV in this study?
We recommend beginning HIV therapy directly after diagnosis. However, it is up to you and your doctor to decide when to start HIV therapy and what medications you will use.
Can I participate in other studies at the same time?
In general, it is not a problem to participate in this and other studies at the same time. If you intend to, we would ask you to speak with the study team first so that we can give you more detailed advice about your specific situation. Perhaps the study team will also recommend a study on their own which may be suitable for you.
Am I insured against accidents that might occur during the study?
In the context of this study, there is insurance coverage against consequential damage of taking biological samples and against commuting accidents according to § 2 Abs. 1 Nr. 13b of the Sozialgesetzbuch (SGB) VII. Please contact us if you have suffered any damage or injuries. The study team will then inform the responsible Unfallkasse Nordrhein-Westfalen.
Will I be informed about new findings?
You will be informed during the study of all important new findings such as changes in benefits, risks, or new alternatives to study participation. If you have been informed of new findings, you will be asked to resume your participation in the study on your next visit.
Are there alternatives to study participation?
You can also opt out of participating in the study or, if possible, participate in other studies.
Will my data be handled confidentially?
All personal data and medical findings are treated confidentially and are subject to medical confidentiality and the Data Protection Act. All study records of your study participation are maintained by the main investigator at their study center. Each study participant receives a patient number, which is known only to the study team at the test center and with which the confidentiality of the study data is guaranteed. Blood tests will only be labeled with the date, patient number, and the corresponding study visit number.
Can I stop participating in the study at any time?
Participation in this study is completely voluntary. You can refuse to participate in the study or withdraw from the study at any time. Your decision not to participate in the study or to opt out at a later date will not affect your usual care. If, for any reason, you decide to quit the study early, you will be asked to come to the trial center for a final visit.
If you choose to withdraw your consent, the study team will not contact you unless you are in need of contact for safety or well-being reasons, and the ethics committee and the attending physician agree.