What do I have to do if I want to participate in this study?
If you would like to participate in this study, you should register at a study site in your area (here you will find the contact details of all sites). There you must sign a consent form before any further tests or procedures can be performed. After informed consent and a detailed education, you will be physically examined and blood will be drawn to see if you qualify.
You can also get in touch with one of the contributing counseling centers/checkpoints who will advise you and refer you to one of the study sites (here you will find the contact details of the responsible counseling centers/checkpoints).
Does the participation cost money?
All treatments and examinations performed during the study are free of charge for you.
Will my travel expenses and my time expenses be compensated?
Your travel expenses and time spent on the study will be paid for. For each scheduled visit, you will receive, depending on the time required, 25-30 €. For your final visit, you will be paid 50 euros.
How many volunteers will participate in this study?
It is intended to include up to 1000 people in the study.
How long will I participate in this study?
You will be observed for a total of 12 months.
Will I benefit from participating in the study?
While you may benefit from clinical trials 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 and other sexually transmitted diseases. Every 3 months you will be examined for sexually transmitted diseases free of charge. You will be informed about your health condition. If you are diagnosed with an infection (HIV or other), you will receive immediate treatment. From the insights gained in this study, you and others may benefit in the future.
How often and what exactly am I being tested on?
We will ask you to come to the study site every three months. During these visits, you will submit a blood and urine sample. The blood sample is being tested for HIV, syphilis and hepatitis A, B and C. The urine specimen is tested for chlamydia (Chlamydia trachomatis), lymphogranuloma venerum, gonorrhea (Neisseria gonorrhoeae), mycoplasma (Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma urealyticum, Urealyticum parvum), trichomonads (Trichomonas vaginalis), soft chancre (Haemophilus ducreyi) and herpes (Herpes simplex virus type 1, herpes simplex virus type 2, cytomegalovirus) and varicella (varicella zoster virus). In addition, smears are made from anus and throat. This is done because studies have shown that – depending on the pathway of entry of the pathogen – some sexually transmitted diseases are overlooked. You can also make these smear tests yourself, if you prefer.
Why must smears be made from the anus and throat?
Chlamydia trachomatis, Neisseria gonorrhoeae, Treponema pallidum (causative agent of syphilis), Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma urealyticum, Ureaplasma parvum, Trichomonas vaginalis, Lymphogranuloma venerum and Haemophilus ducreyi are all microorganisms that can be treated with antibiotics. Some infections can not be detected in the blood. Therefore, urine specimens and smears are required to exclude infections in the mouth and anus.
Are there treatments for hepatitis?
Hepatitis A, B and C, herpes, varicella infection and HIV infection are viral diseases. You can get vaccinated against hepatitis A and B as well as varicella. If you have received such a vaccine, you will know after the tests whether you are protected from an infection. If you have not yet been vaccinated, we recommend that you are done so immediately. Although the body can usually eliminate hepatitis A from itself, we recommend close monitoring nevertheless by a specialist. There is now a treatment for hepatitis C which can cure it in almost all cases. Infections from herpes viruses are usually asymptomatic, but can also be treated with medication.
What happens if my HIV test is positive?
If you test positive for HIV, you will be counseled on what you can do to help yourself and your partners, and how we can help you.
If necessary, we will suggest that you undergo further examination and treatment. You will then be referred to a suitable health facility or to a doctor of your choice. If you become infected with HIV in the course of this study, you will be asked to provide additional blood and offered to participate in a study of acute HIV infection, such as: B. TOPHIV or RV464.
What happens if I am tested positive for a sexually transmitted disease or hepatitis A, B or C?
If you are positive for any other sexually transmitted disease or hepatitis A, B or C, you will be contacted to seek medical treatment at the trial site or to another hospital for further diagnosis and treatment. If you have been infected with the hepatitis C virus, you will be asked for another blood sample.
Will I get a PrEP in this study?
Studies have shown that the HIV infection risk decreases by more than 80% when using the HIV drug Truvada before or after any intercourse or throughout. The drug is not provided in this study. However, we recommend that you talk to the investigator about this prevention method. The investigator can explain how to get access to the drug. However, we do not recommend pre-exposure prophylaxis (PrEP) as a substitute for the use of condoms: Rather, PrEP merely provides additional protection.
Can I perform a PrEP while participating in the study?
Yes. If you would like to do a PrEP to prevent HIV infection, we encourage you to do so and will provide you with information for properly performing a PrEP.
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 do so, we would like to ask you to speak with the study team first, so that we can give you more detailed advice, taking into account your specific situation.
Will my data be treated confidentially?
All personal data and medical findings are treated confidentially and are subject to medical confidentiality and the Data Protection Act. All study records for your study participation are maintained by the main examiners at this location. Each study participant receives a patient number that is known only to the study team at the study site and is guaranteed with the confidentiality of the study data. Blood tests will only provide the date, patient number, and study visit number.