HIV and STIs Clinical Study in Germany
HIV and STIs Clinical Study in Germany
The BRAHMS study is a prospective observational cohort study aiming to investigate how often
 people that are at risk to get infected with HIV contract HIV and how long people stay in the
 study. The University Hospital Essen is interested in finding out how often participants
 contact other sexually transmitted infections (STI) and hepatitis as well as in the
 development of HIV vaccines to test in the future. The University Hospital Essen will
 therefore also ask participants to fill out a questionnaire asking their general willingness
 to participate in such a trial (i.e., where the vaccine might be targeted to an HIV subtype
 not as common in Europe) to understand whether such testing would be possible in the future
 in Germany.
In Germany, new HIV diagnoses are steadily increasing again since 2000. 74% of infected
 individuals living in Germany are men who have sex with men (MSM) whereas only 15% were
 infected by heterosexual contact. The HIV epidemic is mainly restricted to big cities such as
 Cologne, Berlin, Hamburg. The successful conduct of HIV vaccine efficacy trials requires
 recruitment, enrolment, and long-term retention of informed, willing, and HIV-negative but
 at-risk participants. Therefore, the University Hospital Essen plans a vaccine preparedness
 study to assess the feasibility of future HIV vaccine efficacy trials in Germany, a subtype B
 prevalent region in Europe, as this has never been assessed in Germany.

 Notably investigators conduct a cohort study to characterize HIV incidence and retention
 among high risk, HIV uninfected MSM/Transgender women (TGW)/Transgender Men (TGM)/Intersex in
 the setting of prevention modalities that may be available to participants, including PrEP
 and regular HIV risk reduction counselling and testing. The design of the study will address
 several unique questions about the community at highest risk for HIV infection and will
 provide strong data for prevention methods including PrEP.

 Moreover, it has been clearly demonstrated that sexually transmitted infections (STIs) can
 increase the risk of acquiring a HIV infection. Therefore, early diagnosis and treatment of
 STI is crucial to reduce this risk factor of HIV acquisition and to inform individuals about
 their risk to become HIV infected. As STIs are a crucial factor in the scope of an incidence
 analysis of HIV in MSM and are underdiagnosed often, extensive screening measures are
 implemented within the study to an extent never performed in Germany before.
Inclusion Criteria:

 1. HIV-uninfected

 2. 18-55 years of age

 3. Male sex - (at birth, chosen or intersexual)

 4. Able and willing to give informed consent

 5. Able to read and write in German or English language

 6. Willing to provide identification card

 7. Willing to be followed for 12 months in the study and undergo study procedures
 including testing for HIV and receipt of HIV test results

 8. Willing to provide contact information for themselves and, if available, one personal
 contact who would know their whereabouts during the study period

 9. Willing to provide information regarding risk behaviors

 10. Demonstrates any one of the following risk factors:

 1. reports condomless anal intercourse with at least two unique male partners in the
 past 24 weeks (partners must be either HIV-infected or of unknown HIV status) or

 2. documented history (lab work, physician's note etc.) of syphilis in the past 24
 weeks or

 3. documented history of rectal gonorrhea or chlamydia in the past 24 weeks or

 4. documented history of rectal mycoplasma genitalium in the past 24 weeks or

 5. documented history of acute Hepatitis C virus (HCV) infection in the past 24
 weeks

 Exclusion Criteria:

 1. Any significant condition (including medical, psychologic/psychiatric and social)
 which, in the judgment of the study investigator, might interfere with the conduct of
 the study or be detrimental to the participant.

 2. Participation in a previous HIV vaccine study, unless documented placebo recipient.

 3. Concurrent participation in investigational agents for treatment or prevention of
 HIV-1 infection (e.g. Discover Study)