HIV and STIs Clinical Study 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

• HIV-uninfected
• 18-55 years of age
• Male sex - (at birth, chosen or intersexual)
• Able and willing to give informed consent
• Able to read and write in German or English language
• Willing to provide identification card
• Willing to be followed for 12 months in the study and undergo study procedures including testing for HIV and receipt of HIV test results
• Willing to provide contact information for themselves and, if available, one personal contact who would know their whereabouts during the study period
• Willing to provide information regarding risk behaviors
• Demonstrates any one of the following risk factors:

• 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
• documented history (lab work, physician's note etc.) of syphilis in the past 24 weeks or
• documented history of rectal gonorrhea or chlamydia in the past 24 weeks or
• documented history of rectal mycoplasma genitalium in the past 24 weeks or
• documented history of acute Hepatitis C virus (HCV) infection in the past 24 weeks

Exclusion criteria

• 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.
• Participation in a previous HIV vaccine study, unless documented placebo recipient.
• Concurrent participation in investigational agents for treatment or prevention of HIV-1 infection (e.g. Discover Study)