HIV and STIs Clinical Study in Germany
Condition: HIV Infections; Sexual Behavior; Risk Reduction
MeSH terms: Infections
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Determine the Incidence and Retention Rate
Intervention type(s): Other
Intervention description(s): Determine the incidence of HIV and the retention rate of MSM/TGW/TGM/Intersex at risk for HIV infection
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will consist of 1,000 HIV uninfected MSM/TGW/TGM/Intersex ages 18-55
        years at risk for HIV infection at all study sites. Incidence rate will be evaluated across
        all sites as a primary objective. Each participant will be followed for a total of 12
        months with assessment of HIV and STI status and risk behavior conducted at screening,
        three months (V2), six months (V3), nine months (V4), and twelve months (V5). It is
        anticipated that total accrual will take approximately 12 months.
      
Biospecimen description: 
      urine, blood (serum, plasma), swabs (oral, rectal)
    
Keywords: HIV; Pre-exposure prophylaxis; Sexually Transmitted Diseases