Prospective Observational Cohort HIV & STI Study in Europe
Condition: HIV Infections; HIV-1-infection; Risk Reduction; Sexual Behavior
MeSH terms: Infections; Communicable Diseases
Study type: Observational

Summary: 
      The University Hospital Essen is sponsoring the Multicenter human immunodeficiency virus
      (HIV) and sexually transmitted infections Prevention Network Study (STIPnet) which is funded
      by Janssen, Pharmaceutical Companies of Johnson & Johnson.

      STIPnet study is a prospective observational cohort study aiming to determine the incidence
      and point prevalence of HIV infection and the most common sexually transmitted infections
      (STIs) in individuals with sexual risk behavior. In addition, the University Hospital Essen
      will examine whether individuals at risk for HIV and STI infections would retain in such a
      study (retention rate) and would be willing to participate in potential HIV and STI
      prevention trials (willingness to participate).
    

Detailed description: 
      To develop and test novel prevention methods or interventions against sexually transmitted
      infections (STIs), knowledge is required on whether there are increased rates of transmission
      in a given population. In order for trials testing new prevention methods to be feasible and
      affordable, the goal is to define a group at risk where there will be at least an annual 3%
      incidence of new infections of the respective STI. The group definitions will be based on
      factors such as gender, age, sexual behavior, economic status and others. However, defining
      such groups is labor-intensive and costly and often not do-able for vaccine developers and
      developers of novel prevention/diagnostic methods. Thus, as identification and testing of the
      most at-risk groups to study these medicinal products is too costly, only a limited number of
      novel prevention methods are brought into clinical trials. Here the investigators plan to
      define factors such as behavioral or co-infections associated with individual STIs for
      potential future prevention trials. Given the increased susceptibility of human
      immunodeficiency (HIV) infection with STI infections, early diagnosis and treatment of STI is
      substantial to reduce risk factor of HIV acquisition and to inform individuals about their
      risk of becoming HIV infected. As STIs are a crucial factor in the scope of an incidence
      analysis of HIV in men who have sex with men (MSM) and are often underdiagnosed, extensive
      screening measures are implemented within this study.

      Thus, the STIPnet study is building up a platform for effective recruitment, retention and
      assess important epidemiological patterns and thus, designed as a vaccine preparedness study,
      to gather information on the most common STIs and prepare sites for potential future vaccine
      trials. Indeed, several potential HIV&STI vaccines are currently in development.

      At-risk volunteers are screened every three months for HIV and other STIs, thereby
      establishing disease prevalence and incidence in communities that might someday support
      future vaccine trials. Behavioural data are also collected and participants complete a
      questionnaire that assesses the willingness to participate in future vaccine studies.
    

Intervention name(s): Determine the Incidence and Point Prevalence
Intervention type(s): Behavioral
Intervention description(s): Determine the Incidence and Point Prevalence of human immunodeficiency virus (HIV) Infection and the Most Common Sexually Transmitted Infections in Individuals With Sexual Risk Behavior.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will consist of a minimum of 3,300 and a maximum of 3,800 HIV
        uninfected men who have sex with men (MSM)/Transgender Men (TGW)/Transgender Woman
        (TGM)/Intersex ages 18-55 years at risk for HIV infection at all study sites. Each
        participant will be followed for a total of 12 months with assessment of HIV and STI status
        and risk behavior conducted at screening/enrollment, three months (V1), six months (V2),
        nine months (V3), and twelve months (V4). It is anticipated that total accrual will take
        until LPI is enclosed. It is estimated that a total of max. 4,540 participants will be
        screened.
      
Biospecimen description: 
      Urine Blood (Serum, Plasma) Swabs (oral,rectal)
    
Keywords: Sexually Transmitted Infection; HIV Vaccine Trials Network; Pre-exposure prophylaxis