NCT03866759

Prospective Observational Cohort HIV & STI Study in Europe

European HIV&STI Prevention Network Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,593 (actual)
• Sponsor: Hendrik Streeck · Academic / Other
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV Infections
• HIV-1-infection
• Risk Reduction
• Sexual Behavior

Interventions

Type	Name	Description
BEHAVIORAL	Determine the Incidence and Point Prevalence	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.

Timeline

• Start date: 2019-04-24
• Primary completion: 2022-08-22
• Completion: 2022-08-22
• First posted: 2019-03-07
• Last updated: 2022-11-29

Locations

15 sites across 5 countries: France, Hungary, Italy, Poland, Spain