Status:
COMPLETED
Prospective Observational Cohort HIV & STI Study in Europe
Lead Sponsor:
Hendrik Streeck
Collaborating Sponsors:
Janssen, LP
Conditions:
HIV Infections
HIV-1-infection
Eligibility:
MALE
18-55 years
Brief 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, Pharma...
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 popu...
Eligibility Criteria
Inclusion
- HIV-uninfected as defined as negative HIV-Ab-Elisa, negative HIV viral load or negative HIV Ag-Test at time point of screening.
- 18-55 years of age
- Male sex - (at birth, chosen or intersex)
- Able and willing to give informed consent
- Able to read and write in local or English language
- Willing to show identification card
- Willing to be followed for at least 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 (unknown HIV status or HIV+ untreated individuals) in the past 24 weeks or
- documented history (lab work, physician's note etc) of syphilis, rectal neisseria gonorrhea, mycoplasma genitalium, chlamydia or acute Hepatitis C virus (HCV) infection in the past 24 weeks
Exclusion
- 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.
- Prior or concurrent participation in a candidate HIV vaccine study, unless documented placebo recipient.
- Concurrent participation in investigational HIV treatment or prevention studies (Please note: previous participation is not an exclusion criterion).
- Employees of the study sites cannot participate but are eligible to participate at a different study site.
Key Trial Info
Start Date :
April 24 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 22 2022
Estimated Enrollment :
3593 Patients enrolled
Trial Details
Trial ID
NCT03866759
Start Date
April 24 2019
End Date
August 22 2022
Last Update
November 29 2022
Active Locations (15)
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1
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France
2
Hôpital de la Croix-Rousse
Lyon, France
3
Hospital Saint Louis
Paris, France
4
Hôpital Lariboisière
Paris, France