Prospective Observational Cohort HIV & STI Study in Europe
NCT ID: NCT03866759
Last Updated: 2022-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3593 participants
OBSERVATIONAL
2019-04-24
2022-08-22
Brief Summary
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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).
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. 18-55 years of age
3. Male sex - (at birth, chosen or intersex)
4. Able and willing to give informed consent
5. Able to read and write in local or English language
6. Willing to show identification card
7. 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
8. Willing to provide contact information for themselves and, if available, one personal contact who would know their whereabouts during the study period
9. Willing to provide information regarding risk behaviors
10. Demonstrates any one of the following risk factors:
1. reports condomless anal intercourse with at least two unique male partners (unknown HIV status or HIV+ untreated individuals) in the past 24 weeks or
2. 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 Criteria
2. Prior or concurrent participation in a candidate HIV vaccine study, unless documented placebo recipient.
3. Concurrent participation in investigational HIV treatment or prevention studies (Please note: previous participation is not an exclusion criterion).
4. Employees of the study sites cannot participate but are eligible to participate at a different study site.
18 Years
55 Years
MALE
Yes
Sponsors
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Janssen, LP
INDUSTRY
Hendrik Streeck
OTHER
Responsible Party
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Hendrik Streeck
Prof. Dr. med. Hendrik Streeck
Principal Investigators
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Hendrik Streeck, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Institute for HIV Research
Locations
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Centre Hospitalier Universitaire de Bordeaux
Bordeaux, , France
Hôpital de la Croix-Rousse
Lyon, , France
Hospital Saint Louis
Paris, , France
Hôpital Lariboisière
Paris, , France
Hôpital Saint-Antoine
Paris, , France
Semmelweis University
Budapest, , Hungary
Hospital Maggiore Policlinico
Milan, , Italy
Hospital San Raffaele
Milan, , Italy
National Institute for Infectious Diseases L. Spallanzani
Rome, , Italy
Centrum PrEP Gdańsk
Gdansk, , Poland
Pomeranian Medical University
Szczecin, , Poland
Chmielna Express Warsaw
Warsaw, , Poland
Center for Prevention and Treatment of Infectious Diseases and Addiction Treatment
Wroclaw, , Poland
Hospital Universitari Germans Trias i Pujol
Barcelona, , Spain
Vall d'Hebron Research Institute
Barcelona, , Spain
Countries
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Other Identifiers
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STIPnet Study
Identifier Type: -
Identifier Source: org_study_id
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