Prospective Observational Cohort HIV & STI Study in Europe

NCT ID: NCT03866759

Last Updated: 2022-11-29

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

3593 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-24

Study Completion Date

2022-08-22

Brief Summary

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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

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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

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HIV Infections HIV-1-infection Risk Reduction Sexual Behavior

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. HIV-uninfected as defined as negative HIV-Ab-Elisa, negative HIV viral load or negative HIV Ag-Test at time point of screening.
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

1. 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.
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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Janssen, LP

INDUSTRY

Sponsor Role collaborator

Hendrik Streeck

OTHER

Sponsor Role lead

Responsible Party

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Hendrik Streeck

Prof. Dr. med. Hendrik Streeck

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status

Hôpital de la Croix-Rousse

Lyon, , France

Site Status

Hospital Saint Louis

Paris, , France

Site Status

Hôpital Lariboisière

Paris, , France

Site Status

Hôpital Saint-Antoine

Paris, , France

Site Status

Semmelweis University

Budapest, , Hungary

Site Status

Hospital Maggiore Policlinico

Milan, , Italy

Site Status

Hospital San Raffaele

Milan, , Italy

Site Status

National Institute for Infectious Diseases L. Spallanzani

Rome, , Italy

Site Status

Centrum PrEP Gdańsk

Gdansk, , Poland

Site Status

Pomeranian Medical University

Szczecin, , Poland

Site Status

Chmielna Express Warsaw

Warsaw, , Poland

Site Status

Center for Prevention and Treatment of Infectious Diseases and Addiction Treatment

Wroclaw, , Poland

Site Status

Hospital Universitari Germans Trias i Pujol

Barcelona, , Spain

Site Status

Vall d'Hebron Research Institute

Barcelona, , Spain

Site Status

Countries

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France Hungary Italy Poland Spain

Other Identifiers

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STIPnet Study

Identifier Type: -

Identifier Source: org_study_id

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