Clinical trial NCT03866759: Prospective Observational Cohort HIV & STI Study in Europe
Official title: European HIV&STI Prevention Network Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
HIV-1-infection
Risk Reduction
Sexual Behavior
Keywords: Sexually Transmitted Infection
HIV Vaccine Trials Network
Pre-exposure prophylaxis
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
Collaborators: name: Janssen, LP
First posted: 2019-03-07
Enrollment: 3593
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
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.

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, 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Choice of a cohort of volunteers at-risk for HIV and other STIs
timeFrame: Through study completion, an average of 2 years
measure: Relationship between STIs and certain behavior and risk of HIV infection
timeFrame: Through study completion, an average of 2 years
measure: Incidence of HIV and other STIs in a cohort of individuals at risk for HIV and other STI infections
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Prevalence of HIV and other STIs in a cohort of individuals at risk for HIV and other STI infections
timeFrame: At screening (until last participant is included), an average of 1 year
measure: Co-occurence of STIs and HIV
timeFrame: Through study completion, an average of 2 years
measure: Retention rates for prospective prevention studies for individuals at risk for HIV and STI infections.
timeFrame: Through study completion, an average of 2 years
measure: Willingness to participate in future clinical trials, such as those of candidate vaccines through questionnaire
timeFrame: At enrollment (day 0, can be same day as screening day) and at visit 4 (visit 4 is day 364)
measure: Attitudes regarding HIV and STI prevention methods
timeFrame: At screening, at visit 1, 2, 3, 4 (visit 1 is day 84, visit 2 is day 168, visit 3 is day 252 and visit 4 is day 364)
measure: Incidence between individuals at risk for HIV and STI infections across sites and countries
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
city: Lyon
country: France
facility: Hôpital de la Croix-Rousse
city: Paris
country: France
facility: Hospital Saint Louis
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Hôpital Saint-Antoine
city: Budapest
country: Hungary
facility: Semmelweis University
city: Milan
country: Italy
facility: Hospital Maggiore Policlinico
city: Milan
country: Italy
facility: Hospital San Raffaele
city: Rome
country: Italy
facility: National Institute for Infectious Diseases L. Spallanzani
city: Gdańsk
country: Poland
facility: Centrum PrEP Gdańsk
city: Szczecin
country: Poland
facility: Pomeranian Medical University
city: Warszawa
country: Poland
facility: Chmielna Express Warsaw
city: Wrocław
country: Poland
facility: Center for Prevention and Treatment of Infectious Diseases and Addiction Treatment
city: Barcelona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Vall d'Hebron Research Institute
Study officials:
affiliation: Institute for HIV Research
name: Hendrik Streeck, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: