Prospective Observational Cohort HIV & STI Study in Europe

NCT03866759 | Completed DMC

• 1 other identifier: STIPnet Study
• Study Type: observational
• Target: 3,593
• Locations: 5 countries
• Sites: 15

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).

Conditions

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

Keywords

Sexually Transmitted Infection; HIV Vaccine Trials Network; Pre-exposure prophylaxis

Outcome Measures

Primary Outcomes (3)

• Choice of a cohort of volunteers at-risk for HIV and other STIs

  Participants will receive questionnaires. The group definitions will be based on factors such as gender, age, education, sexual behavior, economic status, pre- and post-exposure prophylaxis and others. Descriptive statistics will be generate to choose a cohort of volunteers at-risk for HIV and other STIs.

  Through study completion, an average of 2 years

• Relationship between STIs and certain behavior and risk of HIV infection

  Participants will receive a questionnaire about behavior and risk of HIV infection. Descriptive statistics will be generate to summarize the relationship between STIs and HIV infection.

  Through study completion, an average of 2 years

• Incidence of HIV and other STIs in a cohort of individuals at risk for HIV and other STI infections

  Descriptive statistics will be generated to summarize incidence (as measured as new HIV and STI infections occurring during the study period) HIV and STI infections. The power calculation targets a 3% incidence rate per year.

  Through study completion, an average of 2 years

Secondary Outcomes (6)

• Prevalence of HIV and other STIs in a cohort of individuals at risk for HIV and other STI infections

  At screening (until last participant is included), an average of 1 year

• Co-occurence of STIs and HIV

  Through study completion, an average of 2 years

• Retention rates for prospective prevention studies for individuals at risk for HIV and STI infections.

  Through study completion, an average of 2 years

• Willingness to participate in future clinical trials, such as those of candidate vaccines through questionnaire

  At enrollment (day 0, can be same day as screening day) and at visit 4 (visit 4 is day 364)

• Attitudes regarding HIV and STI prevention methods

  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)

Interventions

Determine the Incidence and Point Prevalence BEHAVIORAL

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

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Men who have sex with Men (MSM) Transgender Men (TGM) Transgender Women (TSW) Intersex
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.
• Employees of the study sites cannot participate but are eligible to participate at a different study site.

Sponsors & Collaborators

• Hendrik Streeck: lead
• Janssen, LP: collaborator

Study Sites (15)

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, France

Location

Hôpital de la Croix-Rousse

Lyon, France

Location

Hospital Saint Louis

Paris, France

Location

Hôpital Lariboisière

Paris, France

Location

Hôpital Saint-Antoine

Paris, France

Location

Semmelweis University

Budapest, Hungary

Location

Hospital Maggiore Policlinico

Milan, Italy

Location

Hospital San Raffaele

Milan, Italy

Location

National Institute for Infectious Diseases L. Spallanzani

Rome, Italy

Location

Centrum PrEP Gdańsk

Gdansk, Poland

Location

Pomeranian Medical University

Szczecin, Poland

Location

Chmielna Express Warsaw

Warsaw, Poland

Location

Center for Prevention and Treatment of Infectious Diseases and Addiction Treatment

Wroclaw, Poland

Location

Hospital Universitari Germans Trias i Pujol

Barcelona, Spain

Location

Vall d'Hebron Research Institute

Barcelona, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine Blood (Serum, Plasma) Swabs (oral,rectal)

MeSH Terms

Conditions

HIV Infections; Risk Reduction Behavior; Sexual Behavior; Sexually Transmitted Diseases

Interventions

Prevalence

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morbidity; Vital Statistics; Data Collection; Epidemiologic Methods; Investigative Techniques; Demography; Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Hendrik Streeck, Prof. Dr.

  Institute for HIV Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med. Hendrik Streeck

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: March 7, 2019
• Study Start: April 24, 2019
• Primary Completion: August 22, 2022
• Study Completion: August 22, 2022
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: After publication. No end date
• Access Criteria: Researchers who would like to access the data after completion of trial should provide a written request to studien@hiv-forschung.de

Locations

PL (4); ES (2); IT (3); FR (5); HU (1)