Prospective Observational Cohort HIV & STI Study in Europe

European HIV&STI Prevention Network Study

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).

Study Overview

• Status: Completed
• Conditions: HIV Infections; Sexual Behavior; HIV-1-infection; Risk Reduction
• Intervention / Treatment: Behavioral: Determine the Incidence and Point Prevalence

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.

• Study Type: Observational
• Enrollment (Actual): 3593

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • Centre Hospitalier Universitaire de Bordeaux
  • Lyon, France
    • Hôpital de la Croix-Rousse
  • Paris, France
    • Hospital Saint Louis
  • Paris, France
    • Hopital Saint-Antoine
  • Paris, France
    • Hopital Lariboisiere
• Hungary
  • Budapest, Hungary
    • Semmelweis University
• Italy
  • Milan, Italy
    • Hospital Maggiore Policlinico
  • Milan, Italy
    • Hospital San Raffaele
  • Rome, Italy
    • National Institute for Infectious Diseases L. Spallanzani
• Poland
  • Gdańsk, Poland
    • Centrum PrEP Gdańsk
  • Szczecin, Poland
    • Pomeranian Medical University
  • Warszawa, Poland
    • Chmielna Express Warsaw
  • Wrocław, Poland
    • Center for Prevention and Treatment of Infectious Diseases and Addiction Treatment
• Spain
  • Barcelona, Spain
    • Hospital Universitari Germans Trias I Pujol
  • Barcelona, Spain
    • Vall d'Hebron Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence 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 prevalence (as measured as HIV and STIs positive cases during screening visit) HIV and STI infections. Baseline HIV and STI prevalence will be defined as the number of HIV or STI infected individuals identified at screening divided by the total number of individuals who are screened for HIV or STI. Once enrollment is completed, baseline HIV or STI prevalence will be calculated.	At screening (until last participant is included), an average of 1 year
Co-occurence of STIs and HIV	Analysis of laboratory and other testing results. Descriptive statistics will be generated to evaluate 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.	The primary assessment of retention will be conducted assuming a binomial distribution and individuals will be considered retained at 12 months if they complete the final study visit. Retention will also be estimated with 95% CI for each study visit. A summary of participant attendance and loss to follow-up will be made every 3 months to monitor the retention rate by site, and to help ensure that the overall 12-month retention rate of the study visit will be no less than 85%.	Through study completion, an average of 2 years
Willingness to participate in future clinical trials, such as those of candidate vaccines through questionnaire	Willingness to participate in vaccine trials will be estimated assuming a binomial distribution. Factors associated with willingness to participate in vaccine trial will be evaluated using logistic regression models	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	Attitudes regarding PrEP will be evaluated using descriptive statistics and questionnaires. Behavioral questionnaire over time will be assessed by frequency tables and bar graphs.	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)
Incidence between individuals at risk for HIV and STI infections across sites and countries	Descriptive statistics will be generated to summarize incidence (as measured as new HIV and sexual transmitted infections occurring during the study period) HIV and STI infections. Data may be compared across sites for comparison and evaluation of factors impacting incidence.	Through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Hendrik Streeck
• Collaborators: Janssen, LP
• Investigators: Principal Investigator: Hendrik Streeck, Prof. Dr., Institute for HIV Research

Publications and helpful links

Helpful Links

• Study information

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2019
• Primary Completion (Actual): August 22, 2022
• Study Completion (Actual): August 22, 2022

Study Registration Dates

• First Submitted: February 15, 2019
• First Submitted That Met QC Criteria: March 5, 2019
• First Posted (Actual): March 7, 2019

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Pre-exposure prophylaxis; Sexually Transmitted Infection; HIV Vaccine Trials Network
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: STIPnet Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The study collaborators recognize the importance of disseminating scientific and medical study data as soon as the study data sets are complete and analysed; therefore, the study leadership would encourage their presentation, discussion and publication at seminars or conferences (national, regional and international) and in reputable scientific journals in open access. All publications resulting from this study will be cleared through the collaborating partners to the study. Anonymous data can be obtained upon request to the PI of the study.Confidentiality of participants will be maintained by the fact that no individual results will be reported or published, only group/aggregate results. Data collected during the trials that underlie the results presented in scientific publications will be shared. Distribution of study data must be always approved by the scientific steering committee of the study and final approval needs to be obtained by the PI.
• IPD Sharing Time Frame: After publication. No end date
• IPD Sharing Access Criteria: Researchers who would like to access the data after completion of trial should provide a written request to studien@hiv-forschung.de

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No