HIV InfectionsNCT03866759
Prospective Observational Cohort HIV & STI Study in Europe
An observational study of HIV Infections and HIV-1-infection, run by Hendrik Streeck at 15 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, HIV-1-infection, Risk Reduction
- What is being tested?
- Determine the Incidence and Point Prevalence
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 3,593 participants
- Where
- 15 sitesin 5 countries
- Study dates
- 24 Apr 2019to 22 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- HIV-uninfected as defined as negative HIV-Ab-Elisa, negative HIV viral load or negative HIV Ag-Test at time point of screening.
- 18-55 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
Show all 12Show fewer
- 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
Who cannot join
- 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.
- Concurrent participation in investigational HIV treatment or prevention studies (Please note: previous participation is not an exclusion criterion).
- Employees of the study sites cannot participate but are eligible to participate at a different study site.
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
France5 sites
Centre Hospitalier Universitaire de Bordeaux
Bordeaux
Hôpital de la Croix-Rousse
Lyon
Hospital Saint Louis
Paris
Hôpital Lariboisière
Paris
Hôpital Saint-Antoine
Paris
Poland4 sites
Centrum PrEP Gdańsk
Gdansk
Pomeranian Medical University
Szczecin
Chmielna Express Warsaw
Warsaw
Center for Prevention and Treatment of Infectious Diseases and Addiction Treatment
Wroclaw
Italy3 sites
Hospital Maggiore Policlinico
Milan
Hospital San Raffaele
Milan
National Institute for Infectious Diseases L. Spallanzani
Rome
Spain2 sites
Hospital Universitari Germans Trias i Pujol
Barcelona
Vall d'Hebron Research Institute
Barcelona
About this study
Official title: 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).
Read the 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.
- Conditions
- HIV Infections, HIV-1-infection, Risk Reduction, Sexual Behavior
- Being tested
- Determine the Incidence and Point Prevalence
- Keywords
- Sexually Transmitted Infection, HIV Vaccine Trials Network, Pre-exposure prophylaxis
- Medical subject headings
- HIV Infections, Risk Reduction Behavior, Sexual Behavior, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determine the Incidence and Point PrevalenceBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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%.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start24 Apr 2019
- Primary completion22 Aug 2022
- Study completion22 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,593 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hendrik Streeck
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen, LP
- Responsible party
- Sponsor-investigator, Hendrik Streeck, University Hospital, Essen
- Investigators
- Hendrik Streeck, Prof. Dr., Principal investigator, Institute for HIV Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866759
- Sponsor's protocol ID
- STIPnet Study
- Status last verified
- Nov 2022
- First submitted
- 15 Feb 2019
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European HIV&STI Prevention Network Study
- ClinicalTrials.gov ID
- NCT03866759
- Acronym / sponsor ID
- STIPnet Study
- Conditions
- HIV Infections, HIV-1-infection, Risk Reduction, Sexual Behavior
- Keywords
- Sexually Transmitted Infection, HIV Vaccine Trials Network, Pre-exposure prophylaxis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,593 participants (actual)
- Lead sponsor
- Hendrik StreeckUniversity, hospital or other
- Collaborators
- Janssen, LP
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 22 Aug 2022 (actual)
- Study completion
- 22 Aug 2022 (actual)
- First posted
- 7 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (12 listed)
- HIV-uninfected as defined as negative HIV-Ab-Elisa, negative HIV viral load or negative HIV Ag-Test at time point of screening.
- 18-55 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
Key exclusion criteria (4 listed)
- 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.
- Concurrent participation in investigational HIV treatment or prevention studies (Please note: previous participation is not an exclusion criterion).
- Employees of the study sites cannot participate but are eligible to participate at a different study site.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Determine the Incidence and Point PrevalenceDetermine the Incidence and Point Prevalence of human immunodeficiency virus (HIV) Infection and the Most Common Sexually Transmitted Infections in Individuals With Sexual Risk Behavior. | Behavioural | – |
Primary outcome
Choice of a cohort of volunteers at-risk for HIV and other STIs
Time frame: Through study completion, an average of 2 years
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.
Relationship between STIs and certain behavior and risk of HIV infection
Time frame: Through study completion, an average of 2 years
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.
Incidence of HIV and other STIs in a cohort of individuals at risk for HIV and other STI infections
Time frame: Through study completion, an average of 2 years
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.
6 secondary outcomes
Prevalence of HIV and other STIs in a cohort of individuals at risk for HIV and other STI infections
Time frame: At screening (until last participant is included), an average of 1 year
Co-occurence of STIs and HIV
Time frame: Through study completion, an average of 2 years
Retention rates for prospective prevention studies for individuals at risk for HIV and STI infections.
Time frame: Through study completion, an average of 2 years
Willingness to participate in future clinical trials, such as those of candidate vaccines through questionnaire
Time frame: 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
Time frame: 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
Time frame: Through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Individual participant dataSharing planned: Yes. 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.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hendrik Streeck, Prof. Dr. principal investigator
Institute for HIV Research
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and HIV-1-infection, run by Hendrik Streeck at 15 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France, Poland, Italy, Spain, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Choice of a cohort of volunteers at-risk for HIV and other STIs (time frame: Through study completion, an average of 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.