European HIV&STI Prevention Network Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,593
- 试验地点
- 15
- 主要终点
- Relationship between STIs and certain behavior and risk of HIV infection
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
- •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
排除标准
- •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.
结局指标
主要结局
Relationship between STIs and certain behavior and risk of HIV infection
时间窗: 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.
Choice of a cohort of volunteers at-risk for HIV and other STIs
时间窗: 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.
Incidence of HIV and other STIs in a cohort of individuals at risk for HIV and other STI infections
时间窗: 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.
次要结局
- Co-occurence of STIs and HIV(Through study completion, an average of 2 years)
- 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))
- 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))
- Retention rates for prospective prevention studies for individuals at risk for HIV and STI infections.(Through study completion, an average of 2 years)
- 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)
- Incidence between individuals at risk for HIV and STI infections across sites and countries(Through study completion, an average of 2 years)
研究者
Hendrik Streeck
Prof. Dr. med. Hendrik Streeck
University Hospital, Essen