HIV and STIs Clinical Study in Germany

Study Overview
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Brief Summary
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The BRAHMS study is a prospective observational cohort study aiming to investigate how often people that are at risk to get infected with HIV contract HIV and how long people stay in the study. The University Hospital Essen is interested in finding out how often participants contact other sexually transmitted infections (STI) and hepatitis as well as in the development of HIV vaccines to test in the future. The University Hospital Essen will therefore also ask participants to fill out a questionnaire asking their general willingness to participate in such a trial (i.e., where the vaccine might be targeted to an HIV subtype not as common in Europe) to understand whether such testing would be possible in the future in Germany.

Detailed Description
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In Germany, new HIV diagnoses are steadily increasing again since 2000. 74% of infected individuals living in Germany are men who have sex with men (MSM) whereas only 15% were infected by heterosexual contact. The HIV epidemic is mainly restricted to big cities such as Cologne, Berlin, Hamburg. The successful conduct of HIV vaccine efficacy trials requires recruitment, enrolment, and long-term retention of informed, willing, and HIV-negative but at-risk participants. Therefore, the University Hospital Essen plans a vaccine preparedness study to assess the feasibility of future HIV vaccine efficacy trials in Germany, a subtype B prevalent region in Europe, as this has never been assessed in Germany. Notably investigators conduct a cohort study to characterize HIV incidence and retention among high risk, HIV uninfected MSM/Transgender women (TGW)/Transgender Men (TGM)/Intersex in the setting of prevention modalities that may be available to participants, including PrEP and regular HIV risk reduction counselling and testing. The design of the study will address several unique questions about the community at highest risk for HIV infection and will provide strong data for prevention methods including PrEP. Moreover, it has been clearly demonstrated that sexually transmitted infections (STIs) can increase the risk of acquiring a HIV infection. Therefore, early diagnosis and treatment of STI is crucial to reduce this risk factor of HIV acquisition and to inform individuals about their risk to become HIV infected. As STIs are a crucial factor in the scope of an incidence analysis of HIV in MSM and are underdiagnosed often, extensive screening measures are implemented within the study to an extent never performed in Germany before.

Official Title
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Longitudinal Incidence Study in Subtype B-Prevalent Region Among Men Who Have Sex With Men at Risk for Human Immunodeficiency Virus (HIV) Infection to Determine Feasibility of HIV Vaccine Efficacy Trials

Conditions
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HIV Infections, Sexual Behavior, Risk Reduction

Intervention / Treatment
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* Other: Determine the Incidence and Retention Rate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-uninfected 18-55 years of age Male sex - (at birth, chosen or intersexual) Able and willing to give informed consent Able to read and write in German or English language Willing to provide identification card Willing to be followed for 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 in the past 24 weeks (partners must be either HIV-infected or of unknown HIV status) or documented history (lab work, physician's note etc.) of syphilis in the past 24 weeks or documented history of rectal gonorrhea or chlamydia in the past 24 weeks or documented history of rectal mycoplasma genitalium in the past 24 weeks or documented history of acute Hepatitis C virus (HCV) infection in the past 24 weeks Exclusion Criteria: 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. Participation in a previous HIV vaccine study, unless documented placebo recipient. Concurrent participation in investigational agents for treatment or prevention of HIV-1 infection (e.g. Discover Study)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Determine the Incidence and Retention Rate|Determine the incidence of HIV and the retention rate of MSM/TGW/TGM/Intersex at risk for HIV infection|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of HIV in a cohort of MSM/TGW/TGM/Intersex at risk for HIV infection | Descriptive statistics will be generated to summarize incidence (as measured as new HIV infections occurring during the study period) HIV infections. The power calculation targets a 3% incidence rate per year. An overall estimate of HIV incidence and 95% confidence intervals (CI) will be estimated assuming a Poisson distribution. | Through study completion, an average of 2 years | 
| Retention rate of MSM/TGW/TGM/Intersex at risk for HIV infection in a cohort study | 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 a 95% CI for each study visit. Factors associated with overall retention will be assessed in a logistic regression model. | Through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of HIV infection among screened participants | Descriptive statistics will be generated to summarize prevalence (as measured as HIV positive cases study period) HIV infections. Once enrolment is completed, baseline HIV prevalence will be calculated. | At screening (until last participant in), an average of 1 year | 
| Relationship between certain behavior and risk of HIV infection | Participants will receive questionnaires. The risks of HIV infection will be based on factors such as sexual behavior, pre- and post-exposure prophylaxys and others. Descriptive statistics will be generating to summarize risk factors associated with HIV infection. | Through study completion, an average of 2 years | 
| Willingness of MSM/TGW/TGM/Intersex at risk for HIV infection to participate in a future HIV vaccine trial | Willingness to participate in an HIV vaccine trial will be estimated assuming a binomial distribution. Factors associated with willingness to participate in vaccine trial will be evaluated using logistic regression models. | At visit 1 and 5 (visit 1 is day 0, visit 5 is day 364) | 
| Prevalence of STIs in MSM/TGW/TGM/Intersex at risk for HIV infection | Descriptive statistics will be generated to summarize prevalence (as measured as STIs positive cases study period) STI infections. Once enrolment is completed, baseline STI prevalence will be calculated. | At screening (until last participant in), an average of 1 year | 
| Incidence of STIs in MSM/TGW/TGM/Intersex at risk for HIV infection | Descriptive statistics will be generated to summarize incidence (as measured as new STI infections occurring during the study period) STI infections. An overall estimate of STI incidence and 95% confidence intervals will be estimated assuming a Poisson distribution. | Through study completion, an average of 2 years | 
| Attitudes regarding pre-exposure prophylaxis (PrEP) among MSM/TGW/TGM/Intersex at risk for HIV infection | Attitudes regarding PrEP will be evaluated using questionnaires. Behavioural questionnaire over time will be assessed by frequency tables and bar graphs. | At screening and at visit 1,2,3,4 and 5 (visit 1 is day 0, visit 2 is day 84, visit 3 is day 168, visit 4 is day 252, visit 5 is day 364) | 
| Relative HIV incidence between MSM/ TGW/TGM/Intersex across sites | Descriptive statistics will be generated to summarize incidence (as measured as new HIV infections occurring during the study period) HIV infections. The power calculation targets a 3% incidence rate per year. Data may be compared across sites for comparison and evaluation of factors impacting incidence. | Through study completion, an average of 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Pre-exposure prophylaxis, Sexually Transmitted Diseases