NCT03884816

HIV and STIs Clinical Study in Germany

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,017 (actual)
• Sponsor: Hendrik Streeck · Academic / Other
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• HIV Infections
• Sexual Behavior
• Risk Reduction

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-06-01
• Primary completion: 2021-03-22
• Completion: 2021-03-22
• First posted: 2019-03-21
• Last updated: 2022-11-29

Locations

10 sites across 1 country: Germany