HIV and STIs Clinical Study in Germany

NCT ID: NCT03884816

Last Updated: 2022-11-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1017 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2021-03-22

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. HIV-uninfected

2. 18-55 years of age

3. Male sex - (at birth, chosen or intersexual)

4. Able and willing to give informed consent

5. Able to read and write in German or English language

6. Willing to provide identification card

7. Willing to be followed for 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 in the past 24 weeks (partners must be either HIV-infected or of unknown HIV status) or

2. documented history (lab work, physician's note etc.) of syphilis in the past 24 weeks or

3. documented history of rectal gonorrhea or chlamydia in the past 24 weeks or

4. documented history of rectal mycoplasma genitalium in the past 24 weeks or

5. documented history of 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. Participation in a previous HIV vaccine study, unless documented placebo recipient.

3. Concurrent participation in investigational agents for treatment or prevention of HIV-1 infection (e.g. Discover Study)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

US Military HIV Research Program

NETWORK

Sponsor Role: collaborator

United States Army Medical Materiel Development Activity

FED

Sponsor Role: collaborator

Federal Ministry of Health, Germany

OTHER_GOV

Sponsor Role: collaborator

German Center for Infection Research

OTHER

Sponsor Role: collaborator

Hendrik Streeck

OTHER

Sponsor Role: lead

Responsible Party

Hendrik Streeck

Prof. Dr. med. Hendrik Streeck

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hendrik Streeck, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Institute for HIV Research

Locations

Praxis Dr. Cordes

Berlin, , Germany

Zentrum für Infektiologie Berlin Prenzlauer Berg (ZIBP)

Berlin, , Germany

Praxis Jessen

Berlin, , Germany

WIR "Walk In Ruhr"

Bochum, , Germany

Praxis Hohenstaufenring

Cologne, , Germany

Universitätsklinikum

Cologne, , Germany

HPSTD clinic

Essen, , Germany

Infektiologikum

Frankfurt am Main, , Germany

ifi-Institut für interdisziplinäre Medizin

Hamburg, , Germany

Interdisziplinäres HIV-Zentrum am Klinikum rechts der Isar (IZAR)

München, , Germany

Countries

Germany

Related Links

http://www.hiv-forschung.de

Study Information (see cohort studies BRAHMS Study)

Other Identifiers

BRAHMS Study

Identifier Type: -

Identifier Source: org_study_id