HIV and STIs Clinical Study in Germany

NCT03884816 | Completed DMC

• 1 other identifier: BRAHMS Study
• Study Type: observational
• Target: 1,017
• Locations: 1 country
• Sites: 10

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.

Conditions

HIV Infections; Sexual Behavior; Risk Reduction

Keywords

HIV; Pre-exposure prophylaxis; Sexually Transmitted Diseases

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Prevalence of HIV infection among screened participants

  At screening (until last participant in), an average of 1 year

• Relationship between certain behavior and risk of 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

  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

  At screening (until last participant in), an average of 1 year

• Incidence of STIs in MSM/TGW/TGM/Intersex at risk for HIV infection

  Through study completion, an average of 2 years

Interventions

Determine the Incidence and Retention Rate OTHER

Determine the incidence of HIV and the retention rate of MSM/TGW/TGM/Intersex at risk for HIV infection

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Men who have sex with Men (MSM) Transgender Women (TGW) Transgender Men (TGM) Intersex
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of 1,000 HIV uninfected MSM/TGW/TGM/Intersex ages 18-55 years at risk for HIV infection at all study sites. Incidence rate will be evaluated across all sites as a primary objective. Each participant will be followed for a total of 12 months with assessment of HIV and STI status and risk behavior conducted at screening, three months (V2), six months (V3), nine months (V4), and twelve months (V5). It is anticipated that total accrual will take approximately 12 months.

You may qualify if:

• HIV-uninfected
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hendrik Streeck: lead
• US Military HIV Research Program: collaborator
• United States Army Medical Materiel Development Activity: collaborator
• Federal Ministry of Health, Germany: collaborator
• German Center for Infection Research: collaborator

Study Sites (10)

Praxis Dr. Cordes

Berlin, 10243, Germany

Location

Zentrum für Infektiologie Berlin Prenzlauer Berg (ZIBP)

Berlin, 10439, Germany

Location

Praxis Jessen

Berlin, 10777, Germany

Location

WIR "Walk In Ruhr"

Bochum, 44787, Germany

Location

Praxis Hohenstaufenring

Cologne, 50674, Germany

Location

Universitätsklinikum

Cologne, 50937, Germany

Location

HPSTD clinic

Essen, 45147, Germany

Location

Infektiologikum

Frankfurt am Main, 60596, Germany

Location

ifi-Institut für interdisziplinäre Medizin

Hamburg, 20099, Germany

Location

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

München, 81675, Germany

Location

Related Links

• Study Information (see cohort studies BRAHMS Study)

Biospecimen

Retention: SAMPLES WITH DNA

urine, blood (serum, plasma), swabs (oral, rectal)

MeSH Terms

Conditions

HIV Infections; Sexual Behavior; Risk Reduction Behavior; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hendrik Streeck, Prof. Dr.

  Institute for HIV Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med. Hendrik Streeck

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 21, 2019
• Study Start: June 1, 2018
• Primary Completion: March 22, 2021
• Study Completion: March 22, 2021
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: After publication. No end date
• Access Criteria: Researchers who would like to access the data after completion of trial should provide a written request to studien@hiv-forschung.de

Locations

DE (10)