HIV InfectionsNCT03884816
HIV and STIs Clinical Study in Germany
An observational study of HIV Infections and Sexual Behavior, run by Hendrik Streeck at 10 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Sexual Behavior, Risk Reduction
- What is being tested?
- Determine the Incidence and Retention Rate
- How many people
- 1,017 participants
- Where
- 10 sitesGermany
- Study dates
- 1 Jun 2018to 22 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
Praxis Dr. Cordes
Berlin, 10243
Zentrum für Infektiologie Berlin Prenzlauer Berg (ZIBP)
Berlin, 10439
Praxis Jessen
Berlin, 10777
WIR "Walk In Ruhr"
Bochum, 44787
Praxis Hohenstaufenring
Cologne, 50674
Universitätsklinikum
Cologne, 50937
HPSTD clinic
Essen, 45147
Infektiologikum
Frankfurt am Main, 60596
ifi-Institut für interdisziplinäre Medizin
Hamburg, 20099
Interdisziplinäres HIV-Zentrum am Klinikum rechts der Isar (IZAR)
München, 81675
About this study
Official title: 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
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.
Read the 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
- Being tested
- Determine the Incidence and Retention Rate
- Keywords
- HIV, Pre-exposure prophylaxis, Sexually Transmitted Diseases
- Medical subject headings
- HIV Infections, Sexual Behavior, Risk Reduction Behavior, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determine the Incidence and Retention RateOther
Determine the incidence of HIV and the retention rate of MSM/TGW/TGM/Intersex at risk for HIV infection
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, an average of 2 years
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 Jun 2018
- Primary completion22 Mar 2021
- Study completion22 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,017 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hendrik Streeck
- Sponsor type
- University, hospital or other
- Collaborators
- US Military HIV Research Program, United States Army Medical Materiel Development Activity, Federal Ministry of Health, Germany, German Center for Infection Research
- Responsible party
- Sponsor-investigator, Hendrik Streeck, University Hospital, Essen
- Investigators
- Hendrik Streeck, Prof. Dr., Principal investigator, Institute for HIV Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884816
- Sponsor's protocol ID
- BRAHMS Study
- Status last verified
- Nov 2022
- First submitted
- 19 Mar 2019
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study collaborators recognize the importance of disseminating scientific and medical study data as soon as the study data sets are complete and analyzed; therefore, the study leadership would encourage their presentation, discussion and publication at seminars or conferences (national, regional and international) and in reputable scientific journals in open access. All publications resulting from this study will be cleared through the collaborating partners to the study. Anonymous data can be obtained upon request to the PI of the study. Confidentiality of participants will be maintained by the fact that no individual results will be reported or published, only group/aggregate results. Data collected during the trials that underlie the results presented in scientific publications will be shared. Distribution of study data must be always approved by the scientific steering committee of the study and final approval needs to be obtained by the PI.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03884816
- Acronym / sponsor ID
- BRAHMS Study
- Conditions
- HIV Infections, Sexual Behavior, Risk Reduction
- Keywords
- HIV, Pre-exposure prophylaxis, Sexually Transmitted Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,017 participants (actual)
- Lead sponsor
- Hendrik StreeckUniversity, hospital or other
- Collaborators
- US Military HIV Research Program, United States Army Medical Materiel Development Activity, Federal Ministry of Health, Germany, German Center for Infection Research
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 22 Mar 2021 (actual)
- Study completion
- 22 Mar 2021 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Determine the Incidence and Retention RateDetermine the incidence of HIV and the retention rate of MSM/TGW/TGM/Intersex at risk for HIV infection | Other | – |
Primary outcome
Incidence of HIV in a cohort of MSM/TGW/TGM/Intersex at risk for HIV infection
Time frame: Through study completion, an average of 2 years
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.
Retention rate of MSM/TGW/TGM/Intersex at risk for HIV infection in a cohort study
Time frame: Through study completion, an average of 2 years
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.
7 secondary outcomes
Prevalence of HIV infection among screened participants
Time frame: At screening (until last participant in), an average of 1 year
Relationship between certain behavior and risk of HIV infection
Time frame: 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
Time frame: 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
Time frame: At screening (until last participant in), an average of 1 year
Incidence of STIs in MSM/TGW/TGM/Intersex at risk for HIV infection
Time frame: Through study completion, an average of 2 years
Attitudes regarding pre-exposure prophylaxis (PrEP) among MSM/TGW/TGM/Intersex at risk for HIV infection
Time frame: 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
Time frame: Through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Study Information (see cohort studies BRAHMS Study)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The study collaborators recognize the importance of disseminating scientific and medical study data as soon as the study data sets are complete and analyzed; therefore, the study leadership would encourage their presentation, discussion and publication at seminars or conferences (national, regional and international) and in reputable scientific journals in open access. All publications resulting from this study will be cleared through the collaborating partners to the study. Anonymous data can be obtained upon request to the PI of the study. Confidentiality of participants will be maintained by the fact that no individual results will be reported or published, only group/aggregate results. Data collected during the trials that underlie the results presented in scientific publications will be shared. Distribution of study data must be always approved by the scientific steering committee of the study and final approval needs to be obtained by the PI.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hendrik Streeck, Prof. Dr. principal investigator
Institute for HIV Research
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Sexual Behavior, run by Hendrik Streeck at 10 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of HIV in a cohort of MSM/TGW/TGM/Intersex at risk for HIV infection (time frame: Through study completion, an average of 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.