Clinical trial NCT03884816: HIV and STIs Clinical Study in Germany
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Sexual Behavior
Risk Reduction
Keywords: HIV
Pre-exposure prophylaxis
Sexually Transmitted Diseases
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
Collaborators: name: US Military HIV Research Program
name: United States Army Medical Materiel Development Activity
name: Federal Ministry of Health, Germany
name: German Center for Infection Research
First posted: 2019-03-21
Enrollment: 1017
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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)

Primary outcomes:
measure: Incidence of HIV in a cohort of MSM/TGW/TGM/Intersex at risk for HIV infection
timeFrame: Through study completion, an average of 2 years
measure: Retention rate of MSM/TGW/TGM/Intersex at risk for HIV infection in a cohort study
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Prevalence of HIV infection among screened participants
timeFrame: At screening (until last participant in), an average of 1 year
measure: Relationship between certain behavior and risk of HIV infection
timeFrame: Through study completion, an average of 2 years
measure: Willingness of MSM/TGW/TGM/Intersex at risk for HIV infection to participate in a future HIV vaccine trial
timeFrame: At visit 1 and 5 (visit 1 is day 0, visit 5 is day 364)
measure: Prevalence of STIs in MSM/TGW/TGM/Intersex at risk for HIV infection
timeFrame: At screening (until last participant in), an average of 1 year
measure: Incidence of STIs in MSM/TGW/TGM/Intersex at risk for HIV infection
timeFrame: Through study completion, an average of 2 years
measure: Attitudes regarding pre-exposure prophylaxis (PrEP) among MSM/TGW/TGM/Intersex at risk for HIV infection
timeFrame: 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)
measure: Relative HIV incidence between MSM/ TGW/TGM/Intersex across sites
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Praxis Dr. Cordes
city: Berlin
country: Germany
facility: Zentrum für Infektiologie Berlin Prenzlauer Berg (ZIBP)
city: Berlin
country: Germany
facility: Praxis Jessen
city: Bochum
country: Germany
facility: WIR "Walk In Ruhr"
city: Essen
country: Germany
facility: HPSTD clinic
city: Frankfurt am Main
country: Germany
facility: Infektiologikum
city: Hamburg
country: Germany
facility: ifi-Institut für interdisziplinäre Medizin
city: Köln
country: Germany
facility: Praxis Hohenstaufenring
city: Köln
country: Germany
facility: Universitätsklinikum
city: München
country: Germany
facility: Interdisziplinäres HIV-Zentrum am Klinikum rechts der Isar (IZAR)
Study officials:
affiliation: Institute for HIV Research
name: Hendrik Streeck, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: