The Robert Koch Institute (RKI): main building in Berlin. more
Germany’s Public Health institute RKI monitors the population’s health and wellbeing. more
The Robert Koch Institute is the German government's central institution for the identification, surveillance and prevention of infectious diseases in the Portfolio of the German Ministry of Health. more
Heads: Dr. Karolin Meixenberger & Dr. Kirsten Hanke
The HIV-1 Seroconverter Study is a multicentre, prospective long-term observation study that has been carried out at the RKI since 1997. In 2021, a reorientation of the HIV-1 Seroconverter Study was started in order to adapt the questions, data collection and laboratory tests to the current public health situation and the current HIV and STI infection situation in Germany. In this way, the strengths and potential of the study can be exploited in the best possible way and the greatest possible benefit for people living with HIV in Germany can be drawn from the study results.
As part of the study, important unanswered questions about HIV infection are examined in study participants whose HIV infection time can be narrowly defined using laboratory diagnostic parameters. For this purpose, clinical and epidemiological data are collected annually from the study participants and a blood sample is taken for molecular biological and serological tests.
Around 44 study institutions run by established doctors and clinics are currently taking part in the study. A total of over 3,600 participants were included in the study and around 1,000 study participants are currently under observation. The study population consists largely of men who have sex with men and living in urban areas.
A major focus of the study is the long-term observation of the influence of viral properties (e.g. drug resistance mutations, subtype, co-receptor use) and human genetic factors on transmissibility, disease progression and therapy response. In the case of transmitted drug resistance, the effectiveness of single antiretroviral drugs or entire drug classes is impaired so that they can no longer be used for first line antiretroviral therapy. In addition, due to natural polymorphisms, some HIV subtypes show reduced susceptibility to certain antiretroviral drugs, and there have been reports of subtype-specific properties in terms of transmission or pathogenesis in certain populations or risk groups. Due to the observation of the study participants over a longer period of time, the development of drug resistance during therapy and its consequences can also be observed. Furthermore, the evolution of multiple infections and superinfections as well as the intra- and inter-patient evolution of HIV in the study cohort can be analyzed. The study will also explore the persistence of drug resistant HIV and its onward transmission, as well as the importance of minor virus subpopulations with drug resistance mutations.
Another focus of the study is the investigation of co-infections with other sexually transmitted viral and bacterial pathogens, such as Hepatitis B, Hepatitis C and Treponema pallidum. The investigation of the occurrence, spread and treatment of sexually transmitted pathogens (STI) in the HIV-infected study participants provides important information on vulnerable groups, test behavior, therapy, possible drug resistance developments, possible influences on the transmission potential of the pathogens and possible consequences for the course of the disease. Due to the use of partially identical drugs for therapy and their synergistic or antagonistic effects, knowledge of co-infections and the analysis of drug resistance development is important for recommendations for effective and cost-efficient therapy of co-infections.
Sample material
For molecular-biological and serological tests within the framework of the HIV-1 Seroconverter Study, 20-30 ml of EDTA blood must be sent to the HIV study laboratory with each basic and follow-up questionnaire. The EDTA blood sample should be stored at room temperature until shipped.
In exceptional cases, at least 8 ml of EDTA plasma can be sent in after consultation with the HIV study laboratory. The EDTA plasma must be stored at 4°C until dispatch.
In order to be able to answer the study goals of the HIV-1 Seroconverter Study - such as the investigation of the influence of drug resistance mutations, subtype and other viral factors on the course of the disease and the treatment response - in the best possible way, we ask you to send blood samples in a treatment-naïve state to the HIV study laboratory if you include new study participants.
In addition to the regular initial and follow-up samples, we also ask for additional EDTA blood samples in the event of treatment failure of study participants.
Sample information sheet
For the first or follow-up samples, please fill out the basic or follow-up questionnaire completely and place it in the document compartment of the leak-proof shipping bag for the EDTA blood sample.
If the questionnaire is not completely filled out when the sample is sent, you can alternatively enclose a copy of the completed first page of the questionnaire with the sample. In this case, please send the completed questionnaire later in a postage-paid envelope to FG34.
For additional EDTA blood samples in the event of therapy failure, please use the sample information sheet from the HIV study laboratory.
Sample shipment
We will be happy to arrange for a courier to pick up samples from treatment-naïve study participants or study participants who have failed treatment so that the sample material for genotypic drug resistance testing arrives at the HIV study laboratory as fresh as possible. Please use the unstamped brown transport boxes for this. For a transport order, please contact us by email and let us know the exact pick-up address and the possible pick-up time. Collection within Berlin is possible from Monday to Friday, outside of Berlin from Monday to Thursday. In order to ensure timely collection, please note that the last transport orders from the HIV study laboratory are made at 3 p.m.
Please send us EDTA blood samples from study participants under antiretroviral therapy in the pre-paid white transport boxes by Deutsche Post. Please write in the sender field and seal the shipping boxes at the tuck-in flap.
Study centers outside of Berlin please also use the pre-paid white transport boxes and transport with Deutsche Post for EDTA blood samples from treatment-naïve study participants on Fridays!
You will receive the required shipping material and, if desired, monovettes (Sarstedt) for taking EDTA blood from us free of charge.
Sequence transmission
If no treatment-naïve EDTA blood sample has been sent to the HIV study laboratory when a new study participant is included, or if no additional EDTA blood sample has been sent to the HIV study laboratory in the event of therapy failure, we ask that the HIV sequences from the genotypic drug resistance testing are transmitted if possible.
Please send us the associated HIV sequences of all available genome regions from viral RNA or proviral DNA in txt or fasta format, stating the seroconverter number, the date of blood collection and the therapy status, in compliance with data protection via the web application Cryptshare (https://austausch.rki.de).
If you have any questions about the provision of data via Cryptshare, please email the HIV study laboratory. We will be happy to send you detailed instructions.
Pre-analytics handbook
In accordance with the DIN EN ISO 15189 standard, the pre-analytical handbook includes specific instructions for the proper collection and handling of primary samples with the aim of optimizing the pre-analytical phase of examination procedures offered by the HIV study laboratory. It serves to inform the sender.
Documents for participation in the HIV-1 Seroconverter Study
The HIV-1 Seroconverter Study is conducted in compliance with the DSGVO and with a positive ethics vote. Study participants sign a consent form. A cooperation agreement is concluded with the study centers. You can download the current study documents here:
Shipping management
Sabrina Neumann
Telephone +49 (0)30-18754-2243
Fax: +49 (0)30-18754-2605
Email: Serokonverter.HIV [at] rki.de
Heads of InzSurv-HIV & IGS-HIV
Dr. Karolin Meixenberger
Telephone +49 (0)30-18754-2277
Fax: +49 (0)30-18754-2605
Email: Serokonverter.HIV [at] rki.de
Dr. Kirsten Hanke
Telephone +49 (0)30-18754-2639
Fax: +49 (0)30-18754-2605
Email: Serokonverter.HIV [at] rki.de
Date: 22.01.2024
