Low-threshold drug use services, substitution services and, where applicable, prisons in 13 sentinel cities and regions in Germany,
Testing by Labor Krone GbR,
Further laboratory tests by the National Reference Centre for Hepatitis C Viruses, Institute for Virology at Düsseldorf University Hospital,
Guidance of the project by an interdisciplinary advisory board.
Funding: Federal Ministry of Health Study period: 01.04.2024 until 31.03.2026
Knowledge video on HIV, hepatitis B and C for participants
Wissensvideo zu HIV, Hepatitis B und C für Teilnehmende auf Englisch
The video is available in Arabic, Farsi, German, Polish, Russian and Ukrainian here.
Study aims
The aim of ‘DRUCK-Surv - Surveillance of Drugs and Chronic Infectious Diseases’ is to establish a recurring nationwide data collection on hepatitis C, B (HCV, HBV) and HIV in the context of injecting drug use in sentinel cities and regions, taking into account the findings from the DRUCK 2.0 pilot project and conducting a first wave of data collection. The overarching aim is to obtain data at regular intervals to inform both national and international reporting and regional care. This should enable adjustments and readjustments of measures at national and regional level with regard to the federal government's BIS 2030 strategy and the achievement of the elimination of these infections among people who inject drugs by 2030. As data collection continues at regular intervals, nationwide and regional trends among people who inject drugs can also be analysed for the first time.
Summary
Germany is committed to the 2030 Agenda for Sustainable Development Goals (SDGs) and the global goals of eliminating HIV, viral hepatitis and other sexually transmitted infections by 2030. People who inject drugs are particularly exposed to high infection risks and have the highest prevalence of these infections in Germany compared to other groups. It is therefore important to reach people who use drugs with increased efforts in group-specific prevention and care. In order to measure the progress made towards elimination and to be able to adapt prevention and care services in line with demand in the short term, a solid data basis is required based on regularly collected, validated indicators at national and regional level.
Ten years after the first data collection on drugs and chronic infections (DRUCK study), the DRUCK 2.0 pilot study 2020-2022 evaluated methods that enable this data to be collected with the least possible effort and the greatest possible acceptance on the part of the organisations conducting the study and the target population. In addition to new regional data on prevalence and behaviour, the data collection in Berlin and Bavaria on low-threshold drug use services and substitution services has provided valuable insights for a planned nationwide roll-out. In DRUCK-Surv, data is collected from people who have ever injected drugs or are currently injecting drugs (in the last 12 months) and are at least 16 years old in 13 sentinel cities and regions in Germany.
The sentinel cities and regions are selected on the basis of various criteria (equal distribution by total population of the regions North, East, South, Southwest and West; city size; presence of drug consumption rooms, other substance use services and substitution services; presence of at least 6-7 drug help and substitution facilities willing to participate and able to recruit at least 200 participants in total). Relevant facilities that can participate in the study are low-threshold drug use services (including outreach projects), drug consumption rooms and substitution services. Several cities in a region can join as one sentinel region to reach the minimum number of participants.
In 2024, the network formation, the conclusion of contracts with the facilities, as well as the logistical, ethical and data protection preparations will take place. Training material for virtual and on-site trainings will be prepared and the first trainings for services staff will be held.
Data collection will take place in 2025: during a period selected by each participating facility, at least 30 people per facilities who have injected drugs in the last 12 months or ever will be recruited to participate. Around 200-300 participants will be recruited from the staff of the 6-7 facilities in each sentinel city or region. The staff will invite potential participants, inform them about the study and obtain their consent, assist them in completing a pseudonymised questionnaire on risk and prevention behaviour, access to harm reduction and HCV, HBV and HIV testing and treatment, and collect a venous or capillary blood sample dripped onto filter paper. The questionnaires are sent to the RKI, where the data is entered and validated on an ongoing basis. The samples are analysed for HCV, HBV and HIV in a central laboratory. Molecular analyses and genotyping of the HCV-positive samples are carried out at the National Reference Centre for Hepatitis C Viruses at Düsseldorf University Hospital. The results are sent from the laboratory to the RKI, where they are merged with the survey data using the pseudonym created. In addition, the individual test results are communicated to the participants by trained staff in the facilities. Participants receive an incentive of 15 euros. All study documents will be made available in relevant languages; language mediation, if necessary, will be provided by the facilities.
The results of the first round of data collection will be analysed from the last quarter of 2025 onwards and discussed with the established network of facilities and cities at a face-to-face meeting in early 2026. Reports will be prepared for each sentinel city and region as well as an overall national report. The next round of data collection for 2028-29 will also be planned at the final meeting.
DRUCK-Surv runs from April 2024 to March 2026 and is divided into 3 work packages.
Expected results
The indicators collected will be used to assess the current coverage of harm reduction and prevention measures (access to substitution, new injection equipment, naloxone, HBV vaccination), testing for and treatment of HCV, HBV and HIV, and the prevalence of these infections in the sentinel cities and regions and at national level. Specific risk groups and barriers to accessing interventions can also be identified. The results provide information on how measures can be adapted and further improved at various levels. Due to the number and diversity of the facilities, different people who inject drugs are reached, so that the sample allows for a variety of analyses, including subgroups.
Videos, a project description, newsletter and the study overview (all in German) can be found on the German website
Frequently Asked Questions (FAQ)
Approximately 30 minutes should be scheduled per person. It is a good idea to prepare the documents (stick the barcodes) for several participants on one study day and to test several people together and hand out the questionnaire. It is important that the participants receive a brief testing consultation before each test. After the participants have completed the questionnaire, the brief testing consultation takes place and then the blood sample is taken. Participants can also drip the drops of blood onto the dry blood cards themselves, or the centre staff can take the blood from the participant's fingertip. Two cards with 5 drops each must be collected. To obtain the drops of blood, the appropriate finger must be pressed often, and another finger may have to be pricked a second time.
The effort per person may vary greatly depending on how much support is required. We ask you to support people as much as possible if they need it. This will also help to regulate the number of staff required.
Date:
30/01/2025
The survey is designed in the best possible way so that it can be carried out during routine work. This has already been evaluated in the DRUCK 2.0 pilot study. The work processes are relatively simple and can be easily standardised. Online training is available for the exact study procedure. The individual work steps will also be made available online as a video. In addition, there will be precise standard operating procedures (SOPs) and checklists with all the information. If you have any questions, please do not hesitate to contact us by e-mail: druck-surv [at] rki.de.
Date:
30/01/2025
Yes, participants will receive an incentive in the form of a 15€ voucher. The vouchers can be used directly (without registration). They can be used to purchase everyday items, e.g. in a supermarket or drugstore.
Date:
30/01/2025
All study documents are also available in Arabic, English, Farsi, French, Polish, Romanian, Russian, Turkish and Ukrainian. As the ad hoc telephone interpreting service offered to the drug services in the DRUCK 2.0 pilot study was not used in these languages, such a service was not included in DRUCK-Surv. We therefore request that participants without sufficient German language skills are offered language mediation in the required language by existing staff.
Date:
30/01/2025
Deutsche Aidshilfe (DAH) offers an adapted training course on testing counselling as part of the DRUCK-Surv study. A total of five three-hour online training sessions will take place, for which participating staff can register. The dates will be sent out by the DAH. After an introduction, the training sessions will also involve practising a counselling session in groups of two. The training courses are free of charge for DRUCK-Surv facilities. Furthermore, various information materials are provided free of charge by the DAH. Important tips and information on test counselling training in the selected study setting can also be found in a DAH handbook.
Date:
30/01/2025
Before the start of the study, each participating service indicated the approximate number of people that could be recruited. We use this information as a guideline for the individual institutions. The entire study population was divided approximately equally between the 13 study regions. During the course of the study, we continuously monitor whether the specified numbers of people are reached. If this is not the case, we can then adjust accordingly and release more people for recruitment at other services.
Date:
30/01/2025
The limited time period was set to facilitate the logistics of study preparation in the respective study region and to reduce the possibility of people participating twice, e.g. if they forget whether they have already participated in this study or if the institution does not recognise the person.
Date:
30/01/2025
The quantity depends on the number of people you have enrolled. There is a total budget for 3000 tests. These have been allocated to the regions and individual services. As soon as the survey begins, we will remain in close contact and may also send additional material and kits or swap them between the facilities. Not all kits will be sent out for the time being, so there is still room for redistribution.
Date:
30/01/2025
A total of 2,000 people who have injected drugs in the last 12 months and 1,000 people who have ever injected drugs but not in the last 12 months will be recruited for DRUCK-Surv. Each service has determined the approximate number of people in each category that can be recruited. When approaching people to participate in the study, recruitment should preferably not be based on risk (e.g. ‘those who need it most’) or feasibility (e.g. ‘those who speak German well’ or ‘those who can complete the questionnaire on their own’). If possible, people should be included randomly. Different strategies can be used for this, e.g. every 2nd person in the week, all people on one day of the week and test weeks can also be a possibility.
Date:
30/01/2025
During the data collection phase, the RKI continuously checks how many people have been recruited from which groups. The services receive feedback on the current status. This allows recruitment to be adjusted accordingly on site.
Date:
30/01/2025
The recruited persons must be asked whether they have already taken part in the study. We assume an honest answer.
However, multiple participation cannot be ruled out, especially as people could participate in different organisations.
Checking the identity of the participants (e.g. by showing their identity card) is not intended and not desired. This is a pseudonymised study and the participants should also be able to take part in the study without providing personal information (address, name).
The questionnaires are checked for plausibility and completeness at the RKI. If an increased number of questionnaires with exactly the same response pattern and corresponding identical laboratory findings are found in a region, duplicate data sets may be subsequently excluded from the analyses. However, this has no effect on the participating persons.
Date:
30/01/2025
This is a pseudonymised study. Each participating person receives a unique ID at the start of the study. This ID can be found on all relevant study documents. The participants' real names are not recorded anywhere. The participant's consent is also only given by stating the ID. A signature may be illegible. Participants agree on a personal password to collect their results. This password is noted on a contact list together with the ID. To collect the test results, participants must enter their personal password. The rights of data subjects can only be exercised by participants for as long as the personal reference can be established. The personal reference can only be established through the ID. After the questionnaires are merged with the laboratory data, the ID is removed from the electronic data records. After this, no direct personal reference can be established in the data.
Date:
30/01/2025
Based on our experience with other studies (DRUCK study, POINT study, HepMig study) and our networks (e.g. low-threshold practice centres, DAH), we assume that being informed about one's own infection status already has a health benefit. However, good and transparent information on this topic is necessary. Participants without insurance must know before testing that the treatment is not part of the study and that treatment is difficult or impossible in Germany if they do not have insurance cover. This is therefore also reflected in the study information and the standardised operating procedures (SOPs). The DRUCK-Surv study received an ethics vote from the Berlin Medical Association on 5 December 2024 (Eth-SB-24-080). All recommendations made by the ethics committee were implemented. On 8 January 2025, the implementation of these recommendations was confirmed by the Berlin Medical Association.
Date:
30/01/2025
The laboratory results are sent by post to the participating services. These results should be kept there for a maximum of eight weeks. Participants can collect their results using their personal password (pseudonym; documented in the contact list at the service). The findings must be issued during a medical consultation. The facilities should use existing co-operations for this purpose. The medical cooperation partners, clearing centres and medical networks, if available, were identified for each study city. The list is made available to the low-threshold services. Should difficulties arise here, the study team at the RKI can help to find solutions.
Date:
30/01/2025
Depending on the survey period, the materials are sent to the participating facilities in the respective region around three weeks before the start of the study.
Date:
30/01/2025
All services receive a selection of promotional materials. This includes flyers and posters with information about the study. The study package also includes information materials from Deutsche Aidshilfe (DAH) on HIV and viral hepatitis, which can be handed out to participants when they report their findings. These materials can be ordered free of charge from the DAH at https://www.aidshilfe.de/shop.
Date:
30/01/2025
The data collected will form the basis for political decisions, in line with the motto ‘data for action’. The study results provide valuable insights into the prevalence and care of hepatitis C, B and HIV among drug users in Germany and make it possible to evaluate the success of current prevention and care measures. Targeted adjustments and improvements in care can be made on the basis of the data collected. The data will also provide regional information on the status and can be used accordingly. There will be a major final meeting in 2026. Here, key results of the survey will be discussed and possible recommendations for action will be made. The RKI team will analyse the data collected and make it available for national and regional reporting.
Date:
30/01/2025
DRUCK-Surv 2025 is the first Germany-wide round of data collection on drugs and chronic infectious diseases, which is to be repeated at regular intervals (e.g. every 2-3 years) at low cost. In this way, trends over time can be described and continuous monitoring is possible. DRUCK-Surv 2025 is funded by the Federal Ministry of Health. No funding is currently available for future survey rounds. In some cases, these would have to be taken over by the federal states and local authorities in future rounds. The RKI study team has already informed the federal states about this during project preparation. Continuous national data collection (surveillance) is intended to inform and support the elimination process for HIV and viral hepatitis.
Date:
30/01/2025
Injecting drug use is decreasing in favour of other forms of use. Nevertheless, injecting is still the most important transmission route for blood-borne infections. However, in order to be able to include people who have since switched to other forms of use, we have extended the inclusion criteria in DRUCK-Surv compared to the previous DRUCK studies. For the first time, we include people who have ever injected drugs in their lives, i.e. who have ever had a relevant risk of infection. However, we also explicitly ask everyone about smoking and sniffing/snorting.
A study that includes all drug users would still have to differentiate between different infection risks and subgroups and would involve a very detailed questionnaire. However, the results generated should be specific enough to derive preventive measures. The focus is therefore on injecting use.
