Surveillance of HIV pre-exposure prophylaxis provision within the SHI system in Germany (PrEP-Surv)

Contact:
Project lead: Dr. Daniel Schmidt Phone: +49 (0)30 18754 3101 E-Mail: SchmidtD[at]rki.de	Project IT: Konstantinos Voulgaris Phone: +49 (0)30 18754 5228 E-Mail: VoulgarisK[at]rki.de
Phone: +49 (0)30 18754 0 (Zentrale) E-Mail: prep.surv.hiv[at]rki.de
Department of Infectious Disease Epidemiology Department 34

Background

Since September 2019, people with statutory health insurance (SHI) who are at substantial risk of HIV infection have been entitled to coverage of HIV pre-exposure prophylaxis (PrEP). PrEP is an HIV prevention method in which HIV-negative people take a drug that has been approved for HIV therapy for many years (tenofovir disoproxil + emtricitabine, TDF/FTC) in order to protect themselves from HIV infection. SHI coverage of PrEP includes counseling, the supply of medication and the necessary examinations.

The Robert Koch Institute (RKI) was commissioned by the German Federal Ministry of Health (BMG) to scientifically monitor and evaluate the introduction PrEP as a SHI service. This was done in the research project led by the RKI: "Evaluation of the introduction of HIV pre-exposure prophylaxis as a benefit of statutory health insurance" (EvE-PrEP). The evaluation covered the period 01.09.2019 to 31.12.2020. The project duration was 01.01.2020 to 31.12.2021. Further information on EvE-PrEP and study results can be found on the project homepage: EvE-PrEP

Project description

Based on the results of the PrEP evaluation, the RKI will establish and consolidate the monitoring of HIV-PrEP provision in Germany from 2022. To this end, the BMG is funding the project: "Surveillance of HIV pre-exposure prophylaxis provision within the SHI system in Germany" (PrEP-Surv).

Project duration

The duration of the PrEP-Surv project is 01.01.2022 to presumably 31.12.2024.

Goals

The aim of the project is to set up and establish a PrEP surveillance and to monitor the development of STI and HIV infection incidence among PrEP users in Germany. The RKI is thus also meeting the requirements for Europe-wide PrEP monitoring, which are being developed by the European Center for Disease Prevention and Control (ECDC) as part of an "Operational Guidance on HIV-PrEP".

The project is divided into three main modules:

Use of secondary data and strengthen digitization
Use of secondary data from pharmacies, health insurance companies and data from the Health Data Lab (FDZ) of the Federal Institute for Drugs and Medical Devices (BfArM)
Strengthening PrEP provision at German HIV specialty care centers and digitalization in the private practice sector
Collection of data on PrEP use and PrEP provision in HIV care centers in the network of the German Association of Outpatient Physicians for Infectious Diseases and HIV Medicine e.V. (dagnä),
development of concepts for the digitalization of data transmission from the practice software
Community involvement
Involvement of communities with a potential need for PrEP to assess need, knowledge and use of PrEP as well as barriers to PrEP access in the communities

Cooperations

The project is managed by the Robert Koch Institute. Cooperation partners are the dagnä with their participating centers and their proven care structures, experts from the department of Medical Management at the University of Duisburg-Essen with their expertise in the field of routine data from health insurance companies and the BARMER Institute for Health Systems Research.

News from the project

As part of the digitalization of the healthcare system and the widespread use of the electronic patient record (ePA) from 2025, for the PrEP-Surv main module "Strengthening digitalisation in the private practice sector" a medical information object (MIO) for PrEP users is being prepared for handover to the German Association of Statutory Health Insurance Physicians (KBV) and the mio42 GmbH. The data model for the MIO PrEP report is to be harmonized and implemented by October 2024. The MIO also serves as a template for another MIO for HIV care in accordance with the HIV/AIDS quality assurance agreement of the KBV.

On 27.06.2024, Dr Daniel Schmidt took part in the parliamentary breakfast on the topic: "HIV as a focal point: How do we ensure the future provision of innovative HIV treatment options for people living with HIV in Germany?". In an open discussion round, Mrs Kordula Schulz-Asche (MdB Bündnis 90/Die Grünen), Heiko Karcher (dagnä), Barbie Breakout (HIV activist) and others discussed challenges in the care of people living with HIV and existing gaps in care.

The 5th meeting of the Community Advisory Board in the PrEP-Surv project took place on 31 May 2024.

From 16 to 17 April 2024 an HIV Network Meeting took place at the European Center for Disease Prevention and Control (ECDC). Dr. Daniel Schmidt gave a presentation on PrEP implementation and PrEP surveillance in Germany.

The 19th Munich AIDS & Infectiology Days took place from 22 to 24 March 2024. Dr. Daniel Schmidt gave a lecture and presented the results of the survey on how people deal with PrEP shortages.

Saarländischer Rundfunk conducted an interview with Dr. Daniel Schmidt, which appeared in a television report on PrEP in Wir im Saarland - Das Magazin. The report "PrEP - The pill against HIV" from 01.02.2024 can be seen here.

PrEP-Surv conducted a survey on how people deal with PrEP shortages, in which over 1,000 people took part. Thank you for your active participation!

The Deutsche Presse-Agentur (dpa) conducted an interview with Dr. Daniel Schmidt on the occasion of World AIDS Day, which was quoted in articles by Deutsches Ärzteblatt and queer.de, among others.

The Community Advisory Board of the PrEP-Surv project has published a statement with proposals for securing, improving and expanding PrEP provision in Germany.

On September 22-23, 2023, the Fast Track City Summit Berlin took place in the Rotes Rathaus. Together with Astrid Leicht (Fixpunkt e.V.) and Elena Rodriguez (ViRo Praxis), Daniel Schmidt (RKI) organized the event "PrEP Controversies of a Success Story" with presentations and discussion. The recording of the event can be viewed here.

At the 33rd dagnä workshop, which took place from September 1 - 2, 2023 in Berlin, Dr. Daniel Schmidt presented the results of the PrEP-Surv surveys at HIV specialty care centers in the dagnä network.

The Deutsches Ärzteblatt reports on PrEP and the PrEP-Surv project in an article and an interview. Both can be found under Publications.

Results of the 2nd survey at Dagnä centers have been published. The Epidemiological Bulletin can be found below under Publications. (Status: 20.07.2023)

The overall results of the PrEP evaluation (EvE-PrEP) were published in an article in the Bundesgesundheitsblatt.

The 11th German-Austrian AIDS Congress (DÖAK 2023) took place in Bonn from March 23-25, 2023 with the active participation of PrEP-Surv.
The following activities took place with the organization or participation of the PrEP-Surv team:

Participation in the program committee for the organization of the DÖAK 2023 (D. Schmidt)
Organization of the symposium "Digitalization in healthcare" with the presentation "Digitalization in healthcare using the example of HIV & PrEP" (D. Schmidt, K. Voulgaris)
Presentation "PrEP in Germany - Results from the PrEP evaluation and the national PrEP surveillance" (D. Schmidt) at the symposium "Sexual Health and Prevention"
Presentation "PrEP in Germany - PrEP for all?" and discussion in the community workshop "PrEP for all - intersectionality and care" (D. Schmidt)
Founding meeting of the expert advisory board for the creation of an MIO (abbreviation for: Medical Information Object) for HIV-PrEP

Results of the 1st survey at Dagnä centers have been published. The Epidemiological Bulletin can be found below under Publications. (Status: 16.02.2023)

Further meetings of the Community Advisory Board in the PrEP-Surv project took place. The 2nd meeting took place on 29.09.2022, the 3rd meeting on 25.01.2023 and the 4th meeting on 22.03.2023. (Status: 16.05.2023)

In the Ärztezeitung podcast on World AIDS Day, RKI epidemiologist Daniel Schmidt answered important questions about HIV:

Podcast of the Ärztezeitung (1.12.2022)
Podcast on Youtube (30.11.2022)

The study information for the Dagnä center surveys can be downloaded here as a PDF (12.07.2022) (PDF, 223 KB, File does meet accessibility standards.)

The 1st meeting of the Community Advisory Board in the PrEP-Surv project took place on 17.06.2022. PDF for download (17.06.2022) (PDF, 676 KB, File does meet accessibility standards.)

The result of the data protection review by the data protection officer of the Robert Koch Institute did not raise any data protection concerns about the implementation of the project, as no personal data is processed. (03.06.2022)

Note: A list of HIV specialty care centers that provide PrEP can be found at: https://www.dagnae.de/wp-content/uploads/2023/01/PrEP_Übersicht-230130.pdf (as of: 30.01.2023).