FluVac
FluVac is a collaborative project in the area of Real-World Data between MUC Research and Clinovate (link). The aims of FluVac were, first, to determine retrospectively the influenza (flu) vaccination rates among PLWH (people living with HIV) in Germany during flu seasons 2018/19 and 2019/20 and to compare them with data on the vaccination coverage in the German general population.
Second, to show the feasibility of using a software solution cvSentinel with interfaces adapted to the site-specific electronic patient management systems that allows live extraction of data from medical records.
In total, 11,740 anonymized patient records from six sites were extracted and analyzed. Overall vaccination rates in the 2 periods were 33% and 36%, with rates being somewhat higher in older individuals or those with certain comorbidities.
It is important to recognize that prior to the pandemic, overall influenza vaccination coverage in key risk groups in Germany was well below WHO and European Council targets.
Finally, it has to be emphasized that by automatically extracting real-world data from routine electronic patient records, we can gain insights – also in other indications – that will benefit research and patient care. At the same time, this will make it easier for physicians to participate in study projects.
Reference
A first presentation and discussion of the results took place in the “Forum Forschung” at the 18th Munich AIDS and COVID Days. Furthermore, the final data were presented at the HIV Drug Therapy Congress in Glasgow 2022.
Link to the Poster
Find-HIV
Study for the early identification of HIV with the help of standardized diagnosis criteria
In this cross-sectional study over the years 2019-2020, characteristics of newly HIV-positive diagnosed persons were gathered, and the phenomenon of late presentation analyzed in more detail.
The aim was to identify patient- and system-related risk factors for late presentation as well as possible gaps in medical care. A better understanding of these factors should help to formulate strategies for an earlier HIV-diagnosis.
The project was led by the Bohlen and Halbach endowed chair for medical management at the University Duisburg-Essen as manager of a consortium, in cooperation with the partners dagnä, MUC Research and CLINOVATE.
MUC Research was acting as CRO responsible for data management, biometrics and monitoring as well as the creation of an electronic study platform, in close cooperation with CLINOVATE (programming, hosting).
More information is available on the dagnä website (in German).
Previous publications are found in Deutschen Ärzteblatt 2021;118 (43) and in AIDS Care Dec. 2021 The most recent publication about Find-HIV was published online ahead of print in AIDS Care 2023 Mar
DUALIS
A prospective, multicenter, randomized, open-label trial to assess the safety, tolerability and efficacy of dual therapy with boosted Darunavir + Dolutegravir when switching from standard of care ART in HIV-patients with sustained virological suppression: The DUALIS study
A clinical (phase III-) study investigating the safety and efficacy of a switch to dual antiretroviral therapy with boosted Dolutegravir and Darunavir in comparison to ongoing NRTI-based triple therapy with boosted Darunavir.
MUC Research´s tasks for this study are data management, writing the statistical analysis plan and performing statistical analyses.
The main publication for DUALIS appeared in Open Forum Infectious Diseases Aug 2020. Along with various poster presentations for international conventions, other publications followed followed in AIDSResTherapy Sep 2021, in the Journal of Antimicrobial Chemotherapy and in HIV Res Clin Pract 2021 Dec 23
