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Effectiveness and cost-effectiveness of four different strategies for SARS-CoV-2 surveillance in the general population (CoV-Surv Study): study protocol for a two-factorial randomized controlled multi-arm trial with cluster sampling.
Deckert, Andreas; Anders, Simon; De Allegri, Manuela; Nguyen, Hoa Thi; Souares, Aurélia; McMahon, Shannon; Meurer, Matthias; Burk, Robin; Sand, Matthias; Koeppel, Lisa; Hein, Lena Maier; Roß, Tobias; Adler, Tim; Siems, Tobias; Brugnara, Lucia; Brenner, Stephan; Herbst, Konrad; Kirrmaier, Daniel; Duan, Yuanqiang; Ovchinnikova, Svetlana; Boerner, Kathleen; Marx, Michael; Kräusslich, Hans-Georg; Knop, Michael; Bärnighausen, Till; Denkinger, Claudia.
  • Deckert A; Heidelberg Institute of Global Health, University of Heidelberg, Im Neuenheimer Feld 324, 69120, Heidelberg, Germany. a.deckert@uni-heidelberg.de.
  • Anders S; Center for Molecular Biology Heidelberg (ZMBH), University of Heidelberg, Im Neuenheimer Feld 282, 69120, Heidelberg, Germany.
  • De Allegri M; Heidelberg Institute of Global Health, University of Heidelberg, Im Neuenheimer Feld 324, 69120, Heidelberg, Germany.
  • Nguyen HT; Heidelberg Institute of Global Health, University of Heidelberg, Im Neuenheimer Feld 324, 69120, Heidelberg, Germany.
  • Souares A; Heidelberg Institute of Global Health, University of Heidelberg, Im Neuenheimer Feld 324, 69120, Heidelberg, Germany.
  • McMahon S; Heidelberg Institute of Global Health, University of Heidelberg, Im Neuenheimer Feld 324, 69120, Heidelberg, Germany.
  • Meurer M; Center for Molecular Biology Heidelberg (ZMBH), University of Heidelberg, Im Neuenheimer Feld 282, 69120, Heidelberg, Germany.
  • Burk R; Center for Molecular Biology Heidelberg (ZMBH), University of Heidelberg, Im Neuenheimer Feld 282, 69120, Heidelberg, Germany.
  • Sand M; GESIS Leibniz-Institute for the Social Sciences, B2/1, 68159, Mannheim, Germany.
  • Koeppel L; Division of Clinical Tropical Medicine, University of Heidelberg, Im Neuenheimer Feld 324, 69120, Heidelberg, Germany.
  • Hein LM; Division of Computer Assisted Medical Interventions (CAMI), German Cancer Research Centre (DKFZ), Im Neuenheimer Feld 223, 69120, Heidelberg, Germany.
  • Roß T; Division of Computer Assisted Medical Interventions (CAMI), German Cancer Research Centre (DKFZ), Im Neuenheimer Feld 223, 69120, Heidelberg, Germany.
  • Adler T; Division of Computer Assisted Medical Interventions (CAMI), German Cancer Research Centre (DKFZ), Im Neuenheimer Feld 223, 69120, Heidelberg, Germany.
  • Siems T; Institute for Applied Mathematics, University of Heidelberg, Berliner Str. 41-49, 69120, Heidelberg, Germany.
  • Brugnara L; Heidelberg Institute of Global Health, University of Heidelberg, Im Neuenheimer Feld 324, 69120, Heidelberg, Germany.
  • Brenner S; evaplan GmbH at the University Hospital, Ringstr.19b, 69115, Heidelberg, Germany.
  • Herbst K; Heidelberg Institute of Global Health, University of Heidelberg, Im Neuenheimer Feld 324, 69120, Heidelberg, Germany.
  • Kirrmaier D; Center for Molecular Biology Heidelberg (ZMBH), University of Heidelberg, Im Neuenheimer Feld 282, 69120, Heidelberg, Germany.
  • Duan Y; Center for Molecular Biology Heidelberg (ZMBH), University of Heidelberg, Im Neuenheimer Feld 282, 69120, Heidelberg, Germany.
  • Ovchinnikova S; Center for Molecular Biology Heidelberg (ZMBH), University of Heidelberg, Im Neuenheimer Feld 282, 69120, Heidelberg, Germany.
  • Boerner K; Center for Molecular Biology Heidelberg (ZMBH), University of Heidelberg, Im Neuenheimer Feld 282, 69120, Heidelberg, Germany.
  • Marx M; Department of Infectious Diseases, Virology, University of Heidelberg, Im Neuenheimer Feld 267, 69120, Heidelberg, Germany.
  • Kräusslich HG; Heidelberg Institute of Global Health, University of Heidelberg, Im Neuenheimer Feld 324, 69120, Heidelberg, Germany.
  • Knop M; evaplan GmbH at the University Hospital, Ringstr.19b, 69115, Heidelberg, Germany.
  • Bärnighausen T; Center for Molecular Biology Heidelberg (ZMBH), University of Heidelberg, Im Neuenheimer Feld 282, 69120, Heidelberg, Germany.
  • Denkinger C; Center for Molecular Biology Heidelberg (ZMBH), University of Heidelberg, Im Neuenheimer Feld 282, 69120, Heidelberg, Germany.
Trials ; 22(1): 656, 2021 Sep 26.
Article in English | MEDLINE | ID: covidwho-1440949
ABSTRACT

BACKGROUND:

To achieve higher effectiveness in population-based SARS-CoV-2 surveillance and to reliably predict the course of an outbreak, screening, and monitoring of infected individuals without major symptoms (about 40% of the population) will be necessary. While current testing capacities are also used to identify such asymptomatic cases, this rather passive approach is not suitable in generating reliable population-based estimates of the prevalence of asymptomatic carriers to allow any dependable predictions on the course of the pandemic.

METHODS:

This trial implements a two-factorial, randomized, controlled, multi-arm, prospective, interventional, single-blinded design with cluster sampling and four study arms, each representing a different SARS-CoV-2 testing and surveillance strategy based on individuals' self-collection of saliva samples which are then sent to and analyzed by a laboratory. The targeted sample size for the trial is 10,000 saliva samples equally allocated to the four study arms (2500 participants per arm). Strategies differ with respect to tested population groups (individuals vs. all household members) and testing approach (without vs. with pre-screening survey). The trial is complemented by an economic evaluation and qualitative assessment of user experiences. Primary outcomes include costs per completely screened person, costs per positive case, positive detection rate, and precision of positive detection rate.

DISCUSSION:

Systems for active surveillance of the general population will gain more importance in the context of pandemics and related disease prevention efforts. The pandemic parameters derived from such active surveillance with routine population monitoring therefore not only enable a prospective assessment of the short-term course of a pandemic, but also a more targeted and thus more effective use of local and short-term countermeasures. TRIAL REGISTRATION ClinicalTrials.gov DRKS00023271 . Registered November 30, 2020, with the German Clinical Trials Register (Deutsches Register Klinischer Studien).
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Controlled clinical trial / Health economic evaluation / Observational study / Prognostic study / Qualitative research / Randomized controlled trials / Risk factors / Screening study Limits: Humans Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2021 Document Type: Article Affiliation country: S13063-021-05619-5

Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Controlled clinical trial / Health economic evaluation / Observational study / Prognostic study / Qualitative research / Randomized controlled trials / Risk factors / Screening study Limits: Humans Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2021 Document Type: Article Affiliation country: S13063-021-05619-5