Effectiveness and cost-effectiveness of four different strategies for SARS-CoV-2 surveillance (COVID-19) in the general population: study protocol for a cluster-randomised, two-factorial controlled trial.

Conditions

COVID-19 pandemic surveillance U07.2

Andreas Deckert, Simon Anders, Ivonne Morales, Manuela De Allegri, Hoa Thi Nguyen et al. (25 authors)

JMIR Public Health and Surveillance2023-05-263 citations

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 A, Anders S, De Allegri M, Nguyen HT, Souares A, McMahon S, Meurer M, Burk R, Sand M, Koeppel L, Hein LM, Roß T, Adler T, Siems T, Brugnara L, Brenner S, Herbst K, Kirrmaier D, Duan Y, Ovchinnikova S, Boerner K, Marx M, Kräusslich HG, Knop M, Bärnighausen T, Denkinger C.

2021-09-263 citations

10.1186/s13063-021-05619-5

Effectiveness and cost-effectiveness of four different strategies for SARS-CoV-2 surveillance in the general population (CoV-Surv Study): a structured summary of a study protocol for a cluster-randomised, two-factorial controlled trial.

Deckert A, Anders S, de Allegri M, Nguyen HT, Souares A, McMahon S, Boerner K, Meurer M, Herbst K, Sand M, Koeppel L, Siems T, Brugnara L, Brenner S, Burk R, Lou D, Kirrmaier D, Duan Y, Ovchinnikova S, Marx M, Kräusslich HG, Knop M, Bärnighausen T, Denkinger C.

2021-01-0823 citations

10.1186/s13063-020-04982-z

Interventions

Group 1: Individuals (one per household) receive information and study material by mail with instructions on how to produce a saliva sample and how to return the sample by mail. Once received by the l

Eligibility

Sex/Gender

All

Age

7 Years to No maximum

Inclusion criteria

Inclusion criteria: Quantitative study: participants age 7 years or older; presence of an online (alternatively paper-based) voluntary consent form for the participation in the online/paper-based health screening; presence of an online (alternatively paper-based) voluntary consent form for providing a saliva sample and related data for research purposes. For minors: Presence of consent for participation by the legal representative. Qualitative study component: participants and non-responders of the main study aged 18 and over; existing telephone or alternatively paper-based or electronic (interview: email; survey: online tool) declaration of consent for participation in the interview or the survey; existing telephone or, alternatively, paper-based or electronic (interview: email; survey: online tool) declaration of consent for the use of the data. NOTE: The planned recruitment number of 10,000 (regarding the primary endpoint number of tests performed) and the achieved number of 5319 refer to the gargle samples received. However, to achieve these numbers, more subjects were recruited as pre-screening was performed in 2 study arms.

Exclusion criteria

Exclusion criteria: Quantitative Study: failure to meet any of the inclusion criteria; withdrawal of consent. Qualitative Study Component: failure to meet any of the inclusion criteria; withdrawal of consent.

Design outcomes

Primary

Measure	Time frame
Primary study outcomes: 1) Cost per correctly screened person 2) Cost per positive case 3) Positive detection rate 4) Precision of positive detection rate	—

Secondary

Measure	Time frame
Secondary study outcomes: 1) Participation rate 2) Costs per asymptomatic case 3) Prevalence estimate 4) Number of asymptomatic cases per arm 5) Ratio of symptomatic to asymptomatic cases per arm 6) Participant satisfaction Additional study outcomes (not part of trial): 1) Cost effectiveness of each of the four surveillance strategies compared to the purely passive monitoring (i.e. status quo) 2) Development of a prognostic model to predict hospital utilization caused by SARS-CoV-2 3) Time from test shipment to test application and time from test shipment to test result 4) Qualitative interviews: perception and preferences of the persons to be tested with regard to test strategies	—

Measure

Time frame

Secondary study outcomes: 1) Participation rate 2) Costs per asymptomatic case 3) Prevalence estimate 4) Number of asymptomatic cases per arm 5) Ratio of symptomatic to asymptomatic cases per arm 6) Participant satisfaction Additional study outcomes (not part of trial): 1) Cost effectiveness of each of the four surveillance strategies compared to the purely passive monitoring (i.e. status quo) 2) Development of a prognostic model to predict hospital utilization caused by SARS-CoV-2 3) Time from test shipment to test application and time from test shipment to test result 4) Qualitative interviews: perception and preferences of the persons to be tested with regard to test strategies

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Countries

Germany

Contacts

Public ContactAndreas Deckert

Heidelberg Institute of Global Health

a.deckert@uni-heidelberg.de06221 56-37260

Outcome results

None listed