Pooled and conventional nucleic acid testing strategies for SARS-CoV-2 to screen direct care research staff and protect HIV patients
Pooled and conventional nucleic acid testing strategies for SARS-CoV-2 to screen direct care research staff and protect HIV patients
批准号:
10166377
负责人:
CONSTANCE ANN BENSON
金额:
$84.56万
依托单位国家:
美国
项目类别:
财政年份:
2020
资助国家:
美国
项目状态:
已结题
起止时间:
2020-06-23 至 2021-11-30
关键词:
2019-nCoVAIDS preventionAcquired Immunodeficiency SyndromeAddressAdministrative SupplementAffectAntibodiesAntiviral AgentsBiologicalBiological AssayBlood DonationsCOVID-19COVID-19 pandemicCaliforniaCaringCharacteristicsChinaClinicClinical Trials UnitColoradoComplementDiseaseDisease OutbreaksEnsureEnvironmentEnzyme-Linked Immunosorbent AssayEpidemicEquipmentFDA approvedGoalsGrantHIVHealth PersonnelHealth systemHospitalsHuman ResourcesImmune responseImmunoglobulin GIndividualInfectionInfrastructureLocal GovernmentLocationMalignant NeoplasmsMeasuresMethodsMonitorNoseNucleic Acid Amplification TestsNursing HomesOutcomeParticipantPatientsPersonsPneumoniaPolymerase Chain ReactionPopulationPrevalenceProceduresPublic HealthReagentResearchResearch ActivityResearch PersonnelRiskSARS coronavirusSamplingSecureSeroprevalencesService provisionServicesSiteSpecimenSwabTechniquesTestingUniversitiesVisitVulnerable PopulationsWorkWorkplacebaseclinical centerclinical research sitecostcost effectivecost efficienthigh riskinnovationnovelpandemic diseaseparent grantpathogenic viruspreventprevention serviceprofessional atmosphereprogramsresponsescreeningtesting servicestransmission processtreatment researchtreatment services
中文摘要
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英文摘要
ABSTRACT
An outbreak of serious pneumonia caused by a previously unknown viral pathogen, severe acute respiratory
syndrome coronavirus (SARS-CoV-2), emerged in Wuhan, China in December 2019. Inadequate access to
testing has limited our understanding of the extent of this new epidemic in the U.S. A cost effective accurate and
rapid testing strategy is urgent to fill this gap.
This administrative supplement to the UCSD Collaborative HIV Clinical Trials Unit (CTU) to screen all patient-
facing research staff and a proportion of research participants is directly responsive to PA-18-591 and NOSI AI-
20-031 as it may allow safe resumption of key research services at our three U.S. Clinical Research Sites (CRSs)
(UCSD Antiviral Research Center [AVRC] CRS, the University of Southern California [USC] CRS and the
University of Colorado Hospital [UCH] CRS), serving persons with HIV (PWH) who may be at higher risk for
COVID-19. Continuity of research coordinated with care is critical in progress toward ending the HIV epidemic
without putting staff and participants at risk for COVID-19 acquisition in the research setting. No other local
government or health systems are undertaking this approach.
Our goal is to implement and evaluate a cost-effective screening approach to determine the prevalence of SARS-
CoV-2 in asymptomatic research staff who are in direct contact with PWH and research participants being seen
for study visits, identify new incident infections and potentially prevent asymptomatic carrier transmission of
SARS-CoV-2 to PWH. This proposal is conceptually innovative in that it applies nucleic acid test (NAT) pooling
techniques to save testing supplies, personal protective equipment and money to address an immediate need
for increased testing. As there are no technical barriers, testing can start immediately.
We will screen (1) direct care research personnel 3 days/week at UCSD (n=40) and weekly at USC (n=8) and
UCH (n=20) for asymptomatic SARS-CoV-2 and (2) a subset of 10 research participants at each site every
testing day. Self-collected nasal swab samples will be tested using a NAT pooling platform (UCSD AVRC CRS)
or individual RT-PCR based commercial SARS-CoV-2 testing (USC and UCH CRSs).
Our rationale is that by leveraging our CTU expertise in pooled NAT, the infrastructure capacity of the three
CRSs and the San Diego Center for AIDS Research (CFAR), we will implement and evaluate a cost-effective
screening approach to determine the prevalence of SARS-CoV-2 infection and SARS-CoV-2 immune response
(i.e. seroprevalence) among direct care research staff and returning research participants (Aim 1) and to
determine the test characteristics of pooled testing (UCSD AVRC) compared to individual RT-PCR based
commercial SARS-CoV-2 testing (USC and UCH CRSs, Aim 2). Once validated, this approach can be deployed
in other settings to help ensure safe return to work procedures or in high-risk settings such as healthcare workers
in cancer or HIV clinics or nursing homes.
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会议论文
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批准号:9319811
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项目类别:
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资助金额:$95.55万
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财政年份:2015
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负责人:CONSTANCE ANN BENSON
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依托单位:
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批准号:9040412
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资助金额:$100.0万
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A Novel Wireless Ingestible Sensor System for Measurement of Medication Adherence in HIV Treatment and Prevention
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批准号:9751389
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资助金额:$68.83万
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依托单位:
A Novel Wireless Ingestible Sensor System for Measurement of Medication Adherence in HIV Treatment and Prevention
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批准号:9145781
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资助金额:$98.01万
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财政年份:2015
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负责人:CONSTANCE ANN BENSON
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依托单位:
CLINICAL TRIAL: ADULT AIDS CLINICAL TRIALS GROUP LONGITUDINAL LINKED RANDOMIZED
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批准号:8166818
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项目类别:
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资助金额:$0.04万
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财政年份:2009
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负责人:CONSTANCE ANN BENSON
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依托单位:
AIDS Clinical Trials Group Network
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批准号:7923515
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项目类别:
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资助金额:$113.09万
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财政年份:2009
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负责人:CONSTANCE ANN BENSON
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依托单位:
UCSD Department of Medicine HIV/AIDS Clinical Trials Unit
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批准号:7994193
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项目类别:
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资助金额:$464.62万
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财政年份:2007
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负责人:CONSTANCE ANN BENSON
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依托单位:
The UCSD CD4 Collaborative Clinical Trial Unit
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批准号:9179576
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项目类别:
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资助金额:$237.0万
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财政年份:2007
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负责人:CONSTANCE ANN BENSON
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依托单位:
UCSD Department of Medicine HIV/AIDS Clinical Trials Unit
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批准号:7345449
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项目类别:
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资助金额:$312.15万
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财政年份:2007
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负责人:CONSTANCE ANN BENSON
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依托单位:
UCSD Collaborative Clinical Trials Unit
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批准号:10304895
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项目类别:
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资助金额:$362.34万
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财政年份:2007
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负责人:CONSTANCE ANN BENSON
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依托单位:
UCSD Department of Medicine HIV/AIDS Clinical Trials Unit
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批准号:7095762
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资助金额:$203.7万
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财政年份:2007
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负责人:CONSTANCE ANN BENSON
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依托单位:
UCSD Department of Medicine HIV/AIDS Clinical Trials Unit
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批准号:8392953
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项目类别:
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资助金额:$319.29万
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财政年份:2007
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负责人:CONSTANCE ANN BENSON
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依托单位:
The UCSD CD4 Collaborative Clinical Trial Unit
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批准号:8784154
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项目类别:
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资助金额:$10.33万
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财政年份:2007
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负责人:CONSTANCE ANN BENSON
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依托单位:
UCSD Collaborative Clinical Trials Unit
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批准号:10057305
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项目类别:
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资助金额:$363.45万
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财政年份:2007
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负责人:CONSTANCE ANN BENSON
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依托单位:
UCSD Department of Medicine HIV/AIDS Clinical Trials Unit
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批准号:7742604
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项目类别:
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资助金额:$475.43万
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财政年份:2007
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负责人:CONSTANCE ANN BENSON
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依托单位:
UCSD Collaborative Clinical Trials Unit
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批准号:10531580
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项目类别:
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资助金额:$323.47万
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财政年份:2007
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负责人:CONSTANCE ANN BENSON
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依托单位:
UCSD Department of Medicine HIV/AIDS Clinical Trials Unit
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资助金额:$291.91万
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财政年份:2007
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负责人:CONSTANCE ANN BENSON
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依托单位:
UCSD Department of Medicine HIV/AIDS Clinical Trials Unit
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项目类别:
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资助金额:$475.8万
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财政年份:2007
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负责人:CONSTANCE ANN BENSON
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依托单位:
CLINICAL TRIAL: TRIAL IN ANTIRETROVIRAL NAIVE HIV SUBJECTS
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负责人:CONSTANCE ANN BENSON
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依托单位:
海外基金