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Study Type(s)

Topic Area(s)

Document Type(s)

Study Method(s)

Document Method(s)

PROBeX: Data and Quality Management Plan SOP (1287)

PROBeX SOPTB/Coinfection Studies PROBeX HIV Data EntryLaboratoryManagementParticipantTestingAssuranceControlQuality PlanResults Drug Review ARTTreatment Report AfricaEvaluationTuberculosisDiagnosis XDRStorageDocumentsResistanceBedaquilineGeneticMechanismsInteractionsPharmakineticSynthesisMedicationsRitonavirLopinavir FilesInternational 2020Community HealthImmunologyVirologyGeneticsClinicalProspective Cohort StudyQuantitativeClinical

Data management SOP for PROBeX.

TRAX: Infection Control SOP (1243)

TRAX SOP TRAXTB/Coinfection StudiesPreventionContactTestingCommunityResourceControl Social Rural DrugInterventionTreatmentTransmissionInfectionNetwork AfricaClusterTracingResistantGenotypeTuberculosisMortalityPatternsEpidemiologyLimitedCo-infection SouthHospitalsImmunocompromisedCongregateInteractionSettings Nurse Home TB XDRHealthcare TraceVentilationInternational 2014TRAX-Document MethodsClinicalPreventionCommunity HealthBehavioralHealth EquityVirologyGeneticsClinicalCross Sectional StudyClinicalChart ExtractionQualitative

Prevention of XDR TB spread to TRAX staff.

Le Kip Kip: Protocol (1201)

Le Kip KipProtocolsLe Kip KipPrevention Data PrEPPopulationAdherenceBackgroundAssuranceControl DesignProceduresQualityReferencesPersistenceTimeline Social Access Uptake Female WomenInterventionObjectivesStatisticalEconomic HumanInfluence PeerOutcomesTransmissionProtectionSubjects YoungInfectionOptimizationScale-upEmpower AfricaMultiphaseMOST FrameworkEvaluationStrategyModification ActorIntensityDurationClusterProgramExistingInfrastructureEffectiveness CostModelingAdoptionAdolescentAdvertising Worker SexCampaignCondoms Girls RefillRationaleConsiderations SourceInternational 2023PreventionCommunity HealthBehavioralImplementationClinicalStandard RCTClinicalImplementation ScienceQual + Quant

Protocol for Le Kip Kip, includes; key roles, background and rationale, objectives, study design, study population, study procedures, statistical considerations, access to source data/documents, quality control and quality assurance, protection of human subjects, timeline, references.

PrEP@Home: Protocol (1080)

PREP at HomeProtocolsPREP@HomeIntroduction HumanSpecimensInterventionMulti-SiteTelemedicine RemotePersistence CareReportingAdverseSubjectStatistics SafetyReferencesProtocolProceduresMonitoringMethods DesignAdministrationControlConsiderationBehavioral Trial System PrEPOverviewLaboratory EventDomestic 2023mHealthClinicalHealth EquityBehavioralPreventionStandard RCTQual + QuantClinical

Expanded standard protocol including introduction, methods, study overview, study intervention, trial design, procedures, laboratory specimens and procedures, safety monitoring and adverse event reporting, statistical considerations, human subjects considerations, administrative procedures, and references for the PrEP@Home Study.