Monitoring

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Study Type(s)

Topic Area(s)

Document Type(s)

Study Method(s)

Document Method(s)

PROBeX: Study Reporting Plan SOP (1288)

PROBeX SOPTB/Coinfection Studies PROBeX HIV DataRetention StudyTesting SiteEnrollmentMonitoringProtocol Safety PlanReportingResults DrugDistributionSpecimen ARTTreatment AfricaTuberculosisDiagnosis XDRStorageResistanceBedaquilineGeneticMechanismsInteractionsPharmakineticSynthesisMedicationsRitonavirLopinavirInternational 2020Community HealthImmunologyVirologyGeneticsClinicalProspective Cohort StudyQuantitativeClinical

Tracking study progress SOP for PROBeX.

PROBeX: Protocol (1267)

PROBeXConsent FormsTB/Coinfection Studies PROBeXConsent HIVScreening DataProcedureRecruitmentTestingAnalysisBenefitsMonitoringProtocol RisksConfidentialityTimeline DrugInformed Viral Clinic ARTAntiretroviralTreatment Urine Load AfricaTuberculosisMortalityHospitals Sputum CD4Diagnosis BloodStorage PlasmaDocumentationResistanceBedaquilineGeneticMechanismsInteractionsPharmakineticSynthesisMedicationsRitonavirLopinavir Global FDAInhibitorTransmissions GenomeSequencingTherapyPharmacodynamicsSchedulePharmacogenetics PKSub-studyPhlebotomyPopulationsVulnerableInternational 2020Community HealthImmunologyVirologyGeneticsClinicalProspective Cohort StudyQuantitativeClinical

Protocol for PROBeX study.

TRAX: Temperature Monitoring, Maintenance and Servicing SOP (1254)

TRAX SOP TRAXTB/Coinfection StudiesContactTestingCommunityResourceMonitoring Social Rural DrugInterventionSpecimen LabTransmissionNetworkMaintenance AfricaClusterTracingResistantGenotypeTuberculosisMortalityPatternsEpidemiologyLimitedCo-infection SouthHospitalsImmunocompromisedCongregateInteractionSettingsTechnician IALCHTemperatureRefrigeratorFreezerServicingInternational 2014TRAX-Document MethodsClinicalPreventionCommunity HealthBehavioralHealth EquityVirologyGeneticsClinicalCross Sectional StudyClinicalChart ExtractionQualitative

Specimen freezer temperature monitoring protocol for TRAX study.

TRAX: Temperature Monitoring and Evaluation SOP (1251)

TRAX SOP TRAXTB/Coinfection StudiesContactEquipmentTestingCommunityResourceMonitoring Social Rural DrugInterventionTransmissionNetwork AfricaClusterTracingResistantGenotypeTuberculosisMortalityPatternsEpidemiologyLimitedCo-infection SouthHospitalsImmunocompromisedCongregateInteractionSettings LogTemperatureRefrigeratorRecording RangeInternational 2014TRAX-Document MethodsClinicalPreventionCommunity HealthBehavioralHealth EquityVirologyGeneticsClinicalCross Sectional StudyClinicalChart ExtractionQualitative

Refrigerator temperature monitoring protocol for TRAX study staff.

TRAX: Site Visits & Monitoring SOP (1233)

TRAX SOP TRAXTB/Coinfection StudiesContact DataTesting SiteCommunityResourceMonitoring Social Rural DrugInterventionTransmissionNetwork AfricaClusterTracingResistantGenotypeTuberculosisMortalityPatternsEpidemiologyLimitedCo-infection SouthHospitalsImmunocompromisedCongregateInteractionSettings GCP RSPHInternational 2014PreventionCommunity HealthBehavioralHealth EquityVirologyGeneticsClinicalCross Sectional StudyClinicalChart ExtractionQualitative

Monitoring site visits procedure for Emory RSPH staff in TRAX study.

PrEP 2-1-1: Protocol (1188)

PrEP 2-1-1ProtocolsPrEP 2-1-1Prevention Data EventInterviewLaboratoryManagementOverview PrEPPopulation SurveyTestingBehavior SexualAdherenceAnalysisBackground MobileMonitoring MSM PhoneProceduresReferences SafetyAdverseReporting AppApplicationUsabilityInterventionObjectivesSpecimensFeasibilityAcceptabilitySelf-testEfficacyRegimenLocationsBiohazardContainmentAdministrative PillOn-demand 2-1-1AccountingDevelopment HarmReduction Urine Effect Side WebFunctionalitySatisfactionInternetMotivationPrEPsmartIMB ModelDomestic 2024PreventionCommunity HealthBehavioralDevelopmentalmHealthClinicalStandard RCTQualitativeClinicalClinicalQual + Quant

Protocol for the PrEP 2-1-1 study, includes background, objectives, research locations, study population, study overview, PrEPsmart app, data management and analysis, safety monitoring and adverse event reporting, laboratory specimens and biohazard containment, administrative procedures, and references.

DOT Diary: Protocol (1180)

DOT DiaryProtocolsDOT DiaryPrevention Data EventLaboratoryManagement Oral PrEPPopulationProcedure DiaryBehavior SexualAdherenceAnalysisBackground Design MobileMonitoring MSMReferences SafetyAdverseLongitudinalApplicationObjectivesSpecimenMonitorFeasibility PilotEfficacyPictureSmartPhoneTechnologyObservationalArtificialIntelligenceReliabilityAutomatedAccessibilityDevelop ReportOptimizePlausibilityIndividual DoseRegimen YoungLocationsBiohazardContainmentAdministrativeDomestic 2019PreventionCommunity HealthBehavioralDevelopmentalmHealthClinicalStandard RCTClinicalQual + Quant

Protocol for DOT Diary Study, includes; background, study objectives, research locations, study population, study design, data management and analysis, safety monitoring and adverse event reporting, laboratory specimens and biohazard containment, administrative procedures, references.

PrEP@Home: Baseline Survey (1108)

PREP at HomeSurveysPREP@Home Acute STIBaselineLaboratory PrEPProvider Survey SystemTesting Site HealthBehavioralSubstanceHistory SexualMonitoring Risk CarePersistence RemoteTelemedicineMulti-Site SocialEducationEmploymentMarital Income StatusResiliencyLiteracyStability AccessKnowledge MentalPerceived StigmaDemographicsEngagementCoverageWillingnessSymptomsHealthcare PEPEthnicity Gender RaceIdentityAttitudeIntentionOutness PayNetworkingGeosocialAwarenessDomestic 2023PAH-Document MethodsQuantitativePreventionBehavioralHealth EquitymHealthClinicalStandard RCTClinicalQual + Quant

Baseline survey including demographics, gender identity, race and ethnicity, education, employment, healthcare coverage, health access and engagement, health literacy, acute symptoms, marital status, HIV/STI testing history, sexual history, basic HIV knowledge, perceived HIV risk, PEP awareness, PrEP knowledge/attitudes, PrEP intentions, PrEP stigma, sexual stigma, outness to provider, mental health, resiliency, substance use, willingness to pay, income, housing stability, and use of social/geosocial networking sites for the PrEP@Home Study.

PrEP@Home: Follow up Survey (1106)

PREP at HomeSurveysPREP@Home AcuteFollow-upLaboratory PrEP Survey SystemBehavioralSubstanceHistory SexualAdherenceMonitoring CarePersistence RemoteTelemedicineMulti-Site SocialDepressionAnxiety UseHousingQuestions StigmaScreener PHQ-2Coverage Side CostSymptomsHealthcareNetworkingGeosocialEffects GAS-2CAGE-AID SUSDomestic 2023PAH-Document MethodsQuantitativePreventionBehavioralHealth EquitymHealthClinicalStandard RCTClinicalQual + Quant

Follow-up survey including adherence, side effects, acute symptoms, sexual history, PrEP stigma, PHQ-2/GAS-2 screener, substance use, CAGE-AID questions, housing, SUS, healthcare coverage, cost, and use of social/geosocial networking sites for the PrEP@Home Study.

PrEP@Home: Enrollment SOP (1098)

PREP at Home SOPPREP@HomeEligibilityBaselineLaboratory PrEPParticipant Staff SOP System VisitBehavioralEnrollmentMonitoring CarePersistence RemoteTelemedicineMulti-SiteProcessRandomizationDomestic 2023PreventionBehavioralHealth EquitymHealthClinicalStandard RCTClinicalQual + Quant

Enrollment SOP describing how staff handles the enrollment process for all participants in the PrEP@Home Study, including study visit eligibility, baseline visit, enrollment, and randomization.

PrEP@Home: Retention Plan SOP (1097)

PREP at Home SOPPREP@HomeAppointmentBaselineExampleFollow-upLaboratory PrEPParticipantReminderRetention Staff SOP System SiteBehavioralMonitoring Script Plan CareResponsibilitiesPersistence RemoteTelemedicineMulti-Site Status KitScheduleCoordinator RoleMessageDomestic 2023PreventionBehavioralHealth EquitymHealthClinicalStandard RCTClinicalQual + Quant

SOP for participant retention plans, including retention coordinator roles and responsibilities, baseline appointment scheduling scripts, follow-up care kit and appointment reminders, example message scripts, and change of status at the end of the study for the PrEP@Home Study.

PrEP@Home: Protocol (1080)

PREP at HomeProtocolsPREP@HomeAdministration EventLaboratoryOverview PrEP System TrialBehavioralConsiderationControl DesignMethodsMonitoringProceduresProtocolReferences SafetyStatisticsSubjectAdverseIntroductionReporting CarePersistence RemoteTelemedicineMulti-SiteInterventionSpecimens HumanDomestic 2023PreventionBehavioralHealth EquitymHealthClinicalStandard RCTClinicalQual + Quant

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.

PrEP@Home: Division of AIDS (DAIDS) Table for Grading the Severity of Adult & Pediatric Adverse Events CRF (1062)

PREP at Home CRFPREP@Home Event FormLaboratory PrEP Staff SystemBehavioralMonitoringAdverse CarePersistence RemoteTelemedicineMulti-Site CFRDomestic 2023PreventionBehavioralHealth EquitymHealthClinicalStandard RCTClinicalQual + Quant

CRF from Division of AIDS (DAIDS), U.S. Department of Health and Human Services: Severity grading table for adult and pediatric adverse events for the PrEP@Home Study.