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PROBeX: Unscheduled Visits and Unscheduled Test Results SOP (1299)

PROBeX SOPTB/Coinfection Studies PROBeX HIVAppointment StaffTesting VisitResults Record Drug Clinic ARTTreatment AfricaTuberculosisPatient Sputum TBDiagnosis Blood XDRResistanceBedaquilineGeneticMechanismsInteractionsPharmakineticSynthesisMedicationsRitonavirLopinavirSamplingHospitalUnscheduled MissedInternational 2020Community HealthImmunologyVirologyGeneticsClinicalProspective Cohort StudyQuantitativeClinical

PROBeX unscheduled visits SOP.

PROBeX: Site Visits and Monitoring SOP (1296)

PROBeX SOPTB/Coinfection Studies PROBeX HIVLaboratoryParticipant StaffTesting Visit SiteProtocol DrugDeviationMonitor Review ARTTreatmentProtectionSubjects Report AfricaTuberculosisPatientDiagnosis XDRStorageDocumentsDocumentResistanceBedaquilineGeneticMechanismsInteractionsPharmakineticSynthesisMedicationsRitonavirLopinavirScheduleActionsInternationalActivitiesViolationDebriefInternational 2020Community HealthImmunologyVirologyGeneticsClinicalProspective Cohort StudyQuantitativeClinical

PROBeX international staff monitoring SOP.

TRAX: Blood Storage SOP (1229)

TRAX SOP TRAXTB/Coinfection StudiesContactEquipment StaffTestingTransportationCommunityResourceCollection Safety Social Rural DrugInterventionSpecimensTransmissionNetwork AfricaClusterTracingResistantGenotypeTuberculosisMortalityPatternsEpidemiologyLimitedCo-infection SouthHospitalsImmunocompromisedCongregateInteractionSettingsLabratorySamplesStorage PPEReagentsSupplies PlasmaInternational 2014TRAX-Document MethodsClinicalPreventionCommunity HealthBehavioralHealth EquityVirologyGeneticsClinicalCross Sectional StudyClinicalChart ExtractionQualitative

TRAX staff protocol for blood and sputum storage including; safety precautions, specimen handling, and equipment needed.

Project nGage: Fidelity Assessment Checklist (1200)

Project nGageResearch Staff InstructionsProject nGagePreventionAppointmentChecklist GuideInformationInterviewRetention Staff HealthBehavioralBehaviorAdherence Black MSM RiskLinkage Care YBMSM SocialSupportPositiveInterventionBarriers ViralInsurancePrimaryAntiretroviral PeerFidelity PilotEfficacyMinorityReductionMotivationIMB ModelNetwork SMMReceiptOrganicMaintenanceConfidantCulturalVisualizationAssessmentBooster AIDS LoadNavigationOutreachDomestic 2017PreventionCommunity HealthBehavioralImplementationHealth EquityDevelopmentalClinicalStandard RCTClinicalQualitative

Study staff fidelity checklist for Project nGage study.

Project nGage: Intervention Manual (1199)

Project nGageResearch Staff InstructionsProject nGagePreventionWorksheetAppointmentBaseline GuideInformationInterviewOverviewProcedureRetention StaffScripts SOP HealthBehavioralBehaviorAdherence Black MSM Plan RiskLinkage CareTraining YBMSM SocialSupportPositiveInterventionBarriers Viral ClinicInsurancePrimary PLWHAntiretroviral Peer PilotEfficacyMinorityRelationshipReductionMotivationIMB ModelNetwork SMMReceiptOrganicMaintenanceConfidantCulturalVisualizationAssessmentBooster ModuleAlgorithm PIE FactPersonalized AIDS LoadNavigationOutreachMedicationDomestic 2017nGage-Document MethodsQualitativePreventionCommunity HealthBehavioralmHealthHealth EquityClinicalDevelopmentalStandard RCTClinicalQualitative

Intervention Manual for Project nGage; akin to a broad SOP/protocol with surveys for study staff. Includes overview, baseline visit details, Session I: identifying network support and engaging support confidant, Module A: support matters! Providing support for young people living with HIV, PIE worksheet, Module B: motivating social support, Module C: information is power, essential information about HIV and AIDS, what happens at the clinic, HIV medications and adherence, common barriers to taking medications and attending appointments, Session II Module D: personalized care and support plan with worksheet, barriers and solutions worksheets, telephone follow-up sessions for index-support confidant dyads with scripts, references.

Project WERK: Fidelity Data Dictionary Spreadsheet (1198)

Project WERKResearch Staff InstructionsProject WERKPreventionAppointmentChecklist DataInformation PrEPRetention Staff HealthBehavioralBehaviorAdherence Black MSM RiskLinkage YBMSM SocialSupportInterventionBarriersSpreadsheetInsuranceFidelity PilotEfficacyMinorityReductionMotivationIMB ModelNetwork SMM YBSMMNegativeReceiptOrganicMaintenanceConfidantCulturalVisualizationAssessmentBoosterDictionaryDomestic 2024BehavioralPreventionCommunity HealthHealth EquityDevelopmentalClinicalStandard RCTClinicalQual + Quant

Fidelity data dictionary spreadsheet, based off of the fidelity checklist for Project WERK study.

Project WERK: Fidelity Checklist (1197)

Project WERKResearch Staff InstructionsProject WERKPreventionAppointmentChecklistInformation PrEPRetention Staff HealthBehavioralBehaviorAdherence Black MSM RiskLinkage YBMSM SocialSupportInterventionBarriersInsuranceFidelity PilotEfficacyMinorityReductionMotivationIMB ModelNetwork SMM YBSMMNegativeReceiptOrganicMaintenanceConfidantCulturalVisualizationAssessmentBoosterDomestic 2024BehavioralPreventionCommunity HealthHealth EquityDevelopmentalClinicalStandard RCTClinicalQual + Quant

Study staff fidelity checklist for Project WERK study.

Project WERK: Intervention Manual (1196)

Project WERKResearch Staff InstructionsProject WERKPreventionScreeningWorksheetAppointmentBaselineFollow-upInformationInterviewOverview PrEPProcedureRetention StaffScripts SOP Survey Text Health AbuseBehavioralBehaviorAdherence Black MSM PhoneReferences Plan RiskLinkage CareTraining YBMSM Social StatusSupportInterventionBarriers ClinicInsurancePrimary PilotEfficacyMinorityRelationshipReductionMotivationIMB ModelNetwork SMM YBSMMNegativeReceiptOrganicMaintenanceConfidantCulturalVisualizationAssessmentBoosterSociogram ModuleAlgorithm BriefInstrument StrainDisengagementRefusal ChangePsychoeducation PIE FactPersonalizedMonthlySessionsDomestic 2024PW-Document MethodsClinicalQualitativeQuantitativeBehavioralPreventionCommunity HealthHealth EquityDevelopmentalClinicalStandard RCTClinicalQual + Quant

Intervention Manual for Project WERK; akin to a broad SOP/protocol with surveys and interview guides for study staff.

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: 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.