Procedure

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PROBeX: Obtaining Informed Consent SOP (1285)

PROBeX SOPTB/Coinfection Studies PROBeXConsent HIVScreeningProcedureTestingConfidentiality DrugInformedSpecimen ARTTreatmentDiscussion AfricaTuberculosisPatient SputumDiagnosis Blood XDRStorageResistanceBedaquilineGeneticMechanismsInteractionsPharmakineticSynthesisMedicationsRitonavirLopinavirPharmacogeneticInternational 2020Community HealthImmunologyVirologyGeneticsClinicalProspective Cohort StudyQuantitativeClinical

Obtaining informed consent SOP for PROBeX.

PROBeX: Collection, Transportation and Processing for Intensive PK Sampling SOP (1283)

PROBeX SOPTB/Coinfection Studies PROBeXConsent HIVChecklistLaboratoryProcedureTestingTransportationCollection DrugSpecimen ARTTreatment AfricaTuberculosisPatient LogDiagnosis Blood XDR PlasmaFreezerResistanceBedaquilineGeneticMechanismsInteractionsPharmakineticSynthesisMedicationsRitonavirLopinavirSampling PKProcessingIntensivePharmacokineticLabellingCryoboxInternational 2020PRO-Document MethodsClinicalCommunity HealthImmunologyVirologyGeneticsClinicalProspective Cohort StudyQuantitativeClinical

PROBeX collection, transportation and processing of intensive PK sampling SOP.

PROBeX: Source Documentation and Participant Source File SOP (1282)

PROBeX SOPTB/Coinfection Studies PROBeXClinical HIV DataInformationParticipantProcedureTestingResultsRecords Drug ARTTreatment Africa SourceTuberculosisDiagnosis XDRDocumentationResistanceBedaquilineGeneticMechanismsInteractionsPharmakineticSynthesisMedicationsRitonavirLopinavir FileInternational 2020PRO-Document MethodsClinicalChart ExtractionCommunity HealthImmunologyVirologyGeneticsClinicalProspective Cohort StudyQuantitativeClinical

Source documentation and participant source file SOP in PROBeX study.

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: Sputum Collection & Transportation SOP (1232)

TRAX SOP TRAXTB/Coinfection StudiesContactLaboratoryParticipantProcedureTestingTransportationCommunityResourceCollection Social Rural DrugInterventionSpecimen ClinicTransmission SampleNetwork AfricaClusterTracingResistantGenotypeTuberculosisMortalityPatternsEpidemiologyLimitedCo-infection SouthHospitalsImmunocompromisedCongregateInteractionSettingsTransfer Nurse SputumCounselorInternational 2014TRAX-Document MethodsClinicalPreventionCommunity HealthBehavioralHealth EquityVirologyGeneticsClinicalCross Sectional StudyClinicalChart ExtractionQualitative

Sputum collection and transportation TRAX study staff protocol.

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: 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.

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.