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Study Type(s)

Topic Area(s)

Document Type(s)

Study Method(s)

Document Method(s)

PROBeX: Sputum Collection, Transportation and Storage of Sputum Samples SOP (1302)

PROBeX SOP TB/Coinfection Studies PROBeX HIV Testing Transportation Collection Drug Specimen Clinic ART Treatment Sample Biohazard Africa Tuberculosis Nurse Patient Sputum Culture Home Cough Diagnosis XDR Storage Field Resistance Bedaquiline Genetic Mechanisms Interactions Pharmakinetic Synthesis Medications Ritonavir Lopinavir Breath Tube Hospital Gloves Bottle Sizwe Dinuzulu Bacterium Incubated International 2020 PRO-Document Methods Clinical Community Health Immunology Virology Genetics Clinical Prospective Cohort Study Quantitative Clinical

PROBeX handling of sputum samples SOP.

PROBeX: Filing Study Related Documents SOP (1300)

PROBeX SOP TB/Coinfection Studies PROBeX Consent Eligibility HIV Screening Data Email Form Laboratory Testing Enrollment Protocol Record Drug ART Treatment Africa Tuberculosis Patient Log Diagnosis XDR Documents Ethics Resistance Bedaquiline Genetic Mechanisms Interactions Pharmakinetic Synthesis Medications Ritonavir Lopinavir Filing Link Locator Committee Letters International 2020 Community Health Immunology Virology Genetics Clinical Prospective Cohort Study Quantitative Clinical

PROBeX filing study documents SOP.

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

PROBeX SOP TB/Coinfection Studies PROBeX HIV Appointment Staff Testing Visit Results Record Drug Clinic ART Treatment Africa Tuberculosis Patient Sputum TB Diagnosis Blood XDR Resistance Bedaquiline Genetic Mechanisms Interactions Pharmakinetic Synthesis Medications Ritonavir Lopinavir Sampling Hospital Unscheduled Missed International 2020 Community Health Immunology Virology Genetics Clinical Prospective Cohort Study Quantitative Clinical

PROBeX unscheduled visits SOP.

PROBeX: Site Visits and Monitoring SOP (1296)

PROBeX SOP TB/Coinfection Studies PROBeX HIV Laboratory Participant Staff Testing Visit Site Protocol Drug Deviation Monitor Review ART Treatment Protection Subjects Report Africa Tuberculosis Patient Diagnosis XDR Storage Documents Document Resistance Bedaquiline Genetic Mechanisms Interactions Pharmakinetic Synthesis Medications Ritonavir Lopinavir Schedule Actions International Activities Violation Debrief International 2020 Community Health Immunology Virology Genetics Clinical Prospective Cohort Study Quantitative Clinical

PROBeX international staff monitoring SOP.

PROBeX: Blood Sample Collection, Transportation, Processing and Storage SOP (1294)

PROBeX SOP TB/Coinfection Studies PROBeX HIV Testing Transportation Collection Safety Drug Specimen Viral ART Treatment Sample Load Africa Tuberculosis Patient CD4 Diagnosis Blood XDR Storage Plasma Resistance Bedaquiline Genetic Mechanisms Interactions Pharmakinetic Synthesis Medications Ritonavir Lopinavir PK Processing Pharmacogenetic Tube Hospital District International 2020 PRO-Document Methods Clinical Community Health Immunology Virology Genetics Clinical Prospective Cohort Study Quantitative Clinical

PROBeX blood sample processing SOP.

PROBeX: Initial Visit SOP (1292)

PROBeX SOP TB/Coinfection Studies PROBeX Consent HIV Baseline Contact Form Interview Testing Visit Site History Enrollment Record Medical Drug Initial Privacy Demographics ART Treatment Assessment Africa Tuberculosis Patient Log Diagnosis XDR Resistance Bedaquiline Genetic Mechanisms Interactions Pharmakinetic Synthesis Medications Ritonavir Lopinavir Family International 2020 PRO-Document Methods Clinical Community Health Immunology Virology Genetics Clinical Prospective Cohort Study Quantitative Clinical

PROBeX initial visit SOP.

PROBeX: Exit from Study SOP (1291)

PROBeX SOP TB/Coinfection Studies PROBeX HIV Follow-up Management Study Testing Drug Exclusion Withdrawal ART Treatment Africa Tuberculosis Patient Diagnosis XDR Resistance Bedaquiline Genetic Mechanisms Interactions Pharmakinetic Synthesis Medications Ritonavir Lopinavir Exit Death Lost Decision Termination Voluntarily Absence International 2020 Community Health Immunology Virology Genetics Clinical Prospective Cohort Study Quantitative Clinical

PROBeX exit from study SOP.

PROBeX: Obtaining Medical History SOP (1289)

PROBeX SOP TB/Coinfection Studies PROBeX Clinical HIV Information Testing History Record Medical Drug ART Treatment Africa Tuberculosis Patient Diagnosis XDR Resistance Bedaquiline Genetic Mechanisms Interactions Pharmakinetic Synthesis Medications Ritonavir Lopinavir Files Obtaining International 2020 PRO-Document Methods Clinical Chart Extraction Community Health Immunology Virology Genetics Clinical Prospective Cohort Study Quantitative Clinical

SOP for obtaining medical history PROBeX.

PROBeX: Obtaining Informed Consent SOP (1285)

PROBeX SOP TB/Coinfection Studies PROBeX Consent HIV Screening Procedure Testing Confidentiality Drug Informed Specimen ART Treatment Discussion Africa Tuberculosis Patient Sputum Diagnosis Blood XDR Storage Resistance Bedaquiline Genetic Mechanisms Interactions Pharmakinetic Synthesis Medications Ritonavir Lopinavir Pharmacogenetic International 2020 Community Health Immunology Virology Genetics Clinical Prospective Cohort Study Quantitative Clinical

Obtaining informed consent SOP for PROBeX.

PROBeX: Obtaining and Reporting Clinic and Lab Assessments SOP (1284)

PROBeX SOP TB/Coinfection Studies PROBeX Counseling HIV Laboratory Research Testing Safety Test Height Weight Drug Viral Lab Clinic Pregnancy ART Treatment Report Urine Assessment Load Africa Tuberculosis Patient Sputum CD4 Diagnosis Blood XDR Storage Plasma Resistance Bedaquiline Genetic Mechanisms Interactions Pharmakinetic Synthesis Medications Ritonavir Lopinavir Schedule X-ray Draw Electrocardiogram International 2020 PRO-Document Methods Clinical Community Health Immunology Virology Genetics Clinical Prospective Cohort Study Quantitative Clinical

Reporting lab assessments SOP for PROBeX.

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

PROBeX SOP TB/Coinfection Studies PROBeX Consent HIV Checklist Laboratory Procedure Testing Transportation Collection Drug Specimen ART Treatment Africa Tuberculosis Patient Log Diagnosis Blood XDR Plasma Freezer Resistance Bedaquiline Genetic Mechanisms Interactions Pharmakinetic Synthesis Medications Ritonavir Lopinavir Sampling PK Processing Intensive Pharmacokinetic Labelling Cryobox International 2020 PRO-Document Methods Clinical Community Health Immunology Virology Genetics Clinical Prospective Cohort Study Quantitative Clinical

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

TRAX: Assigning Study Enrollment ID SOP (1242)

TRAX SOP TRAX TB/Coinfection Studies Consent Eligibility Contact Testing Community Resource Enrollment Records Confidentiality Social Rural Drug Intervention Transmission Network Africa Cluster Tracing Resistant Genotype Tuberculosis Mortality Patterns Epidemiology Limited Co-infection South Hospitals Immunocompromised Congregate Interaction Settings Patient ID No.Assignment International 2014 Prevention Community Health Behavioral Health Equity Virology Genetics Clinical Cross Sectional Study Clinical Chart Extraction Qualitative

TRAX study staff study participants ID assignment protocol.

TRAX: Patient Interview SOP (1241)

TRAX SOP TRAX TB/Coinfection Studies Administration Contact Interview Testing Community Resource Social Questionnaire Rural Drug Intervention Transmission Network Africa Cluster Tracing Resistant Genotype Tuberculosis Mortality Patterns Epidemiology Limited Co-infection South Hospitals Immunocompromised Congregate Interaction Settings Patient Personal Identifiers International 2014 TRAX-Document Methods Qualitative Prevention Community Health Behavioral Health Equity Virology Genetics Clinical Cross Sectional Study Clinical Chart Extraction Qualitative

TRAX study staff participant interview administration standardization protocol.

TRAX: Medical Records Review SOP (1239)

TRAX SOP TRAX TB/Coinfection Studies Contact Testing Community Resource Records Social Medical Rural Drug Intervention Chart Transmission Facility Network Africa Cluster Tracing Resistant Genotype Tuberculosis Mortality Patterns Epidemiology Limited Co-infection South Hospitals Immunocompromised Congregate Interaction Settings Patient Clinics International 2014 TRAX-Document Methods Chart Extraction Prevention Community Health Behavioral Health Equity Virology Genetics Clinical Cross Sectional Study Clinical Chart Extraction Qualitative

Medical records extraction protocol for TRAX study staff.

TRAX: Data Quality & Management Plan SOP (1231)

TRAX SOP TRAX TB/Coinfection Studies Contact Data Management Participant Testing Community Resource Social Rural Drug Intervention Chart Extraction Transmission Network Africa Cluster Tracing Resistant Genotype Tuberculosis Mortality Patterns Epidemiology Limited Co-infection South Hospitals Immunocompromised Congregate Interaction Settings Patient Documents QM International 2014 Prevention Community Health Behavioral Health Equity Virology Genetics Clinical Cross Sectional Study Clinical Chart Extraction Qualitative

Data collection and management TRAX staff protocol.

TRAX: PreScreening CRF (1227)

TRAX Case Report Forms TRAX TB/Coinfection Studies Contact Testing Community Resource Social Rural Drug Intervention Transmission Network Africa Cluster Tracing Resistant Genotype Tuberculosis Mortality Patterns Epidemiology Limited Co-infection South Hospitals Immunocompromised Congregate Interaction Settings Patient Result TB XDR Eligible International 2014 Prevention Community Health Behavioral Health Equity Virology Genetics Clinical Cross Sectional Study Clinical Chart Extraction Qualitative

Prior eligibility screening potential TRAX participants including XDR TB lab results, current XDR TB treatment, located in past three attempts.

TRAX: Patient Interview Form (1226)

TRAX Case Report Forms TRAX TB/Coinfection Studies Contact Interview Testing Community Resource Substance History Social Rural Drug Alcohol Intervention Specimen Treatment Transmission Network Africa Cluster Tracing Resistant Genotype Tuberculosis Mortality Patterns Epidemiology Limited Co-infection South Hospitals Immunocompromised Congregate Interaction Settings Patient Sputum Sociodemographic Drink Smoking Tobacco Cough TB Symptoms Exposure Diagnosis ARV Blood International 2014 TRAX-Document Methods Qualitative Prevention Community Health Behavioral Health Equity Virology Genetics Clinical Cross Sectional Study Clinical Chart Extraction Qualitative

TRAX study staff form for interviewing participants on; sociodemographic information, substance use, alcohol use, smoking history, TB symptoms in the past six months, past medical history, HIV diagnosis, HIV testing and specimen collection.

TRAX: Screening CRF (1222)

TRAX Case Report Forms TRAX TB/Coinfection Studies Consent Screening Contact Participant Testing Community Resource Criteria Social Rural Drug Residence Intervention Inclusion Exclusion Lab Transmission Network Africa Cluster Tracing Resistant Genotype Tuberculosis Mortality Patterns Epidemiology Limited Co-infection South Hospitals Immunocompromised Congregate Interaction Settings Patient Age English International 2014 Prevention Community Health Behavioral Health Equity Virology Genetics Clinical Cross Sectional Study Clinical Chart Extraction Qualitative

Participant initial TRAX screening form including; exclusion and inclusion criteria.

TRAX: Diagnostic TB Culture DST Results CRF (1220)

TRAX Case Report Forms TRAX TB/Coinfection Studies Contact Testing Community Resource Collection Results Social Rural Drug Intervention Transmission Network Africa Cluster Tracing Resistant Genotype Tuberculosis Mortality Patterns Epidemiology Limited Co-infection South Hospitals Immunocompromised Congregate Interaction Settings Patient Sputum Susceptibility Smear Culture Diagnostic DST International 2014 TRAX-Document Methods Clinical Prevention Community Health Behavioral Health Equity Virology Genetics Clinical Cross Sectional Study Clinical Chart Extraction Qualitative

Participant TB culture and DST results including: sputum collection, smear results, culture results, drug susceptibility testing (DST) results, interpretation for TRAX records.

TRAX: Study Activities Checklist CRF (1217)

TRAX Case Report Forms TRAX TB/Coinfection Studies Screening Checklist Contact Testing Community Resource Enrollment Social Rural Drug Intervention Number Transmission Network Africa Cluster Tracing Resistant Genotype Tuberculosis Mortality Patterns Epidemiology Limited Co-infection South Hospitals Immunocompromised Congregate Interaction Settings Patient Activity Log International 2014 Prevention Community Health Behavioral Health Equity Virology Genetics Clinical Cross Sectional Study Clinical Chart Extraction Qualitative

Participant activity tracking log for TRAX including; screening, enrollment via a patient visit, enrollment after the patient visit.