Plasma

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Document Type(s)

Study Method(s)

Document Method(s)

PROBeX: Blood Sample Collection, Transportation and Processing for Intensive Pharmacokinetics Sub-study SOP (1301)

PROBeX SOP TB/Coinfection Studies PROBeX HIV Equipment Preparation Testing Transportation Collection Drug Patients Clinic ART Treatment Africa Tuberculosis Diagnosis Blood XDR Plasma Cryovial Freezer Resistance Bedaquiline Genetic Mechanisms Interactions Pharmakinetic Synthesis Medications Ritonavir Lopinavir Sampling PK Sub-study Phlebotomy Cryobox Month Tubes Pharmokinetics PBMCs International 2020 PRO-Document Methods Clinical Community Health Immunology Virology Genetics Clinical Prospective Cohort Study Quantitative Clinical

PROBeX blood sample handling for intensive PK sub-study.

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: Collection, Transportation and Processing for Sparse PK Sampling SOP (1293)

PROBeX SOP TB/Coinfection Studies PROBeX Consent HIV Equipment Form Laboratory Testing Transportation Collection Drug ART Treatment Africa Tuberculosis Diagnosis Blood XDR Plasma Document Cryovial Temperature Freezer Resistance Bedaquiline Genetic Mechanisms Interactions Pharmakinetic Synthesis Medications Ritonavir Lopinavir Sampling PK Phlebotomy Processing Cryobox Sparse Month Centrifuge Tubes Position International 2020 PRO-Document Methods Clinical Community Health Immunology Virology Genetics Clinical Prospective Cohort Study Quantitative Clinical

PROBeX transportation and processing sparse PK sampling SOP.

PROBeX: Follow up Study Visits SOP (1290)

PROBeX SOP TB/Coinfection Studies PROBeX HIV Follow-up Instructions Interview Testing Visit Collection Drug Patients Events Specimen Viral Clinic ART Treatment Sample Monthly Load Medication Africa Tuberculosis Sputum CD4 TB Diagnosis XDR Storage Plasma Resistance Bedaquiline Genetic Mechanisms Interactions Pharmakinetic Synthesis Medications Ritonavir Lopinavir Sampling PK Frequency Electrocardiogram Routine Logs Dosage International 2020 PRO-Document Methods Clinical Community Health Immunology Virology Genetics Clinical Prospective Cohort Study Quantitative Clinical

Follow up visit 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.

PROBeX: Monthly Follow-up Visit CRF (1281)

PROBeX CRF TB/Coinfection Studies PROBeX HIV Screening Management Testing Depression Weight Drug Lab Pregnant ART Treatment Sample Africa Tuberculosis Sputum CD4 Cough TB Diagnosis Blood XDR Plasma Resistance Bedaquiline Genetic Mechanisms Interactions Pharmakinetic Synthesis Medications Ritonavir Lopinavir X-ray Physical Lactate Fever Lymph Nodes Rash Blisters Chest Pain Muscle Diarrhea Jaundice Difficulty Joint Breath Swelling Legs Feet Numbing Hallucinations Limbs Confusion Sleeping Convulsions Seizures Fatigue Weakness Vomiting Tests Electrocardiogram Visual International 2020 PRO-Document Methods Clinical Community Health Immunology Virology Genetics Clinical Prospective Cohort Study Quantitative Clinical

PROBeX monthly follow-up CRF.

PROBeX: Protocol (1267)

PROBeX Consent Forms TB/Coinfection Studies PROBeX Consent HIV Screening Data Procedure Recruitment Testing Analysis Benefits Monitoring Protocol Risks Confidentiality Timeline Drug Informed Viral Clinic ART Antiretroviral Treatment Urine Load Africa Tuberculosis Mortality Hospitals Sputum CD4 Diagnosis Blood Storage Plasma Documentation Resistance Bedaquiline Genetic Mechanisms Interactions Pharmakinetic Synthesis Medications Ritonavir Lopinavir Global FDA Inhibitor Transmissions Genome Sequencing Therapy Pharmacodynamics Schedule Pharmacogenetics PK Sub-study Phlebotomy Populations Vulnerable International 2020 Community Health Immunology Virology Genetics Clinical Prospective Cohort Study Quantitative Clinical

Protocol for PROBeX study.

TRAX: Blood Storage SOP (1229)

TRAX SOP TRAX TB/Coinfection Studies Contact Equipment Staff Testing Transportation Community Resource Collection Safety Social Rural Drug Intervention Specimens Transmission Network Africa Cluster Tracing Resistant Genotype Tuberculosis Mortality Patterns Epidemiology Limited Co-infection South Hospitals Immunocompromised Congregate Interaction Settings Labratory Samples Storage PPE Reagents Supplies Plasma International 2014 TRAX-Document Methods Clinical Prevention Community Health Behavioral Health Equity Virology Genetics Clinical Cross Sectional Study Clinical Chart Extraction Qualitative

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