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PITT Study: Blood Collection SOP (1350)

PITT Study SOP PITT Study Screening Collection Quality Completion Drug Intervention Treatment Strategy Infrastructure Modeling Tuberculosis Blood Resistance Therapy Disease Lung Respiratory Pulse Pulmonary Georgia Impairment Non-Communicable Chronic Post-TB Biomarkers Inflammation Destruction Spirometry Oximetry Hypertension Hyperglycemia Metabolic Hyperlipodemia Anthropometric Disorder BMI Circumference Waist Rehabilitation Infectious Antimicrobial Biomedical Morbidity Mycobacterium Tomography M/XDR International 2018 PITT-Document Methods Clinical Community Health Behavioral Global Health Clinical Prospective Cohort Study PITT-Study Methods Clinical Chart Extraction Quantitative

Blood collection SOP for PITT Study.

PITT Study: COVID Screening & Questionnaire CRF (1348)

PITT Study CRF PITT Study Screening Collection Quality Completion Questionnaire Drug Intervention Treatment Outcomes Strategy Infrastructure Modeling Tuberculosis Symptoms Resistance Therapy Disease Lung Respiratory Pulse Pulmonary Georgia Impairment Non-Communicable Chronic Post-TB Biomarkers Inflammation Destruction Spirometry Oximetry Hypertension Hyperglycemia Metabolic Hyperlipodemia Anthropometric Disorder BMI Circumference Waist Rehabilitation Infectious Antimicrobial Biomedical Morbidity Mycobacterium Tomography M/XDR COVID International 2018 PITT-Document Methods Quantitative Clinical Community Health Behavioral Global Health Clinical Prospective Cohort Study PITT-Study Methods Clinical Chart Extraction Quantitative

COVID Screening & Questionnaire for PITT Study, includes: COVID screening, COVID data collection form, symptoms, and outcomes.

COHSONET: TB Suspect Evaluation CRF v.2 (1318)

COHSONET CRF COHSONET HIV Contact Survey Testing Community History Collection Social Positive Transmission Sample Infection Network Negative Africa Tuberculosis Epidemiology Sputum Culture Cough Diagnosis Rapid Household Environment Index Disease Symptom Clinician CXR TST International 2024 COH-Document Methods Clinical Community Health Global Health Immunology Clinical Cross Sectional Study Qual + Quant Chart Extraction Clinical

COHSONET TB suspect CRF v.2.

COHSONET: TB Suspect Evaluation CRF v.1 (1307)

COHSONET CRF COHSONET HIV Contact Survey Testing Community History Collection Social Positive Transmission Sample Infection Network Negative Africa Tuberculosis Epidemiology Sputum Culture Cough Diagnosis Rapid Household Environment Index Disease Symptom Clinician CXR TST International 2024 COH-Document Methods Clinical Community Health Global Health Immunology Clinical Cross Sectional Study Qual + Quant Chart Extraction Clinical

COHSONET TB suspect CRF v.1.

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: 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: 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: Intensive PK Sampling CRF

PROBeX CRF TB/Coinfection Studies PROBeX Administration HIV Testing History Collection Height Weight Drug Specimen ART Treatment Dose Urine Africa Tuberculosis Transport Diagnosis XDR Resistance Bedaquiline Genetic Mechanisms Interactions Pharmakinetic Synthesis Medications Ritonavir Lopinavir Sampling Schedule PK Physical Exam Linezolid Levofloxacin Pyrazinamide Ethionamide Isoniazid Vomit Draw Hours Minutes International 2020 PRO-Document Methods Clinical Community Health Immunology Virology Genetics Clinical Prospective Cohort Study Quantitative Clinical

Intensive PK sampling CRF for PROBeX study.

PROBeX: Blood Results Eligibility Confirmation CRF (1273)

PROBeX CRF TB/Coinfection Studies PROBeX Eligibility HIV Testing Collection Results Drug Specimen ART Treatment Africa Tuberculosis Diagnosis Blood XDR Resistance Bedaquiline Genetic Mechanisms Interactions Pharmakinetic Synthesis Medications Ritonavir Lopinavir Creatinine ALT Bilirubin Haemoglobin FBC Platelets Chemistry Potassium Albumin ALP TSH Lactate International 2020 PRO-Document Methods Clinical Community Health Immunology Virology Genetics Clinical Prospective Cohort Study Quantitative Clinical

PROBeX study eligibility from blood results CRF.

PROBeX: Sputum Results Eligibility Confirmation CRF (1271)

PROBeX CRF TB/Coinfection Studies PROBeX Eligibility HIV Testing Collection Results Drug Specimen ART Treatment Africa Tuberculosis Sputum Culture Diagnosis XDR Resistance Bedaquiline Genetic Mechanisms Interactions Pharmakinetic Synthesis Medications Ritonavir Lopinavir Isoniazid Assay PCR Injectables Rifampicin Kanamycin Streptomycin Fluoroquinolones Amikacin Capreomycin Moxifloxacin Confirmation Ofloxacin International 2020 PRO-Document Methods Clinical Community Health Immunology Virology Genetics Clinical Prospective Cohort Study Quantitative Clinical

CRF for sputum lab in PROBeX study.

PROBeX: Sputum Labs CRF (1270)

PROBeX CRF TB/Coinfection Studies PROBeX HIV Testing Collection Results Drug Molecular Specimen ART Treatment Sample Africa Tuberculosis Sputum Smear Culture DST Diagnosis XDR Labratory Resistance Bedaquiline Genetic Mechanisms Interactions Pharmakinetic Synthesis Medications Ritonavir Lopinavir Isoniazid Assay PCR Injectables Rifampicin Kanamycin Streptomycin Oflozacin Fluoroquinolones Amikacin Capreomycin Moxifloxacin Clodazimine Phenotypic International 2020 PRO-Document Methods Clinical Community Health Immunology Virology Genetics Clinical Prospective Cohort Study Quantitative Clinical

CRF for sputum lab in PROBeX study.

TRAX: Parent or Legal Guardian Informed Consent Form (1260)

TRAX Consent Forms TRAX TB/Coinfection Studies Consent Contact Information Testing Community Resource Benefits Collection Procedures Risks Confidentiality Social Rural Drug Informed Intervention Transmission Network Africa Cluster Tracing Resistant Genotype Tuberculosis Mortality Patterns Epidemiology Limited Co-infection South Hospitals Immunocompromised Congregate Interaction Settings Sputum TB Blood XDR Children Parent Guardian International 2014 Prevention Community Health Behavioral Health Equity Virology Genetics Clinical Cross Sectional Study Clinical Chart Extraction Qualitative

Parent or legal guardian informed consent form for children participating in TRAX study.

TRAX: Adult Informed Consent Form (1258)

TRAX Consent Forms TRAX TB/Coinfection Studies Consent Contact Form Information Participation Research Testing Community Resource Benefits Collection Risks Participants Confidentiality Social Rural Drug Informed Intervention Specimen Adult Transmission Future Network Africa Cluster Tracing Resistant Genotype Tuberculosis Mortality Patterns Epidemiology Limited Co-infection South Hospitals Immunocompromised Congregate Interaction Settings TB XDR Voluntary International 2014 Prevention Community Health Behavioral Health Equity Virology Genetics Clinical Cross Sectional Study Clinical Chart Extraction Qualitative

TRAX study adult participant informed consent form.

TRAX: Sputum Collection & Transportation SOP (1232)

TRAX SOP TRAX TB/Coinfection Studies Contact Laboratory Participant Procedure Testing Transportation Community Resource Collection Social Rural Drug Intervention Specimen Clinic Transmission Sample Network Africa Cluster Tracing Resistant Genotype Tuberculosis Mortality Patterns Epidemiology Limited Co-infection South Hospitals Immunocompromised Congregate Interaction Settings Transfer Nurse Sputum Counselor International 2014 TRAX-Document Methods Clinical Prevention Community Health Behavioral Health Equity Virology Genetics Clinical Cross Sectional Study Clinical Chart Extraction Qualitative

Sputum collection and transportation TRAX study staff protocol.

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.

TRAX: Alternate CD4 Viral Load Lab Results CRF (1223)

TRAX Case Report Forms TRAX TB/Coinfection Studies Contact Laboratory Testing Community Resource Collection Social Rural Drug Intervention Viral Transmission Network Load Africa Cluster Tracing Resistant Genotype Tuberculosis Mortality Patterns Epidemiology Limited Co-infection South Hospitals Immunocompromised Congregate Interaction Settings Result CD4 International 2014 TRAX-Document Methods Clinical Prevention Community Health Behavioral Health Equity Virology Genetics Clinical Cross Sectional Study Clinical Chart Extraction Qualitative

TRAX participant lab results including: CD4 count and viral load.

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: Baseline Auramine Results CRF (1218)

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

Participant stain results including: date of sputum collection and auramine stain results for TRAX.

Planning4PrEP: Specimen Collection and Reminder Call Scripts (1156)

Planning4PrEP Scripts Planning4PrEP Prevention Interview PrEP Reminder Survey Collection Methods Mixed Phone Script Female Women Specimen Call AYAW Domestic 2022 Prevention Behavioral Community Health Health Equity Clinical Qual + Quant Clinical Qualitative

Specimen collection and study visit reminder phone scripts for the Planning4PrEP study.

PrEP@Home: Rapid HIV Procedures Using the INSTI HIV-1HIV-2 Antibody Test SOP (1096)

PREP at Home SOP PREP@Home INSTI Laboratory PrEP Staff SOP System Behavioral Collection Monitoring Care Test Persistence Remote Telemedicine Multi-Site Sample Blood Domestic 2023 PAH-Document Methods Clinical Prevention Behavioral Health Equity mHealth Clinical Standard RCT Clinical Qual + Quant

SOP for collecting INSTI HIV-1/HIV-2 Antibody Test blood samples for the PrEP@Home Study.

PrEP@Home: Specimen Collection & Results Sheet (1055)

PREP at Home Research Staff Instructions PREP@Home Worksheet Laboratory PrEP System Behavioral Collection Monitoring Results Care Persistence Remote Telemedicine Multi-Site Specimen Domestic 2023 PAH-Document Methods Clinical Prevention Behavioral Health Equity mHealth Clinical Standard RCT Clinical Qual + Quant

Specimen collection and results sheet for the PrEP@Home Study.