Protocol

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Study Type(s)

Topic Area(s)

Document Type(s)

Study Method(s)

Document Method(s)

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: 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: Study Reporting Plan SOP (1288)

PROBeX SOP TB/Coinfection Studies PROBeX HIV Data Retention Study Testing Site Enrollment Monitoring Protocol Safety Plan Reporting Results Drug Distribution Specimen ART Treatment Africa Tuberculosis Diagnosis XDR Storage Resistance Bedaquiline Genetic Mechanisms Interactions Pharmakinetic Synthesis Medications Ritonavir Lopinavir International 2020 Community Health Immunology Virology Genetics Clinical Prospective Cohort Study Quantitative Clinical

Tracking study progress SOP for PROBeX.

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 Sample Collection & Transportation SOP (1238)

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

Procedure for protocol deviations of TRAX study.

TRAX: Protocol Deviations SOP (1237)

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

Procedure for protocol deviations of TRAX study.

TRAX: Culture of Mtb & Waste Management SOP (1230)

TRAX SOP TRAX TB/Coinfection Studies Contact Testing Community Resource Protocol Social Rural Drug Intervention Transmission Network Africa Cluster Tracing Resistant Genotype Tuberculosis Mortality Patterns Epidemiology Limited Co-infection South Hospitals Immunocompromised Congregate Interaction Settings Culture Mycobacteria Mtb Waste Incubation Agar Dilution Centrifugation Disposal International 2014 TRAX-Document Methods Clinical Prevention Community Health Behavioral Health Equity Virology Genetics Clinical Cross Sectional Study Clinical Chart Extraction Qualitative

Mycobacteria tuberculosis storage and waste management protocol for TRAX staff.

PrEP@Home: Reportable Events SOP (1105)

PREP at Home SOP PREP@Home Event IRB Laboratory PrEP Staff SOP System Behavioral Monitoring Protocol Adverse Care Persistence Remote Telemedicine Multi-Site Reportable Deviations Domestic 2023 Prevention Behavioral Health Equity mHealth Clinical Standard RCT Clinical Qual + Quant

IRB reportable adverse events and protocol deviation SOP for the PrEP@Home Study.

PrEP@Home: Protocol (1080)

PREP at Home Protocols PREP@Home Administration Event Laboratory Overview PrEP System Trial Behavioral Consideration Control Design Methods Monitoring Procedures Protocol References Safety Statistics Subject Adverse Introduction Reporting Care Persistence Remote Telemedicine Multi-Site Intervention Specimens Human Domestic 2023 Prevention Behavioral Health Equity mHealth Clinical Standard RCT Clinical Qual + Quant

Expanded standard protocol including introduction, methods, study overview, study intervention, trial design, procedures, laboratory specimens and procedures, safety monitoring and adverse event reporting, statistical considerations, human subjects considerations, administrative procedures, and references for the PrEP@Home Study.

PrEP@Home: Protocol Deviation CRF (1067)

PREP at Home CRF PREP@Home Laboratory PrEP System Behavioral Monitoring Protocol Care Persistence Remote Telemedicine Multi-Site Deviation CFR Domestic 2023 Prevention Behavioral Health Equity mHealth Clinical Standard RCT Clinical Qual + Quant

Protocol deviation CRF for the PrEP@Home Study.

C-PLEASURE: Study Visit SOP (1033)

C-PLEASURE SOP C-PLEASURE Clinical Visit SOP Follow-up Baseline Size Prevention Pleasure Performance Fit Consent Condom Protocol Domestic 2017 Clinical Community Health Clinical Behavioral Prevention Crossover RCT Clinical Qual + Quant

SOP for study visits for C-Pleasure Study.

C-PLEASURE: Protocol Publication (1019)

C-PLEASURE Publications C-PLEASURE Data Baseline Size Prevention Pleasure Performance Fit Consent Condom Clinical Protocol Domestic 2017 Clinical Community Health Behavioral Prevention Crossover RCT Clinical Qual + Quant

Publication of Protocol & Baseline Data for C-PLEASURE study.