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**Tuberculosis Trials Consortium Awards for the 2021-2030 Cycle**
March 31, 2021
Dear Colleague:
The U.S. Centers for Disease Control and Prevention is pleased to announce the members of its Tuberculosis Trials Consortium (TBTC) for the 2021-2030 cycle.
CDC’s domestic tuberculosis (TB) program conducts vital, unparalleled clinical trials and epidemiologic research through the TBTC, which advances the TB elimination strategy in the United States and globally. Earlier this fiscal year, CDC awarded contracts for the next ten-year research cycle, 2021 – 2030, initiating the 28th year of this collaborative effort.
Since it began in 1993, TBTC has been responsible for several major clinical trials that have significantly impacted TB treatment. The results of TBTC Studies 22 and 26 substantially influenced the most recent American Thoracic Society/CDC guidelines for treatment of both TB disease and latent TB infection. Most recently, the landmark TBTC Study 31/ACTG A5439 demonstrated that the efficacy of a four-month daily treatment regimen containing a combination of rifapentine and moxifloxacin is non-inferior to the standard six-month daily regimen at curing drug-susceptible TB disease. The results of this study will help inform future TB disease treatment guidelines and innovations for designing future clinical trials. Other TBTC study results have led to modification of CDC’s recommendations for treatment of TB and HIV.
TBTC sites are funded in one of two ways, through individual contracts with CDC or as part of a sub-network coordinated by the Washington DC Veterans Affairs Medical Center. Every 10 years both sides of the consortium undergo competition. This open competition ensures that the consortium’s activities remain vigorous and innovative, as well as ensure that the costs remain competitive. As in prior years, this exercise resulted in awards to new as well as previous clinical sites. The new and continuing members of TBTC combine outstanding scientific expertise and superb TB trials capacity. As in the past, some of these awards reflect collaborations involving North American and international institutions. This cycle of TBTC also consists of both prior and new vendors, as well as investigators from Veterans’ Affairs (VA) Medical Center sites, and CDC scientists. Below is a description of the contracted members of TBTC for the 2021-2030 cycle.
***CASE-KAMPALA:***Case Western Reserve University and the Uganda-Case Western Reserve University Research Collaboration, in Kampala, Uganda (Site #30), PIs John L. Johnson, MD; Harriet Mayanja-Kizza; Moses L. Joloba
***CORNELL/HAITI:*** Joan & Sanford I. Weill Medical College of Cornell University (Site #45) under PI Daniel Fitzgerald, MD and GHESKIO Centers in Port-au-Prince, Haiti (Site #67) under Jean William Pape, MD
***DENVER:***The Denver Metro Tuberculosis Clinic, part of Denver Public Health, in Denver, Colorado (Site #22), PI Robert Belknap, MD
**MCGILL/CAB-V:** The CAB-V Network (an established group of investigators at 8 sites in the 5 largest cities in Canada, and the largest cities in Australia, Benin, and Vietnam), PI’s Dick Menzies (McGill University); James Johnston (University of British Columbia) and Greg Fox (University of Sydney), including the following:
**Canadian sites**
McGill University Health Centre tertiary hospital, Montreal, Canada (Site #25), PI Dick Menzies, MD
Edmonton TB Clinic, Alberta, Canada (Site #99), PI Dick Menzies, MD
Toronto Western Hospital, Toronto, Canada (Site #50), PI Dick Menzies, MD
TB clinic Calgary TB Clinic Alberta, Canada (Site #51), PI Dick Menzies, MD
Vancouver, British Columbia, Centre for Disease Control, Vancouver (Site #52) PI James Johnston, MD**Australian Sites**
Royal Prince Alfred Hospital, Sydney, Australia (Site #71), PI Greg Fox, MD
Parramatta Chest Clinic Parramatta, Australia (Site #72), PI Greg Fox, MD
Liverpool Hospital, Liverpool, Australia (Site #73), PI Greg Fox, MD**Vietnam Sites**
District 6 TB Unit, Ho Chi Minh City, Vietnam (Site #74), PI Greg Fox, MD
Phoi Viet Respiratory Centre, Ho Chi Minh City, Vietnam (Site #75), PI Greg Fox, MD
Thot Not District TB Unit, Can Tho Province (Site #76), PI Greg Fox, MD**Benin Site**
National Referral University Hospital for Pneumo-physiology in Cotonou, Benin (Site #77), PI Menonli Adjobimey, MD
***MUSC/UCTLI:*** The Medical University of South Carolina under PI Susan Dorman, MD, in collaboration with the University of Cape Town Lung Institute (UCTLI) in Cape Town, South Africa (Site #09), PI Dr. Rodney Dawson (Bio Analytical Research Corporation partnership)
***SEATTLE:*** The Seattle & King County – Public Health TB Control Program, in Seattle, Washington (Site #26), PIs Masa Narita, MD and David Horne, MDBelow is the list of VA Medical Center sites with the site name and the PI:
***SAN ANTONIO:*** San Antonio VA Medical Center, University of Texas/San Antonio VA Hospital (Site #63), PI Marc Weiner, MD
***STELLENBOSCH:*** Stellenbosch University, Cape Town, South Africa, PI Anneke Hesseling, MD; administered via sub-contract under the Washington DC VA Medical Center
***WASHINGTON DC:*** Washington DC VA Medical Center, Washington, District of Columbia, coordinating center for the VA Affiliates Group (Site# 53), PI Debra Benator, MD
***MINNEAPOLIS:*** Minneapolis VA Medical Center, (Site# 60), PI Dimitri Drekonja; in collaboration with R. Bryan Rock PhD
***NEW YORK:*** VA New York Harbor Healthcare System (Site #64), in collaboration with New York City Bureau of Tuberculosis Control, PI Jana Preis**Current TBTC Studies**
TBTC studies are large and complex and include TBTC protocol teams to ensure accuracy. TBTC has a long practice of including co-chairs from multiple institutions for studies, which further fortifies the consortium’s studies stability. As an example, TBTC study 31 had more than 25 investigators on the protocol team from more than 15 institutions. There will be continuity among some of the study co-chairs and members of the protocol team and among the CDC study officers for each active TBTC study (Studies 35 and 37). CDC has initiated startup activities with the new vendors (such as Institutional Review Board approvals, patient recruitment, drug distribution, and laboratory set-up) and they will transition into leadership roles within the Consortium. CDC will also conduct a review of gaps in expertise among CDC staff and currently funded sites, in order to determine whether there is additional scientific coverage necessary following the transition to the new Consortium. The new Consortium will be engaged in the active studies described below:
**Study 35** is an investigation to prevent TB in children by establishing, for the first time, what dose of medication should be used. A major obstacle to dosing young children has been the lack of TB medicines specifically formulated for children, many of whom have difficulty swallowing tablets that were made for adults. Study 35 is making use of a new combined formulation of medication that can be dissolved in water and tastes like mango, making it easier for children to swallow.
**Study 37** is evaluating shortening treatment for latent TB infection. The study compares patients taking six weeks of daily medication to the currently recommended three to four months of medication. As TB prevention medication may have dangerous side effects, such as hepatotoxicity, and must be taken daily, a shorter treatment will be enormously beneficial to patients. This study will inform improvements on adherence to therapy and greatly lessen the chances of progression to active disease.
CDC is confident that TBTC will continue to contribute to development of stronger approaches to treatment and prevention of TB over the next decade.

Sincerely,
Philip LoBue, MD, FACP, FCCP
Director
Division of Tuberculosis Elimination
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
							
					
						Page last reviewed:  April 1, 2021					Content source: 	Division of Tuberculosis Elimination, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention homeTuberculosisBasic TB Factsplus iconHow TB SpreadsLatent TB Infection and TB DiseaseSigns & SymptomsTB Risk FactorsExposure to TBTB PreventionVaccinesTB & HIV CoinfectionTB and DiabetesTB TermsPersonal StoriesTesting & Diagnosisplus iconWho Should be TestedTesting for TB InfectionTesting in BCG-Vaccinated PersonsTB Screening and Testing of Health Care PersonnelTesting During PregnancyDiagnosing latent TB infection and TB diseaseTreatmentplus iconDeciding When to Treat Latent TB InfectionTreatment Regimens for Latent TB Infection (LTBI)Treatment for TB DiseaseAdverse EventsTB Treatment of Persons Living with HIVTB Treatment and PregnancyTB Treatment for ChildrenFrequently Asked QuestionsDrug-Resistant TBResearchplus iconTB Epidemiologic Studies Consortiumplus iconResearch ProjectsPublicationsTB Trials Consortiumplus iconStudy DescriptionsBackgroundBehavioral & Social Science ResearchHealth Care Settingsplus iconTB Infection Control in Health Care SettingsResources for TB Screening and Testing of Health Care Personnelplus iconFrequently Asked QuestionsTB in Specific Populationsplus iconHealth DisparitiesAsian PersonsBlack or African American PersonsHispanic or Latino PersonsChildrenPregnancyCorrectional FacilitiesPeople Experiencing HomelessnessInternational TravelersLaboratory Informationplus iconDrug Susceptibility TestingFalse-Positive Investigation ToolkitInterim Laboratory Biosafety Guidance for XDR  tuberculosis strainsModel Performance Evaluation Program (MPEP)Rapid Molecular Testing to Detect Drug-Resistant TB in the USplus iconExecutive SummaryIntroductionBackground on Tests for Molecular Detection of DRGeneral Considerations and Principles for a Molecular DR Testing ServicePossible Scenarios and Scope of Testing for a Molecular DR Testing ServiceResearch NeedsGeneral Recommendations of the Expert PanelCommunication Plan for the ReportRecommendationsReferencesPanel Members and CDC ParticipantsAppendix 1Appendix 2Appendix 3The Uses of Nucleic Acid Amplification Tests for the Diagnosis of TBplus iconGeneral ConsiderationsGeneral Recommendations of the Expert PanelRecommendations to ACET, CDC, DTBEData & Statisticsplus iconTB Incidence in the United StatesReported TB in the US, 2022 Surveillance Reportplus iconNational DataReporting Area DataRisk FactorsDemographicsTB Treatment and Case OutcomesDrug-Resistant TBMolecular SurveillanceTuberculosis in the United States, 2022 (Slide Set)Archived Surveillance Reports and Slide Sets2021 State and City ReportArchived State and City ReportsProfessional Resources & Toolsplus iconTools for Healthcare ProvidersResources for TB Programsplus iconStrengthening Civil Surgeons’ Capacity to Improve LTBI Surveillance and Outcomes Among Status AdjustersNotice of Funding Opportunity (NOFO)Program EvaluationTB Centers of ExcellenceTB Elimination AllianceTB Genotypingplus iconConventional TB GenotypingWhole Genome SequencingTB GIMSAnalytic ToolsLatent Tuberculosis Infection ResourcesPublications & Productsplus iconPatient and Public MaterialsFact SheetsGuidelinesplus iconControl & EliminationDrug-Resistant TBInfection Control & PreventionLaboratory & GenotypingTB & HIVTB in Specific PopulationsTesting & DiagnosisTreatmentVaccines & ImmunizationsArchived TB GuidelinesGuides & Toolkitsplus iconAggregate ReportsCDC TB Surveillance TrainingCore CurriculumEffective TB Interviewing for Contact InvestigationEthnographic GuidesFalse-Positive Investigation ToolkitForging Partnerships to Eliminate TuberculosisGuide to Application of GenotypingLTBI: A Guide for Primary Health Care ProvidersMantoux Tuberculin Skin Testing ProductsReport of Verified Case of Tuberculosis (RVCT)Self-Study ModulesTB Contact Investigation Interviewing Skills CourseTB eDOT ToolkitUnderstanding the TB Cohort Review ProcessNewslettersplus iconTB Notes, No. 4, 2023TB Notes, No. 3, 2023TB Notes. No. 2, 2023TB Notes. No. 1, 2023TB Notes, No. 4, 2022TB Notes, No. 3, 2022TB Notes, No. 2, 2022TB Notes, No. 1, 2022TB Notes, No. 4, 2021TB Notes, No. 3, 2021TB Notes, No. 2, 2021TB Notes, No. 1, 2021Pamphlets, Brochures, Bookletsplus iconQuestions and AnswersPatient Education SeriesTuberculosis - Get the FactsTuberculosis - The Connection between TB and HIV12-Dose Regimen for Latent TB Infection-Patient Education BrochurePostersplus iconMantoux Tuberculin Skin Test Wall ChartWorld TB DayThink TBStop TBTake on TBReports & Articlesplus iconDTBE Authored Journal ArticlesTuberculosis Laboratory Aggregate ReportsSlide Setsplus iconIntroduction to TuberculosisEpidemiology of Tuberculosis Among Non-U.S.​–Born Persons in the United States, 1993–2016Self-Study Modules on Tuberculosis, 1-5 Slide SetsThe Tuberculosis (TB) in Correctional Settingsplus iconFacilitator GuideIntroduction to TB GenotypingEpidemiology of Tuberculosis in Correctional Facilities, United States, 1993-2017Prevention and Control of Tuberculosis in Correctional and Detention FacilitiesGuidelines for Preventing the Transmission of M. TB in Health care SettingsInvestigation of Contacts of Persons with Infectious TBEpidemiology of Pediatric Tuberculosis in the United StatesTargeted Tuberculosis Testing and Treatment of Latent Tuberculosis InfectionElectronic Tools & ResourcesWeb-Based Courses & Webinarsplus iconTB 101 for Health Care WorkersContent SyndicationInfographicsplus iconSocial Media GraphicsCustomizable Take on TB Infographic with InstructionsEventsWorld TB Dayplus iconU.S. TB ChampionsHistoryFeaturesplus iconTB Risk FactorsTreating Latent TB Infection with Short-Course RegimensWorld Tuberculosis (TB) Day 2021World Tuberculosis (TB) Day 2020Linksplus iconState TB Control OfficesAbout Usplus iconMission Statement and Activitiesplus iconDTBE Strategic PlanNational TB Program ObjectivesOrganization ChartAdvisory Groupsplus iconFederal TB Task Force To receive email updates about this page, enter your email address: Email Address			What's this?				Submit


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