TB Notes 42017
Notes from the Director
The past couple of months have been full of exciting updates from DTBE staff. Patient enrollment has begun for the “eDOT Study.” This study will assess whether directly observed therapy (DOT) that employs electronic communication methods, such as video via computer or cellphone, is a non-inferior approach to monitor TB treatment adherence, compared to traditional DOT. The study is a collaboration between the New York City Department of Health and Mental Hygiene, Columbia University, and DTBE. CDC’s Antibiotic Resistance Solutions Initiative funds the project.
On July 20th, DTBE presented the results of a systematic literature review and meta-analysis on the regimen of isoniazid and rifapentine (often referred to as “3HP”) to subject matter experts representing various fields, settings, and geographic locations in the United States. The meeting was intended to increase the transparency of DTBE’s guidance development, and to strengthen the quality of recommendations.
Another exciting advancement is CDC’s Epidemiology and Laboratory Capacity for Infectious Diseases Cooperative Agreement, which will fund a new national laboratory equipped to perform whole genome sequencing for all isolates of Mycobacterium tuberculosis received from newly diagnosed patients in the United States. The National Tuberculosis Molecular Surveillance Center will advance CDC, state, and local TB control programs’ abilities to identify and investigate outbreaks of TB, and strengthen surveillance of drug-resistant TB. This technology will help to target public health interventions and better respond to emerging resistance.
In other news, DTBE is exploring new ways to communicate relevant and timely information about TB prevention and control. The Division recently launched a new video for general audiences, “5 Things to Know about TB.”
Congratulations to the Tuberculosis Trials Consortium Drug Management Module Team, winner of the August 2017 National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Director’s Recognition Award! The team studies drug logistics and data collection for Study 31, a Phase III treatment-shortening trial for drug-susceptible TB being conducted at 22 domestic and international clinical trial sites, which are managed through an online system known as TBTC2.
Finally, I want to thank all of you for your hard work, resilience, and commitment to the important mission of TB elimination.
Philip LoBue, MD, FACP, FCCP
Division of Tuberculosis Elimination
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
CDC Retires Latent TB Infection Mobile App
The Latent Tuberculosis Infection Mobile app will be retired September 8, 2017. Visit the Latent TB Infection Online Hub for clinical information, guidance, fact sheets, and messages on targeted testing recommendations for latent TB infection. Updates about future mobile app developments will be posted here as well.
Submitted by John Parmer, PhD, MS, DTBE
New Video: 5 Things to Know About TB
DTBE is excited to debut a new video, “5 Things to Know About TB.” The video highlights the continuing problem of TB in the United States and the importance of addressing latent TB infection through targeted testing and treatment. The video was created for a general audience and can be shared on websites and social media platforms. Since August 1, the video has been viewed over 4,000 times on YouTube, Twitter, and Facebook!
Submitted by Leeanna Allen, MPH, DTBE
Tuberculosis: A New Screening Recommendation and an Expanded Approach to Elimination in the United States
DTBE is working with partners and health care providers to promote testing and treatment for latent TB infection in at-risk communities. As part of our provider outreach efforts, a new article “Tuberculosis: A New Screening Recommendation and an Expanded Approach to Elimination in the United StatesExternal” has been published in the latest issue of the American Journal of NursingExternal (AJN). This article provides nurses in a variety of clinical and community settings with
• a general overview of TB transmission, pathogenesis, and epidemiology;
• preventive care recommendations for targeted testing among high-risk groups; and
• CDC and the U.S. Preventive Service Task Force’s recommendations on screening for latent TB infection.
Continuing education credit for the article is available. We also invite you to listen to the “Behind the ArticleExternal” podcast, as John Parmer, DTBE Health Communication Specialist, speaks with AJN editor-in-chief Shawn Kennedy about the important role nurses play in TB control programs, and the opportunities for nurses to expand TB testing and treatment in a variety of clinical and community settings.
Submitted by John Parmer, PhD, MS, DTBE
DTBE is pleased to announce the establishment of the National Tuberculosis Molecular Surveillance Center (NTMSC) at the Michigan Department of Health and Human Services (MDHHS) Bureau of Laboratories. The center will be equipped to perform both conventional genotyping and whole genome sequencing (WGS) for all isolates of Mycobacterium tuberculosis. The NTMSC is supported by funding available through CDC’s Epidemiology and Laboratory Capacity for Infectious Diseases Cooperative Agreement (ELC) and is a new activity for CDC’s Antibiotic Resistance Laboratory Network aimed at strengthening national TB surveillance for outbreak detection and drug resistance. MDHHS has extensive experience with the genotyping of M. tuberculosis and has participated in CDC-sponsored genotyping activities since the early 1990s. Their genotyping team currently performs MIRU-VNTR genotyping on 9,000 isolates and WGS on 750 isolates each year.
We anticipate that WGS typing will begin by March 2018. All isolates submitted for genotyping will be sequenced; no additional request for testing is necessary. As presented at this year’s National TB Controllers Association meeting, we have a multi-year plan for the incorporation of WGS results into the molecular surveillance of tuberculosis. In the years 2018 – 2020, conventional genotyping and WGS will be performed in parallel to allow for a 3-year transition between methods. Additional details and educational opportunities will be provided to partners over the next several months.
The NTMSC will also allow for national surveillance of molecular drug resistance and aid the potential establishment of new testing algorithms that could be used to develop new diagnostics or programs to aid clinical decision making. Alerts will be integrated into data analysis tools such that CDC is notified when resistance to rifampin, the most important first-line anti-tuberculosis drug, is detected. CDC will notify state partners to ensure isolates from patients with potentially drug-resistant TB are referred to a CLIA-compliant laboratory for additional testing.
Please note that the NTMSC is a surveillance activity for transmission and drug resistance and will not be replacing the clinical testing provided by DTBE’s Molecular Detection of Drug Resistance (MDDR) service or the National DST Reference Center located at the California Microbial Disease Laboratory. We look forward to the roll out of universal WGS in support of our public health partners.
Submitted by James Posey, PhD, DTBE
TB Trials Consortium (TBTC) Study 31External (also known as ACTG A5349; “Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: A randomized, open-label, controlled phase 3 clinical trial”) continues to enroll. As of July 24, 2017, the study had enrolled 1,085 participants. The AIDS Clinical Trials Group (ACTG) network is collaborating with TBTC, contributing substantially to enrollment with 15 sites open for enrollment. The TBTC Study 32 (Opti-Q) has completed enrollment and is beginning data analysis. TBTC’s 40th semiannual meeting will be October 16-18, 2017, in Atlanta. Those interested to attend should contact Ms. Barbara DeCausey (404-639-5330; email@example.com).
DTBE issued “Recommendations for Use of an Isoniazid-Rifapentine Regimen with Direct Observation to Treat (DOT) Latent Mycobacterium tuberculosis Infection” in 2011. Since then, new research on the 3HP regimen has been conducted and published, providing evidence that was not available in 2011. DTBE held a subject matter expert meeting in Atlanta, Georgia, on July 20, 2017, to present the results of a systematic literature review and meta-analysis on the 3HP regimen. Experts’ individual viewpoints about the strength of the presented evidence were obtained at the meeting. Information obtained from subject matter experts, representing various fields, settings, and geographic locations in the United States, will complement the systematic review process, and will be utilized to prepare updated guidance for use of 3HP for treatment of latent TB infection in the United States
Submitted by Barbara DeCausey, MPH, MBA, DTBE
DTBE is focused on latent tuberculosis infection as a key to TB elimination. The Tuberculosis Epidemiologic Studies Consortium (TBESC) has developed and is testing a new latent TB infection surveillance system.
TBESC, in collaboration with Northrop Grumman (NG), developed the Surveillance for TB Elimination Management System (STEMS). STEMS is a real-time case management and surveillance system for latent TB infection currently used by all TBESC health department sites and the Dr. Bates Outreach Clinic, Arkansas Department of Health.
STEMS was beta tested at three sites–Hawaii, Arizona, and Washington. The system was improved using feedback from beta testing and pilot tested at all TBESC sites in September 2016. Updated versions are released periodically with improvements suggested by sites.
In addition to helping local health departments conduct latent TB infection surveillance and manage cases, data collected in STEMS will be used to create TB prevention cascades to cure for high-risk populations. Key variables identified throughout STEMS as minimum data elements, will help sites identify gaps in latent TB infection diagnosis, care, and treatment completion. Individual forms include registration, referral, patient history and risk factors, clinical evaluation, TST, QFT, T-SPOT, latent TB infection treatment, and discharge. A contact investigation module is currently under development.
Sites can either enter data directly into STEMS or coordinate with NG to upload data from existing electronic health record systems. On June 6, 2017, Denver became the first site to electronically upload its data, followed by Nashville (July 6) and Maricopa (July 17). These sites can now see their data in STEMS and make edits to their forms when needed. Miami is currently in preparation for electronic data transfer. The system offers efficient monitoring of patients with provision for calendar appointments, reminder alerts, and report generation. External sites including those in the Pacific Islands have expressed interest in using STEMS for latent TB infection case management and surveillance. Local areas interested in using STEMS should discuss the opportunity with their state health department and CDC public health advisor before contacting Kumar Batra for access to STEMS.
Submitted by Kiana N. Woods, MBA, M.Ed., DTBE
The “eDOT Study”
On June 23rd the New York City Department of Health and Mental Hygiene’s Bureau of Tuberculosis Control (NYC DOHMH BTBC) held an in-service for program staff to initiate a study to evaluate traditional directly observed therapy (DOT) and electronic forms of DOT (eDOT) for TB treatment. The short title is the “eDOT Study.” Funded through the CDC’s Antibiotic Resistance Solutions Initiative, the study will assess whether eDOT that employs electronic communication methods, such as video via computer or cellphone, is a non-inferior approach to monitor TB treatment adherence, compared to traditional in-person DOT (ipDOT), in which a trained person is in the physical presence of patients as anti-TB drugs are ingested.
The staff from four DOHMH operated TB clinics; Corona TB Chest Center in Queens, Washington Heights TB Chest Center in Manhattan, Fort Greene TB Chest Center in Brooklyn, and Morrisania TB Chest Center in the Bronx, gathered at program headquarters. They listened as Director of Planning and Policy Dr. Michelle Macaraig provided background on the study; Assistant Commissioner Dr. Joseph Burzynski explained the study’s design; and Clinical Operations Director Mr. Errol Robinson and Public Health Associate Mr. C. Kin Lam discussed logistics and answered staff questions.
The assembled staff learned that after providing written informed consent, patients newly diagnosed with drug-sensitive or non-rifamycin resistant TB would be randomly assigned to either ipDOT or eDOT. Following 20 doses of medicine, participants who received ipDOT will switch to eDOT while those who were initially assigned to eDOT will switch to ipDOT. Afterwards patients will continue treatment using their preferred DOT method.
The team aims to recruit 304 patients into this study over a two-year period. The research team will compare:
- The proportion of medication doses that are directly observed by ipDOT versus eDOT,
- Patient adherence to scheduled DOT sessions,
- Patient characteristics associated with adherence across ipDOT, eDOT with live video, and eDOT with recorded video,
- The type, frequency, and time between initial symptoms of medication side effects and discussion with a medical provider across DOT methods,
- Treatment outcomes, and
- Patient perceptions of quality of care, overall satisfaction with patient-staff rapport, and confidence to adhere across eDOT and ipDOT. Data for an economic evaluation will be collected.
The decision to discontinue eDOT and patient preferences for DOT methods will be assessed as well.
Corona, Washington Heights, Morissania, and Fort Greene clinic staff have been working for several months to train the study facilitators, Matthew Dias, Sarah Kiskadden-Bechtel, and Michael Reeves on clinic operations and DOT procedures in preparation for the official start of the study.
These staff warmly cheered for the study facilitators as Dr. Burzynski introduced the facilitators to the entire group that had gathered for the in-service. Some good-natured competitive comments were heard as staff from the different clinics claimed they would recruit the first patient into the study.
Planning for the eDOT Study began a little over a year ago as a collaboration between the NYC DOHMH BTBC, Columbia University, and DTBE. Dr. Burzynski serves as the DOHMH Principal Investigator for the “eDOT Study.” Dr. Michelle Macraig is the co-Principal Investigator. Dr. Neil Schluger serves as the Columbia University Study Lead. Drs. Joan Mangan and Neela Goswami serve as the CDC Study Leads. The study team also includes: Dr. Sapna Bamrah Morris, Ms. Christine Chuck, Dr. Richard Garfein (Consultant), Mr. C. Kin Lam, Dr. Diana Nilsen, Dr. Margaret Oxtoby (Consultant), Mr. Errol Robinson, Dr. Brock Stewart, Dr. Andrew Vernon (Consultant), Dr. Garrett Asay, and Mr. Marco Salerno (Data Analyst).
The group hopes to share preliminary results early next year.
C. Kin Lam, MPH – Public Health Associate and Study Coordinator
Michelle Macaraig, DrPH – NYC DOHMC BTBC Study Lead
Joan Mangan, PhD, MST, DTBE – CDC Study Lead
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