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Division of Tuberculosis Elimination Strategic Plan 2016-2020

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Background

Background: Tuberculosis (TB) is caused by a bacterium called Mycobacterium tuberculosis. The bacteria usually attack the lungs, but TB bacteria can attack any part of the body such as the kidney, spine, and brain. TB disease is almost always curable if treated promptly with the correct medications. If not treated properly, however, TB disease can be fatal. TB is spread through the air from one person to another. Not everyone infected with TB bacteria becomes sick. As a result, two TB-related conditions exist: latent TB infection and TB disease. People with latent TB infection are not infectious and cannot spread TB bacteria to others. However, if TB bacteria become active in the body and multiply, the person will go from having latent TB infection to being sick with TB disease. The lifetime risk of progressing from latent TB infection to TB disease is 5-10%.

Since 1953, in cooperation with state and local health departments, the United States (U.S.) national tuberculosis program has collected information on each newly reported case of tuberculosis (TB) disease in the United States. In the early 20th century, TB was the leading cause of death in the United States. From that point TB cases steadily declined until the 1980s and early 1990s when a TB resurgence occurred with over 25,000 TB cases being reported per year. The resurgence was associated with the emergence of the HIV epidemic, increased immigration from countries with high TB rates, and a deterioration of TB control programs in many jurisdictions. Following a major investment in TB control activities at all levels of government, TB cases began to decline again. In 2014, the reported number of U.S. TB cases was 9,421, with a case rate of 3.0 cases per 100,000 population (30 per million population). Since the 1992 TB resurgence peak in the United States, the number of TB cases reported annually has decreased by 65%.

Vision, Mission, and DTBE Strategic Framework

Vision: Elimination of tuberculosis in the United States (defined as < 1 case/million annually)

Mission: The mission of the Division of Tuberculosis Elimination (DTBE) is to promote health and quality of life by preventing, controlling, and eventually eliminating tuberculosis in the United States.

DTBE Strategic Framework: DTBE’s strategic plan is aligned with the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) Strategic Plan Through 2020. The NCHHSTP goals are to decrease incidence of infection, decrease morbidity and mortality, and decrease health disparities. DTBE’s goal is to reduce TB morbidity in the United States with a particular focus on reducing disparities in TB morbidity among disproportionately affected groups, including foreign-born persons and racial and ethnic minorities. DTBE’s strategies, while similar to those laid out in the Center’s plan, focus on efforts unique to TB control and are aimed at eliminating TB. The six specific strategies that provide the framework for DTBE’s strategic plan are derived from the U.S. government’s response  to the Institute of Medicine Report, Ending Neglect: The Elimination of Tuberculosis in the United States (2000), which were reaffirmed in A Call for Action on the Tuberculosis Elimination Plan  published by STOP TB USA in 2010.

Core Values and Guiding Principles

DTBE embraces the core values enumerated in NCHHSTP’s strategic plan. The core values that guide how we think and work together, how we serve our communities, how we make decisions, and how we determine our priorities include the following.

  • Accountability: Be a diligent steward of the use of funds to achieve NCHHSTP’s public health mission
  • Respect: Treat persons with dignity and honesty; value diversity and differences of opinion
  • Integrity: Be accurate, consistent, and honest
  • Excellence: Achieve the highest standard of performance in public health science, program, and policy
  • Diversity: Recruit and maintain a highly trained, inclusive, and professional workforce
  • Transparency: Keep the public, partners, and staff informed about our programs, policy, and science
  • Equity: Work to achieve optimal health for the populations we serve
  • Innovation: Create an environment that encourages and values new ideas

Guiding Principles: NCHHSTP prioritizes cost-effective and scalable programs, policies, and research that will have the greatest impact on its three goals:

  1. reducing incidence of infections,
  2. lowering morbidity and mortality, and
  3. decreasing health disparities.

High impact prevention is an approach to planning and implementing activities that promotes efficient and effective use of limited resources. Accordingly, DTBE will implement programs, policies and research that:

  1. Are most cost-effective in reducing overall incidence, morbidity, mortality, and disparities in health;
  2. Can be feasibly implemented at full scale with currently available resources (programs and policies should be practical to implement at the scale needed to meet the need in the target population);
  3. If prioritized, will have the greatest impact on reducing incidence, morbidity, mortality, and disparities in health when implemented; and
  4. Include populations that are disproportionately affected to reduce disparities by ensuring that those with the highest rates of morbidity or who are most vulnerable are effectively reached.

Challenges and Opportunities

Challenges: As U.S. TB cases continue to decrease, the perception of TB as a public health risk diminishes as well. As a result, TB can seem to be of lower priority to the general public and many policymakers. Competition for public funds puts resources for TB control and research at risk. The greatest challenges include the following.

  • Fewer patients with TB limits routine training opportunities in TB clinical, laboratory, research, and program efforts leading to loss of expertise and experience in TB. This loss of TB expertise and experience has resulted in decreased capacity to appropriately diagnosis, treat, manage, and prevent TB.
  • TB drugs and biologics face the same problems that threaten the supply of antibiotics in general. As demand decreases and drug patents expire, manufacturers may weigh the balance of refurbishing facilities and procuring active ingredients against the profitability of the product. Research and development of new antibiotics has not kept pace with those of other types of medicine. Therefore, periodic shortages and supply interruptions of critical TB medications have occurred in the United States over the past five years, resulting in interruptions in patient treatment, delays in treatment initiation, and potential increased community exposure to TB.
  • While numbers of TB cases decline, outbreaks are increasingly concentrated in more difficult-to-reach populations, including persons born outside the United States, racial and ethnic minorities, and people experiencing homelessness, incarceration, and substance/alcohol use. Also, TB is associated with other acute and chronic health conditions, including diabetes and HIV infection. The complexities of these social determinants and co-morbidities affects the resources required for successful prevention and control efforts.
  • Although the United States has not experienced the high numbers of drug-resistant TB reported globally, the threat of drug-resistant TB, including acquired resistance as a result of delayed diagnosis and inappropriate antibiotic treatment, continues to affect prevention and control efforts.

Opportunities: The decline of TB incidence could be accelerated by prioritizing TB control efforts to address disparities in TB morbidity among people in the United States who are most vulnerable to TB. These vulnerable populations include the following.

  • Foreign-born: 65% of cases; case rate 13 times higher than U.S.-born;
    • In 2013, Mexico, Philippines, Vietnam, China, and India were the leading countries of origin among foreign-born U.S. TB cases;
  • Racial/ethnic minorities: 85% of overall cases; 67% of U.S.-born cases; case rates 7-27 times higher than whites;
  • HIV infected: ~ 7% of cases;
  • Homeless: ~ 6% of all cases and ~ 18% of those with recently acquired TB;
  • Incarcerated: ~ 4% of cases;
  • Substance abuse: 7-11% of cases; and
  • Latent TB infection: Recent estimates indicate that almost 90% of U.S. TB cases result from reactivation of latent TB infection rather than recent transmission. While the U.S. reports fewer than 10,000 TB cases annually, it is estimated that up to 13 million people in the U.S. have latent TB infection. Since the study to determine this estimate did not include certain high-risk populations, such as persons experiencing homelessness or incarceration, the true burden of latent TB infection is likely greater.

Goal and Strategies

Goal: Reduce TB morbidity in the United States with a particular focus on reducing disparities in TB morbidity among disproportionately affected groups, including foreign-born persons and racial and ethnic minorities.
 

Strategies:

  1. Maintain control of TB: Maintain the decline in TB incidence through timely diagnosis of active TB disease, appropriate treatment and management of persons with active TB disease (both drug-susceptible and drug-resistant), investigation and appropriate evaluation and treatment of contacts of infectious TB cases, and prevention of further transmission through infection control
  2. Accelerate the decline: Advance toward TB elimination through targeted testing and treatment of persons with latent TB infection, appropriate regionalization of TB control activities, rapid recognition of TB transmission using DNA fingerprinting methods, and rapid outbreak response
  3. Develop new tools: Develop and assess new tools for the diagnosis, treatment, and prevention of TB
  4. Increase U.S. involvement in international TB control activities:  DTBE does not have the lead in activities that directly support achievement of this goal, because it is no longer a part of DTBE’s mission, DTBE collaborates with the Division of Global HIV and Tuberculosis (proposed), the Division in CDC that is now tasked with reducing the global burden of TB. This collaboration indirectly supports DTBE’s mission because, with 65% of U.S. TB cases occurring in foreign-born persons, reductions in global TB are critical to the goal of U.S. TB elimination. Furthermore, advances made in domestic TB control may be valuable to the global effort if they can be disseminated and implemented in other settings. In this way, DTBE’s research activities (through the TB Trials Consortium and TB Epidemiologic Studies Consortium) and programmatic improvements may indirectly reduce the global TB burden.
  5. Mobilize and sustain support: Mobilize and sustain support for TB elimination by engaging policy and opinion leaders, health care providers, affected communities, and the public
  6. Track progress: Monitor progress toward the goal of TB elimination, and regularly report on progress to all partners, policy makers, and target audiences

Objectives and Targets

Objectives and Targets:

Objectives and Targets table
2020 NTIP Target NCHHSTP 2020 Target DTBE Strategies
Reduce the incidence of TB disease 1.4/100,000 1.4/100,000 I, II, V
Decrease the incidence of TB disease among U.S.-born persons 0.4/100,000 I, II, V
Decrease the incidence of TB disease among foreign-born persons 11.1/100,000 11.1/100,000 I, II, V
Decrease the incidence of TB disease among U.S.-born
non-Hispanic blacks or African Americans
1.5/100,000 I, II, V
Decrease the incidence of TB disease among children younger than 5 years of age 0.3/100,000 I, II, V
Increase the proportion of TB patients who have a positive or negative HIV test result reported 98% I
2020 NTIP Target NCHHSTP 2020 Target Supports Strategies
For TB patients with positive acid-fast bacillus (AFB) sputum-smear results, increase the proportion who initiated treatment within 7 days of specimen collection 97% I, II
For patients whose diagnosis is likely to be TB disease, increase the proportion who are started on the recommended initial 4-drug regimen 97% I, II
For TB patients ages 12 years or older with a pleural or
respiratory site of disease, increase the proportion who have a sputum culture result reported
98% I
For TB patients with positive sputum culture results, increase the proportion who have documented conversion to negative results within 60 days of treatment initiation 73% I
For patients with newly diagnosed TB disease for whom 12 months or less of treatment is indicated, increase the proportion who complete treatment within 12 months 95% I
For TB patients with positive AFB sputum-smear results, increase the proportion who have contacts elicited 100% I, II
For contacts to sputum AFB smear-positive TB cases, increase the proportion who are examined for infection and disease 93% I, II
For contacts to sputum AFB smear-positive TB cases diagnosed with latent TB infection, increase the proportion who start treatment 91% I, II
2020 NTIP Target NCHHSTP 2020 Target DTBE Strategies
For contacts to sputum AFB smear-positive TB cases who have started treatment for latent TB infection, increase the proportion who complete treatment 81% I, II
For TB patients with cultures of respiratory specimens identified with M. tuberculosis complex (MTBC), increase the proportion reported by the laboratory within 25 days from the date the specimen was collected 78% I
For TB patients with respiratory specimens positive for MTBC by nucleic acid amplification (NAA), increase the proportion reported by the laboratory within 6 days from the date the specimen was collected 92% I
Increase the proportion of culture-confirmed TB patients with a positive nucleic acid amplification test (NAAT) result reported within 2 days of specimen collection I
For TB patients with positive culture results, increase the proportion who have initial drug-susceptibility results reported 100% I
For TB patients with a positive culture result, increase the proportion who have a MTBC genotyping result reported 100% I, II
For immigrants and refugees with abnormal chest radiographs (X-rays) read overseas as consistent with TB, increase the proportion who initiate a medical examination within 30 days of notification 84% I, II
2020 NTIP Target NCHHSTP 2020 Target DTBE Strategies
For immigrants and refugees with abnormal chest X-rays read overseas as consistent with TB, increase the proportion who complete a medical examination within 90 days of notification 76% I, II
For immigrants and refugees with abnormal chest X-rays read overseas as consistent with TB who are diagnosed with latent TB infection or have radiographic findings consistent with prior pulmonary TB (ATS/CDC Class 4) on the basis of examination in the U.S., for whom treatment was recommended, increase the proportion who start treatment 93% I, II
For immigrants and refugees with abnormal chest X-rays read overseas as consistent with TB who are diagnosed with latent TB infection or have radiographic findings consistent with prior pulmonary TB (ATS/CDC Class 4) on the basis of examination in the U.S., and who have started on treatment, increase the proportion who complete treatment 83% I, II

 

DTBE Activities

Activities: DTBE activities support the NCHHSTP Strategic Plan 

Specifically, to fulfill our mission and implement our strategies for TB Elimination, DTBE carries out the following:

  1. Conducts routine surveillance (including drug susceptibility), outbreak detection and surveillance, and specialized periodic surveys
    Supports strategies: I, II, VI
    Examples: National Tuberculosis Surveillance System (NTSS), Tuberculosis Genotyping Information System (TB GIMS), Aggregate Reports on Program Evaluation (ARPE), tuberculosis infection prevalence component of the National Health and Nutrition Examination Survey (NHANES), Large Outbreaks of Tuberculosis Surveillance (LOTUS)
  2. Provides funding and embedded staff to state and local TB programs to support case finding and reporting, completion of treatment, contact investigation, and targeted testing and treatment of latent TB infection
    Supports strategies: I, II, VI
    Examples: Funding Opportunity Announcement for Tuberculosis Elimination and Laboratory Cooperative Agreement, DTBE public health advisors and medical officers assigned to state and local TB programs, specific initiative to address latent TB infection testing and treatment in at-risk populations
  3. Supports expert medical care through funding expert medical consultation
    Supports strategies: I, II
    Examples: Regional Training and Medical Consultation Centers (RTMCCs)
  4. Guides preparedness and provides programmatic consultation, technical assistance, and outbreak response assistance to state and local health departments
    Supports strategies: I, II
    Examples: DTBE Outbreak Response Plan, Outbreak Evaluation Unit, TB Epi-Aids and onsite and distance technical assistance from program consultants and other subject matter experts
  5. Conducts program evaluation to improve programs
    Supports strategy: VI
    Examples: National TB Indicators Project (NTIP), program evaluation component of Tuberculosis Elimination and Laboratory Cooperative Agreement, Tuberculosis Program Evaluation Network (TB-PEN)
  6. Provides laboratory diagnostic services; builds and maintains laboratory capacity
    Supports strategies: I, II, III
    Examples: National TB Reference Laboratory, laboratory capacity building through Tuberculosis Elimination and Laboratory Cooperative Agreement, Cooperative Agreement support to Association of Public Health Laboratories, National TB Laboratory Center of Excellence, national TB genotyping contract, Molecular Detection of Drug Resistance Service
  7. Conducts critical, programmatically relevant behavioral, epidemiological, clinical, laboratory, and operational research to develop and evaluate new tools and interventions for diagnosis, treatment, prevention, and control of TB (to help programs work more effectively and more efficiently)
    Supports strategy: III
    Examples: Tuberculosis Trials Consortium (TBTC), Tuberculosis Epidemiologic Studies Consortium (TBESC), Laboratory Applied Research Team work on whole genome sequencing for outbreak detection, improving molecular detection of drug resistance and TB immunology
  8. Provides data management; statistical, economic and epidemiologic modeling; and information technology support
    Supports strategies: I, II, III, IV, VI
    Examples: Data management and statistical support for NTSS, TB GIMS, TBTC, TBESC, economic and epidemiologic modeling activities, including those through NCHHSTP modeling cooperative agreement
  9. Supports intramural infrastructure (salaries, travel, equipment, and supplies) required for maintaining subject matter experts in TB
    Supports strategies: I, II, III, VI
    Examples: DTBE program consultants and other public health advisors, medical officers, epidemiologists, scientists, statisticians, laboratorians, administrative staff, and infrastructure needed to support their work
  10. Obtains external expert consultation and advice to ensure that research and program activities are responsive to emergent public health concerns
    Supports strategies: I, II, V, VI
    Examples: Advisory Council for the Elimination of TB (ACET), Office of Infectious Diseases Board of Scientific Counselors, ad-hoc consultations
  11. Develops and evaluates evidence-based training and educational materials, policies, and guidelines to ensure competency in TB diagnosis, treatment, laboratory capacity, and programmatic prevention and control
    Supports strategies: I, II, III, IV, V, VI
    Examples: TB Core Curriculum, TB Self-Study Modules, TB Program Managers’ Course, TB Laboratory Course, TB Treatment Guidelines, Interferon-gamma Release Assay Guidelines, Guidelines on Infection Control in Healthcare Settings and Correctional Facilities.
  12. Develops education, risk, and media communications (web- and print-based) to aid in preparedness and public awareness of TB prevention and control issues
    Supports strategies: I, II, III, V
    Examples: Online TB Fact Sheets, DTBE internet and intranet sites, media releases and responses, talking points, Twitter account
  13. Cultivates relevant external partnerships, as well as collaborates within CDC and across other federal agencies
    Supports strategies: I, II, III, IV, V
    Examples: Stop TB USA, National TB Controllers’ Association, American Thoracic Society, Infectious Diseases Society of America, American Academy of Pediatrics, the Association of Public Health Laboratories, Federal TB Task Force

Overarching Tactics

Overarching Tactics: Increase emphasis or develop new activities:

Sustain commitment

  • Build and maintain partnerships, including with other disease programs and providers

Make the argument: Publish additional studies on cost effectiveness, costs of treatment, and return on investments

  • Establish Economics and Program Evaluation Team within DTBE (DMSB)
  • Continue to share stories of persons affected by TB
  • Monitor cooperative agreement activities on health economics and cost effectiveness

Maintain basic TB control functions

  • Support case finding and treatment by epidemiologic and demographic characteristics of jurisdictions (funding formula)
  • Support jurisdictions in contact investigation practices and implementation of recommendations
  • Engage state authorities in situations where state or local TB programs are incapable of implementing practices to halt transmission among vulnerable populations

Expand effective latent TB infection testing and treatment

  • When U.S. Preventive Services Task Force review is complete, disseminate results among TB controllers, Centers for Medicare & Medicaid Services state contacts, and Federally Qualified Health Centers (FQHCs); publish Dear Colleague letter to organizations representing private providers (ATS, ILA, IDSA); identify contacts at large HMO or insurance providers (e.g., Kaiser Permanente)
  • Increase outreach to FQHCs
  • If review does not result in a recommendation to provide latent TB infection testing at the population level (either a Grade A or B), outreach and education will be even more important, to ensure persons at risk can still be provided with access to TB screening and treatment
  • Develop messaging and other communication strategies for improving treatment initiation (and completion) for those infected who are at highest risk of progressing to TB disease
  • Champion major initiative for expanded targeted latent TB infection testing and treatment with the following components
    • Develop registry/surveillance system for latent TB infection
    • Scale up  testing to targeted populations
    • Publish guidance on identifying persons who will benefit most from targeted testing
    • End wasteful testing of low-risk persons
    • Scale up use of interferon-gamma release assays, especially for foreign-born persons
    • Scale up use of short course latent infection treatment (e.g., 12 dose treatment for latent TB infection)
    • Develop outreach and communication tools to engage affected communities and their medical providers
  • Develop funding opportunity for intensive targeted latent TB infection testing and treatment demonstration project

Maintain or increase focus on prevention of TB disease in U.S. for foreign-born persons

  • Take advantage of new diagnostics (e.g., interferon-gamma release assay) and treatment/drug regimens (12 dose treatment for latent TB infection)
  • Consider expanding TB Technical Instructions (TI) for overseas TB screening for immigration to include additional visa categories (students, temporary workers); President’s budget for FY 2016 includes funding for antimicrobial resistance, which can be directed to this effort via Division of Global Migration and Quarantine

Maximize impact of limited resources

  • Promote and harness scientific and technological advancement
  • Share federal policies and programs that could augment TB programs’ efforts; for example, some programs already use 340B program for discounted drug purchases, some use Medicaid Section 1115 waivers, some have adopted TB Medicaid Option, and others making advances under Affordable Care Act
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