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TB Notes 2, 1999

International Activities

Stop TB Initiative | TB Control in India | Consequences of TB Treatment for Immigrants Applying for Legal Permanent Residence

The "Stop TB" Initiative

In November 1998, Dr. Gro Harlem Brundtland, the recently appointed Director General of the World Health Organization, launched the "Stop TB" Initiative. The "Stop TB" Initiative is a WHO-hosted global partnership whose mission is to put TB higher on the public health agenda internationally and to substantially increase the investment in TB worldwide. It aims to increase involvement of international partners at all levels, including international health agencies, donor agencies, governments, nongovernmental organizations, professional societies, and community organizations involved in TB at the country level. The focus of the initiative is on the 22 "high-burden" countries that WHO has identified as responsible for approximately 80% of all reported cases of TB in the world. These include Afghanistan, Bangladesh, Brazil, Cambodia, China, the Democratic Republic of the Congo, Ethiopia, India, Indonesia, Kenya, Myanmar, Nigeria, Pakistan, Peru, the Philippines, the Russian Federation, South Africa, Thailand, Uganda, the United Republic of Tanzania, Viet Nam, and Zimbabwe. In addition, countries with extremely high rates of TB, especially those impacted by the HIV epidemic, will be targeted.

The "Stop TB" Initiative will focus attention on addressing the specific constraints to action on TB identified at the London Ad Hoc Committee Meeting on the Global TB Epidemic held in March 1998. The actions for which constraints were identified at this meeting include political will and commitment, human resource development, secure supply of quality anti-TB drugs, research, financing, organization and management, information systems, and health sector reform.

The main products of the "Stop TB" Initiative will be 1) a global action plan, to offer solutions to the most pressing constraints to action, identify roles of different partners, and guide would-be investors in TB control towards coordinated, prioritized actions; 2) a drug supply facility, to provide universal availability of TB drugs in improved forms, specifically fixed dose combinations; 3) a global research agenda, to build on the work of WHO and others by focusing on community needs, health systems and services research, and a medium/long-term new tools development strategy; and 4) a global charter against TB, to catalyse and secure public agreements among donor agencies and high burden countries on specific steps to be taken to control TB, including tools and indicators to monitor and report on progress.

The founding partners of the "Stop TB" Initiative are the American Lung Association, the American Thoracic Society, CDC , the International Union Against TB and Lung Disease, the Royal Netherlands TB Association (KNCV), the World Bank, and the World Health Organization.

A series of activities and events are planned over the next 1 to 2 years to strengthen the partnership and build the foundation for an expanded global campaign. During the summer, the Initiative will sponsor a series of regional workshops with the highest-burden countries to enhance participation at the country level. In addition, workshops on health-sector development and control of infectious diseases and on political will and commitment to TB control are planned for 1999. A larger ministerial conference, co-organized by the "Stop TB" Initiative members and the Government of the Netherlands, is planned for March 2000. This conference will bring together the ministers of health as well as the persons responsible for finance, development, or planning from the highest-burden countries to set the stage for expanded country action against TB across sectors of government and society.

CDC is actively participating in the "Stop TB" Initiative. Mark Fussell, DTBE public health advisor, has been detailed to WHO headquarters in Geneva as part of the secretariat of the Initiative. Dr. Bess Miller, Associate Director for Science, and Carl Schieffelbein, Deputy Director, DTBE, are the CDC representatives to the Steering Committee. The Division of TB Elimination will be sponsoring the regional workshop in Africa this summer.

—Reported by Bess Miller, MD, MSc
Division of TB Elimination



Stop TB Initiative | TB Control in India | Consequences of TB Treatment for Immigrants Applying for Legal Permanent Residence

Notes from the Field: TB Control in India

The burden of TB in India is simply mind-boggling. There are approximately 2 million new cases of the disease every year — more cases in 4 days than in the entire United States in a year. Every day, more than 1,000 people die from TB in India.

Adding to this epidemic are the dual threats of drug resistance and HIV. Data on the rate of drug resistance in India are sparse, but the best conducted evaluations indicate a rate of primary drug resistance of at least 15% and primary multidrug resistance of around 3% to 3.5%.

For every 1% increase in the prevalence of HIV infection among adults in India, there would be at least 250,000 additional TB cases per year: 1% of 450 million adults (4.5 million HIV-infected persons), 60% of adults are TB-infected (2.7 million), and 7% to 10% progress to active TB per year (plus newly infected persons progressing to active TB.) One challenge is whether effective TB control can be implemented before HIV spreads more widely.

Despite having a remarkable history of research in TB, India’s national performance has not met its expectations. Under the national program, about 1.3 million cases are registered for treatment each year. Only about 260,000 of these (both new and old cases) are smear-positive, and of these, only 20% to 40% complete treatment. This means that of the estimated 800,000 new smear-positive cases arising every year, at most 30% are detected in the program and no more than 10% to 15% of the estimated total complete treatment. On a national scale, the results are thus similar to those in Harlem before the improvement in the control program there, when 11% of patients completed treatment.

Since 1993, India has implemented the World Health Organization (WHO)-recommended strategy of DOTS (directly observed treatment, short-course) on a pilot basis. In these areas, the quality of diagnosis is markedly better — more than half of all pulmonary patients have positive smears and about 80% of patients complete treatment. In 1998, the program was expanded from a pilot population of about 20 million at the beginning of the year to a population of nearly 90 million by the end of the year. The project is mostly funded from a World Bank "soft loan" (i.e., about a 75% grant equivalent because of very low interest and 30-year repayment terms) of $142 million. The British and Danish governments also provide assistance in covering one State each.

In partnership with WHO, CDC provides technical support to the World Bank and the Government of India. In the following paragraphs, the important challenges and issues are summarized. The five-point strategy of DOTS is a good framework for evaluating programs. Although not engraved in stone, this strategy encompasses all key aspects of TB control — political commitment, accurate diagnosis, effective treatment (including an uninterrupted and reliable drug supply), and effective monitoring and supervision (including training).

Political commitment. As in any area, this is important at every level. Broadly speaking, programs need to perform three activities: hire or deploy staff, enter into contracts for services, and procure goods. The speed and quality of each of these three activities is important at national, state, and local levels.

Accurate diagnosis. Diagnosis of TB in high-prevalence countries is best done by direct smear microscopy of three samples obtained on 2 consecutive days (an on-the-spot sample on each day, and an early morning sample on the second day). This simple technique, if done correctly, will identify about 50% to 70% of the total pulmonary cases and about 90% of those who are spreading TB. It is simple, low cost, and highly specific. Patients who have negative smears should be given a 10-day course of antibiotics for respiratory infection (e.g., trimethoprim-sulfamethoxazole) and if symptoms persist, undergo x-ray (and repeat sputum examination, if possible). If the x-ray is abnormal and consistent with TB, then anti-TB treatment is given. Using this algorithm-based diagnostic approach results in placing patients on treatment more rapidly than using available culture techniques, and avoids the risk and expense of culture. Smear-negative patients who do not return for follow-up and those with normal x-rays may be missed, but these patients are unlikely to either be severely ill or to be major transmitters of infection.

The two biggest challenges in this area are to avoid overdiagnosis of smear-negative cases and to ensure that patients from all health institutions are referred for sputum examination. Overdiagnosis of smear-negative cases is a chronic problem. With such a large number of prevalent cases, and so many other respiratory infections, it is likely that many patients who have a cough may have abnormal x-rays. Many of these x-rays may appear quite consistent with TB. Patients with scarred or fibrotic lungs often have a cough and other respiratory symptoms and may expect anti-TB treatment. Often, prescribing anti-TB treatment for these patients is the path of least resistance for physicians. This is addressed in the DOTS program by ensuring that three good-quality smears are examined, and by following the diagnostic algorithm. In this way, the ratio of smear-positive to smear-negative patients improved from 1:4 in the national program to 1:1 in the revised program.

Uninterrupted supply of drugs for short-course chemotherapy. It is axiomatic that patients will not complete treatment unless drugs are available! In India’s DOTS program, all treatment is according to WHO categories, and drugs are packed in blister strips. In the first 2 to 3 months, every dose is directly observed and one blister strip contains all the drugs for one day. In the continuation phase, the first dose each week is directly observed, and the blister strip contains the drugs for the week. The drugs are packaged in boxes, one for each patient. This greatly simplifies logistics of drug delivery, and also gives patients confidence that they will have a full course of treatment available — as soon as a patient begins treatment, he is shown a box, his name is written on it, and he is assured that the full course of drugs will be available. However, the boxes also increase the storage space required by the drugs and reduce shelf life, since rifampin has a shorter shelf life than the other drugs. The program has to avoid drug stock-outs on the one hand, and drug expirations on the other.

Direct observation of treatment. In the United States, DOT is seen as the major technical change in TB control in recent years. However, in many developing countries it is important to stress, on the one hand, that all five components of the DOTS strategy are essential and, on the other hand, that DOT must occur. The WHO formulation for DOT is that it should be done by persons who are accessible and acceptable to the patient and accountable to the health system. Since family members are not accountable to the health system, family observation is not considered an effective means of ensuring DOT; it has been tried in some countries but is not acceptable in the program in India. Ensuring that DOT is convenient to patients is a major challenge. In rural areas, ensuring access over long distances is an issue. This can be managed by involving front-line health staff who are deployed, in India, for every 5,000 population. Where such staff do not exist, community volunteers can be used, and can receive a small honorarium for each patient cured (around $5). In urban areas, the major challenge is the mobile population, migrant workers, and day laborers who must often choose between attending a DOT session and working — and hence, between medicine and food for the day. To address these difficulties, whenever possible volunteers in the community, including cured patients, and community organizations that can open in the early morning or late evening for working patients, are involved in the program.

Additional challenges are social attitudes. In the field of leprosy there is a tradition of helping patients among both the medical community and community organizations. In TB, this tradition does not exist. Encouraging DOT workers to establish a strong rapport and communication with TB patients is key to program success. All over the world, effective DOT providers marvel at and are encouraged by their experience of helping patients get better, often remarking that, for the first time in their health work, they know that they are making a real difference in patients’ lives.

Supervision and monitoring. As in most public health programs, the key to success is not technical excellence but managerial competence. Supervision at all levels needs to be frequent, meaningful, and effective. This means that those who offer DOT are trained, supervised, and given effective backup. Those who perform microscopy and who maintain the TB registers must be trained, given the resources they need to function effectively, and are well supervised. Doctors need to be well trained and need feedback on the quality of their diagnosis and treatment. Program managers at all levels need training, feedback, and supervision.

A key tool for supervision and monitoring is the quarterly reporting system, designed by Dr. Karel Styblo of the International Union Against TB and Lung Diseases. This system is remarkably robust. It is simple enough to be completed by people who are barely literate, intricate enough to be impossible to falsify without extraordinary effort, and powerful enough to be used for clinical management, program management, and epidemiologic analysis. Results from the quarterly reports are used to provide feedback to reporting areas on a quarterly basis on the quality of their diagnosis and treatment. The three key indicators used are 1) the ratio of smear-positive to smear-negative pulmonary cases (no more than one smear-negative case is expected for every smear-positive case, otherwise diagnosis is most likely not being done according to policy), 2) the proportion of new smear-positive patients who convert from smear-positive to smear-negative by the end of the third month of treatment (the target is >90%; anything below 80% indicates a serious problem, most likely failure to ensure effective DOT), and 3) the rate of successful treatment of new smear-positive patients (the goal is 85%; anything below 80% indicates a serious problem). The sputum conversion rate is a key indicator, since it allows monitoring of areas into which the program is newly expanding. This is because treatment outcomes are only available 12 to 15 months after patients begin treatment, but sputum conversion is available 4 to 6 months after patients begin treatment. Case detection rates are also monitored; as programs improve, case detection tends to increase for the first several years, as a result of the "recruitment effect" of providing reliable services.

A new method of providing prompt feedback on these key reports is to travel to areas implementing the program and use an LCD projector and notebook computer to enter and project all areas' reports in standardized software (Epi-Centre). This is useful both because the data entry process identifies discrepancies in reports, which can be corrected on the spot based on the TB registers, and because it allows graphic presentation in maps, bar graphs, pie charts, and lists of relative performance in different areas. This allows for a healthy competition between areas, and group problem-solving on common challenges.

During 1998, the Indian DOTS program increased population coverage from 20 million to about 90 million. By March 1999, 120 million were covered and the program had treated more than 100,000 patients. As of July 1999, more than 10,000 TB patients are being put on treatment under DOTS in India every month. This represents an enormous advance and the savings of more than 15,000 lives in 1999 alone. Based on the experience of this expansion, a decision will be taken on how to most effectively expand DOTS nationally, while still ensuring good quality of treatment. It is an exciting and challenging time, and WHO and CDC are fortunate to be part of the team.

—Reported by Thomas R. Frieden, MD, MPH
Dr. Frieden, who was Director of the New York City Bureau of TB Control from 1992-1996, has been assigned to the WHO’s South East Asia Regional Office since 1996



Stop TB Initiative | TB Control in India | Consequences of TB Treatment for Immigrants Applying for Legal Permanent Residence

Consequences of TB Treatment for Immigrants Applying for Legal Permanent Residence

Several questions have been raised recently by TB controllers in the United States (U.S.) with foreign-born patients who fear that receiving treatment in a publicly funded TB clinic may result in the denial of their adjustment-of-status or immigrant visa application. Written guidance on this issue recently issued by the Immigration and Naturalization Service (INS) explicitly states that non-citizens who receive TB treatment in publicly funded clinics are not in jeopardy of having their application for legal permanent residence denied on grounds that they were likely to become a public charge. To place this concern in context, an explanation of the system for applying for legal permanent residency in the U.S. follows.

Currently, there is basically a two-track system for immigrating to the U.S. One track is based upon employment and the other is based upon family relationship. Both tracks require that a petition must be filed with the INS to classify the applicant under the appropriate preference category. Once the petition has been approved and a visa number is available, the applicant may proceed with the final step of becoming a legal permanent U.S. resident. There are two general avenues for doing this: adjustment-of-status for those individuals residing in the U.S. and eligible to apply, and visa processing for those individuals who are not eligible to apply for adjustment-of-status, or who are not residing in the U.S.

Overseas visa processing entails applying for an immigrant visa at a consular office of a U.S. embassy or consulate. Once issued a visa, applicants may apply for admission to the U.S. on that immigrant visa, and are granted legal permanent residence at the time they pass through the port-of-entry. In 1997, 380,718 persons obtained legal permanent residence in this manner. Adjustment-of-status applicants in the U.S. are granted legal permanent residence at the time their applications are approved by the INS. In 1997, 417,660 persons obtained legal permanent residency in this manner.

An applicant must be admissible when he or she applies for adjustment-of-status or for an immigrant visa. There are several health-related grounds of inadmissibility, including HIV infection, infectious TB, Hansen's Disease (leprosy), syphilis, gonorrhea, and three other sexually-transmitted diseases. Also, immigrant visa and adjustment-of-status applicants who cannot show proof of being fully immunized against certain vaccine-preventable diseases are inadmissible, until they comply with the vaccination requirements or obtain a medical waiver.

Another ground of inadmissibility relates to public charge. Immigrant visa and adjustment-of-status applicants will be found inadmissible on public charge grounds if, in the opinion of the consular officer at the time of application for a visa, or in the opinion of the Attorney General at the time of application for admission or adjustment-of-status, they are likely at any time to become a public charge. In making such a determination, the Department of State or the INS examines the totality of the circumstances, including an evaluation of the alien's age, health status, family status, assets, resources, financial status, and education and skills. In addition, all family-based immigrants and a limited number of employment-based immigrants are required to have a legally binding affidavit of support executed on their behalf.

Not all publicly funded benefits will be considered by the INS or the State Department in deciding whether someone is or is likely to become a public charge. The focus of public charge is on income maintenance and institutionalization for long-term care at government expense. Examples of benefits that will not be considered for public charge purposes include the following:

  • Medicaid and other health insurance and health services (including public assistance for immunizations and for testing and treatment of symptoms of communicable diseases; use of health clinics, prenatal care, etc.) other than support for institutionalization for long-term care.

  • Children’s Health Insurance Program (CHIP)

  • Nutrition programs, including Food Stamps, the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), the National School Lunch and Breakfast programs, and other supplementary and emergency food assistance programs

  • Housing assistance

  • Child care services

  • Energy assistance, such as Low Income Home Energy Assistance program (LIHEAP)

  • Emergency disaster relief

  • Foster care and adoption assistance

  • Educational assistance, including benefits under the Head Start Act and aid for elementary, secondary, or higher education

  • Job training programs

  • In-kind, community based programs, services, or assistance (such as soup kitchens, crisis counseling, and intervention, and short-term shelter)

In conclusion, TB controllers can counsel their patients that receiving TB treatment in a publicly funded health department clinic will not jeopardize their application for legal permanent residence in the U.S.

—Reported by Paul Tribble
Division of Quarantine


Released October 2008
Centers for Disease Control and Prevention
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
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