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
