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PRINCIPLES OF OUT-PATIENT
MDR-TB TREATMENT & MANAGEMENT
SALMAAN KESHAVJEE, MD, PHD
HARVARD MEDICAL SCHOOLBRIGHAM AND WOMEN’S HOSPITAL
PARTNERS IN HEALTH
ISTANBUL, TURKEYAPRIL 2008
GOAL OF TREATMENT
TO DELIVER CARE TO ALL PATIENTS
AND
PROTECT THE POPULATION BY PREVENTING THE AIRBORNE TRANSMISSION OF M. TUBERCULOSIS
BASELINE SITUATION IN PERU 1996-1997
• In 1980s, history of therapeutic anarchy and incomplete treatment that led to drug-resistance
• A very good national TB program • Good coverage in urban slum areas• Decentralized; free• MDR-TB was 3% of new cases and
15% of re-treatment cases
August 1996DOTS-Plus project initiated in Lima’s Northern Cone by Partners In Health and Harvard
Medical School, with the Peruvian National TB Program
.MDR-TB Treatment Using Health- promoters (CHWs)
• Know the community well• Lives near the patient• Previous experience in the
community• Receives training in MDR-TB
management• Is an community-based extension
of the health system• Can link up with resources
necessary to enable treatment
Health-promoters provide:
• Accompaniment • Food • Housing and infection control in homes• Transportation• Individual and group therapy
“I began working in SES because I felt I would be closer to the community and I thought that if I am from Carabayllo it was my duty to fight for those that were poorer than me…”
—Health promoter from the first group recruited
Health promoters and social support
• Accompaniment • Social support
– Nutritional supplementation
– Housing assistance– Transportation
stipends• Individual and group
therapy
• Patient-centered care – Communication – Detection and management of social and clinical
factors hindering patient recovery (comprehensive approach)
• Adherence to treatment ( abandonment)• TB/MDR-TB contact tracing
Benefits of Out-patient management
• Patient– Patients can be isolated from their communities– Although care is available, they may not be able to
access it if it is not available close to where they live
• Care in the community– Community member’s can become health promotors– May understand/relate better the issues faced by patients– Share language and culture– Empower the local community from within
Benefits of Out-patient management
Lessons from Peru
• Possible to successfully treat TB and MDR TB in an ambulatory setting• Critical components of care:
– Accompaniment: proper patient supervision, aggressive adverse-effects management and monitoring, and psycho-social support
– “Wraparound services”: food, transportation stipends, economic assistance, etc.• Expanded collaboration from one area in Lima to all of Lima, and
subsequently, to 11 rural regions– Hired and trained 700 community health workers – 6227 patients ever enrolled as of April 2007
Outcomes in 66 pts (Mitnick et al 2003)
died7.58%abandoned
7.58%failed1.52%
cured83.33%
Outcomes in 66 pts (Mitnick et al 2003)
died7.58%abandoned
7.58%failed1.52%
cured83.33%
died10%
cured31%
abandoned12%
active47%
Treatment outcomesas of April 2007
Lessons learned from Peru
• Possible to successfully treat TB and MDR TB in an ambulatory setting
• Critical components of care:– Accompaniment: proper patient supervision,
monitoring, and psycho-social support– “Wraparound services”: food, transportation
stipends, economic assistance, etc.
Lesotho: Basic Data
• Ranks 120 out of 140 on Human Development Index• Only 7% of households have electricity• Only 11.9% of households have running water• 0.043 physicians per 1,000 population• Life expectancy has dropped to 35 years• HIV prevalence 25%• In 2005, reported more than 10,000 cases of TB
(4th highest TB prevalence in the world; 465/100,000)
The extent of drug-resistant TB
Smear + 41%
Smear -59%
~10,000 cases
~70% drug-susceptible
TB
~10% MDR-TB
~20% PDR-TB Continued transmission
~20% PDR-TB
~10% MDR-TB
Susceptible to MDR-TB
Susceptible to re-infection
Higher extra-pulmonary TB
~76-92% HIV+
WHAT ARE THE BARRIERS TO CARE?Lack of:• Diagnostic capacity for TB and MDR-TB• Facilities to care for very sick patients• Infection control in a high HIV setting• Second-line drugs to construct effective regimens• A mechanism to deliver MDR-TB care• Trained human resources
Extreme poverty (the social and economic devastation—legacy of colonialism and apartheid)
Facility to care for the very sick: Refurbished state hospital at Botsabelo to create an MDR-TB referral facility and center of excellence
Infection control in a high HIV setting: masks for all staff and state-of-the art ventilation in facilities
Mechanism to deliver MDR-TB care and trace contacts: Trained health workers to deliver care in the community on a daily basis and are able to trace contacts
Important Elements of Successful Out-patient Management of MDR-TB
• Appropriate technology for the diagnostic challenge
• Community-based care with hospital back-up for the very sick
• Programmatic solutions for social structural barriers to care
HELPING ALL PATIENTS TO BE APPROPRIATELY DIAGNOSED AND TO ACCESS CARE
Factors associated with MDR-TB in Tomsk
Treatment Program
• Inadequate drug regimens for re-treatment
• Unsupervised therapy (no DOT)
• Unreliable drug supply
• Limited political will
• Poor outpatient management systems
Transmission
• Excessive incarceration
• High prevalence of drug resistance
• Rising HIV
• Inpatient management of TB patients during intensive phase
Social/structural context of the post-Soviet period:
• poverty and unemployment• breakdown in state structure • substance abuse• breakdown in family structure• anomie
Tomsk Oblast characteristics
• Density of population varies from 0.3 to 8.8 per km2
• World’s largest swamp
• One fifth of the oblast is covered with rivers
• Only a half of the district (raion) centers are connected with Tomsk City by asphalted roads
Challenges to the Implementation of DOTS-Plus in Tomsk Oblast
• Landscape/Terrain of region• Patient-related issues linked to poverty in post-Soviet period
Patient-related Challenges
• Poverty, poor living conditions, poor nutrition• Alcoholism, drug abuse• Long distances between medical center and patients’ homes in both
urban and rural places• Other priorities: children, job, family problems etc.
• 18-24 month-long course of treatment• BID to TID drug intake of 4-7 medications• Side effects common: almost all patients experience side effects, and
about 10% of patients experience severe side effects• Some patients have severe comorbidities (e.g. diabetes and
alcoholism), which worsen the tolerance of the medications
Challenges to the Implementation of DOTS-Plus in Tomsk Oblast
• Landscape/Terrain of region• Patient-related issues linked to poverty in post-Soviet period• Programmatic challenges
SELECTED CHARACTERISTICS
• Age (mean) 32• Male 86%• Prison 45%• Civilian 55%• Employed 17%• Married 38%• Disability 42%• Homeless 3.3%• Mean previous
treatments: 2 (1-6)• Yrs with TB before
MDR Rx 3.3 (0.1-28.3)
• TB contact 67%• HCW 2.5%• Previous prison 64%• Low BMI 42%• Co-morbidity
– Abnormal LFTs 18%– Substance abuse 50%
• Alcohol hx 35%• Alcohol during Rx 32%• IVDU 18%
• Tobacco use 88%• Cavitary and bilateral
disease 66%
If the patient has the right to care, what needs to be done in order to ensure that they receive care?
Find programmatic solutions for all barriers to care.
Case detection and management of TB and MDR-TB in Tomsk Oblast
General polyclinics:Active and passive
General hospitals:Passive
TB dispensary, rural TB officesAmong TB contacts
Rural clinics,Hospitals
Active and passive
TB Committee in Tomsk TB dispensary (OKEK)
PRISON
PRISONTB Hospital
TB Hospitals Day Care Hospital: TB dispensary
Rural TB offices,Rural feldsheror doctor clinics
Ambulatory treatment
Collaboration with Red CrossHome visits
Collaboration with Red Cross
• Improvement of facilities
• Transportation assistance for patients and health workers
• Food assistance for patients
SOLUTIONS
Case detection and management of TB and MDR-TB in Tomsk Oblast
General polyclinics:Active and passive
General hospitals:Passive
TB dispensary, rural TB officesAmong TB contacts
Rural clinics,Hospitals
Active and passive
TB Committee in Tomsk TB dispensary (OKEK)
PRISON
PRISONTB Hospital
TB Hospital Day Care Hospital: TB dispensary
Rural TB offices,Rural feldsheror doctor clinics
Ambulatory treatment
Collaboration with Red CrossHome visits
Collaboration with Red Cross
Sites where food is given to patients
• Improvement of facilities
• Transportation assistance for patients and health workers
• Food assistance for patients
• Choice of treatment site: TB hospital (intensive phase), day hospital, polyclinic, Red Cross clinic, home
SOLUTIONS
Case detection and management of TB and MDR-TB in Tomsk Oblast
General polyclinics:Active and passive
General hospitals:Passive
TB dispensary, rural TB officesAmong TB contacts
Rural clinics,Hospitals
Active and passive
TB Committee in Tomsk TB dispensary (OKEK)
PRISON
PRISONTB Hospital
TB Hospital Day Care Hospital: TB dispensary
Rural TB offices,Rural feldsheror doctor clinics
Ambulatory treatment
Collaboration with Red CrossHome visits
Collaboration with Red Cross
Sites where patients can receive care
• Improvement of facilities
• Transportation assistance for patients and health workers
• Food assistance for patients
• Choice of treatment site: TB hospital (intensive phase), day hospital, polyclinic, Red Cross clinic, home
• Improved side effect management (provision of ancillary medications)• Improvement of working hours at medical facilities to make it more convenient
for patients• Treatment at home for patients who are unable to ambulate or who live too far • Use of volunteers (e.g. neighbors) for DOT• Rapid search for non-adherent patients and defaulters• The use of enablers and incentives
SOLUTIONS
TREATMENT OUTCOMES OF FIRST COHORT (N=244)TOMSK, RUSSIA
Cure77.0%
Failure6.6%
Death4.9%
Default11.5%
Success stories for community-based care:
– Peru
– Tomsk, Russian Federation
– Latvia
– Manila, Philippines
– Zugdidi, Georgian Republic
– Nepal
– PACT program in the United States
• Directly Observed Therapy (DOT) is more than just observation:
• It is the direct observation of patients taking their medicines• It is the documentation of the visit• It allows a daily rechecking of the patient medications • It is the control of side effects• It involves home visits if patients do not come to the clinic• It involves looking for patients who are non-adherent or are
defaulting
• DOT is an extension of the clinic into the patients community• The system of DOT can be used to find programmatic solutions to
patient barriers
IMPORTANT ELEMENTS
• Food assistance for patients
• Choice of treatment site
• Improved side effect management (provision of ancillary medications)
• Improvement of working hours at medical facilities to make it more convenient for patients
• Treatment at home for patients who are unable to ambulate or who live too far
• Use of volunteers (e.g. neighbors) for DOT• Rapid search for non-adherent patients and defaulters• The use of enablers and incentives
IMPORTANT ELEMENTS
Incentives for patients:• improved nutrition in the hospital with snacks• hot meals at the day hospital• food packets monthly for adherent patients• travel vouchers (government provided)• small gifts for adherence• help with passports, access to pensions, etc.
Incentives for staff:• hot meals at the day hospital• food packets monthly for rural health workers and nurses
IMPORTANT ELEMENTS