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PRINCIPLES OF OUT-PATIENT MDR-TB TREATMENT & MANAGEMENT SALMAAN KESHAVJEE, MD, PHD HARVARD MEDICAL SCHOOL BRIGHAM AND WOMEN’S HOSPITAL PARTNERS IN HEALTH ISTANBUL, TURKEY APRIL 2008

SALMAAN KESHAVJEE, MD, PHD HARVARD MEDICAL SCHOOL … · 2019. 9. 23. · BASELINE SITUATION IN PERU 1996-1997. • In 1980s, history of therapeutic anarchy and incomplete treatment

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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

MODELS FOR RESPONDING TO THE EPIDEMIC I: THE CASE OF PERU

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.

MODELS FOR RESPONDING TO THE EPIDEMIC II: THE CASE OF LESOTHO

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)

Open Society Institute/Pep Bonet

Open Society Institute/Pep Bonet

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+

Open Society Institute/Pep Bonet

Open Society Institute/Pep Bonet

Courtesy of Tara Loyd

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

Open Society Institute/Pep Bonet

Open Society Institute/Pep Bonet

Infection control in a high HIV setting: masks for all staff and state-of-the art ventilation in facilities

Open Society Institute/Pep Bonet

Open Society Institute/Pep Bonet

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

Open Society Institute/Pep Bonet

Poverty: Support for patients and families with food, housing, fuel and transportation

Open Society Institute/Pep Bonet

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

MODELS FOR RESPONDING TO THE EPIDEMIC III: THE CASE OF TOMSK

Tomsk Oblast Population:1,073,600

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

Challenges to the Implementation of DOTS-Plus in Tomsk Oblast

• Landscape/Terrain of region

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

Source: Russian Ministry of Health and Social Development 2007

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.

• Improvement of facilities

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 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

SOLUTIONS

• 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

Area = 317,000 km2

Population = 1,073,600

Tomsk

Prison pilot program Civilian pilot program

Tomsk

TREATMENT OUTCOMES OF FIRST COHORT (N=244)TOMSK, RUSSIA

Cure77.0%

Failure6.6%

Death4.9%

Default11.5%

MODELS FOR RESPONDING TO THE EPIDEMIC IV: LESSONS LEARNED

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

THANK YOU