1 gh friedland, md tuberculosis and hiv models for tb programmes to contribute to the delivery of...
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GH Friedland, MD1
Tuberculosis and HIV
Models for TB programmes to contribute to the delivery of ART
What are the operational research questions?
Gerald Friedland, MDAIDS Program
Yale University School of Medicine
GH Friedland, MD2
• TB and HIV-two cultures• Minimal TB and HIV Program needs• Spectrum of collaboration/integration• Case studies• Operational research issues
Models of TB/HIV Care
GH Friedland, MD3
HIV/TB-Two Cultures
• TB culture: public health approach, with firmly established algorithms, fixed and standardized measures and outcomes
• TB services: geared for chronic care-but relatively short term, standardization, simplified regimen , epidemic control, difficulty with individual nuance and new TB diagnostic dilemmas with HIV disease
• HIV as an “intruder”: disrupting TB strategies andprograms
• HIV culture: individual patient and human rights approach, guidelines but no standardization, familiar with rapid treatment paradigm changes
• HIV services :clinically and patient oriented with only recent emerging public health practices; lifelong treatment, limited experience with TB treatment and public health approach
• TB as a challenge: discomfort with treatment in HIV setting
GH Friedland, MD4
• Comprehensiveness
• Continuity
• Competence
• Compassion
• Cost effectiveness
The Minimum for effective TB-HIV collaboration –
GH Friedland, MD5
The Minimum for effective TB-HIV collaboration – the TB side
• Counseling and Testing for to identify HIV infected• HIV/AIDS staff training/awareness• Co-trimoxazole prophylaxis for TB patients who are
HIV infected• Mechanism for referral for antiretroviral therapy for
TB-HIV co-infected patients who need it (?) • Primary and secondary HIV prevention education for
TB patients• Patient confidentiality
GH Friedland, MD6
• Active TB case finding for all HIV infected patients • TB staff training/awareness • Mechanism for referral for Dx and TB treatment(?)• Mechanism for continuation of HIV treatment• Tuberculin skin testing (TST) for HIV infected?• INH preventive therapy (IPT) for TST+• TB transmission prevention• Patient confidentiality
The Minimum for effective TB-HIV collaboration – the HIV side
GH Friedland, MD7
– Although delivery models differ, outcomes should be identical
– TB treatment success- cure/completion of therapy
– Reduction in HIV disease progression and mortality
– Decrease in transmission of both diseases
Models of TB/HIV CareOUTCOMES
GH Friedland, MD8
Need for many modelsOne model may not fit all countries
Differences in HIV and TB prevalenceDifferences in history, resources, culture, expertiseDifferences in feasibility
One model may not fit one country Urban vs. rural TB clinic vs. primary care clinic
Logical to maximize/exploit existing site infrastructureHospitals, clinics, existing TB DOTS and HIV VCT
programs, nascent HIV programs, availablehuman resources
Models of TB/HIV Care
GH Friedland, MD9
Current and Optimal TB and HIV Program Paradigms
Current TB and HIV Programs Paradigm
Optimal TB and HIV Programs Paradigm
National TB Program
HIV Services
VCTOI Px
AntiretroviralsAdherence Support
NationalHIV Program
NationalHIV Program
CommunicationCollaboration
TB Services
Sputum collectionDOT
Treatment SupportContact TracingLTBI Treatment
TB Services
Sputum collectionDOT
Treatment SupportContact TracingLTBI Treatment
HIV Services
VCTOI Px
AntiretroviralsAdherence Support
National TB Program
CommunicationCollaboration
GH Friedland, MD10
Which model of collaboration ?
TB HIV/AIDS
TB AIDS TB/AIDS
Separate
TB/ HIV patients referral
Full
One stop service for TB-HIV co-infected
TB AIDS
Partial
Some mixing
GH Friedland, MD11
1. HIV programs learn lessons from TB program with little to no integration of services
Malawi
2. TB programs serve as site for some integration and collaboration of services
START- Durban, Sizonqoba-Tugela Ferry
3. HIV and TB programs organized with full integration of services
Khayelitsha
Models of TB/HIV Care and Treatment
GH Friedland, MD12
Malawi model Anthony D Harries, HIV/AIDS Unit,
Ministry of Health, Malawi
• HIV program learns from and uses DOTS model• No true integration of TB and HIV care• Appropriate in Malawi
– Poor infrastructure with very few physicians – Large population with immediate need to start a
significant number of patients on ART• 1 million people infected with HIV• 170,000 people needing HAART
GH Friedland, MD13
Apply Tuberculosis Control structure to HIV treatment and care is one “model”
• Standardised diagnosis and case finding
(smear microscopy and well defined types of TB)
• Standardised treatment
(three treatment categories to cover all types of TB)
• Standardised recording and reporting system
(treatment cards, registers, cohort analysis, monitoring)
• Standardised system of drug procurement
• Management by paramedical officers
• Free drugs for patients
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Standardised Treatment Outcomes
TB Programme:• Cured • Treatment completed• Dead• Defaulted• Failed• Transferred out
ART delivery:• Alive and on ART• Dead• Defaulted• Stopped treatment• Transferred out
GH Friedland, MD15
TB programs serve as site for some integration and collaboration of services
The START study
• Demonstrate effectiveness and safety of HIV/TB integrated treatment strategy in an urban, resourced setting- Prince Zulu Communicable disease clinic, Durban, KwaZuluNatal, South Africa
• Partnership of:– I kithweni Muncipality Department of Health– CAPRISA- US NIH– Nelson R Mandela School of Medicine– Yale University, Columbia University– Irene Diamond Fund, Doris Duke Charitable Foundation
GH Friedland, MD16
START-PilotTB program staff strengthened
Patients with active TB offered HIV counseling & testing
ONCE-DAILY ART (DDI, 3TC, EFAVIRENZ) given concomitantly with standard TB DOT regimen (INH, RIF, ETH, PZA) 5 d/wk with weekend ART self administration
Adherence training and social support emphasized
Transition to ART self-administration at TB Rx completion-Referral to HIV Clinic
Assessment of viral load, CD4, mortality, side effects and toxicities
Assessment of acceptability and cost
GH Friedland, MD17
GH Friedland, MD18
Pilot START ResultsMean Viral load and CD4 change over 21 months
1
1 0
1 0 0
1 0 0 0
1 0 0 0 0
1 0 0 0 0 0
1 0 0 0 0 0 0
0 2 3 4 6 2 1
Me
an
Vir
al
Lo
ad
(c
op
ies/
ml)
0
5 0
1 0 0
1 5 0
2 0 0
2 5 0
3 0 0
3 5 0
4 0 0
4 5 0
Me
an
Ab
solu
te C
D4
Co
un
t (c
ell
s/u
l)
M e a n V ir a l L o a dM e a n C D 4 C o u n t
Self administration
GH Friedland, MD19
TB programs serve as site for some integration and collaboration of services
Sizonq’oba study
• Demonstrate effectiveness and safety of HIV/TB integrated
treatment strategy in a rural, resource-poor setting, Tugela
Ferry, KwaZuluNatal, South Africa
GH Friedland, MD20
The Sizonq’oba rural study
• Project outline: – Strengthening of TB DOT program– Merging TB DOT and Home Based Care Program – Training of physicians, nurses, community health workers-TB and HIV
– TB pts identified in hospital, receive VCT– Once-daily DOT ART added to Home-based /TB DOT program and given with
TB meds in community– Community and family social and adherence support– Community and clinical monitoring for benefit and risk. – Transition to self-administration at completion of TB therapy
– Cost effectiveness study– Sexual risk study
– Separate records, mostly separate staff, program monitoring, reporting, funding
GH Friedland, MD21
adherence support group
GH Friedland, MD22
Integrating 2 vertical services : HIV/AIDS and TB services , Khayelitsha, South Africa
David Coetzee, Eric Goemere
2000: opening HIV/AIDS clinics in public services, next to the TB clinic
2001: first HAART patient … > 1400 patients 9-05
2002: VCT re-enforced in TB service and easier access to HAART
2003: merging both buildings and stepwise integration of HIV and TB services
GH Friedland, MD23
Objectives of TB/HIV integration
• For TB patients• To stimulate VCT among TB clients
• 47 % counselled and 87 % accepted testing-(8-40 Gugulethu) 63 % co-infection
• To accelerate access to HAART for TB/HIV co-infected
• To reduce TB incidence among HIV patients
• To improve TB diagnostic algorithms
• To increase adherence and cure rate among TB patients by using the HIV adherence tools
• HIV 95% (36 mos vs TB ~75% Rx completion
• HIV adherence tools and counselors
GH Friedland, MD24
Objectives of TB/HIV integration
• For HIV patients
• To have an easier access to TB diagnosis and treatment
• To develop a one stop service
• To benefit from existing TB network to support HIV
• For the health services
• To pool TB and HIV staff and integrate training
• To improve staff morale
GH Friedland, MD25
develop a one stop service
• Both building have been merged • 2 different patient flows
– TB non co-infected :2 clinical visit/episode– HIV and co-infected :monthly clinical visit
• A positive impact on TB/HIV patients:– Reduced queuing time– Improved clinical monitoring– Allow adjustment for treatment interactions
• A negative impact on non-co-infected TB cases
GH Friedland, MD26
pool TB and HIV staff and integrate training
• Tb and HIV staff now able to rotate between services • No recruitment out of existing TB service but rather
re-enforcement • Improved staff morale with improved treatment
outcomes• New clinical career path for TB staff• Renewed doctor’s interest in TB
GH Friedland, MD27
Operational Issues in TB and HIV Care
• How to improve diagnosis of HIV in TB patients• Expand voluntary counseling and testing•Provide rapid point of care HIV testing• Provide routine counseling and testing in TB patients• Encourage provider based testing•Perform opt out vs. opt in testing
•How to improve diagnosis of TB and LTBI in HIV patients• Develop algorithms for clinical assessment of TB disease• Develop and use of rapid diagnostic tests
GH Friedland, MD28
Operational Issues in TB and HIV Care
• How to improve treatment of HIV in TB patients• Determine best setting(s) to initiate and continue antiretroviral
therapy in co-infected patients Degree of integration/collaboration
• Elucidate mechanisms to support adherence• Define the role of DOT in antiretroviral therapy
Identify most effective DOT dose, intensity and duration Determine most appropriate person(s) to provide
treatment• Determine role of non-physician health care workers• Determine role of community and family
• Determine training needs
• Determine how to minimize occupational/nosocomial risk from HIV and TB
GH Friedland, MD29
Operational Issues in TB and HIV Care
• How to improve treatment of HIV in TB patients
• Determine optimal time to start antiretroviral therapy
• Identify optimal antiretroviral regimens to use
• Determine how rifampin interactions with antiretroviral agent effect clinical outcomes
• Identify proper dose of antiretrovirals in the presence of rifampin
• Conduct observational and clinical trials to assess treatment effectiveness in co-infected patients
• Establish appropriate schedules for toxicity and efffectiveness monitoring
GH Friedland, MD30
Operational Issues in TB and HIV Care
•How to improve the treatment of TB in HIV patients• Determine ways to strengthen existing TB programs • Evaluate measures of treatment success• Examine role of newer diagnostic tests to assess treatment success.• Determine optimal duration of therapy
•How to accommodate differing TB and HIV traditions and practices
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