Operational Plan for Comprehensive HIV and AIDS Care, Management and Treatment for South Africa

1
Operational Plan for Comprehensive HIV and AIDS
Care, Management and Treatment for South Africa

2
Cabinet Mandate

• On 8 August 2003 Cabinet requested the
  Ministry of Health to
• as a matter of urgency, develop a detailed
  operational plan on an antiretroviral
  treatment programme
• by the end of September 2003

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Pillars

• Ensuring that the uninfected remain HIV negative
• Prevention and changing lifestyles and behaviour
• Broader context - social programmes of
  Government and the wider society that aim to
  reduce poverty through job creation and social
  support
• 5.3 million HIV progress as slowly as
  possible to developing AIDS
• Appropriate treatment of AIDS-related conditions
  including the use antiretroviral therapy in
  patients presenting with low CD4 counts to
• Improve functional health status
• Prolong life

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Guiding Principles

• Quality of Care
• Universal and Equitable Implementation
• Strengthening the National Health System
• Re-informing Prevention
• Providing a Continuum of Care

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Guiding Principles

• Sustainability
• Promotion of healthy lifestyles
• Promotion of individual choice of treatments
• Integration
• Safety of Medicines
• TB

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Goals

• Provide comprehensive care
• Strengthen the National Health System

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Prevention, Care and Treatment of HIV and AIDS

• Prevention, care and treatment
• Nutrition-related Interventions
• Traditional Medicine

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Care and Treatment Plan

• Aim
• prolonged and improved quality of life
• Approach
• Continuum of care
• Service coordination and integration
• Referral systems
• HBC approach
• Integration into current services
• E.g. VCT, PMTCT, TB, PEP, STI management,
• Add on ARVs for people who have progressed to
  stage 3 or 4

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HIV negative
HIV INFECTION DISEASE PROGRESSION
exposure to HIV
Flu like illness

• IEC
• Barrier Methods
• PMTCT
• PEP
• Ongoing counselling

HIV positive
Asymptomatic
Symptomatic -diarrhea -Oral thrush -Weight
loss -TB -Pneumonia

• VCT Avail.
• Counselling
• Support
• Nutrition
• Healthy Life Style

AIDS Disease
Treatment available for OIs
ARV
Death
Year 0
Year 5
Year 10
Year 8
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HIV Testing, Counselling and Clinical Staging
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DRUG REGIMENS
Regimen Drugs Test Frequency
1a d4T / 3TC / NVP CD4 VL ALT Staging, 6-monthly Baseline, 6-monthly Baseline
1b d4T / 3TC / efavirenz CD4 VL Staging, 6-monthly Baseline, 6-monthly ALT
2 AZT / DDI / Lopinavir/ritonavir CD4 FBC Fasting cholesterol Staging, 6-monthly Baseline, 1, 3, 6 mo, continue 6-monthly Baseline only
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Paediatric ARV Regimens and Routine Monitoring on
ARVs
Regimen Drugs Test Frequency
1a d4T/3TC Lopinavir / Ritonavir CD4 VL ALT Chol/TG Staging, 6 monthly Baseline, 6 monthly Baseline Baseline, 12 monthly
1b d4T/3TC/NVP CD4 VL ALT Staging, 6 monthly Baseline, 6 monthly Baseline, 1m, 6 monthly
1c d4T/3TC efavirenz CD4 FBC Staging, 6 monthly Baseline, 1,3,6 mo, 6 monthly
2a AZT/ddI Lopinavir / Ritonavir CD4 FBC Chol/TG Staging, 6 monthly Baseline, 1,3,6 mo, 6 monthly Baseline, q 12 monthly
2b AZT/ddI Efavirenz or NVP CD4 ALT FBC 6 monthly Baseline, 1mo, 6mo (NVP only) Baseline, 1,3,6 mo, then 6 monthly
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Paediatric ARV Regimens and Routine Monitoring on
ARVs

• Notes
• d4T syrup requires refrigeration. If no
  refrigerator at home, switch d4T to AZT.
  Clinician discretion to substitute ABC for d4T in
  infants gt 3 months of age.
• NVP - Choice between first-line regimens is
  informed by (a) previous exposure to NVP within
  last 12 months consider lopinavir/ritonavir (b)
  children without history of NVP exposure can
  receive regimen 1b or 1c, 2b is 2nd line if
  regimen 1a was given
• efavirenz - limited to children gt3 yrs of age and
  gt13 kg.
• For drug failure criteria in paediatrics refer
  to Continuum of Care Building for HIV -
  Paediatric Section, developed by the national
  Department of Health
• Staging initial testing for all
  infants/children after confirmed HIV-positive
• Baseline for ARV eligible children at time of
  ARV initiation
• (See Annex I.6 for paediatric ARV detailed dosing
  and drug information)

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Nutrition

• Contextualised within broader nutritional
  strategies in Government
• Criteria
• Individual with TB and/or HIV and AIDS
• No secure food
• Monthly supply of nutritional supplement
• Monthly supply of supplementary meal
• DOH will
• Review and set specifications of supplement meals
• Review criteria for implementation
• Negotiate on pricing and supply
• Evaluate ongoing research
• Develop appropriate training material
• Coordinate with Social Development Agriculture

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Traditional Healers

• Role and function in the continuum of care if
  recognised (prevention, treatment, care and
  support)
• Compliance, adherence, adverse event reporting,
  referral system
• Ensuring safe traditional health practices
• Support the development of QA mechanisms and
  establishing training priorities
• Research
• traditional medicines on immune system
• Interaction with ARVs, TB and STI treatment

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Human Resources and Facilities

• Accreditation of Service Points
• Human Resource Training
• Provincial Site Assessments

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Strengthening and Accreditation

• Objectives
• Provision of a continuum of care
• Gold standard of care
• Equitable manner
• Service site
• Single facility or grouping of facilities which
  combined meet accreditation criteria
• Can include NGOs, private sector etc.

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Strengthening and Accreditation

• Accreditation requirements which broadly address
  capacity w.r.t. HR, labs, pharmacies, drug
  procurement distribution, referral patterns etc
• Process
• National defines requirements
• Provincial assessment teams for site evaluation
  identification of gaps and developing
  strengthening plan to address gaps (with time
  frames)

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Context of Human Resources in Health

• Public system is under-funded and resources not
  equitably spread across country
• Long-standing vacancies across categories acute
  for dieticians, nutritionists and pharmacists
• Half of hospital beds are occupied by patients
  being treated for AIDS-related illnesses
• 15 of health care workers are HIV-positive

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Short-Term Strategy

• Recruitment strategy to attract new graduates
• Service contracts with health professionals in
  private practice
• Partnerships with the private sector, NGOs and
  CBOs
• Incentives to support health professionals with
  scarce skills and in rural areas
• Streamline requirements for registration of
  foreign health professionals to work in public
  and rural health services
• Development of human resource and skills
  development plans for years 2 - 5

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Short-Term Strategy

• National Training Programme
• Establishment of regional training centres
• Standardised curricula for comprehensive training
  of health professionals in the identified service
  points
• Training of existing health professionals
• Multi-skilling of available health professionals
• Training of utilisation of community service
  practitioners for 2004 to address the immediate
  gaps
• Telephonic clinical consultation support at a
  provincial level for all health professionals
  providing ART treatment care
• Development of skills development plans for years
  2- 5

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Operational Issues

• Drug procurement
• Drug distribution
• Laboratory services

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Drug Procurement

• Key elements
• Reliability, security and sustainability
• Quality
• Sufficient volumes consistently with envisaged
  demands
• Affordability
• Local production

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Drug Procurement

• Approach
• Pooled procurement
• Flexibility
• Compliance with regulatory standards Medicines
  Act, Patent Act, TRIPS
• API production
• Parallel importation
• Activities
• Tendering
• Supplier pre-qualification
• Request for proposals
• Contracts
• Monitoring Evaluation
• Administrative Issues Programme Assessment

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Drug distribution

• Reliable supply consistently through
• Inventory management
• Patient prescription information
• Secured storage facilities
• Efficient secure transport
• Improved packaging
• Key Activities
• Provincial Depot Level (Contingency stock plan)
• Public Health Service level (Pharmacy Contingency
  stock plan)
• Accreditation (checklist)
• Prescription tracking

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Laboratory Services

• Key in disease staging, monitoring
• Infrastructure
• List of baseline tests (biochemistry, full blood
  count)
• Diagnostic, clinical monitoring, viral resistance
• Viral load, CD4
• Strengthening of system
• Facility location
• Volumes
• Transportation
• Turnaround times
• Staffing
• Research

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Social Mobilisation and Communication

• Guiding Principles
• Content
• Balance prevention and care
• Clear messages on ARVs
• Information on the programme
• Healthy lifestyles
• Nutrition
• Adherence
• Process
• 3 tiers of government focus on political
  leaders and key opinion-makers
• PLWHA
• General public
• Health care providers, including traditional
  healers
• Families, communities and caregivers
• NGOs and CBOs
• Sectors of civil society

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Information, Monitoring and Research

• Patient Information System
• Monitoring and Evaluation
• Pharmacovigilance
• Research

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Patient Information System

• Aim
• collect patient-related information to monitor
  compliance, adherence, response etc.
• Standardised forms (integrated with ME)
• Patient-linked through personal identifier
• Build on existing data and IT infrastructure
• Upgrading existing data management IT
  capabilities
• Paper-based systems backup
• Integrated with electronic patient records

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Pharmacovigilance

• Aimed at providing safety profiles for patients
  and determine morbidity mortality associated
  with the use of ARVs
• Existing programme at UCT, but this initiative
  focuses on supporting the ARV rollout
• Strong technical and training support to specific
  groups/audiences

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Research

• Aim
• developing a research agenda for research which
  defines most effective provision of care and
  treatment
• Primary focus operational/health systems and
  behavioural as well as resistance monitoring
• Structures and process to build on current
  arrangements with an advisory group advising on
  priority research and support of the programme

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Funding

• Presents a national budget
• Details all resource requirements for
  implementation
• Combined to provide a uniform estimate of the
  resources required to support the integrated HIV
  and AIDS care and treatment plan over a five-year
  period

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Prevention Component

• Funding for prevention
• The JHTTT report noted the fundamental importance
  of maintaining and strengthening an effective HIV
  prevention programme, and that the availability
  of resources for prevention must not be
  compromised by the expansion of the care and
  treatment response.
• Funds allocated for Prevention through the
  existing enhanced response programme
• R550m per year allocated

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Budget Estimates

• 2003/4 - R296 million
• 2007/8 - R4.5 billion
• 2007/8 includes
• R1 billion - health professionals
• R1.6 billion - ARVs
• R800 million - laboratory monitoring
• R650 million nutritional support

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New cases starting ART
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Strengthening and Upgrading the Health System

• Staffing Requirements
• Upgrading Facilities and Pharmacies
• Upgrading Patient Information, Monitoring
  Evaluation Systems
• Upgrading the National Health Laboratory Service
• Maintaining Health After HIV Infection
• Nutritional Support and Supplementation
• Diagnostic Monitoring Following Diagnosis of HIV
  Infection

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Budget
Total Programme Budget Estimate (Millions of
Rands)
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Challenges

• Strengthening prevention programmes
• Strengthen VCT, PMTCT synergistic effect
• The recruitment, training and retention of
  health care professionals
• Building strong partnerships between health
  facilities and community support structures
• Strong communication and community mobilisation
• Additional financial resources
• Complex to manage integrated

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Challenges

• Improving the integration of services at facility
  level
• Integration of traditional and complementary
  medicines with Western therapies
• Strengthening the National Health Laboratory
  System to meet the demands of the programme
• Coordination of human resources, training,
  laboratory services, pharmaceutical services,
  drug procurement, and information systems
• Ensuring high quality of care in the private
  sector
• Pharmacovigilance in the public and private
  health sectors
• Good patient information