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

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

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

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

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

Goals Provide comprehensive care Strengthen the National Health System

Prevention, Care and Treatment of HIV and AIDS Prevention, care and treatment Nutrition-related Interventions Traditional Medicine

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

HIV negative exposure to HIV Flu like illness HIV positive Asymptomatic Symptomatic -diarrhea -Oral thrush -Weight loss -TB -Pneumonia AIDS Disease Death Year 0Year 5Year 10Year 8 HIV INFECTION DISEASE PROGRESSION IEC Barrier Methods PMTCT PEP Ongoing counselling VCT Avail. Counselling Support Nutrition Healthy Life Style Treatment available for OIs ARV

HIV Testing, Counselling and Clinical Staging

DRUG REGIMENS RegimenDrugsTestFrequency 1ad4T / 3TC / NVP  CD4  VL  ALT  Staging, 6-monthly  Baseline, 6-monthly  Baseline 1bd4T / 3TC / efavirenz  CD4  VL  Staging, 6-monthly  Baseline, 6-monthly ALT – 2AZT / DDI / Lopinavir/ritonavir  CD4  FBC  Fasting cholesterol  Staging, 6-monthly  Baseline, 1, 3, 6 mo, continue 6- monthly  Baseline only

RegimenDrugsTestFrequency 1ad4T/3TC Lopinavir / Ritonavir CD4 VL ALT Chol/TG Staging, 6 monthly Baseline, 6 monthly Baseline Baseline, 12 monthly 1bd4T/3TC/NVPCD4 VL ALT Staging, 6 monthly Baseline, 6 monthly Baseline, 1m, 6 monthly 1cd4T/3TC efavirenz CD4 FBC Staging, 6 monthly Baseline, 1,3,6 mo, 6 monthly 2aAZT/ddI Lopinavir / Ritonavir CD4 FBC Chol/TG Staging, 6 monthly Baseline, 1,3,6 mo, 6 monthly Baseline, q 12 monthly 2bAZT/ddI Efavirenz or NVP CD4 ALT FBC 6 monthly Baseline, 1mo, 6mo (NVP only) Baseline, 1,3,6 mo, then 6 monthly 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 > 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 >3 yrs of age and >13 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)

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

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

Human Resources and Facilities Accreditation of Service Points Human Resource & Training Provincial Site Assessments

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.

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)

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

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

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

Operational Issues Drug procurement Drug distribution Laboratory services

Drug Procurement Key elements: –Reliability, security and sustainability –Quality –Sufficient volumes consistently with envisaged demands –Affordability –Local production

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

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

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

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

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

Patient Information System Aim –collect patient-related information to monitor compliance, adherence, response etc. Standardised forms (integrated with M&E) 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

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

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

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

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

Budget Estimates 2003/4 - R296 million 2007/8 - R4.5 billion 2007/8 includes: –R1 billion - health professionals –R1.6 billion - ARV’s –R800 million - laboratory monitoring –R650 million – nutritional support

New cases starting ART

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

Budget Total Programme Budget Estimate (Millions of Rands)

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

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