National Scaling up of ARV therapy in Malawi: the past and the future

1. National Scaling up of ARV therapy in Malawi:the past and the future Simon Makombe HIV Unit Ministry of Health, Malawi

2. Malawi • 11.5 million people; GNP $200 per capita • 900,000 people infected with HIV • 170,000 people needing ART • 4,000 people on ART in January 2004 [9 sites; no standardised systems]

3. DURBAN 2000XIII World AIDS Conference Countries in sub-Saharan Africa began to think about antiretroviral therapy (ART)

4. Malawi: important steps to ART • Dec 2000: Vice-president AIDS conference • Aug 2001: DOTS-system for ART [Lancet 2001] • Jul 2002: Global fund submission • Oct 2003: National ARV Guidelines • Feb 2004: National ART Scale-up Plan

5. The “medicalised model” in Malawi Doctors to deliver ARV treatment Choice of multiple ARV regimens Mandatory laboratory monitoring “ LFTs, FBC, CD4-counts” Computers to track patient follow-up will preclude rapid and massive scale up

6. The Key is “Keep it standardised and simple”

7. ART Plan (2004-2005): main elements for the public sector • 60 facilities selected for rapid phased scale up • Free ART to HIV-positive eligible patients • One first-line ART regimen only “Triomune” • “Push” system of ART supply to facilities • Standardized system of monitoring/reporting • Quarterly structured supervision

8. The Process of Scale-Up Hospitals briefed and asked to submit applications to be ART sites Intensive training schedule focused on ART Guidelines Hospitals formally accredited for ART ARV drugs distributed and ART delivered to patients

9. Site Classification Low Burden - 25 new pts/month Medium Burden -50 new pts/month High Burden -150 new pts/month Starter/ Continuation Kits Starter Kit – first 2 weeks supply of drugs for 75 new patients (Triomune and Lamivir) Continuation Kit – 1 month supply of drugs for 75 patients for 3 continuous months (Triomune) Drug Procurement

10. ART administration to patients

11. Eligibility for ART • Positive HIV test • An understanding of the implications of ART • WHO Clinical Stage III or Clinical Stage IV • (CD4 counts < threshold where applicable)

12. HIV-positive same day Staged clinically as eligible for ART with no contraindications within one week Attendance at group counselling session one week Attendance for individual counselling and start of ART

13. Monthly Follow-up of Patients • Nurse led clinic – clinician review 3-monthly unless there is an earlier need • Patients weighed and screened with symptom-based enquiry • Patient master card completed • ARV drugs dispensed from clinic

14. REGISTRATION AND MONITORING AT FACILITIES

15. Standardised monitoring toolsborrowed from TB model • ARV Patient Treatment Master card • ARV Identity card for the patients • ARV Patient Register • ARV Drug Register • ARV Quarterly Cohort Analysis forms • ARV Supervision and Monitoring forms

16. National Data Collection and Supervision: Quarterly Site Visits

17. Progress in the Public Sector

18. 2006 - 2010: THE VISION • 5 year ART plan, which includes a 2 year detailed rolling budgeted plan ($47 million) • Goal: 50% Universal access, ie 45,000 new patients on ART per year

19. The Goal

20. CHALLENGES • Human resources • Physical infrastructure (rooms and pharmacies) • Drug supplies • Adequate finances • Ability to continue with national M&E • Integrity of the First Line regimen (drug resistance and long term side effects)

21. The Key will be “maintaining simplicity” • ? Simplify the registration / monitoring system • Reduce patient visits to 2- or 3-monthly • Decentralise to health centres • Allow a lower cadre to manage ART delivery • Maintain quarterly visits