1. Strategic Information for Anti-RetroViral Treatment Programmes Workshop WHO and UNAIDS Geneva June 30- July 2 2003 Ties Boerma HIV Department Surveillance, Research and Monitoring & Evaluation

2. OBJECTIVES OF THE MEETING Assess the needs for strategic information in the context of ART programmes Share experiences in developing monitoring and evaluation systems and other strategic information efforts Explore methods and techniques that can be considered for monitoring ART programmes Develop a list of priority strategic information issues faced by national programmes and large-scale projects and explore ways to address those issues

3. Primary goals of ART programmes - Enhance the length and quality of life of persons with advanced HIV infection - Reduce HIV transmission as a non-conventional prevention tool ** Provision ARV drugs to those who need it - HIV infected persons with advanced infection - Public health approach to delivery of drugs Inclusion of 12 ARVs on WHO Essential Drugs list Standardised combination ARV in poor settings: first and second-line regimens Recommend minimum requirements for safe monitoring of therapy Beginning of a district approach in countries Other elements and links HIV Testing and Counselling Treatment and prophylaxis of opportunistic infections Link with TB Control, PMTCT and Care&Support programmes DEFINING ART PROGRAMMES **Blower and Farmer, AIDScience, 2003, 3 (11)

4. Treatment as a disease control measure (e.g. tuberculosis) Reduced transmission Effective Case Management Case detection, Case treatment Case holding Therapeutic benefits for infected individuals - cure

5. ARV Treatment as a disease control measure Reduced transmission Effective Case Management Case detection, Case treatment Case holding Therapeutic benefits for infected individuals More HIV testing & counselling Stigma reduction Reduction in infectiousness of people on treatment Behavioural disinhibition Diverting resources from prevention Longer duration of infectiousness - + O F T A H C E T R O R S

6. DEVELOPING PROGAMMES Different models in different settings Models not yet well defined - roadmap Strategic information can play an important guiding role in the development of appropriate and effective programmes

7. STRATEGIC INFORMATION

8. WHAT DO WE MEAN BY STRATEGIC INFORMATION? DATA KNOWLEDGE ÎNFORMATION ACTION Analysis Understanding Application Generating information and knowledge to influence policy making, programme action, and research Assessment

9. WHAT KIND OF INFORMATION DO WE NEED? Needs, resources, access, coverage What are and will be the needs for treatment? What resources are available and what will be needed? How many have access? Who has access? Programme Monitoring & Evaluation Is the programme performing according to plans? Is the programme able to contain drug resistance development? Does the programme make a difference? Is it achieving its goals? How much does it cost and how cost effective is it? Patient monitoring Operations Research How can programme implementation be improved? What are the best models of implementation? What can be done to improve health systems? Research Can we provide more efficacious and more effective interventions? What impact do programmes have?

10. Needs, resources, access, coverage

11. Trends in Number of People Living with HIV infection 1980 - 2002 by WHO Region 2002 42 mln people living with HIV 5 mln new infections 3.1 mln deaths SEARO <1%

12. Heterogeneity in the African epidemic Median HIV prevalence (%) in antenatal clinics in cities by subregion in sub-Saharan Africa, 1997-2002

13. Strategic Information - Urban-Rural and Gender HIV prevalence among 15-54 years by place residence for men and women, Burundi, 2001 90% of the population 60% of HIV cases

14. Access to ARV Treatment for HIV: The 3 By 5 goal

15. Drug prices Resource availability Global Fund World Bank MAP US Government Health system capabilities STRATEGIC INFORMATION ON RESOURCES Resource needs GAPS

16. HOW MANY NOW? (COVERAGE) Build national monitoring systems Global coverage survey of key informants 2003 Global district access survey 2004

17. MONITORING AND EVALUATION

18. Input Process Output Outcome Impact A FRAMEWORK for Monitoring and Evaluation for ARV Therapy Programmes Resources Staffing Policies Training Logistics Management Education etc. Services available (testing & counseling, ART, lab) Quality services Public understands ART People on Treatment Knowledge HIV status Stigma lower Behavioural change Survival Quality of life HIV/STI transmission reduced

19. Input Process Output Outcome Impact DATA COLLECTION for Monitoring and Evaluation HIV/STI surveillance, surveys Patient monitoring Household Surveys Facility surveys Patient monitoring Programme Monitoring

20. Input Process Output Outcome Impact M&E of ARV treatment programmes (with examples of indicators) Existence of national policies on ARV (UNGASS) Access % of districts / facilities with ARV treatment services (% of people in need of ARV with access within one hour travel time) Quality % of designated facilities providing ARV treatment in line with national standards (trained person, drugs in stock, treatment register used, treatments correct, lab support) Coverage % of people with advanced HIV infection receiving ARV combination therapy ( UNGASS) Impact Survival rates among HIV infected (at 2 years)

21. Percent of people with advanced HIV infection receiving ARV combination therapy (UNGASS) Number of people receiving treatment at the start of the year + Number of people who commenced in the last 12 months - Number of people who discontinued treatment in the 12 months Number of people with advanced HIV infection (based on estimated number of deaths in the same and following year) * 100 Access to ARV through: private sector, NGOs, employers, research community, public sector

22. Way Forward: development of guidance and tools to countries in developing M&E system Patient monitoring Programme monitoring Treatment register: (Starting treatment, Substitute drugs because of toxicity, Switch regimen because of treatment failure, Stopping treatment) and link this to the supply of drugs –Individual? Electronic? Facility records? Adherence to therapy Assess treatment outcomes: morbidity and mortality reporting (AIDS case definitions, survival analysis)

23. Way Forward: development of guidance and tools to countries in developing M&E system Develop reporting simple systems to monitor at the facility, district, regional/provincial and national levels Develop a simple tool for a facility survey to assess availability & quality, including laboratory support Develop a simple tool to assess community and client preparedness perspectives on ARV treatment (including interaction care-prevention) - operational research

24. Operations Research

25. Building Programmes: Pilot Study Model Research proves intervention works Pilot studies Develop programmes

26. Building Programmes: Scale Up Model Research proves intervention works Lesson learned in other countries Develop programmes Operational research

27. Operations research issues: examples Integrated systems to track patients, drugs and fees at point of delivery Appropriate human resource planning for ARV programmes Working with the private sector – the franchising approach Setting and supervising/regulating health standards in ART programmes Equity of access to ART programmes Measurement of costs of implementing ART programmes Assessment of community preparedness and readiness Measurement of stigma and discrimination in the context of ART programmes Strategies to maximize long-term adherence (chronic disease model) Delivering and sustaining ART in drug-using communities

28. Research CLINICAL When to start treatment What therapies to be used What methods for patient monitoring Operations research? Clinical trials, also observational designs and comparative cohort studies may be used OUTCOME Survival, health, quality of life of patient but also children, family, community PREVENTION Longitudinal studies with trends in behaviour, stigma, risk perception etc.

29. Global partnerships and major initiatives Session 2 Pulling together and using strategic information Stop TB PMTCT+ TAP World Bank WHO IAS Resistance monitoring network Global Fund

30. WHOs role - Building Evidence for Effective ART programmes (The Build Up Initiative) WHO to assist health sector in building effective progammes, link research and programmes FUNCTIONS Focus on coordination of programme oriented research that is conducted while programmes are being developed Initiate and guide multi-country operational research initiatives Support to in-depth research studies (clinical, outcome, prevention) Ensure rapid and wide use of results for policies and programmes in countries and globally OPERATIONAL FEATURES Partnership with donors and countries - steering committee Linking with networks (drug resistance, ITAC, clinical research etc.) Secretariat at WHO OR multi-country research initiatives

31. Agenda Session 3 Assessment of needs and programme inputs Session 4 Assessment of programme outcome (clinical and economic) Session 5 Country and project experiences in M&E systems and strategic information efforts Session 6 Using technology to monitor ART programmes Session 7 Monitoring individual and community knowledge, attitudes and behaviours Session 8 Developing the priority strategic information issues for national programmes and large-scale projects

32. EXPECTED OUTCOMES Consensus on a list of priority strategic information issues and how to address these issues - A clear picture of immediate and mid-term country strategic information needs Increased understanding and partnership globally with strong input from countries to support the development of sound monitoring and evaluation systems for ART programmes