1. TB/HIV Research Priorities in Resource-Limited SettingsWhere we are now and some suggestions for where to go Paul Nunn 14-15 February 2005

2. Contents of Presentation • Current context • TB and HIV epidemics and overlap • Status of analytical and policy response • Definitions • Suggested approaches • Conclusions

3. Current Global Status • 8.8 million new cases in 2003 • 7.6% of total cases HIV+ (674 000) = 12% of adult cases • TB notifications and estimated incidence decreasing in 5 WHO regions, increasing in Africa • Global estimated incidence grew 1% • Prevalence and mortality rates falling • 3% of TB cases tested for HIV

4. 30 30 25 25 20 20 15 15 10 10 5 5 0 0 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 Epidemic in sub-Saharan Africa 1985−2003 Millions Number of people living with HIV and AIDS % HIV prevalence, adult (15-49) % HIV prevalence adult (15-49) Year Source: UNAIDS/WHO, 2004 2004 Report on the Global AIDS Epidemic (Fig 5)

5. TB/HIV in Africa – 2002 • Total cases annually in SSA 2.35m • Cases notified annually in SSA 996k • Estimated no. of notified HIV+ 243k • Number (%) HIV + 596k (25%) • % Adult TB patients HIV+ 37% • Deaths from TB due to HIV 207k • % of HIV deaths due to TB 15% • Treatment success 73% (average 82%)

6. Regional TB incidences

7. TB/HIV policy guidance - 2004 Interim policy M&E Surveillance ART ProTEST lessons TBHIV Clinical HIV testing policy

8. Where are we now? • Global consensus around TB/HIV interim policy • As yet, low dissemination of policy • Slow country level implementation of joint TB/HIV activities • Some technical approaches undefined eg TB/HIV for IDU • Low awareness of what needs to be done and how • Operating in the context of weak health systems • Lack of human resources • Competing priorities: DOTS expansion, ARV scale up etc • "Money, money everywhere, but not a drop to spend" etc

9. Suggested Definitions

10. TB/HIV research in resource-limited settings: • Research aimed at improving the care of people with HIV-associated TB in resource limited settings • Research aimed at improving the prevention of HIV-associated TB • Research within the domain of "TB/HIV" – the additional things TB programmes and AIDS programmes need to do to address the TB/HIV overlap • Research aimed at improving TB/HIV control policies (health systems and policy research) • Research aimed at improving operations of HIV and TB control (operational research or targeted evaluation)

11. TB/HIV research definition continued • It therefore includes health policy, health systems and operational research that address TB/HIV; • And also, new tools development that addresses the particular problems of the coinfected, eg TB diagnostics for those with HIV, ARVs compatible with rifampicin; • And also clinical trials that answer operational questions in TB/HIV eg when should HIV+ TB patients start ARVs?

12. TB/HIV research definition concluded • We do not include research that specifically addresses TB or HIV issues, with no particular reference to the TB/HIV overlap eg development of new drugs for TB, ways of counselling and testing for HIV to decrease HIV transmission, etc • We have not included basic research, as not being focused on resource-limited settings

13. A suggested approach

14. Three levels of research • Research to answer specific technical questions eg does cotrimoxazole preventive therapy add protection to ARVs? • Research to address how technical interventions can alleviate burden of TB/HIV, and how much (health systems research) • Research to evaluate the whole TB/HIV package – analogous to the multi-country evaluation of IMCI

15. The rationale for health systems research for TB/HIV • TB/HIV depends strongly on TB and HIV/AIDS control • TB and HIV/AIDS control severely limited by weak health systems – and evidence base on health systems is also weak • Many of the research questions in background papers are about how to implement TB/HIV activities within health systems • The cross-cutting topics in agenda address the interaction between TB/HIV and health systems

16. Policy-maker's Questions Lavis J et al. Use of research to inform public policymaking. Lancet 2004;364:1615-21 • What is the best solution to the TB/HIV problem? • What is the overall benefit of implementing the TB/HIV policy package, and how much does it cost, relative to the other interventions we are, or could be doing? • What are the best ways to implement activities to solve the TB/HIV problem in my health system? • What governance, financial and delivery arrangements are the most conducive to the effectiveness of the package, in our setting? • How can I bring about the necessary changes in the health system to implement TB/HIV activities? • What informational, educational and financial (incentive) approaches are needed to change behaviours to implement the package?

17. Assessment of the TB/HIV package • We need to demonstrate success/failure • Whether it can/cannot be implemented (process indicators) • Whether it has/has not impact (impact indicators) • We need to show where it fails, so as to improve it, and avoid wasting time and resources • We need to do it fast, so that we encourage more rapid implementation (if we show it works) • Therefore we need to build assessment into implementation • TB/HIV annual survey of policy and practice • Revision of routine recording and reporting for TB • Additional "targeted evaluation"/operational research • How to record and report "HIV-side" activities? • Just do it and evaluate, or more formal assessment?

18. What is expected of us at this meeting? • Develop the agenda of research priorities • Then develop plans for implementation • Find financial support • Identify teams of countries/researchers able and willing • Provide technical assistance • Advocate for TB/HIV research

19. Conclusions • Reaching TB and HIV MDGs depends on improving TB and HIV control, especially in high HIV areas • Improving control depends on improving health systems • International consensus around 12 point package of TB/HIV collaborative activities • A way forward: • Refine the best technical solutions • Define how they fit into complex, under-resourced health systems • Once we have a list of priorities, we should look ahead to • funding needs, • human resources, • advocacy