1. TB/HIV Research Priorities in Resource- Limited Settings Where 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. Epidemic in sub-Saharan Africa 19852003 0 5 10 15 20 25 30 1985198619871988198919901991199219931994199519961997199819992000200120022003 Millions 0 5 10 15 20 25 30 % HIV prevalence adult (15-49) Number of people living with HIV and AIDS % 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 SSA2.35m Cases notified annually in SSA996k Estimated no. of notified HIV+243k Number (%) HIV +596k (25%) % Adult TB patients HIV+37% Deaths from TB due to HIV207k % of HIV deaths due to TB15% 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