Optimising TB/HIV Programme service delivery through TB/HIV research: The WHO/TDR model.

1. Optimising TB/HIV Programme service delivery through TB/HIV research: The WHO/TDR model. PC Onyebujoh MD, PhD, FRCP (Lond)

2. This talk will cover…… • Background information on TDR structure and organization • Global TB/HIV epidemiology • TDR TB/HIV Portfolio activities • TDR TB/HIV research model and impact on National Control Programmes • Conclusions and way forward

3. TDR was established as a special programme 30 years ago • Mission • To develop new and improved tools for tropical disease control • To strengthen the research capability of disease endemic countries (DECs) • Track record • Supported >10,000 projects; trained >1,500 PhD scientists • Five of 10 tropical diseases targeted for global / regional elimination • Key strengths • UN’s convening power • Location in WHO and links to ministries and control • Partner network and brokering capabilities • Long-standing DEC relationships • Governance structure

4. Need for new TDR vision/strategy triggered by critical trends in global research environment Epidemiological Changes Infectious disease burden remains high Growing regional variation Enhanced research capabilities in DEC's Global research environment for tropical diseases Momentum through new players / initiatives Rise in pharmaceutical product development DEC's left behind in priority setting Complexity and fragmentation

5. What is Needed? Extension of TDR Mandate to cover 'infectious diseases of needy populations' Greater social contextualisation of research (including gender issues) bringing closer to control needs An effective global research effort on infectious diseases of poverty in which disease endemic countries play a pivotal role

6. New TDR Vision To foster: An effective global research effort on infectious diseases of poverty in which disease endemic countries play a pivotal role

7. TDR Structure

8. Operationalise through Business Lines

9. What we want to achieve Innovation Interventions Access

11. Global burden of TB in 2008 Estimated number of cases Estimated number of deaths 1.8 million 1.6 – 2.3m 9.4 million (range, 8.9–9.9 m) All forms of TB 1.4 million (15%) 1.3 – 1.6 m 0.52 million 0.45 – 0.62m HIV-associated TB Multidrug-resistant TB (MDR-TB) 0.44 million 0.39 – 0.51m 150,000 0.05 – 0.27m

12. 240 700 200 600 500 160 400 120 300 80 200 40 100 0 2005 2006 2007 2008 2005 2006 2007 2008 100 80 60 Thousands 40 20 2005 2006 2007 2008 TB/HIV intervention scale-up in Africa TB patients tested for HIV HIV+ TB patients on CPT 45% 73% Thousands Thousands 11% HIV+ TB patients on ART 31%

17. The TB/HIV Portfolio (BL 8): Overall Objective • To optimize treatment, case management and delivery of care for all patients' populations with tuberculosis and HIV-infected tuberculosis, including patients with additional co-morbid diseases.

18. TDR's TB/HIV Research Portfolio • Specific Objectives • Develop the evidence for shortening and simplification of TB treatment in TB and HIV-infected TB patient populations (Gatifloxacin & 4FDC studies) • Develop the evidence for management of HIV-infected TB patients: • optimal timing & concomitant use of anti-TB and antiretroviral drugs (TB-HAART) • more effective anti-TB chemotherapy regimen for treatment with HAART (Rifabutin) • bio/surrogate markers and ImRx for IRIS and HIV-infected TB. • Strategies for operational implementation of TB and HIV/AIDS case management and Rx in DECs (OR studies)

19. Benefits from embedding research in control Progs • Integrating research strengthens the health system, whatever the research findings. • Conducting research close to near normal health service conditions produces results which health services can use immediately; also reduces research costs considerably. • Rigorous research including randomisation is possible when there is a partnership between researchers, health services and patients.

20. Lessons learnt in integrating research into programmes • Genuine partnership and trust essential between researchers, health service staff and patients. • Provide opportunity for health service to ask relevant questions. • Keep research simple. Answer few questions to a high quality. • Critical that researchers remain independent and maintain equipoise about the interventions that they evaluating. • Maintain good open communications between researchers, health care staff, patient bodies. Conduct regular meetings to maintain interest and motivation.

21. Quality of data • Test understanding of and adherence to SOPs regularly and rely more on within-job training, drama and role play. • Audit procedures regularly, especially at the beginning. • Analyse data regularly, especially during the first week or so to spot problems, gaps. • Maintain 100% accuracy target on all research data. Have stringent and immediate internal checks on data to prevent errors – e.g. • Check data collected by health service physicians while patient is still in clinic • Re-interview samples of patients about their understanding of consent as they leave the interview room.

22. Conclusion & Way forward • Scale up programme-relevant research to address health issues within the context of Programatic capacity • Donors and technical partners should work with multi& bilateral agencies to facilitate « prog-embedded research » • Donors and technical agencies should engage more actively with GFATM and recepient countries in supporting TB/HIV control efforts

23. Acknowledgement • NPR/TDR Collegues • Prof Shabbar Jaffar, TEG, LSHTM • Dr JB Levin UKMRC, Uganda • Dr Peter Mwaba, PS MOH Zambia • Mr kevin Bellis HLSP/DFID, S.Africa • National TB control Programme managers (Tanzania, Uganda, Zambia &S.Africa)

24. Thank You

25. TB Data for South Africa 2009 Population 2009 (millions) 50 Estimates of burden * 2009 Number (thousands) Rate (per 100 000 pop) Mortality (excluding HIV) 26 (14–42) 52 (29–85) Prevalence (incl HIV) 400 (180–650) 808 (362–1 288) Incidence (incl HIV) 490 (400–590) 971 (791–1 169) Incidence (HIV-positive) 280 (230–340) 563 (461–675) Case detection, all forms (%) 74 (61–91) Case notifications 2009 New cases (%) Retreatment cases (%) Smear-positive 139 468 (41) Relapse 20 117 (31) Smear-negative 55 083 (16) Treatment after failure 2 895 (4) Smear unknown 92 104 (27) Treatment after default 5 671 (9) Extrapulmonary 53 411 (16) Other 37 233 (56) Other 0 (0) Total new 340 066 Total retreatment 65 916 Total < 15 years 49 825 Total new and relapse 360 183 (89% of total) Total cases notified 405 982

26. TB Data for Ireland 2009 Population 2009 (millions) 5 Estimates of burden * 2009 Number (thousands) Rate (per 100 000 pop) Mortality (excluding HIV) 0.022 (0.018–0.03) 0.49 (0.4–0.66) Prevalence (incl HIV) 0.47 (0.15–0.8) 10 (3.3–18) Incidence (incl HIV) 0.38 (0.34–0.44) 8.5 (7.6–9.8) Incidence (HIV-positive) 0.014 (<0.01–0.025) 0.31 (0.14–0.56) Case detection, all forms (%) 89 (77–100) Case notifications 2009 New cases (%) Retreatment cases (%) Smear-positive 95 (29) Relapse 7 (44) Smear-negative 61 (18) Treatment after failure Smear unknown 58 (17) Treatment after default Extrapulmonary 60 (18) Other 9 (56) Other 59 (18) Total new 333 Total retreatment 16 Total < 15 years 15 Total new and relapse 340 (70% of total) Total cases notified 488