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Operational research to Policy and Practice: examples

This study explores the impact of implementing HIV testing and cotrimoxazole preventive therapy in TB patients in Malawi to reduce case fatality. Results show a significant mortality reduction, paving way for policy adoption and nationwide intervention rollout. The research, conducted in Thyolo and Karonga districts, offers valuable insights for public health interventions to combat TB-HIV co-infection.

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Operational research to Policy and Practice: examples

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  1. Operational research to Policy and Practice: examples Anthony D Harries, The Union, Paris, France London School Hygiene & Tropical medicine

  2. MALAWI 16 Million people GNP $380 1 Million PLHIV 20,000 TB cases per yr Life expectancy 59 years World Health Statistics 2014

  3. Malawi TB Control Programme • Nationwide coverage of “DOTS” by 1984 • Initially very good progress • Good case finding • Good treatment outcomes • THEN – along came HIV

  4. Adult HIV-prevalence in Malawi Increased case numbers Increased case fatality

  5. Notified TB cases in Malawi: 1985 - 2005 26% 52% 67% 75% 75% HIV-prevalence rate in TB patients

  6. Can HIV testing and cotrimoxazole preventive therapy (CPT) reduce TB treatment mortality?

  7. Background and problem • Cote d’Ivoire RCT: CPT associated with significant mortality reduction in HIV-infected TB patients (Wiktor et al, Lancet 1999) • UNAIDS 2000 Provisional Recommendations • Malawi Ministry of Health: CPT may not have the same efficacy in Malawi as Cote d’Ivoire because different resistance patterns and different spectrum of HIV-related illness • Malawi not prepared to adopt UNAIDS Recommendations on CPT because no evidence of effectiveness and may be dangerous • Strong endorsement for district operational research

  8. Aim of district studies:Thyolo and Karonga To determine the feasibility and effectiveness of “HIV testing and CPT” in reducing case fatality in a cohort of TB patients registered under routine program conditions

  9. Methods Patients: • TB patients registered in DTO office • TB treatment started - standardized regimens • All patients offered HIV testing /counselling • HIV-positive patients offered CPT End of Treatment Outcomes: • Mortality

  10. Analysis • HIV test +CPT group:the cohort of all TB patients offered HIV testing and CPT and registered during a full 1 year period • Control group:the cohort of all TB patients not offered HIV testing and CPT and registered the previous year during a full 1 year period Comparison of mortality at the end of treatment between the two groups

  11. Thyolo HIV test+CPT 1061 Control 925 Karonga HIV test+CPT 362 Control 355 Results [1]: Registered cases

  12. Results [2]: Interventions in HIV+CPT group

  13. Thyolo: HIV test+CPT 28% Control 36% p < 0.001 Karonga: HIV test+CPT 29% Control 37% p < 0.001 Results [3]: case fatality in all TB types CPT safe in both districts with non-severe skin reactions at 2% and 5%

  14. Number of TB patients that needed treatment with “HIV testing and CPT” to prevent one death = 12in both Thyolo and Karonga“estimated cost to prevent one death = USD$100”

  15. Conclusion and Policy • In the two districts, the package of “HIV testing and CPT” given to TB patients at or shortly after registration was associated with a significant reduction in case fatality • October 2002: Ministry of Health Meeting with national stakeholders – policy adopted to roll out the intervention Zachariah et al, AIDS 2003; Mwaungulu et al, Bulletin WHO 2004

  16. HIV Testing and care in TB patients in Malawi: progress every 2 years Source: Malawi NTP

  17. TB treatment outcomes in patients with new smear-positive PTB at national level Source: Malawi NTP

  18. India

  19. Screening TB patients for diabetes in India

  20. Diabetes Mellitus increases the risk of TB by a factor of 2 - 3 Stevenson et al, Chronic Illness 2007 Jeon and Murray, PLoS Medicine 2008 Dooley and Chaisson, Lancet Infectious Diseases, 2009 Ruslami et al, Tropical Medicine & International Health, 2010 Goldhaber-Fiebert et al, International Journal Epidemiology 2011 Some evidence that poor DM control increases TB risk (HbA1c >7% = RR 2.56) [USA,UK, Canada, Mexico, Russia, India, Taiwan, South Korea, Indonesia]

  21. Framework for a public health approach to bi-directional screening and care for TB and diabetes Launched in August 2011

  22. The recommendations Document available at: http://www.who.int/tb/publications/2011/en/index.html

  23. Bi-Directional Screening and Care of TB and Diabetes Mellitus India World Diabetes Foundation Support • National Stakeholders Meeting • Training for implementers • Implementation of screening • Review of activities and data • National Stakeholders Meeting

  24. Screen TB patients for DM Is there is a known diagnosis of DM? No known diagnosis - screen first with RBG If RBG ≥ 6.1 mmol/l, screen with FBG If FBG ≥ 7.0 mmol/l, then diagnose DM and refer to DM care

  25. Screening TB patients for DM in India India TB-DM study group TMIH 2013: 18: 636-45

  26. Screening TB patients for DM in India Policy decision from India RNTCP and NCD that all TB patients in India be routinely screened for DM

  27. India TB-Diabetes Study Group

  28. Back of the TB Treatment card used in India

  29. Simple parameters added for routine recording in quarterly TB reports • Number of TB patients registered • Number of TB patients screened for DM • Number of TB patients diagnosed with DM

  30. Conclusion • With the research think ahead to what you want to achieve • Ensure that the research is done in close collaboration with the programme and with the decision makers • Involve the decision makers at the beginning and at the end

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