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Operational research to Policy and
Practice: examples
Anthony D Harries,
The Union, Paris, France
London School Hygiene & Tropical medicine
MALAWI
16 Million people
GNP $380
1 Million PLHIV
20,000 TB cases per yr
Life expectancy 59 years
World Health
Statistics 2014
Malawi TB Control Programme
•
•
•
•
Nationwide coverage of “DOTS” by 1984
Initially very good progress
Good case finding
Good treatment outcomes
• THEN – along came HIV
Adult HIV-prevalence in Malawi
Adult HIV prevalence
0.16
0.14
0.12
0.10
Increased case numbers
Increased case fatality
0.08
0.06
0.04
0.02
0.00
1985
1990
1995
2000
2005
Notified TB cases in Malawi: 1985 2005
30000
25000
20000
Sm-TB
Sm+PTB
15000
10000
5000
0
1985
26%
1989
52%
1993
67%
1997
2001
75%
HIV-prevalence rate in TB patients
2005
75%
Deaths in New Sm+ve PTB
patients in Malawi
25
20
15
% deaths
10
5
0
86
88
90
92
Year
94
96
98
Can HIV testing and cotrimoxazole
preventive therapy (CPT) reduce
TB treatment mortality?
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
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
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
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
Results [1]: Registered cases
Thyolo
Karonga
HIV test+CPT
1061
HIV test+CPT
362
Control
925
Control
355
Results [2]: Interventions in HIV+CPT group
Thyolo
Karonga
Number enrolled
1061
362
HIV tested
91%
73%
HIV-positive
69%
51%
Started CPT
94%
96%
Results [3]: case fatality in all TB types
Thyolo:
Karonga:
HIV test+CPT
28%
HIV test+CPT
29%
Control
36%
Control
37%
p < 0.001
p < 0.001
CPT safe in both districts with non-severe skin reactions at 2% and 5%
Number of TB patients that needed
treatment with “HIV testing and CPT”
to prevent one death = 12
in both Thyolo and Karonga
“estimated cost to prevent one death = USD$100”
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
HIV Testing and care in TB patients in
Malawi: progress every 2 years
MALAWI
2004
2006
2008
2010
2012
TB patients
26136
26659
25688
22536
20463
HIV tested
26%
66%
84%
88%
93%
HIV positive
72%
66%
63%
64%
59%
Start CPT
97%
98%
96%
94%
88%
Start ART
<10%
38%
38%
54%
81%
Source: Malawi NTP
TB treatment outcomes in patients with
new smear-positive PTB at national level
Year
Treatment Success
Death
Other
2002
71%
19%
10%
2004
71%
16%
13%
2006
79%
13%
8%
2008
85%
8%
7%
2010
88%
8%
4%
Source: Malawi NTP
India
Screening TB patients for
diabetes in India
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]
Framework for a public
health approach to bidirectional screening and
care for TB and diabetes
Launched in August 2011
The recommendations
Document available at: http://www.who.int/tb/publications/2011/en/index.html
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
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
Screening TB patients for DM in India
Indicator
TOTAL
Number of patients with TB registered and enrolled
Number (%) with known diagnosis of DM
8269
682 (8)
Number needing to be screened with RBG
7587
Number (%) actually screened with RBG
7467 (98)
Number with RBG >110 mg/dl and needing to be screened with FBG
Number (%) screened with FBG
Number (%) with FBG ≥ 126 mg/dl (newly diagnosed with DM)
2838
2703 (95)
402 (5)
Number (%) with known and newly diagnosed DM
1084 (13)
Number (%) with known / newly diagnosed DM referred to DM care
1033 (95)
India TB-DM study group TMIH 2013: 18: 636-45
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
India TB-Diabetes Study Group
Back of the TB Treatment card used in India
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
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