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INDEPTH Tuberculosis Working Group. Dr. Kayla Laserson INDEPTH AGM, Ghana, September 2010. 0 - 24. 25 - 49. 50 - 99. 100 or more. No report. Tuberculosis Notification Rate, 2008. Notified TB cases (new and relapse) per 100 000 population.
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INDEPTH Tuberculosis Working Group Dr. Kayla Laserson INDEPTH AGM, Ghana, September 2010
0 - 24 25 - 49 50 - 99 100 or more No report Tuberculosis Notification Rate, 2008 Notified TB cases (new and relapse) per 100 000 population 22 High Burden Countries: 11 have at least 1 HDSS Center (Bangladesh, Ethiopia, India, Indonesia, Kenya, Mozambique, South Africa, Tanzania, Thailand, Uganda, Vietnam)
April 2010: First Face-to-Face Meeting, Kisumu, Kenya • Facilitators • Dr. Kayla Laserson – KEMRI/CDC HDSS, Kisumu, Kenya • Dr. Christian Wejse – Bandim HDSS, Guinea • The workshop intended to facilitate INDEPTH centers to create a TB research agenda within HDSS centers • Centers presented background of their site and TB activities to date • Participating INDEPTH centers • Ballabgarh, India • Bandim, Guinea Bissau • Dodalab, Vietnam • Dodowa, Ghana • Filabavi, Vietnam • Kanchanaburi, Thailand • Karonga, Malawi • Kintampo, Ghana • Kisumu, Kenya • Matlab, Bangladesh • Navrongo, Ghana • Nouna, Burkina Faso • Vadu, India
Initial TB-related Activities for HDSS Centers • Link National Program TB patient registers to HDSS data • A primary step to evaluate TB in the context of an HDSS; draw upon other groups/studies which are linking data, such as INESS • Link SES data/asset scores/etc to notified TB cases (or TB prevalence data if it exists) • To establish the association between TB and SES/other RF in the HDSS's and allow the DSS's to compare across centers • Evaluate the association between recent/new in-migrants and TB and HIV (where possible)
Groups and Group Leaders • Collaborative prevalence studies/risk factors (WHO) and other regular prevalence surveys – Dr. Sanjay Juvekar • Clinical trials readiness – Dr. K. Zaman • Effect of being a TB suspect or having TB on HHS, SES and mortality (VA) – Dr. Christian Wejse • Mapping – Prof. Amara
Surveillance of TB Risk Factors • Specific objectives • Document available data on TB risk factors • Establish surveillance of selected TB risk factors • Study the prevalence of reported TB • Methods • Routine update : Adding one question to round: Since the last time we visited your house, is there anybody living in this house who has been diagnosed with TB/ has had regular contact with an individual who has TB? • Periodic surveys • All centers are currently using different tools • Should use INDEPTH SES tool • Other important risk factors: migration, crowding, pollution in general, mental illness/stress, worm infestation, other infectious diseases, diabetes, malnutrition
Establish TB Trial Network • Objectives • To assess the capacity and identify gaps to conduct clinical trials • To evaluate investigational products in dx, treatment and prevention of TB • To provide evidence to health planners and policy makers • Utilize the HDSS for long term safety monitoring • HDSS network has the required strength • Large population sample • Ability to follow participants long term • Can follow contacts as well • Can recruit more than 2000 smear +ve TB in a year • Differing epidemiology of TB • Long term follow up of adverse events • Established communication between INDEPTH network centers • Available data on SES, and other determinants (e.g. nutrition, GIS) • Available data on other diseases/morbidity (cost-saving to sponsor)
INDEPTH Centers as TB Intervention Trial Platforms: Potential Number of TB Cases • Kisumu HDSS, Kenya: 800 smear +ve • HDSS Filabavi & Dodolab, Vietnam: 100 smear +ve • Bandim HDSS, Guinea Bissau: 100 smear +ve • Matlab HDSS, Bangladesh: 150 smear +ve • Karonga HDSS, Malawi: 150 smear +ve • Filabavi HDSS, Vietnam: 400 smear +ve • Nouna HDSS, Bukina Faso: 40 smear +ve • All HDSS centers, Ghana: 150 smear +ve • KEMRI/WRP: 100 smear +ve • Kanchanaburi HDSS, Thailand: 150 smear +ve • KEMRI/CDC Kibera, Kenya: 50 smear +ve • Ballargbarh HDSS, India: 100 smear +ve More than 2000 smear +ve All centers are GCP compliant except Kibera, Kenya and Kanchanaburi, Thailand
Effects of Assumed Negative/ Having TB on Health Outcomes • TB suspects who are assumed not to have TB/TB cases/ no TB or suspect • 3 years data • Analysis - Compare longitudinal outcomes in compounds with assumed TB negative with compounds without such persons • Work on-going In Bandim: Christian Wejse will present an update at the TB Working Group meeting
Comprehensive Mapping Exercise • TB data collected by each site, clinical/lab/pharmaceutical capacity at each site, and how linkages are made based on HDSS • Site Assessment Forms • Summary will be presented in TB Working Group Session
Critical Path to TB Drug Regimens (CPTR) • INDEPTH invited to June 2010 launch after GATES call with ED, and INDEPTH TB working group • Mission • To bring novel scientific tools, strategies, and approaches that incorporate the most advanced methods into TB product development • INDEPTH to participate in Research Resources Group and expects to serve as a clinical trials platform • Application made to US FDA for a cooperative agreement to support CPTR (pending) • Letter of support from INDEPTH • Steve Wandiga, Kisumu, Kenya HDSS: POC
WHO TB Research Movement • Basic research • Development of new tools (drugs, diagnostics, and vaccines) • Operational/ implementation research • Workshop May 2010 • Report shared with INDEPTH centers • Helping to identify centers for clinical trials • Identified INDEPTH as ideal • Pursuing discussions/search for funding
WHO Assessment of Possible TB Operational/Implementation Research Areas for INDEPTH centers • Incidence • Link with NTP data • Service provider mapping combined with universal referral and notification of TB cases • GIS mapping • Repeated prevalence surveys • Prevalence • Death • Verbal autopsy • Link with death registration and hospital data • Risk factors and social determinants • Effect size, interaction, multilevel analysis to explore pathways, population attributable fractions • Link with incidence, prevalence and death data • Expand baseline data on TB risk factors
WHO Assessment of Possible TB Research Areas for INDEPTH centers (2) • Effectiveness of intensified case finding approaches • Service provider mapping and engagement - referral, notification, diagnosis • Contact investigations, link with baseline data • Universal screening for chronic cough - referral • Universal X-ray and cough screening, diagnosis with smear microscopy and culture (prevalence survey methodology) • Targeted screening of risk groups (risk factors, poverty, migration, etc) • Completeness of case notification and detection • Completeness of treatment adherence
Conclusion/ Way Forward • Considerable interest and capacity at INDEPTH centers • Considerable interest by GATES (CPTR) and WHO • Further analyses at centers (where possible/affordable) to build up body of data/publications • Further discussions/funding applications: core support from INDEPTH? • Please join the TB Working Group! • Meets Tomorrow 5-6:30pm