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CDC Activities in TB/HIV Research Perspectives on Using Research to Strengthen and Inform Programs. Charles D. Wells, MD Chief, International Research and Programs Branch Division of Tuberculosis Elimination U.S. Centers for Disease Control and Prevention 14 February 2005.
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CDC Activities in TB/HIV ResearchPerspectives on Using Research to Strengthen and Inform Programs Charles D. Wells, MD Chief, International Research and Programs Branch Division of Tuberculosis Elimination U.S. Centers for Disease Control and Prevention 14 February 2005
TB/HIV Research at CDC • Mission • To conduct applied practical research for improving TB & HIV program capacity for better control of HIV-associated TB • To evaluate impact of interventions • To contribute to broader evidence base for TB/HIV policy, guidelines, recs. (dx & rx) • Groups • DTBE – IRPB, TBTC, MLB, etc. • GAP – C&TB, S&IDB, country-level programs • Partners – MOH, USAID, WHO, MRC, KNCV, IUATLD, NIH, PATH, etc.
Major Areas of Focus • Surveillance • Epidemiology • TB case finding • OR capacity building • TB prevention • MDRTB / HIV • Diagnosis • Treatment
Surveillance • NTP strengthening and foundation for research • TB recording/reporting - ETR & ETR.net • Patient-based – WHO core data • 7 SS African countries • HIV data collection • Thailand – electronic reporting, HIV and DR surveillance in 4 HB provinces + BMA • TB/HIV surveillance capacity building project (PEP) • DR surveillance – Botswana with ↑ DR • New tools - Oraquick® on sputum (Botswana)
Epidemiology • Epidemiological studies • HIV risk factors - Botswana • Treatment default - Botswana & S Africa • Impact of ARV’s on TB epi – Brazil • Thailand TB/HIV observational cohort study • Prospective, comprehensive • Evaluate mortality risk factors • Impact of interventions • Evaluating tools: ARTI - Botswana, 2002-2004 • Latin squares sampling - ↓ sample size, trends • ARV and IPT program roll out
TB Case Finding • TB screening in context of HIV CT (VCT) settings • IPT pilot, Botswana, 2000-01 • CXR limited value in asymptomatic attendees • Comparing enhanced TB screening to current standards - Ethiopia • Yield of CXR screening – Vietnam and Kaliningrad • Integrating TB screening in roll out of diverse HIV CT program in SA • Broader evaluation of TB CF among focus countries
Operations Research Capacity Building • Adapting general TB OR training for NTPs • USAID supported • Course + proposals/funding + mentorship • 10 trainings, 200 staff, 55 proposals • Modified for TB/HIV OR training • More targeted lectures and field exercise • FSU/Baltics – 11/04 • 3 national projects – treatment adherence, nosocomial transmission, cross-referral • Africa TB/HIV OR course – Malawi, 6/04
TB Prevention • IPT pilot – Botswana, 2000-2001 • 600/1000 started IPT, 70% completed • Symptom screen sufficient • MOH IPT program roll out, 2003 • >8,000 enrolled on IPT • Info system, evaluation late 05 • DR monitoring – 1995-96, 1999, 2002, late 2005 • IPT trial of duration (6 mos vs. 3 yrs), 11/04 • N=1800; R/DB/PC; builds on IPT program • TBTC Study 26, on-going • 3 mo H/RPT vs. 9 mo H; 4000 enrolled • Substudies – viral hep, peds PK
MDR TB / HIV • E Europe (Russia, Baltics) • TB screening and PT OR (Orel and Kaliningrad) • Baltics – rapid dx, evaluate PT strategies • Africa • Botswana - DRS ‘05 to evaluate link of DR with HIV • South Africa – MRC leadership • MDR TB outcome studies (effects of HIV) • ARV’s + MDR TB treatment – MRC/CDC • Airborne Infection Research (AIR) Facility • Transmission/IC intervention studies
Diagnosis • Smear negative study • Prospective, case-control study • Abx non-response predictive of cx+ TB • Sero-diagnostic studies, Botswana • Adult: 4 assays, 15% dx by blood cx alone • Peds: 2 assays; 16% micro confirmation • Algorithms for TB diagnosis • TB/HIV cohort study (MGIT), Thailand • FIND collaboration – evaluate MGIT feasibility (GAP/DTBE) • Line-probe assay - rapid dx of R res, Latvia/Vietnam • Feasibility & CE
TB Treatment • Operational (ARV access/delivery) • HIV CT in TB clinical settings (Opt out – Botswana) • MRC/CDC project in KZN of ARV initiation among hosp. TB patients (3/05) • Clinical • TBTC Study 27 • HRZE vs. HRZMox, 50% enrolled, 2 mo cx conv. • TBTC Study 28 • HRZE vs. MoxRZE, 2 mo cx conv., 4/05 • Empiric treatment studies