A randomized controlled trial of standard versus intensified tuberculosis diagnostics on treatment decisions by physicians in Northern Tanzania.

Abstract

BACKGROUND: Routine tuberculosis culture remains unavailable in many high-burden areas, including Tanzania. This study sought to determine the impact of providing mycobacterial culture results over standard of care [unconcentrated acid-fast (AFB) smears] on management of persons with suspected tuberculosis. METHODS: Adults and children with suspected tuberculosis were randomized to standard (direct AFB smear only) or intensified (concentrated AFB smear and tuberculosis culture) diagnostics and followed for 8 weeks. The primary endpoint was appropriate treatment (i.e. antituberculosis therapy for those with tuberculosis, no antituberculous therapy for those without tuberculosis). RESULTS: Seventy participants were randomized to standard (n = 37, 53%) or intensive (n = 33, 47%) diagnostics. At 8 weeks, 100% (n = 22) of participants in follow up randomized to intensive diagnostics were receiving appropriate care, vs. 22 (88%) of 25 participants randomized to standard diagnostics (p = 0.14). Overall, 18 (26%) participants died; antituberculosis therapy was associated with lower mortality (9% who received antiuberculosis treatment died vs. 26% who did not, p = 0.04). CONCLUSIONS: Under field conditions in a high burden setting, the impact of intensified diagnostics was blunted by high early mortality. Enhanced availability of rapid diagnostics must be linked to earlier access to care for outcomes to improve.

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Citation

Published Version (Please cite this version)

10.1186/1471-2334-14-89

Publication Info

Reddy, Elizabeth A, Boniface N Njau, Susan C Morpeth, Kathryn E Lancaster, Alison C Tribble, Venance P Maro, Levina J Msuya, Anne B Morrissey, et al. (2014). A randomized controlled trial of standard versus intensified tuberculosis diagnostics on treatment decisions by physicians in Northern Tanzania. BMC Infect Dis, 14. p. 89. 10.1186/1471-2334-14-89 Retrieved from https://hdl.handle.net/10161/13774.

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Scholars@Duke

Thielman

Nathan Maclyn Thielman

Professor of Medicine

Broadly, my research focuses on a range of clinical and social issues that affect persons living with or at risk for HIV infection in resource-poor settings. In Tanzania, our group is applying novel methods to optimize HIV testing uptake among high-risk groups. We recently demonstrated that the Discrete Choice Experiment (DCE), a form of stated preference survey research, is a robust tool for identifying (a) which characteristics of HIV testing options are most preferred by different populations and (b) which tradeoffs individuals make in evaluating testing options. Building on more than a decade of productive HIV testing research in the Kilimanjaro Region, the next phase of our NIMH funded project will test the hypothesis that DCE-derived HIV testing options significantly increases rates of testing among groups at high risk for HIV infection. This work holds promise not only for optimizing HIV testing uptake in the Kilimanjaro Region, but also for applying novel tools in the service of translational epidemiology and implementation research.

Cunningham

Coleen Kathryn Cunningham

Adjunct Professor in the Department of Pediatrics

Dr. Cunningham is a pediatric infectious diseases physician who has focused her research on the prevention and treatment of HIV infection in children.  She has also played important roles in evaluation of vaccines for other infectious diseases and recently has worked on Ebola virus treatment studies.  She is currently working on studies of active and passive immunization to prevent HIV transmission in neonates born to HIV infected women.

Chow

Shein-Chung Chow

Professor of Biostatistics & Bioinformatics

My research interest includes statistical methodology development and application in the area of biopharmaceutical/clinical statistics such as bioavailability and bioequivalence, clinical trials, bridging studies, medical devices, and translational research/medicine. Most recently, I am interested in statistical methodology development for the use of adaptive design methods in clinical trials and methodology development for assessment of biosimilarity of follow-on biologics. In addition, I am also interested in methodology development for statistical evaluation of traditional Chinese medicine (TCM) clinical trials.

Stout

Jason Eric Stout

Professor of Medicine

My research focuses on the epidemiology, natural history, and treatment of tuberculosis and nontuberculous mycobacterial infections. I am also interested in the impact of HIV infection on mycobacterial infection and disease, and in examining health disparities as they relate to infectious diseases, particularly in immigrant populations.

Crump

John Andrew Crump

Adjunct Professor in the Department of Medicine

I am based in northern Tanzania where I am Site Leader for Duke University’s collaborative research program based at Kilimanjaro Christian Medical Centre and Director of Tanzania Operations for the Duke Global Health Institute. I oversee the design and implementation of research studies on infectious diseases, particularly febrile illness, invasive bacterial disease, HIV-associated opportunistic infections, clinical trials of antiretroviral therapy and prevention of mother-to-child transmission of HIV, and infectious diseases diagnostics. In addition, I am a medical epidemiologist with the US Centers for Disease Control and Prevention (CDC). My CDC work focuses on enteric infection epidemiology and prevention in developing countries, particularly invasive salmonelloses.

Bartlett

John Alexander Bartlett

Professor of Medicine

My clinical investigation is focused on the pathogenesis and treatment of HIV infection and its complications, especially in resource-limited settings.

Key Words: HIV infection, AIDS, treatment strategies, treatment failure, co-infections, resource-limited settings

Hamilton

Carol Dukes Hamilton

Professor Emeritus of Medicine

Carol Dukes Hamilton, MD, MHS is a Professor of Medicine, Emeritus, in the Infectious Diseases Division, Department of Medicine, Duke University Medical Center.  She has nearly 40 years of experience spanning clinical care, research, public health, and global leadership. She served as clinician and full-time faculty at Duke University Medical Center from 1991 until 2008, concentrating on outpatient and inpatient clinical care (HIV/AIDS, tuberculosis [TB], and routine infectious disease problems). She expanded the nascent Antibiotic Decision Support Team (ADST) and helped establish the Division’s research program in Dar es Salaam, and later Moshi, Tanzania. While at Duke, Dr. Hamilton led the North Carolina TB Control Program in Raleigh, from 2001-2008, serving as the TB Controller for the State.  After achieving Full Professor, with Tenure status at Duke, she was recruited to Family Health International (now FHI 360) to lead development of their TB research portfolio of work, and subsequently led all TB programmatic work as well, working in numerous countries in sub-Saharan Africa (primarily Zambia, Mozambique and Nigeria), and Asia (primarily China, Myanmar, Indonesia, Cambodia), while maintaining her Duke affiliation as a Consulting Professor.  She served in several leadership positions at FHI 360, including Director of Scientific Affairs in the largest unit, the Global Health, Population & Nutrition Group, where she oversaw the quality of research done globally in health and nutrition at the organization. Dr. Hamilton has over 100 peer-reviewed publications, mostly focused on HIV/AIDS, TB and the intersection between the two diseases.  Dr. Hamilton has won numerous awards including the CDC’s Charles C. Shepard Science Award (2012), the National TB Controllers Association’s Robert Koch Award (2012), the International TB Control Cooperation Award from the China Clinical Center on Tuberculosis and the National TB Society (2014), and the US CDC’s Fred Gordin TBTC award (2018).  She retired from FHI 360 in 2018, and is now Professor, Emeritus at Duke, providing mentoring and consultation at both Duke and FHI 360.


Key words: Tuberculosis; mycobacteria other than TB (MOTT); HIV/AIDS; HAART; genomics; global health; public health;


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