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International Health

The Consortium to Respond Effectively to the AIDS/TB Epidemic

The Consortium to Respond Effectively to the AIDS/TB Epidemic (CREATE) is an $80 million Gates-funded project based at the Center for TB Research, led by Professor Dick Chaisson who has a joint appointment in the Department and is based in the School of Medicine. The consortium’s overall mission is to research the impact of new interventions for controlling the AIDS & TB epidemic.

Informational video from the Thibela TB project, Courtesy of CREATECREATE conducts three large-scale projects in Brazil, South Africa and Zambia. Each project tests a different type of intervention:

  1. South Africa (Thibela TB): Mass TB preventive therapy for gold miners using a cluster randomized trial with a study population of around 60,000.
  2. South Africa and Zambia (ZAMSTAR): Enhanced TB case finding, using a community randomized trial with a study population of around 1 million.
  3. Brazil (THRio): Preventive TB therapy and ARVs for HIV patients in Rio de Janeiro using a phased implementation trial with a study population of 19,000. 

Professor Larry Moulton, International Health, is the chief statistician for CREATE. With such unique and large interventions, it was essential that the study designs produce the most reliable and informative data possible. Moulton, along with colleague Professor Richard Hayes from the London School of Hygiene and Tropical Medicine, led the design of these complex protocols, and they continue to address the many issues that arise during data collection. Their collaboration on the CREATE project resulted in their co-authoring the book entitled, Cluster Randomised Trials, published in 2009 by Chapman & Hall. 

While the Consortium is led at the Johns Hopkins Center for Tuberculosis Research, it utilizes research, administrative, and communications strengths from organizations across the globe. The partnership includes

CREATE is now approaching its 5th year when final study results and recommendations will be published.  Look for results from the three studies at the CREATE website.

Thibela TB  
Thibela TB ("prevent TB" in Sotho, a predominant language of South African gold miners) is a cluster-randomized trial to measure the impact of community-wide isoniazid preventive therapy (IPT) on TB incidence at the community level, in a population with a high prevalence of HIV. Mine shafts, rather than individuals, have been randomized to the intervention.

This community randomized trial in Zambia and South Africa tests two interventions to reduce TB prevalence: improved TB case finding through increased access to TB diagnostics for those with symptoms, and household interventions centered on families with a TB case, which include offering TB screening, TB preventive therapy, and linking to HIV testing and care. Assistant Professor Bill Pan, International Health, was brought onto the project to develop spatial mapping and analysis. His work helps illustrate how TB spreads through the community and offers avenues for better screening and pinpointed interventions.

THRio study, which stands for “TB/HIV no Rio”
This study is designed to determine whether routine detection and treatment of  latent TB infection in patients served by HIV clinics in Rio de Janeiro, Brazil, reduces TB incidence. This is the first study to examine the impact of widespread use of isoniazid preventive therapy (IPT) in an HIV infected population.

Select Articles from the CREATE Project
Special AIDS Supplement Issue: Implementation of isoniazid preventive therapy to control HIV-related tuberculosis: Evidence, challenges and policy. Volume 24, Suppl. 5, November 2010. Editors: Richard Chaisson, Alison Grant, Haileyesus Getahun, and Judith Glynn

Statistical design of THRio: a phased implementation clinic-randomized study of a tuberculosis preventive therapy intervention. Moulton LH, Golub JE, Durovni B, Cavalcante SC, Pacheco AG, Saraceni V, King B, Chaisson RE. Clin Trials. 2007;4(2):190-9.

The implementation of isoniazid preventive therapy in HIV clinics: the experience from the TB/HIV in Rio (THRio) study. Durovni B, Cavalcante SC, Saraceni V, Vellozo V, Israel G, King BS, Cohn S, Efron A, Pacheco AG, Moulton LH, Chaisson RE, Golub JE. AIDS. 2010 Nov;24 Suppl 5:S49-56.

--Brandon Howard, February 2011