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No. 1, 2009

CLINICAL AND HEALTH SYSTEMS RESEARCH BRANCH UPDATES

Release of Guides Promoting Cultural Sensitivity

DTBE’s Clinical and Health Systems Research Branch is pleased to announce the publication of the complete set of ethnographic guides, entitled Promoting Cultural Sensitivity:  A Practical Guide for Tuberculosis Programs That Provide Services to Persons (from China, Laos, Mexico, Somalia, Vietnam). You may have already seen the Hmong and Somali modules that were published in the fall last year, but the release of the Mexican, Chinese, and Vietnamese modules earlier this year completes the set of five ethnographic guides. 

Each module in the series focuses on a distinct cultural group and contains a two-page summary of program tips, as well as chapters on the selected population’s history and immigration to the United States; culture; and health issues relevant to TB care. The final chapter summarizes the common perceptions, attitudes, and beliefs about TB that emerged from DTBE’s 2003 ethnographic study of foreign-born persons in the United States. Appendices containing tips on eliciting patients’ perceptions of TB, working with interpreters, cultural competence resources, TB screening policies, and references are included in the guides. The series aims to help TB program staff gain a deeper understanding of pertinent issues that will lead to heightened cultural sensitivity, better communication skills and, ultimately, enhanced effectiveness of care and services in cross-cultural settings. 

The modules have been distributed widely to TB controllers and programs throughout the United States. The guides in pdf format are available on DTBE’s website. A CD-ROM containing all five guides is also available in limited quantities.

A sixth guide, which will focus on Karen persons from Myanmar (formerly known as Burma), is currently being developed.  Data collection is in progress. The guide is expected to be released toward the end of the year. Stay tuned!

—Reported by Robin Shrestha-Kuwahara, MPH
Div of TB Elimination

Tuberculosis Trials Consortium (TBTC) Updates

The TBTC continues its quest for the elusive goal of short-course therapy for TB treatment. CDC, currently represented by the TBTC, has been the federal agency assigned to conduct USPHS TB clinical trials since 1961. The consortium has now embarked on TBTC Study 29, the third in a series of Phase 2 randomized clinical trials, each trying to determine whether a new regimen appears potent and safe enough, during the first 2 months of treatment, to support a Phase 3 treatment-shortening trial. Secondary analyses help to evaluate important safety features and variations in response to treatment by region and clinical details.

The first patient for TBTC Study 29, “Evaluation of a rifapentine-containing regimen for intensive phase treatment of pulmonary tuberculosis,” enrolled on December 8, 2008, in Harlingen, Texas. The goal of this Phase 2 clinical trial is to evaluate the antimicrobial activity and safety of an experimental intensive-phase (first 8 weeks of treatment) TB treatment regimen in which rifapentine is substituted for rifampin. Sputum smear–positive pulmonary TB suspects are enrolling at 23 sites in the U.S., Canada, Uganda, Brazil, Spain, and South Africa. As of April 28, 2009, 127 patients (26%) were enrolled, making full enrollment by the end of 2009 a good possibility. A strongly positive result from this study would support evaluating a rifapentine-based, 3- or 4-month regimen in a Phase 3 trial.

TBTC Study 28, “Evaluation of a moxifloxacin-based, isoniazid-sparing regimen for tuberculosis treatment,” has been published in the American Journal of Respiratory and Critical Care Medicine, with Susan Dorman from Johns Hopkins University as first author. This study showed moxifloxacin to be safe and effective during intensive-phase TB treatment, although it did not show moxifloxacin to have a statistically significant advantage in improving culture negativity at the end of 2 months.

At the 2008 Union meeting in Paris, TBTC researchers presented analyses on combined data from Study 28 and the very similar TBTC Study 27, which substituted moxifloxacin for isoniazid and also found no statistically significant advantage for moxifloxacin at the end of 2 months:

  1. Lower 2-month sputum culture conversion is associated with extensive cavitation and region of enrollment (Goldberg SV, Whitworth WC, Muzanye G, Padayatchi N, Villarino ME, Goodman P, Johnson JL, Dorman SE, Chaisson RE, Burman W, and the TB Trials Consortium)
     
  2. Does the presence of isoniazid during intensive phase of TB treatment affect the risk of hepatotoxicity? (Burman W, Bliven EE, Goldberg S, Borisov A, Johnson JL, Saukkonen J, Dorman SE, Chaisson RE, and the TB Trials Consortium).

There were two new findings from these secondary analyses. First, lower sputum conversion in liquid cultures is associated with extensive cavitation and region of enrollment. In addition, the presence of isoniazid was not associated with a lower risk of hepatotoxicity among patients on rifampin- and pyrazinamide-containing intensive-phase regimens.

—Reported by Stefan Goldberg, MD
Div of TB Elimination

Last Reviewed: 05/13/2009

 

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