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No. 3, 2010

UPDATES FROM THE TB EPIDEMIOLOGIC STUDIES CONSORTIUM AND THE TB TRIALS CONSORTIUM

An earlier version of this article appeared in The Northeastern Spotlight volume 5, No. 2, Summer 2010.

TBESC Task Order 11 Update: Addressing TB Among African Americans in the Southeast

Tuberculosis rates in the United States represent a significant health disparity between African Americans and non-Hispanic whites.  While TB rates have declined among all racial/ethnic groups, TB rates for African Americans have remained more than eight times higher than rates for non-Hispanic whites.  African Americans accounted for 25.3% of all reported cases of TB in 2008 and over 45% of cases among U.S.-born persons, although they represent only 12.4% of the U.S. population.1,2

The Tuberculosis Epidemiological Studies Consortium (TBESC) funded Task Order 11 in an attempt to understand this persistent disparity in TB rates between white Americans and African Americans.  The PIs on this study are Nickolas DeLuca and Wanda Walton from CDC, and Rachel Royce from the North Carolina site of TBESC at RTI International.

Task Order 11 was conceived in two phases. The first phase entailed conducting formative research at three sites to determine TB knowledge, attitudes, and sources and preferences for medical information.  Using information from the first phase, an advocacy, communication, and social mobilization (ACSM) intervention consisting of local TB “summits” was designed to increase public awareness and encourage collaboration between community stakeholders and local health departments.  Summits were held in four sites in 2008 and 2009.

Phase 1 – Formative Research

County-level surveillance data were used to identify areas in the southeastern United States with high TB rates, along with disparities in rates between African Americans and non-Hispanic whites.  Two urban counties, DeKalb County (GA) and Davidson County (TN), were selected, along with one rural county, Montgomery County (NC). Between April 2006 and March 2007, individual interviews and focus groups were conducted at each site with six groups of individuals:

  • African Americans undergoing treatment for TB,
  • African Americans receiving LTBI treatment,
  • African Americans considered to be at high risk for TB according to local epidemiological information,
  • Community leaders,
  • Community health providers, and
  • Local health department staff.

Interviews with patient and community participants revealed misconceptions about TB and LTBI, including the idea that an annual tuberculin skin test was a vaccination against TB.  Participants noted the lack of attention given to TB, compared to other diseases such as HIV and STIs. TB was seen as being stigmatizing, with concern being expressed about police officers using masks and gloves when arresting people presumed to have TB.

Regarding sources of health information, many patients and community members stressed the need for direct, oral, and personal communication.  While television and the Internet could play a role in providing information, these individuals wanted the opportunity to ask questions.  Community members voiced concerns about the treatment that African Americans receive at public health clinics, but those who had actually received services expressed positive views of the health department.

Phase 2 – Advocacy, Communication, and Social Mobilization Intervention

Review of the Phase 1 Formative Research results suggested that an ACSM intervention would be a fruitful way to address the situation of TB among African Americans in the Southeast. ACSM approaches are advocated by the World Health Organization’s Stop TB strategy.3

The purpose of advocacy is to educate decision makers and other community leaders about TB and encourage support for TB control program policies. The communication component seeks to provide persons with or at risk for TB and community members with accurate information about TB and TB control program services, as well as reduce stigma and discrimination associated with TB. Finally, social mobilization brings community stakeholders together in order to raise awareness and promote action for TB control program improvement and sustainability.

This approach was first tested in a national summit “Stop Tuberculosis in the African-American Community,” held in Atlanta in May 2006 and sponsored by CDC and RTI International. Evaluation results indicated that the summit succeeded in increasing awareness about this health disparity, bringing together new partners, and motivating them to engage in a variety of activities focused on curbing TB in this community.

Four communities were then chosen to host local TB summits. Three were communities in which the formative research took place, and the fourth was Memphis, TN. In each community, RTI field staff worked with the local health department to engage in a planning process with community partners to tailor the summit to their needs. All sites succeeded in mobilizing community partners to plan and implement the summits. Each summit had an informational segment.  Attendees were shown a video which was a component of the Southeastern National TB Center (SNTC) toolkit Working Together to Stop TB, developed by RTI International under contract with the SNTC. Additionally, a local TB clinician spoke, followed by a question and answer session. The other major segment of the program was devoted to developing short-term action plans. Summit participants were contacted at 3 months and 6 months after the summit to ascertain progress on their action plans. Health department staff and community partners were generally enthusiastic about the summits and felt that they had contributed to an increased awareness about TB in the community. Most action items focused on new outreach activities, which varied from distributing the aforementioned video to beauty salons and barbershops, to staging a 1-day health fair in the rural community that included TB testing for approximately 25 people.

Evaluation of follow-up data is currently underway.  Preliminary analysis indicates that relationships between the health department and community groups were formed and in many cases reinforced.  However, for these relationships to thrive and to sustain mutually beneficial activities, the health department would need to devote consistent attention to nurturing the relationships. Health department staff members are trained most often as clinicians or as educators to work one-on-one with individual patients, and not so much as community liaisons. During the intervention, it became apparent in some of the communities that there would be a need for additional resources, along with training and guidance, for health department staff to assume an expanded role consistently and confidently.

Conclusion

TBESC Task 11 represents one of the first major attempts to investigate TB in the African-American community as well as to implement an ACSM intervention in that community. Phase I generated new insights into the communities’ understanding of TB that can be of use to TB control programs planning activities with this community. Full analysis of the ACSM intervention will provide information on the short-term impact of a modest investment of resources on enriching and sustaining partnerships and activities. Material developed to help sites plan and execute the summits may be useful to others interested in trying this approach and will be made available to all who are interested.

—Submitted by Paul Colson, PhD, Program Director, Charles P. Felton Natl TB Center, Columbia University;
Rachel Royce, PhD, MPH, Principal Investigator of the NC Site of the TBESC, RTI International;
and Julie Franks, PhD, Health Educator & Evaluator, Charles P. Felton Natl TB Center, Columbia University

References

  1. CDC. Racial Disparities in Nationally Notifiable Diseases—United States, 2002. MMWR 2006: 54(01), 9-11.
  2. CDC. Trends in Tuberculosis—United States, 2005. MMWR 2006; 55(11), 305-308.
  3. Stop TB Partnership. Advocacy, Communication, and Social Mobilization for Tuberculosis Control: A Handbook for Country Programmes. Geneva: World Health Organization; 2007.

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Consortia Session at the 2010 ATS International Conference

An overview of the Tuberculosis Epidemiologic Studies Consortium (TBESC) recompetition and the new Tuberculosis Trials Consortium (TBTC) was the focus of a session at the 2010 American Thoracic Society International Conference in New Orleans in May 2010.  The session also included an update on recent research involving high-dose rifamycins and the use of the QuantiFERON-Gold In-Tube (QFT GIT) test in predicting TB among U.S. visa applicants.  The purpose of this session, held on May 16, 2010, was to present data on recent studies performed by the consortia and describe plans for both research consortia.

Denise Garrett, MD, provided an overview of the TBESC recompetition. After reviewing the progress made by the current consortium, she reported that a Strategic Planning Workgroup had been formed to assist with the selection of the research focus of the new consortium.  She stated that the focus of the new consortium will be research related to latent tuberculosis infection (LTBI). Unlike the current TBESC, which currently has implemented 33 studies, the new consortium will focus on one main intervention related to LTBI, with several smaller substudies. Next steps in planning for the new TBESC include issuing the request for proposal (RFP) for new sites. This RFP is expected to be issued in the fall of 2010. 

Elsa Villarino, MD, updated session participants on the composition and activities of the new TBTC. In 1995, the TBTC began enrollment for its first study, and in 1997 became a consortium guided by bylaws. The TBTC was re-competed in 1999, and established a consortium of 23 sites. In 2009 TBTC was re-competed once again, and increased its international presence. In the 2010-2020 TBTC, there are 11 sites in North America and 10 sites outside of North America. TBTC is concluding Study 26, a 3-month treatment regimen of INH and rifapentine for LTBI. It is also enrolling patients in Study 29, a trial of high-dose rifapentine to shorten treatment of pulmonary TB.

Randall Reves, MD, presented results from the TBESC study titled, “Evaluation of QFT GIT and TST during TB screening of U.S. Visa Applicants in Vietnam.” Data from this study, designed to evaluate QFT vs. TST and determine the ability to follow applicants in the United States, will be relevant to the over 1 million persons screened by panel physicians and civil surgeons each year. Dr. Reves reported that QFT had high sensitivity (89%) when used to screen patients for TB, and that QFT could be used as a “gateway” to prevent excess chest x-rays. However, he also noted that use of QFT without chest x-ray would result in occasional missed TB cases.

Eric Nuermberger, MD, presented data on the TBTC study called “High-Dose Rifamycins – Opportunities.” Dr. Nuermberger reported that rifapentine has a much longer half-life than rifampin (14-18 hours vs. 2-4 hours), and that rifapentine provides a greater rifamycin exposure than does rifampin for the same dose. The study currently underway involves randomization of smear-positive pulmonary TB patients to rifapentine 10 mg/kg or rifampin 10 mg/kg. Both groups also receive isoniazid, ethambutol, and pyrazinamide. Currently, 80% of enrollment is complete; study endpoints include sputum culture conversion at 2 months and discontinuation regimen. The study will also look at death and time to culture conversion as secondary outcomes.

Despite its being held shortly after a thunderstorm causing widespread flooding and a tornado warning, the TBESC/TBTC session was very well attended. The audience asked questions demonstrating their interest in present and future TB research being performed by the consortia. These presentations were useful in providing an overview of some of the important research being done in LTBI and TB diagnosis and prevention both domestically and internationally. 

—Reported by Suzanne Beavers, MD
Div of TB Elimination

 

TBESC Meeting in San Francisco

Approximately 150 principal investigators, project coordinators, and TBESC study staff attended the 17th semiannual meeting of the Tuberculosis Epidemiologic Studies Consortium (TBESC) held July 28-29 at the Hilton Financial District in San Francisco, CA. Meeting participants were welcomed by Jenny Flood, MD, MPH, from the California Department of Health, and by Phil LoBue, MD, Associate Director for Science for the Division of Tuberculosis Elimination.  Meeting participants attended scientific sessions and breakout sessions to discuss the progress of research studies and plans for data analysis.  The meeting was also a productive forum for the many manuscripts to be written now that studies are being completed with the end of the first consortium.

Meeting attendees attended updates from several TBESC research studies. In one study, “Factors Associated with Acceptance of and Adherence to Treatment for Latent Tuberculosis Infection,” Yael-Hirsch Moverman and Paul Colson, PhD, reported that males and persons with social support are more likely to accept treatment for latent tuberculosis infection (LTBI), The most common reason for refusing LTBI treatment, Dr. Colson stated, were concerns about medication tolerability and toxicity.  The study also queried participants about their knowledge of tuberculosis (TB) and LTBI; greater knowledge about both was associated with greater acceptance of LTBI treatment.

 Participants also heard an update on “Evaluation of new IGRAs in the diagnosis of LTBI in health care workers,” presented by Bob Belknap, MD. They found that only 3% of health care workers with a negative QuantiFERON-TB Gold In-Tube (QFT GIT) test at baseline had a positive QFT at 6 months, whereas almost 53% of persons with a positive QFT at baseline testing had reverted to a negative QFT at 6 months. QFT conversions were more common than tuberculin skin test conversions (0.4%), and weren’t explained by QFT results that were borderline positive.

Other first-day highlights included a presentation on the TBESC recompetition by Denise Garrett, MD, TBESC project officer, “Prospective Evaluation of Immunogenetic and Immunologic Markers for Susceptibility to M. tuberculosis infection and Progression from M. tuberculosis Infection to Active TB.”

On the second day of the meeting, principal investigators presented data from Task Order 9, “Missed Opportunities for TB Prevention in the Foreign-born.” Dr. Katz reported that most (78%) foreign-born persons in the study were diagnosed with TB as a result of a medical evaluation for their symptoms; only approximately 6% of study participants were diagnosed with TB during the visa screening process.  Study PIs also presented data on the epidemiology of TB in study participants. Of the approximately 1,200 persons with pulmonary TB, 54% had smear-positive disease. Smear-negative cases were more than twice as likely to be prevented by Division of Global Migration and Quarantine or civil surgeon screening than were smear-positive cases.

During the second day of the meeting, participants also heard updates on activities of the External Relations Committee, the Publications and Presentations Committee, and the Translating Research into Practice Workgroup. The principal investigators of Task Order 20, “Evaluation of QFT-GIT and TST during TB Screening of U.S. Visa Applicants in Vietnam,” also provided an update on their analysis.

The next TBESC meeting will be in Atlanta, GA, on January 19-20, 2011.

—Reported by Suzanne Beavers, MD
Div of TB Elimination

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