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TB Notes Newsletter

No. 3, 2005

Clinical and Health Systems Research Branch Updates

Tuberculosis Trials Consortium (TBTC) Study 27 and 28 Update

TBTC Study 27, “An Evaluation of the Activity and Tolerability of Moxifloxacin During the First 2 Mos. of Treatment for Pulmonary Tuberculosis,” enrolled its first patient on July 25, 2003, and completed enrollment on March 14, 2005. Initially proposed to study 300 patients and to take 3 years to complete, the final enrollment was 336 patients.  Findings from preliminary analyses were presented at the TBTC meeting and American Thoracic Society (ATS) conference in May 2005.Approximately half of the enrollments occurred at the TBTC site in Kampala, Uganda, with the next largest enrollment occurring at the site in Durban, South Africa.

At the end of study enrollment, a large amount of generic ethambutol, good through November 2005, remained from the original bulk purchase from Versapharm. The surplus was offered to the African sites, whose high case rates would enable them to use it quickly in their routine clinical practice; the offer was accepted by the Uganda site. At the end of March, after completing the necessary paperwork, the CDC pharmacy sent 36,000 400 mg ethambutol tablets to Uganda, where they were very much appreciated. For readers who may wonder, matching placebo tablets that were also left over from Study 27 were destroyed according to CDC pharmacy drug services protocol.

TBTC Study 27 compared moxifloxacin with ethambutol during the first 2 months of therapy. Study 28, “Evaluation of a Moxifloxacin-Based, Isoniazid-Sparing Regimen for Tuberculosis Treatment,” will compare moxifloxacin with isoniazid during the first 2 months of therapy. It has been approved by the CDC IRB and is in the process of IRB review locally by consortium sites. Enrollment starts in early fall 2005.

Patients Enrolled in TBTC Study 27 by Site
See TB Notes No. 4, 2004, for more detail on TBTC Study 27 and 28 at

—Reported by Stefan Goldberg, MD
Div of TB Elimination


Collaboration to Improve TB Services for HIV-Infected Persons

In persons with latent TB infection (LTBI), coinfection with HIV is one of the highest risk factors for development of active TB. In August 2003, the Health Systems Research Team in the Clinical and Health Systems Research Branch of DTBE began a collaborative project with the HIV/AIDS Bureau of the Health Resources and Services Administration (HRSA). The purpose of the collaboration is to help improve the provision of TB services to HIV-infected persons who receive care through Ryan White Comprehensive AIDS Resources Emergency (CARE) Act grantees. The overall aim of the project is to help reduce TB incidence among persons living with HIV/AIDS by facilitating improvements in the detection and treatment of TB and LTBI.

Guidelines have been issued by the US Public Health Service (USPHS) and the Infectious Diseases Society of America (IDSA) for preventing opportunistic infections among HIV-infected persons.1,2  Individuals newly diagnosed with HIV infection should receive a tuberculin skin test (TST) soon after HIV diagnosis and be clinically evaluated for TB disease if they have a positive TST result or have TB symptoms. If there is no evidence of TB disease (and no history of treatment for TB or LTBI), persons with a positive TST result should receive LTBI treatment (recent contacts to TB patients should be treated regardless of TST result). The guidelines also recommend annual repeat testing for persons with negative TST results who may be at a substantial risk of TB exposure. Clinicians should also consider repeat testing if immune function has improved owing to HIV chemotherapy.

Currently, there is limited information concerning the extent to which TB screening and treatment services are being implemented by HIV service providers throughout the United States. A study at three US sites by Lee revealed that about 50% of HIV-infected persons were screened for LTBI, with a mean time of 6 months between HIV diagnosis and TST.3 Approximately 7% had positive TST reactions, and 59% of these individuals were given LTBI treatment. In a study among New York City HIV clinics, Sackoff et al. revealed that 56% of patients with an indication for a TST had a current test result. They found that 41% of patients with TST-positive results completed a 12-month regimen for LTBI.4 Finally, the CDC Supplement to HIV/AIDS Surveillance project found that from 1995 to 1999, 80% of eligible HIV/AIDS patients from 12 state or local health departments reported ever receiving a TST.5 Of the 8% who had a positive TST, 27% did not receive LTBI treatment. The researchers concluded that current rates of LTBI testing and treatment did not fully meet the USPHS/IDSA guidelines. 

The HIV/AIDS Bureau (HAB) of HRSA administers the Ryan White CARE Act. The CARE Act funds primary health care and support services through four titles for approximately 571,000 persons per year, or possibly 75% of HIV-infected persons who know their HIV status. Those who receive services through CARE Act grantees are likely to be persons with limited access to health care and may be at high risk for TB. Because HRSA/HAB has access to this high-risk population and because DTBE has prioritized TB prevention among HIV-infected persons, the two agencies joined together in this collaborative project. The relationship between HRSA/HAB and DTBE was formalized in a Memorandum of Understanding (MOU), which facilitates study collaboration and enables the exchange of information and resources.

The project is divided into two parts. Part One, recently completed, identified the HRSA/HAB policies, procedures, and baseline levels of TB screening and treatment through extant data reported to HRSA/HAB by CARE Act grantees. The specific study questions for Part One were

  • What written policies are in place for HAB grantees to provide TB services?
  • What is the current rate of TB screening and treatment of HIV-infected clients at HAB grantees?
  • Based on data from CARE Act Data Reports and earlier Title III Program Data Reports, which HAB grantees have achieved high rates of TB screening and treatment? 

The methods employed for Part One included the establishment of the MOU; interviews with HRSA/HAB headquarters staff about TB services, policies, and reporting; and an informal collection of written policies, procedures, and training curricula from Title III and IV clinics. Title III supports outpatient primary medical care and early intervention services to people living with HIV/AIDS through grants to public and private nonprofit organizations. Title IV supports coordinated primary care services and access to research for children, youth, and women with HIV disease and their families. CDC project staff also analyzed data from all reporting grantees through the CARE Act Data Report (CADR) on TB screening and treatment services. TB variables included the number of clients who received a TST, received treatment owing to a positive TST, or were diagnosed with active TB in the reporting year. HAB has revised its CADR as of 2005 to include additional TB variables, such as completion of LTBI treatment, partly as a result of this project. The results of Part One were presented at the 2005 National TB Controllers Association in Atlanta, Georgia.  

The primary objective of Part Two is to facilitate improvement in the detection and treatment of LTBI and TB by developing knowledge of successful TB services provision at selected CARE Act Title III grantees, strengthening the capacity of Title III service providers, and improving collaboration between Title III grantees and TB providers.  Proposed study questions for Part Two are

  • How do the selected Title III grantees successfully provide TB prevention services?
  • What ecological and program characteristics and activities are associated with higher rates of TB screening and treatment at the selected Title III HIV clinics?
  • How much does it cost to provide TB screening and treatment services at the selected Title III HIV clinics?

A total of six CARE Act Title III grantees in New York City, Los Angeles, and Miami, all areas with high HIV/TB co-morbidity, will participate in the case studies. Using qualitative and quantitative methods, CDC project staff will document the range of program designs and practices that have achieved success in TB service provision. Methods will include 1) key informant interviews with HIV clinic staff; 2) chart abstractions of a random sample of Title III HIV-infected clients; 3) a review of written TB policies, protocols, and other documents relevant to TB services provision; 4) interviews with clinic staff about cost of providing TB screening and treatment services; 5) focus groups with a randomly selected sample of clients; 6) observation of program operations; 7) and if appropriate, interviews with staff members from collaborating TB programs.

After results are shared with HAB and study sites, HAB in coordination with CDC will develop a dissemination strategy that identifies potential users and targets findings and mechanisms appropriate for each group. Depending on the nature of the findings, the dissemination strategy may involve HAB’s AIDS Education and Training Centers (AETCs). Study findings will reach a wider audience through CDC and HAB publications and a peer-reviewed journal.

In the final phase, HAB project staff will develop an implementation strategy in collaboration with CDC. It is intended that this strategy will promote the use of study findings by Title III HIV providers beyond what could be expected from publication in a peer-reviewed journal. Linkages between Title III HIV providers, AETCs, and DTBE may be established to develop protocols or guidelines for TB services provision improvement. Findings from the study will be considered for incorporation into training and technical assistance activities by HAB’s 11 regional AETCs and their local performance sites as deemed appropriate given the study results. Findings may also be incorporated into training materials and curricula developed by the TB Regional Training and Medical Consultation Centers for broad use by TB providers. DTBE’s Field Services and Evaluation Branch will be consulted to help establish referral mechanisms between HIV providers and local TB providers. Lastly, ongoing information exchange mechanisms will be developed between CDC and HAB for sharing of TB screening and treatment data to monitor TB services provision over time.

In summary, HAB’s access to this at-risk population provides an opportunity to prevent TB morbidity and mortality and to improve TB services for people living with HIV/AIDS.  This collaborative project addresses priorities of both CDC and HAB, as well as the Institute of Medicine6 and the Federal TB Task Force.7 In addition, this collaboration provides an opportunity for staff members from HAB and CDC to build professional relationships and sets the stage for future partnerships that further both agencies’ goals.

—Reported by Heather Joseph, MPH, Cathy Rawls, MPH, CHES, and Suzanne Marks, MPH
Div of TB Elimination

For additional information about this study, please contact the Project Officers: 

Suzanne Marks ( or Heather Joseph ( at DTBE or Alice Kroliczak ( or José Rafael Morales ( at HRSA/HAB.


  1. CDC. Guidelines for preventing opportunistic infections among HIV-infected persons—2002: Recommendations of the US Public Health Service and the Infectious Diseases Society of America. MMWR. 2002:51(RR-8):8-10.
  2. Prevention and treatment of tuberculosis among patients infected with human immunodeficiency virus: Principles of therapy and revised recommendations. MMWR 1998; 47(RR-20).
  3. Lee LM, Buskin SE, and Morse A. Low rates of tuberculin skin testing among persons with diagnosed HIV infection, US, 1995-1997. Presented at the 14th International AIDS Conference. Barcelona, Spain; July 7-12, 2002.
  4. Sackoff JE, Torian LV, Frieden TR, Brudney KF, Menzies IB. Purified protein derivative testing and tuberculosis preventive therapy for HIV-infected patients in New York City. AIDS. 1998;12:2017-2023.
  5. Campsmith ML, Nakashima AK, and Burgess D. Self-reported TB testing and preventive therapy in an HIV-infected population: Results from an interview project in the United States. Presented at CDC. Atlanta, GA, 2000.
  6. Institute of Medicine. Ending Neglect: The Elimination of Tuberculosis in the United States. Washington, DC: National Academy Press.  2000.
  7. CDC. Federal Tuberculosis Task Force Plan in Response to the Institute of Medicine Report, Ending Neglect: The Elimination of Tuberculosis in the United States. September 2003. IOM Recommendation 4.2.2: 35.


Released October 2008
Centers for Disease Control and Prevention
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
Division of Tuberculosis Elimination -

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