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TB Notes 1, 2003

Updates from the Research and Evaluation Branch

Incorporating HIV Counseling, Testing, and Referral into TB Contact Investigations

HIV-infected persons have the greatest risk of developing active TB after contact with infectious TB patients. However, a recent 11-site US study found that less than 15% of close contacts had HIV status recorded in their clinic charts and that nearly 25% of known HIV-infected contacts were not screened completely for active TB according to CDC recommendations.1 Moreover, only one third of known HIV-infected contacts started LTBI treatment, with only half of them completing. In response to these findings, CDC issued a request for task order submission through the TB Epidemiologic Studies Consortium (TBESC) in January 2002 to develop methods of incorporating HIV counseling, testing, and referral (CTR) into TB contact investigations. In late June, the task order was awarded to the New York City Department of Health and Mental Hygiene for a period of 18 months.

In 2000, 9% of TB patients in the United States were HIV positive.2 In New York City, 18% of all TB patients were known to be HIV infected.3 However, of those tested for HIV (approximately 66% of patients), 29% were HIV positive. Contacts to HIV-infected TB patients are more likely to be HIV infected because they include children and sex and drug-using partners. CDC’s Revised Guidelines for HIV Counseling, Testing, and Referral4 define a high HIV-prevalence setting as one in which the client population has a prevalence of greater than or equal to 1%. In the previously mentioned 11-site US study of contact investigations, HIV prevalence among all 6,225 close contacts was approximately 2%.1 Among only those contacts with known HIV status, the prevalence was 13%. These data demonstrate that TB contacts, as well as TB patients, are at high risk for HIV and should receive HIV counseling, testing, and referral.

Identifying HIV-infected contacts allows providers to potentially prevent the development of active TB through LTBI treatment and to link HIV-infected persons to care that will prevent the development of other AIDS opportunistic illnesses. By implementing the project in the Manhattan Borough of New York City, Task Order Number 4 aims to 1) improve HIV counseling, testing, and referral of close contacts to infectious TB patients, 2) promptly identify active TB in HIV-infected close contacts, 3) prevent active TB development through the initiation (regardless of TST results) and completion of LTBI treatment in HIV-infected contacts once active TB has been excluded, and 4) prevent AIDS in HIV-infected contacts through referrals to HIV care.

Project objectives are to offer HIV CTR services to all close contacts identified by infectious TB patients in Manhattan, and to have 50% of close contacts receive HIV testing by the end of the project period. For HIV-positive close contacts, all will be screened for active TB and referred for HIV care and supportive services. It is expected that at least 80% of HIV-positive close contacts will receive such services. In addition, all HIV-infected close contacts who do not have active TB will be offered LTBI treatment, and 70% of those starting are expected to complete it.

Project activities started at the end of November 2002. Dr. Jiehui Li is the New York City Project Officer and Suzanne Marks is the CDC Technical Monitor for Task Order Number 4. Dr. Li has been diligently working with staff in the Manhattan Network to develop implementation and monitoring procedures that are feasible and coordinated with other TB activities. Carla Clark, as the data programmer, has been developing data monitoring and reporting mechanisms. Other project staff are currently being hired. Cynthia Driver, Director of the Epidemiology Unit, and Sonal Munsiff, Director of the New York City Bureau of TB Control, will also contribute time as project staff and as representatives for the TBESC.

-Reported by Suzanne Marks, MPH, MA
Div of TB Elimination

References
1. CDC. Missed opportunities for prevention of tuberculosis among persons with HIV infection - selected locations, United States, 1996-1997. MMWR 2000; 49(30): 685-687.

2. CDC. Reported Tuberculosis in the United States, 2001. Table 11. Atlanta, GA: U.S. Department of Health and Human Services, CDC, September 2002;14.

3. New York City TB Control Program unpublished statistics.

4. CDC. Revised guidelines for HIV counseling, testing, and referral. MMWR Recommendations and Reports 2001; 50(RR-19): 1-85.

Update on the TB Trials Consortium

CDC's TB Trials Consortium (TBTC) has experienced several significant events over the past several months.

1. The primary report of results from USPHS/TBTC Study 22 appeared in The Lancet in August (Lancet 2002; 360:528-534), presenting results among HIV-negative patients treated with a once-weekly isoniazid/rifapentine regimen. While results overall were not satisfactory, it was possible to identify a subgroup of patients in whom the once-weekly regimen appeared to perform quite well. The new ATS/CDC/IDSA treatment guidelines, published in the American Journal of Respiratory and Critical Care Medicine in February 2003 (see cover letter for citation) reflect these results in allowing consideration of this regimen in appropriate, low-risk HIV-negative TB patients. Use of this regimen is expected to be helpful in multiple situations; for example, the regimen is quite attractive for patients who are employed and must miss work for DOT.

2. The primary report from USPHS/TBTC Study 25, a dose-ranging study of two doses of rifapentine as part of TB therapy, was published in June in the American Journal of Respiratory and Critical Care Medicine (Am J Resp Crit Care Med 2002; 165:1526-1530). This study provided important data to support the choice of dose in subsequent trials. Based on results from this study, the 900-mg rifapentine dose is being evaluated in Study 26 (see below).

3. The TB Trials Consortium held its annual Scientific Advisory Group of Experts (SAGE) meeting in Atlanta on September 13, 2002. The SAGE meeting provides a review of all TBTC activities for the senior scientific staff of DTBE, and is programmed to occur each year just prior to the annual round of budget decisions. Review of the TBTC work plan and prior year accomplishments provides the needed background for senior managers to judge the appropriateness of budget requests, and equally importantly provides an opportunity for interaction and feedback between consortium and divisional programmatic leadership.

Among the points of note at this year's meeting was the announcement of the results of both internal and external recompetitions, as listed below:

Seven-year increases were awarded to four existing sites:

  • University of North Texas, which will begin a collaboration with the Dallas County TB Control Program;
  • University of Southern California/LA County, which plans to expand its existing collaboration with Los Angeles County TB Control;
  • Columbia University, which will expand a highly successful collaboration with the New York City Department of Health; and,
  • The San Antonio VA Medical Center, which will expand collaborations with multiple sites in its area. These sites include the Wilford Hall Medical Center and several TB clinics in southwestern Texas. In addition, the award will assist the San Antonio VAMC site to solidify its roles as the laboratory coordinator for the TBTC NAA Study and as a leading site in enrollment into pharmacokinetic studies.

Seven-year awards were also made to three new external sites:

  • Emory University in Atlanta, GA (the principal investigator is Dr. Susan Ray), which will be collaborating with the TB Control Programs in both Fulton and DeKalb Counties;
  • University of California at San Diego (the principal investigator is Dr. Antonino Catanzaro), who will collaborate with the San Diego County TB Control Program; and,
  • The Federal University of Rio de Janeiro in Brazil (the principal investigator in Brazil is Dr. Afranio Kritski), collaborating with the existing TBTC site at Johns Hopkins University in Baltimore.

This is the TBTC's first site outside North America, and thus represents a major new undertaking for the consortium. It is expected that the Brazil site will focus initially on participation in Study 26 (once-weekly treatment of LTBI).

4. The semi-annual TBTC meeting took place in Montreal, Canada, on October 4-5, 2002. Representatives of all new sites were in attendance. Major communications and events included the following:

a. Adoption of a new major study, Study 27, which is a Phase 2 trial studying the impact of substituting moxifloxacin for ethambutol in the initial 2 months of TB therapy. The study will be double-blind and placebo-masked. Approximately one third of the patients are expected to be enrolled at the Kampala, Uganda, site of Case Western Reserve University’s TB Research Unit, through a collaboration between TBTC and Case Western. The manufacturer of moxifloxacin, Bayer Pharmaceuticals, has contributed substantially to the design and support of this trial.

b. TBTC Study 26, the consortium's flagship trial of a once-weekly, 12-dose INH / rifapentine regimen for treatment of LTBI, continues to enroll patients. Almost 1,000 patients were enrolled in the first year, and the inclusion of new sites offers hope that enrollment will continue to increase. With a projected sample size of almost 8,000, Study 26 is an ambitious undertaking whose results could have substantial impact on the drive to eliminate TB.

c. Prof. Denis Mitchison, formerly of the British Medical Research Council's TB Unit, was an invited speaker at this fall's meeting. Prof. Mitchison shared new data on the potential impact of fluoroquinolones in TB therapy and on the mechanisms of action of pyrazinamide.

d. Efforts are underway to establish a centralized IRB process that will help both TBTC and the TB Epi Studies Consortium simplify their activities related to human subject protections. This effort is modeled on the successful pilot effort of the National Cancer Institute, and promises to improve efficiency while preserving robust human subject protections. The project has won approval from OHRP, and is being guided by Drs. Dolly Katz and Naomi Bock.

5. The following staffing changes have taken place: Dr. Naomi Bock has transferred to the Division of HIV/AIDS Prevention in the National Center for HIV, STD, and TB Prevention (NCHSTP). Dr. Andrew Vernon has left his position in DTBE’s Research and Evaluation Branch as the overall coordinator of the TB Trials Consortium to become the Associate Director for Science for NCHSTP. Despite these departures, Drs. Bock and Vernon will maintain affiliations with the TBTC, assisting in selected studies and TBTC functions. Dr. Phil Spradling, who had worked in DTBE’s Surveillance and Epidemiology Branch before leaving for another position in CDC, returned to DTBE to replace Dr. Naomi Bock in the TBTC.

-Reported by Andrew Vernon, MD, MHS
Div of TB Elimination

 


Released October 2008
Centers for Disease Control and Prevention
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