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Current projects - The LAM study
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Dr Tendesayi Kufa - TB/HIV Research Associate
Tel: 011 484 8844 ext 2097
Email:
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The LAM Study [Study of the Performance of the Clearview® ELISA (urine LAM) Test for Screening HIV-infected Persons for TB]
This is a study of the performance of the polyclonal Clearview® ELISA test for screening ambulatory HIV-infected patients in an HIV Clinic in Ekurhuleni Metropolitan Municipality, South Africa.
Methodology:
We are assessing the performance characteristics of the Clearview® ELISA test in comparison to a gold standard of mycobacterial culture and clinical assessment.
Outcome measures:
- The sensitivity and positive predictive value of the Clearview® ELISA test for intensified case-finding for TB among HIV-infected persons.
- The specificity and negative predictive value of the Clearview® ELISA test for ruling out TB prior to initiation of HAART or isoniazid preventive therapy.
- The prevalence of TB among ambulatory HIV-infected persons in Ekurhuleni Metropolitan Municipality.
Procedures:
All HIV-infected patients attending the HIV Clinic at Tembisa Main Clinic are be asked to participate in the study and undergo both standard screening for TB and to provide a urine specimen for the Clearview® ELISA test. Standard screening for TB includes symptom review, sputum smear microscopy, mycobacterial culture, and chest x-ray. The study team collects sputum as part of screening for pulmonary TB, as well as blood as part of screening for extrapulmonary TB. Among patients with lymphadenopathy, the study team collects fine needle aspirates of the abnormal lymph nodes as part of the work up for TB lymphadenitis. Study participants who are symptomatic at the baseline screen are re-screened six weeks later, and if still symptomatic, referred to TB Clinic for further work up and management.
All study participants with a positive sputum smear, positive mycobacterial culture, abnormal chest x-ray, or positive Clearview® ELISA test are referred to the TB Clinic for further work up and management. All study participants who are acutely ill are referred to the TB Clinic and/or Tembisa Hospital for further work up and management. Three months after enrollment into the study, the Study Coordinator contacts the TB Clinic at Tembisa Main Clinic (or the TB Clinics in Ekurhuleni Metropolitan Municipality to which study participants alternatively choose to seek care), Tembisa Hospital and the study participants to assess final diagnoses and response to treatment.TB outcomes will be classified as: not TB, confirmed pulmonary TB, probable pulmonary TB, possible pulmonary TB, confirmed extrapulmonary TB, probable extrapulmonary TB, and possible extrapulmonary TB.
Progress
Participant recruitment started at the end of October and approximately 190 participants had been enrolled and screened for TB by the middle of January. Enrollment is ongoing.
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