Enhanced TB Screening to Determine the Prevalence and Incidence of TB in Patients With HIV
13. september 2017 oppdatert av: University of North Carolina, Chapel Hill
Enhanced TB Screening to Determine the Prevalence and Incidence of TB in a Cohort of HIV Clinic Patients in Lusaka, Zambia
This study will examine an enhanced protocol to systematically screen a cohort of 400 new HIV clinic enrollees for prevalence and 1-year incidence of tuberculosis (TB).
Studieoversikt
Detaljert beskrivelse
Zambia is a high burden country for both HIV and TB infection and HIV clinic enrollees are a high-risk group for active TB.
Current Zambian Ministry of Health screening protocols are symptom-based even though active case-finding studies in HIV-infected populations have shown that symptoms are not always predictive of active TB.
As a result, there may be a significant amount of un-diagnosed TB among HIV-infected Zambians even in the context of accessing HIV care.
This study will examine an enhanced protocol to systematically screen a cohort of 400 new HIV clinic enrollees for prevalence and 1-year incidence of TB using symptoms, light and fluorescence microscopy, chest radiography and TB culture of sputum and extra-pulmonary fluids (when indicated).
In addition, the sensitivity, specificity and cost-effectiveness of each diagnostic tool will be evaluated.
Studietype
Observasjonsmessig
Registrering (Faktiske)
400
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Lusaka, Zambia
- Kalingalinga HIV Care and Treatment Clinic
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
16 år til 99 år (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
Four hundred new enrollees at the Kalingalinga HIV Care and Treatment Clinic who are not currently being treated for TB.
Beskrivelse
Inclusion Criteria:
- Persons with HIV/AIDS, 16 years of age or older, who are enrolling at the Kalingalinga ART clinic and are able and willing to provide informed consent
- Antiretroviral therapy-naïve except for short-course therapy through prevention of mother-to-child-transmission programs
- Not have taken any TB treatment in the past 3 months
- Willing to provide locator information and allow study staff to contact by phone or visit them at home if required
Exclusion Criteria:
- Any condition, including active drug or alcohol use, which in the opinion of the investigators, would interfere with adherence to study requirements
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
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new HIV clinic enrollees
All new enrollees to a Lusaka HIV clinic will receive a full TB work-up.
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All enrollees will receive a comprehensive TB screening regardless of symptom presentation.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Prevalence of undiagnosed TB in those with HIV.
Tidsramme: Enrollment screening visit
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Among the cohort of 400 new enrollees at the clinic, all will be tested for TB at the specified time points using enhanced TB screening.
Initial diagnosis will use smear microscopy and culture.
Chest X-ray will be performed on the second day of enrollment.
Presumptive Diagnosis: As culture results will take several days or weeks to become available, a presumptive diagnosis will be made based on history and physical exam, symptoms, smear microscopy and chest radiography results.
All patients who are smear-positive by at least one sample will be diagnosed with TB per national guidelines.
Patients who are smear-negative or suspected of extra-pulmonary TB based on clinical or radiographic findings may be treated empirically for TB at the discretion of a clinical or medical officer.
Sputum samples will also be sent for testing at the end of the study with the Xpert MTB/RIF assay.
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Enrollment screening visit
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Incidence of TB in a cohort of HIV clinic patients screened as 'TB negative'.
Tidsramme: enrollment, 3, 6, 9 and 12 month visits.
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To account for patients who are censored prior to 12 months of follow-up, the incidence of TB will be calculated as a rate.
Each patient will contribute follow-up time until they are censored, are diagnosed with TB, or have been in the study for 12 months.
Patients who were diagnosed with TB at enrollment will not be included.
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enrollment, 3, 6, 9 and 12 month visits.
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Performance of diagnostic measures
Tidsramme: Days 1, 2, 3; Months 3, 6 9 and 12
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The performance of symptom screening, light microscopy, fluorescence microscopy, chest x-ray, and Xpert MTB/RIF assay compared to culture of sputum and other fluids in HIV-infected patients will be evaluated using data analysis methods.
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Days 1, 2, 3; Months 3, 6 9 and 12
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Cost-effectiveness of each screening/diagnostic tool.
Tidsramme: Days 1, 2, 3 and months 3, 6, 9 and 12
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The primary outcomes of each diagnostic tool (or combination of diagnostic tools) that will be assessed are: cost per case diagnosed/detected, cost per patient cured, cost per case averted.
For instance, the cost per case of active TB detected using the "null" or gold standard screening option will be calculated and compared to the cost per case of active TB detected using each of the other screening options.
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Days 1, 2, 3 and months 3, 6, 9 and 12
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Clinical outcomes
Tidsramme: up to 12 months post-enrollment
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Clinical outcomes will be measured in a cohort of HIV-infected patients and TB/HIV co-infected patients during the first 12 months of HIV care including but not limited to mortality, immune recovery and development of other opportunistic infections.
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up to 12 months post-enrollment
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Stewart Reid, MD, CIDRZ; University of North Carolina at Chapel Hill
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
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- Boehme CC, Nabeta P, Hillemann D, Nicol MP, Shenai S, Krapp F, Allen J, Tahirli R, Blakemore R, Rustomjee R, Milovic A, Jones M, O'Brien SM, Persing DH, Ruesch-Gerdes S, Gotuzzo E, Rodrigues C, Alland D, Perkins MD. Rapid molecular detection of tuberculosis and rifampin resistance. N Engl J Med. 2010 Sep 9;363(11):1005-15. doi: 10.1056/NEJMoa0907847. Epub 2010 Sep 1.
- Behr MA, Warren SA, Salamon H, Hopewell PC, Ponce de Leon A, Daley CL, Small PM. Transmission of Mycobacterium tuberculosis from patients smear-negative for acid-fast bacilli. Lancet. 1999 Feb 6;353(9151):444-9. doi: 10.1016/s0140-6736(98)03406-0. Erratum In: Lancet 1999 May 15;353(9165):1714.
- Wood R, Middelkoop K, Myer L, Grant AD, Whitelaw A, Lawn SD, Kaplan G, Huebner R, McIntyre J, Bekker LG. Undiagnosed tuberculosis in a community with high HIV prevalence: implications for tuberculosis control. Am J Respir Crit Care Med. 2007 Jan 1;175(1):87-93. doi: 10.1164/rccm.200606-759OC. Epub 2006 Sep 14.
- Boehme CC, Nicol MP, Nabeta P, Michael JS, Gotuzzo E, Tahirli R, Gler MT, Blakemore R, Worodria W, Gray C, Huang L, Caceres T, Mehdiyev R, Raymond L, Whitelaw A, Sagadevan K, Alexander H, Albert H, Cobelens F, Cox H, Alland D, Perkins MD. Feasibility, diagnostic accuracy, and effectiveness of decentralised use of the Xpert MTB/RIF test for diagnosis of tuberculosis and multidrug resistance: a multicentre implementation study. Lancet. 2011 Apr 30;377(9776):1495-505. doi: 10.1016/S0140-6736(11)60438-8. Epub 2011 Apr 18.
- Steingart KR, Henry M, Ng V, Hopewell PC, Ramsay A, Cunningham J, Urbanczik R, Perkins M, Aziz MA, Pai M. Fluorescence versus conventional sputum smear microscopy for tuberculosis: a systematic review. Lancet Infect Dis. 2006 Sep;6(9):570-81. doi: 10.1016/S1473-3099(06)70578-3. Erratum In: Lancet Infect Dis. 2006 Oct;6(10):628.
- Harris JB, Hatwiinda SM, Randels KM, Chi BH, Kancheya NG, Jham MA, Samungole KV, Tambatamba BC, Cantrell RA, Levy JW, Kimerling ME, Reid SE. Early lessons from the integration of tuberculosis and HIV services in primary care centers in Lusaka, Zambia. Int J Tuberc Lung Dis. 2008 Jul;12(7):773-9.
- Moore D, Liechty C, Ekwaru P, Were W, Mwima G, Solberg P, Rutherford G, Mermin J. Prevalence, incidence and mortality associated with tuberculosis in HIV-infected patients initiating antiretroviral therapy in rural Uganda. AIDS. 2007 Mar 30;21(6):713-9. doi: 10.1097/QAD.0b013e328013f632.
- Mohammed A, Ehrlich R, Wood R, Cilliers F, Maartens G. Screening for tuberculosis in adults with advanced HIV infection prior to preventive therapy. Int J Tuberc Lung Dis. 2004 Jun;8(6):792-5.
- Day JH, Charalambous S, Fielding KL, Hayes RJ, Churchyard GJ, Grant AD. Screening for tuberculosis prior to isoniazid preventive therapy among HIV-infected gold miners in South Africa. Int J Tuberc Lung Dis. 2006 May;10(5):523-9.
- Lawn SD, Myer L, Bekker LG, Wood R. Burden of tuberculosis in an antiretroviral treatment programme in sub-Saharan Africa: impact on treatment outcomes and implications for tuberculosis control. AIDS. 2006 Aug 1;20(12):1605-12. doi: 10.1097/01.aids.0000238406.93249.cd.
- Wise J. Southern Africa is moving swiftly to combat the threat of XDR-TB. Bull World Health Organ. 2006 Dec;84(12):924-5. No abstract available.
- Hernandez-Garduno E, Cook V, Kunimoto D, Elwood RK, Black WA, FitzGerald JM. Transmission of tuberculosis from smear negative patients: a molecular epidemiology study. Thorax. 2004 Apr;59(4):286-90. doi: 10.1136/thx.2003.011759.
- Kimerling ME, Schuchter J, Chanthol E, Kunthy T, Stuer F, Glaziou P, Ee O. Prevalence of pulmonary tuberculosis among HIV-infected persons in a home care program in Phnom Penh, Cambodia. Int J Tuberc Lung Dis. 2002 Nov;6(11):988-94.
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- Lawn SD, Bekker LG, Miller RF. Immune reconstitution disease associated with mycobacterial infections in HIV-infected individuals receiving antiretrovirals. Lancet Infect Dis. 2005 Jun;5(6):361-73. doi: 10.1016/S1473-3099(05)70140-7.
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Hjelpsomme linker
Studierekorddatoer
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Studer hoveddatoer
Studiestart
1. oktober 2011
Primær fullføring (Faktiske)
1. september 2012
Studiet fullført (Faktiske)
1. mai 2013
Datoer for studieregistrering
Først innsendt
16. januar 2014
Først innsendt som oppfylte QC-kriteriene
20. januar 2014
Først lagt ut (Anslag)
23. januar 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. september 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. september 2017
Sist bekreftet
1. desember 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CIDRZ 1226/IRB12-0416
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