Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Total Enrollment
776 participants
Study Classification
OBSERVATIONAL
Study Start Date
2016-06-22
Study Completion Date
2018-02-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
A parallel-group prospective cohort study among adult persons living with HIV/AIDS to study the effect of a new TB diagnostic test, Xpert MTB/RIF on: 1) TB case detection; 2) time to TB diagnosis and TB treatment; 3) presumptive TB patient drop-out from the TB diagnostic "cascade" before starting TB treatment; and 4) loss to follow-up after initiation of TB treatment.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Trial of Point-of-treatment Xpert MTB/RIF Assay
NCT01554384
Tuberculosis
COMPLETED
NA
Improve Treatment Outcomes for Tuberculosis Infection in Tertiary Care Hospitals
NCT03042754
Tuberculosis
ACTIVE_NOT_RECRUITING
NA
Evaluation of Xpert MTB/RIF Assay for the Rapid Identification of TB and TB Rifampin Resistance in Pulmonary Tuberculosis Suspects
NCT01587469
Tuberculosis
COMPLETED
Evaluating Accuracy, Impact, and Operational Challenges of GeneXpert Use for TB Case Finding Among HIV-infected Persons
NCT02538952
Tuberculosis
Human Immunodeficiency Virus
COMPLETED
PHASE4
The Utility of Intensified Case Finding Combined With a Package of Novel TB Diagnostics Using a Mobile Clinic in Africa
NCT01990274
Tuberculosis
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The Centre for Infectious Disease Research in Zambia (CIDRZ) in collaboration with the Zambian National TB Program (NTP) and the Ministry of Health (MOH) will provide near point-of-care Xpert testing at a high-volume anti-retroviral treatment (ART) clinic in Lusaka, Zambia. A total 892 study participants will be enrolled into two parallel cohorts-an "Xpert" and a "standard of care" (SOC) cohort over a 7-month period. The Xpert cohort will enrol participants at the health centre implementing Xpert. The SOC cohort will enrol participants from one health centre offering the standard of care (sputum smear microscopy plus clinical evaluation). A parallel-group prospective cohort study will be conducted by following participants in one cohort from each site for 210 days from the time of sputum submission, allowing sufficient person-time to observe all outcomes of interest, including completion of a standard course of ATT as well as patient drop-out and loss to follow-up.
A systematic facility assessment survey using an adapted version of the WHO Service Availability and Readiness Assessment tool will be conducted. Key informants will be interviewed.
A systematic facility assessment survey using an adapted version of the WHO Service Availability and Readiness Assessment tool will be conducted. Key informants will be interviewed.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Tuberculosis
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Xpert cohort
HIV-positive presumptive TB patients tested for TB using Xpert MTB/RIF assay (fluorescence microscopy and TB culture also done to serve as reference standard)
Xpert
Intervention Type
DEVICE
The Xpert MTB/RIF assay is a nucleic acid amplification (NAA) test that uses a disposable cartridge with the GeneXpert Instrument System
Standard of Care cohort
HIV-positive presumptive TB patients tested for TB using standard of care testing (sputum smear microscopy plus clinical evaluation)
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Xpert
The Xpert MTB/RIF assay is a nucleic acid amplification (NAA) test that uses a disposable cartridge with the GeneXpert Instrument System
Intervention Type
DEVICE
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Xpert MTB/RIF assay
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Able to spontaneously expectorate at least 2 sputum samples, in accordance with NTP guidelines
* Intend to continue receiving care at the respective study sites for at least 7 months
* Willing to provide locator information and allow contact by phone or home visit in the case of loss to follow up after initiating ATT
* Intend to continue receiving care at the respective study sites for at least 7 months
* Willing to provide locator information and allow contact by phone or home visit in the case of loss to follow up after initiating ATT
Exclusion Criteria
* Received TB treatment within 60 days prior to enrolment and/or were diagnosed with TB within the last 6 months
* Cannot spontaneously expectorate sputum
* Are already enrolled in another study with might interfere with implementation of this study protocol
* Provided a sputum sample that results in a contaminated TB culture result
A key informant will be eligible for inclusion in the SARA facility survey component of the study if they meet the following criteria:
* 18 years of age or older
* clinic staff member at either Chilenje Health Centre or Chelstone Health Centre
* have previously been attached to, or are otherwise familiar with, departments offering HIV, TB and/or laboratory health services
-unwilling or unable to provide verbal informed consent in English
* Cannot spontaneously expectorate sputum
* Are already enrolled in another study with might interfere with implementation of this study protocol
* Provided a sputum sample that results in a contaminated TB culture result
A key informant will be eligible for inclusion in the SARA facility survey component of the study if they meet the following criteria:
* 18 years of age or older
* clinic staff member at either Chilenje Health Centre or Chelstone Health Centre
* have previously been attached to, or are otherwise familiar with, departments offering HIV, TB and/or laboratory health services
-unwilling or unable to provide verbal informed consent in English
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institutes of Health (NIH)
NIH
Sponsor Role
collaborator
University of North Carolina, Chapel Hill
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael Herce, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chelstone and Chilenje Health Centres
Lusaka, , Zambia
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Zambia
References
Explore related publications, articles, or registry entries linked to this study.
Botha E, Den Boon S, Verver S, Dunbar R, Lawrence KA, Bosman M, Enarson DA, Toms I, Beyers N. Initial default from tuberculosis treatment: how often does it happen and what are the reasons? Int J Tuberc Lung Dis. 2008 Jul;12(7):820-3.
Reference Type
BACKGROUND
World Health Organization. (2013). Global tuberculosis report 2013. Geneva: WHO.
Reference Type
BACKGROUND
Millen SJ, Uys PW, Hargrove J, van Helden PD, Williams BG. The effect of diagnostic delays on the drop-out rate and the total delay to diagnosis of tuberculosis. PLoS One. 2008 Apr 9;3(4):e1933. doi: 10.1371/journal.pone.0001933.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Lawn SD, Brooks SV, Kranzer K, Nicol MP, Whitelaw A, Vogt M, Bekker LG, Wood R. Screening for HIV-associated tuberculosis and rifampicin resistance before antiretroviral therapy using the Xpert MTB/RIF assay: a prospective study. PLoS Med. 2011 Jul;8(7):e1001067. doi: 10.1371/journal.pmed.1001067. Epub 2011 Jul 26.
Reference Type
BACKGROUND
Boehme, C. C. Oral Presentation, 20th Conference on Retroviruses and Opportunistic Infections. Georgia World Conference Centre, Atlanta, USA, March 3-6, 2013.
Reference Type
BACKGROUND
Theron G, Zijenah L, Chanda D, Clowes P, Rachow A, Lesosky M, Bara W, Mungofa S, Pai M, Hoelscher M, Dowdy D, Pym A, Mwaba P, Mason P, Peter J, Dheda K; TB-NEAT team. Feasibility, accuracy, and clinical effect of point-of-care Xpert MTB/RIF testing for tuberculosis in primary-care settings in Africa: a multicentre, randomised, controlled trial. Lancet. 2014 Feb 1;383(9915):424-35. doi: 10.1016/S0140-6736(13)62073-5. Epub 2013 Oct 28.
Reference Type
BACKGROUND
Office of the U.S. Global AIDS Coordinator. Scaling Up TB Prevention, Screening, Diagnosis and Care in Zambia: Implementing the WHO 3I's, Program Protocol. Lusaka: Centers for Disease Control and Prevention-Zambia, 2012.
Reference Type
BACKGROUND
Kivihya-Ndugga LE, van Cleeff MR, Githui WA, Nganga LW, Kibuga DK, Odhiambo JA, Klatser PR. A comprehensive comparison of Ziehl-Neelsen and fluorescence microscopy for the diagnosis of tuberculosis in a resource-poor urban setting. Int J Tuberc Lung Dis. 2003 Dec;7(12):1163-71.
Reference Type
BACKGROUND
UNAIDS. Global Report: UNAIDS report on the global AIDS epidemic 2013. Geneva: Joint United Nations Programme on HIV/AIDS, 2013.
Reference Type
BACKGROUND
Getahun H, Harrington M, O'Brien R, Nunn P. Diagnosis of smear-negative pulmonary tuberculosis in people with HIV infection or AIDS in resource-constrained settings: informing urgent policy changes. Lancet. 2007 Jun 16;369(9578):2042-2049. doi: 10.1016/S0140-6736(07)60284-0.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Sreeramareddy CT, Panduru KV, Menten J, Van den Ende J. Time delays in diagnosis of pulmonary tuberculosis: a systematic review of literature. BMC Infect Dis. 2009 Jun 11;9:91. doi: 10.1186/1471-2334-9-91.
Reference Type
BACKGROUND
Cohen T, Murray M, Wallengren K, Alvarez GG, Samuel EY, Wilson D. The prevalence and drug sensitivity of tuberculosis among patients dying in hospital in KwaZulu-Natal, South Africa: a postmortem study. PLoS Med. 2010 Jun 22;7(6):e1000296. doi: 10.1371/journal.pmed.1000296.
Reference Type
BACKGROUND
Vassall A, van Kampen S, Sohn H, Michael JS, John KR, den Boon S, Davis JL, Whitelaw A, Nicol MP, Gler MT, Khaliqov A, Zamudio C, Perkins MD, Boehme CC, Cobelens F. Rapid diagnosis of tuberculosis with the Xpert MTB/RIF assay in high burden countries: a cost-effectiveness analysis. PLoS Med. 2011 Nov;8(11):e1001120. doi: 10.1371/journal.pmed.1001120. Epub 2011 Nov 8.
Reference Type
BACKGROUND
Steingart KR, Sohn H, Schiller I, Kloda LA, Boehme CC, Pai M, Dendukuri N. Xpert(R) MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in adults. Cochrane Database Syst Rev. 2013 Jan 31;(1):CD009593. doi: 10.1002/14651858.CD009593.pub2.
Reference Type
BACKGROUND
Dowdy DW, Davis JL, den Boon S, Walter ND, Katamba A, Cattamanchi A. Population-level impact of same-day microscopy and Xpert MTB/RIF for tuberculosis diagnosis in Africa. PLoS One. 2013 Aug 12;8(8):e70485. doi: 10.1371/journal.pone.0070485. eCollection 2013.
Reference Type
BACKGROUND
Van Rie A, Page-Shipp L, Hanrahan CF, Schnippel K, Dansey H, Bassett J, Clouse K, Scott L, Stevens W, Sanne I. Point-of-care Xpert(R) MTB/RIF for smear-negative tuberculosis suspects at a primary care clinic in South Africa. Int J Tuberc Lung Dis. 2013 Mar;17(3):368-72. doi: 10.5588/ijtld.12.0392.
Reference Type
BACKGROUND
Hanrahan CF, Selibas K, Deery CB, Dansey H, Clouse K, Bassett J, Scott L, Stevens W, Sanne I, Van Rie A. Time to treatment and patient outcomes among TB suspects screened by a single point-of-care xpert MTB/RIF at a primary care clinic in Johannesburg, South Africa. PLoS One. 2013 Jun 6;8(6):e65421. doi: 10.1371/journal.pone.0065421. Print 2013.
Reference Type
BACKGROUND
Clouse K, Page-Shipp L, Dansey H, Moatlhodi B, Scott L, Bassett J, Stevens W, Sanne I, Van Rie A. Implementation of Xpert MTB/RIF for routine point-of-care diagnosis of tuberculosis at the primary care level. S Afr Med J. 2012 Sep 7;102(10):805-7. doi: 10.7196/samj.5851.
Reference Type
BACKGROUND
Lawn SD, Ayles H, Egwaga S, Williams B, Mukadi YD, Santos Filho ED, Godfrey-Faussett P, Granich RM, Harries AD. Potential utility of empirical tuberculosis treatment for HIV-infected patients with advanced immunodeficiency in high TB-HIV burden settings. Int J Tuberc Lung Dis. 2011 Mar;15(3):287-95.
Reference Type
BACKGROUND
Yoon C, Cattamanchi A, Davis JL, Worodria W, den Boon S, Kalema N, Katagira W, Kaswabuli S, Miller C, Andama A, Albert H, Nabeta P, Gray C, Ayakaka I, Huang L. Impact of Xpert MTB/RIF testing on tuberculosis management and outcomes in hospitalized patients in Uganda. PLoS One. 2012;7(11):e48599. doi: 10.1371/journal.pone.0048599. Epub 2012 Nov 6.
Reference Type
BACKGROUND
Global Health Workforce Statistics, World Health Organization, Geneva. Accessed online at: http://www.who.int/hrh/statistics/hwfstats/ on November 24, 2013.
Reference Type
BACKGROUND
WHO. Guidelines for intensified tuberculosis case-finding and isoniazid preventative therapy for people living with HIV in resource-constrained settings. Geneva: World Health Organization, 2011.
Reference Type
BACKGROUND
Treatment of Tuberculosis: Guidelines. 4th edition. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK138748/
Reference Type
BACKGROUND
Global Laboratory Initiative. Laboratory diagnosis of tuberculosis by sputum microscopy: The handbook. Geneva: Global Laboratory Initiative, 2013.
Reference Type
BACKGROUND
Joffe MM, Rosenbaum PR. Invited commentary: propensity scores. Am J Epidemiol. 1999 Aug 15;150(4):327-33. doi: 10.1093/oxfordjournals.aje.a010011.
Reference Type
BACKGROUND
WHO/TDR/FIND. Diagnostics for tuberculosis: Global demand and market potential. Geneva: World Health Organization, 2006.
Reference Type
BACKGROUND
Balcha TT, Sturegard E, Winqvist N, Skogmar S, Reepalu A, Jemal ZH, Tibesso G, Schon T, Bjorkman P. Intensified tuberculosis case-finding in HIV-positive adults managed at Ethiopian health centers: diagnostic yield of Xpert MTB/RIF compared with smear microscopy and liquid culture. PLoS One. 2014 Jan 22;9(1):e85478. doi: 10.1371/journal.pone.0085478. eCollection 2014.
Reference Type
BACKGROUND
Theron G, Peter J, Dowdy D, Langley I, Squire SB, Dheda K. Do high rates of empirical treatment undermine the potential effect of new diagnostic tests for tuberculosis in high-burden settings? Lancet Infect Dis. 2014 Jun;14(6):527-32. doi: 10.1016/S1473-3099(13)70360-8. Epub 2014 Jan 15.
Reference Type
BACKGROUND
Conwell DS, Mosher A, Khan A, Tapy J, Sandman L, Vernon A, Horsburgh CR Jr. Factors associated with loss to follow-up in a large tuberculosis treatment trial (TBTC Study 22). Contemp Clin Trials. 2007 May;28(3):288-94. doi: 10.1016/j.cct.2006.09.003. Epub 2006 Sep 28.
Reference Type
BACKGROUND
Henostroza G, Harris J, Siyambango M, et al. High prevalence of tuberculosis among new HIV care enrolees in Zambia: urgent need for an enhanced screening approach. Oral presentation, 43rd World Conference on Lung Health. Kuala Lumpur Convention Centre, Kuala Lumpur, Malaysia. November 13 - 17, 2012.
Reference Type
BACKGROUND
Zou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004 Apr 1;159(7):702-6. doi: 10.1093/aje/kwh090.
Reference Type
BACKGROUND
Chang K, Lu W, Wang J, Zhang K, Jia S, Li F, Deng S, Chen M. Rapid and effective diagnosis of tuberculosis and rifampicin resistance with Xpert MTB/RIF assay: a meta-analysis. J Infect. 2012 Jun;64(6):580-8. doi: 10.1016/j.jinf.2012.02.012. Epub 2012 Feb 27.
Reference Type
BACKGROUND
Moure R, Martin R, Alcaide F. Effectiveness of an integrated real-time PCR method for detection of the Mycobacterium tuberculosis complex in smear-negative extrapulmonary samples in an area of low tuberculosis prevalence. J Clin Microbiol. 2012 Feb;50(2):513-5. doi: 10.1128/JCM.06467-11. Epub 2011 Dec 7.
Reference Type
BACKGROUND
Ministry of Health, Republic of Zambia. Managing Tuberculosis in the HIV Setting in Zambia. Lusaka: Ministry of Health, 2014.
Reference Type
BACKGROUND
Related Links
Access external resources that provide additional context or updates about the study.
http://www.unc.edu
University of North Carolina website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
US NIH Grant P30 AI50410-17
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
14-1697
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Achieving Tuberculosis (TB) Control In Zambia
NCT03497195
COMPLETED
NA
Evaluation of Four Stool Processing Methods Combined With Xpert MTB/RIF Ultra for Diagnosis of Intrathoracic Paediatric TB (TB-Speed - Stool Processing)
NCT04203628
COMPLETED
NA
Xpert Active Case-finding Trial 2: Community-based Active Case-finding for Tuberculosis in South Africa
NCT03168945
COMPLETED
NA
Xpert MTB/RIF Ultra Trial
NCT07135622
COMPLETED
NA
Improving TB Diagnosis and Treatment Through Basic, Applied and Health Systems Research
NCT03356925
COMPLETED
NA
Medical and Economical Impact of IGRAs Diagnosis of Latent Tuberculosis in HIV-infected Patients
NCT00805272
COMPLETED
NA
Performance of Xpert MTB/RIF and XDR Assay for Diagnosis of Pulmonary Tuberculosis and Resistant Pulmonary TB
NCT06392594
NOT_YET_RECRUITING
Feasibility and Accuracy of a Novel Xpert Cartridge
NCT02251327
COMPLETED
Acceptability and Feasibility of Home-based TB Testing
NCT04973371
COMPLETED
NA
Accuracy and Feasibility of Xpert Ultra
NCT03072576
COMPLETED
Evaluation of PTB Screening in ANC in Lusaka, Zambia
NCT02053129
COMPLETED
NA
Evaluating the Impact of Computer-assisted X-ray Diagnosis and Other Triage Tools to Optimise Xpert Orientated Community-based Active Case Finding for TB and COVID-19
NCT05220163
ACTIVE_NOT_RECRUITING
NA
Study of GeneXpert Mycobacterium Tuberculosis/ Rifampicin (MTB/RIF) Versus the Routine Methods for Detection of Mycobacterium Tuberculosis
NCT06409572
NOT_YET_RECRUITING
DIAgnostics for Multidrug Resistant Tuberculosis in Africa
NCT03303963
COMPLETED
Xpert Active Case-finding Trial 3 (XACT-3)
NCT04303104
ACTIVE_NOT_RECRUITING
NA
Assessing Diagnostics At Point-of-care for Tuberculosis
NCT05941052
RECRUITING
NA
Xpert MTB/Rif, a New Tool for the Diagnosis of Pulmonary Tuberculosis in Two Municipalities in Brazil
NCT01363765
COMPLETED
PHASE4
Alternative Diagnoses in Patients About to Start Empiric Tuberculosis Treatment
NCT06737029
ACTIVE_NOT_RECRUITING
Impact of Systematic Early Tuberculosis Detection Using Xpert MTB/RIF Ultra in Children With Severe Pneumonia in High Tuberculosis Burden Countries (TB-Speed Pneumonia)
NCT03831906
COMPLETED
NA
Xpert MTB/RIF Test in the Diagnosis of Pulmonary Tuberculosis
NCT04433195
UNKNOWN
NA
A One-stop Shop for the Same Day Diagnosis and Management of TB and HIV
NCT04043390
COMPLETED
NA
Evaluation of Xpert MTB/RIF Ultra in Stools and Urine to Improve Tuberculosis Diagnosis in Children
NCT06239337
COMPLETED
Evaluation of an Innovative Tuberculosis Diagnostic Test
NCT02573623
UNKNOWN
Sensitivity and Specificity of Xpert MTB/RIF Ultra
NCT06058065
UNKNOWN
GeneXpert Performance Evaluation for Linkage to Tuberculosis Care
NCT03044158
COMPLETED
NA