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| ID | Type | Description | Link |
|---|---|---|---|
| US NIH Grant P30 AI50410-17 | Other Grant/Funding Number | US NIH |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
| |
| Standard of Care cohort | HIV-positive presumptive TB patients tested for TB using standard of care testing (sputum smear microscopy plus clinical evaluation) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xpert | Device | The Xpert MTB/RIF assay is a nucleic acid amplification (NAA) test that uses a disposable cartridge with the GeneXpert Instrument System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Culture-positive patient drop-out before accessing treatment | For both cohorts, the proportion of patients not started on TB treatment by 210 days post-enrolment will be assessed. | From study enrolment through confirmed drop out date at or before 210-days post enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Time to TB treatment | time in days from study enrolment to initiation of anti-TB therapy (ATT) (through 210 days post-enrolment) | |
| Percentage of participants who receive TB treatment within 14 days of enrolment (effect of Xpert on the accuracy of TB diagnosis) |
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Inclusion Criteria:
Exclusion Criteria:
A key informant will be eligible for inclusion in the SARA facility survey component of the study if they meet the following criteria:
Exclusion criteria:
-unwilling or unable to provide verbal informed consent in English
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Adult presumptive TB patients 18 years or older with documented HIV-positive sero-status presenting for routine HIV care at two health centres in Lusaka, Zambia.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Herce, MD, MPH | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chelstone and Chilenje Health Centres | Lusaka | Zambia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18544210 | Background | 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. | |
| Background | World Health Organization. (2013). Global tuberculosis report 2013. Geneva: WHO. | ||
| 18398459 |
| Label | URL |
|---|---|
| University of North Carolina website | View source |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D000092225 | Tuberculosis, Extrapulmonary |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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|
sensitivity of empirical TB diagnosis and treatment will be defined as the percentage of participants who received TB treatment within 14 days of enrolment among all those with a positive culture but negative or unavailable result for SM (for the SOC cohort), or negative or unavailable SM plus Xpert (for the Xpert cohort)
| study enrolment to 14 days of enrolment |
| Percentage of participants who did not receive TB treatment 14 days post-enrolment (effect of Xpert on the accuracy of TB diagnosis) | the specificity of empirical treatment will be defined as the percentage of participants who did not receive TB treatment 14 days post-enrolment among all those with a negative culture and negative or unavailable result for SM (in the SOC cohort), or negative or unavailable result for SM plus Xpert (in the Xpert cohort) | study enrolment to 14 days of enrolment |
| Time to TB Diagnosis | The World Health Organization definition of a TB case will be used | average of 28 days |
| Number of TB patients lost to follow-up | The number of patients will be measured as time in days from study enrolment to confirmed drop out (confirmed as failure noted at 3 and 6 month chart review) |
| 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. |
| 20825313 | 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. |
| 21507477 | 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. |
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| Background | Boehme, C. C. Oral Presentation, 20th Conference on Retroviruses and Opportunistic Infections. Georgia World Conference Centre, Atlanta, USA, March 3-6, 2013. |
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| 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. |
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| 23762367 | 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. |
| 23034211 | 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. |
| 21333094 | 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. |
| 23139799 | 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. |
| Background | Global Health Workforce Statistics, World Health Organization, Geneva. Accessed online at: http://www.who.int/hrh/statistics/hwfstats/ on November 24, 2013. |
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| 23741786 | Background | Treatment of Tuberculosis: Guidelines. 4th edition. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK138748/ |
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |