Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| PACTR201610001763265 | Registry Identifier | Pan African Clinical Trials Registry | |
| R01HL130192 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Makerere University | OTHER |
| Johns Hopkins Bloomberg School of Public Health | OTHER |
| London School of Hygiene and Tropical Medicine | OTHER |
| Yale University |
Not provided
Not provided
Not provided
Not provided
The investigators' overall objective is to assess the effectiveness, implementation and costs of a streamlined TB diagnostic evaluation strategy based around rapid, onsite molecular testing. The intervention strategy was developed based on theory-informed assessment of barriers to TB diagnostic evaluation at community health centers in Uganda and a process of engagement with local stakeholders. It includes: 1) Point-of-care molecular testing using GeneXpert as a replacement for sputum smear microscopy; 2) Re-structuring of clinic-level procedures to facilitate same-day TB diagnosis and treatment; and 3) Quarterly feedback of TB evaluation metrics to health center staff. The investigators' central hypothesis is that the intervention strategy will have high uptake and increase the number of patients diagnosed with and treated for active pulmonary TB. To test this hypothesis, the investigators will conduct a pragmatic cluster-randomized trial at community health centers that provide TB microscopy services in Uganda in partnership with the National TB Program (NTP). The investigators utilize an effectiveness-implementation hybrid design in which, concurrent with the clinical trial, the investigators will conduct nested mixed methods, health economic and modeling studies to assess 1) whether the intervention strategy modifies targeted barriers to TB diagnostic evaluation; 2) fidelity of implementation of the intervention components (i.e, the degree to which intervention components were implemented as intended vs. adapted across sites); and 3) cost-effectiveness and public health impact.
Aim 1: To compare patient outcomes at health centers randomized to intervention vs. standard-of-care TB diagnostic evaluation strategies. The investigators will randomize 20 community health centers to continue standard TB evaluation (routine microscopy plus referral of patients for Xpert testing per existing processes of care) or to implement the intervention strategy (1. Onsite molecular testing; 2. Re-structuring clinic-level procedures to facilitate same-day TB diagnosis and treatment; and 3. Performance feedback). The investigators will compare reach and effectiveness based on the numbers and proportions of patients (N=5500) who complete TB testing, are found to have TB, and have treatment initiated within one week of specimen provision.
Aim 2: To identify processes and contextual factors that influence the effectiveness and fidelity of the intervention TB diagnostic evaluation strategy. The investigators will use quantitative process metrics to assess the adoption and maintenance over time of the core components of the intervention strategy. The investigators will also collect quantitative and qualitative data to describe the fidelity of implementation of each component and faithfulness to the conceptual model.
Aim 3: To compare the costs and epidemiological impact of intervention vs. standard-of-care TB diagnostic evaluation strategies. The investigators will model the incremental costs and cost-effectiveness of intervention relative to standard-of-care TB diagnostic evaluation from the health system and patient perspective. The investigators will then construct an epidemic model of the population-level impact of the intervention strategy on TB incidence and mortality.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols | |
| Intervention | Experimental | Onsite molecular testing for TB with GeneXpert I + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GeneXpert I | Device | Onsite molecular testing with GeneXpert I as a replacement for microscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number Treated for Microbiologically-confirmed TB Within 14 Days After Presentation to the Health Center for TB Evaluation | Effectiveness outcome. | Within 14 days after presentation to the health center for tuberculosis evaluation |
| Measure | Description | Time Frame |
|---|---|---|
| Number Diagnosed With Microbiologically-confirmed TB | Effectiveness outcome. | Within 14 days after presentation to the health center for tuberculosis evaluation |
| Time to Microbiologically-confirmed TB |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Adithya Cattamanchi, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Francis Njeru Health Center III | Buikwe | Uganda | ||||
| Busana Health Center III |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24623906 | Background | MacPherson P, Houben RM, Glynn JR, Corbett EL, Kranzer K. Pre-treatment loss to follow-up in tuberculosis patients in low- and lower-middle-income countries and high-burden countries: a systematic review and meta-analysis. Bull World Health Organ. 2014 Feb 1;92(2):126-38. doi: 10.2471/BLT.13.124800. Epub 2013 Nov 22. | |
| 19419537 | Background | Cattamanchi A, Dowdy DW, Davis JL, Worodria W, Yoo S, Joloba M, Matovu J, Hopewell PC, Huang L. Sensitivity of direct versus concentrated sputum smear microscopy in HIV-infected patients suspected of having pulmonary tuberculosis. BMC Infect Dis. 2009 May 6;9:53. doi: 10.1186/1471-2334-9-53. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols |
| FG001 | Intervention | Onsite molecular testing for TB with GeneXpert + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback GeneXpert: Onsite molecular testing with GeneXpert as a replacement for microscopy Process re-design: Research and Uganda NTLP staff will engage health center staff in a discussion of how to re-organize clinical, laboratory and pharmacy services to enable same-day TB diagnosis and treatment. Performance Feedback: Feedback of TB diagnostic evaluation quality indicators to health center staff |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 12, 2021 |
Not provided
| OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
| Process re-design | Behavioral | Research and Uganda NTLP staff will engage health center staff in a discussion of how to re-organize clinical, laboratory and pharmacy services to enable same-day TB diagnosis and treatment. |
|
| Performance Feedback | Other | Feedback of TB diagnostic evaluation quality indicators to health center staff |
|
Effectiveness outcome. Time-to-diagnosis if microbiologically-confirmed TB.
| Within 6 months of presentation to the health center for tuberculosis evaluation |
| Number Treated for TB | Effectiveness outcome. | Within 14 days of presentation to the health center for tuberculosis evaluation |
| Time-to-treatment of Microbiologically-confirmed TB | Effectiveness outcome. Time-to-treatment if microbiologically-confirmed TB and treated. | Days from initial health center visit to initiation of treatment if diagnosed, up to 6 months. |
| Number Who Died Within 6 Months | Effectiveness outcome. | Within 6 months of presentation to the health center for tuberculosis evaluation |
| Number of Patients Enrolled | Effectiveness outcome. | Presentation to the health center for tuberculosis evaluation during the 16-month study time frame |
| Number Tested for TB According to National Guidelines | Effectiveness outcome. | Within 6 months of presentation to the health center for tuberculosis evaluation |
| Number Suspected/Diagnosed With Rifampin-resistant TB | Effectiveness outcome. | Within 6 months of presentation to the health center for tuberculosis evaluation |
| Number Diagnosed and Treated for Microbiologically-confirmed TB | Effectiveness outcome. | On the same-day of presentation to the health center for tuberculosis evaluation |
| Number Diagnosed AND Treated for TB | Effectiveness outcome. | On the same-day of presentation to the health center for tuberculosis evaluation |
| Busana |
| Uganda |
| Busesa Health Center IV | Busesa | Uganda |
| Buwama Health Center III | Buwama | Uganda |
| Iganga TC | Iganga | Uganda |
| Bukulula Health Center IV | Kalungu | Uganda |
| Nazigo Health Center III | Kayunga | Uganda |
| Kiganda Health Center IV | Kiganda | Uganda |
| Kira Health Center III | Kira | Uganda |
| Lugasa Health Center III | Lugala | Uganda |
| Bishop Asili Health Center | Luwero | Uganda |
| Kinoni Health Center III | Lwengo | Uganda |
| Kityerera Health Center IV | Mayuge | Uganda |
| Malongo Health Center III | Mayuge | Uganda |
| Mayuge Health Center III | Mayuge | Uganda |
| Wabulungu Health Center III | Mayuge | Uganda |
| Malangala Health Center III | Mityana | Uganda |
| Lwampanga Health Center III | Nakasongola | Uganda |
| Namungalwe Health Center III | Namungalwe | Uganda |
| Nankandulo Health Center IV | Nankandulo | Uganda |
| 26383102 | Background | Chihota VN, Ginindza S, McCarthy K, Grant AD, Churchyard G, Fielding K. Missed Opportunities for TB Investigation in Primary Care Clinics in South Africa: Experience from the XTEND Trial. PLoS One. 2015 Sep 18;10(9):e0138149. doi: 10.1371/journal.pone.0138149. eCollection 2015. |
| 21471088 | Background | Davis J, Katamba A, Vasquez J, Crawford E, Sserwanga A, Kakeeto S, Kizito F, Dorsey G, den Boon S, Vittinghoff E, Huang L, Adatu F, Kamya MR, Hopewell PC, Cattamanchi A. Evaluating tuberculosis case detection via real-time monitoring of tuberculosis diagnostic services. Am J Respir Crit Care Med. 2011 Aug 1;184(3):362-7. doi: 10.1164/rccm.201012-1984OC. Epub 2011 Mar 11. |
| 18647453 | Background | Aspler A, Menzies D, Oxlade O, Banda J, Mwenge L, Godfrey-Faussett P, Ayles H. Cost of tuberculosis diagnosis and treatment from the patient perspective in Lusaka, Zambia. Int J Tuberc Lung Dis. 2008 Aug;12(8):928-35. |
| 17768515 | Background | Kemp JR, Mann G, Simwaka BN, Salaniponi FM, Squire SB. Can Malawi's poor afford free tuberculosis services? Patient and household costs associated with a tuberculosis diagnosis in Lilongwe. Bull World Health Organ. 2007 Aug;85(8):580-5. doi: 10.2471/blt.06.033167. |
| 18163918 | Background | Simwaka BN, Bello G, Banda H, Chimzizi R, Squire BS, Theobald SJ. The Malawi National Tuberculosis Programme: an equity analysis. Int J Equity Health. 2007 Dec 31;6:24. doi: 10.1186/1475-9276-6-24. |
| 18647454 | Background | Botha E, den Boon S, Lawrence KA, Reuter H, Verver S, Lombard CJ, Dye C, Enarson DA, Beyers N. From suspect to patient: tuberculosis diagnosis and treatment initiation in health facilities in South Africa. Int J Tuberc Lung Dis. 2008 Aug;12(8):936-41. |
| 15970047 | Background | Ouyang H, Chepote F, Gilman RH, Moore DA. Failure to complete the TB diagnostic algorithm in urban Peru: a study of contributing factors. Trop Doct. 2005 Apr;35(2):120-1. doi: 10.1258/0049475054037002. No abstract available. |
| 24448973 | Background | Steingart KR, Schiller I, Horne DJ, Pai M, Boehme CC, Dendukuri N. Xpert(R) MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in adults. Cochrane Database Syst Rev. 2014 Jan 21;(1):CD009593. doi: 10.1002/14651858.CD009593.pub3. |
| 21814496 | Background | Dowdy DW, Cattamanchi A, Steingart KR, Pai M. Is scale-up worth it? Challenges in economic analysis of diagnostic tests for tuberculosis. PLoS Med. 2011 Jul;8(7):e1001063. doi: 10.1371/journal.pmed.1001063. Epub 2011 Jul 26. |
| 17159894 | Background | Keeler E, Perkins MD, Small P, Hanson C, Reed S, Cunningham J, Aledort JE, Hillborne L, Rafael ME, Girosi F, Dye C. Reducing the global burden of tuberculosis: the contribution of improved diagnostics. Nature. 2006 Nov 23;444 Suppl 1:49-57. doi: 10.1038/nature05446. No abstract available. |
| 24176144 | 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. |
| 10474547 | Background | Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322. |
| 18631386 | Background | Godin G, Belanger-Gravel A, Eccles M, Grimshaw J. Healthcare professionals' intentions and behaviours: a systematic review of studies based on social cognitive theories. Implement Sci. 2008 Jul 16;3:36. doi: 10.1186/1748-5908-3-36. |
| 1501333 | Background | Davis DA, Thomson MA, Oxman AD, Haynes RB. Evidence for the effectiveness of CME. A review of 50 randomized controlled trials. JAMA. 1992 Sep 2;268(9):1111-7. |
| 25609495 | Background | Cattamanchi A, Miller CR, Tapley A, Haguma P, Ochom E, Ackerman S, Davis JL, Katamba A, Handley MA. Health worker perspectives on barriers to delivery of routine tuberculosis diagnostic evaluation services in Uganda: a qualitative study to guide clinic-based interventions. BMC Health Serv Res. 2015 Jan 22;15:10. doi: 10.1186/s12913-014-0668-0. |
| 22696318 | Background | Ivers N, Jamtvedt G, Flottorp S, Young JM, Odgaard-Jensen J, French SD, O'Brien MA, Johansen M, Grimshaw J, Oxman AD. Audit and feedback: effects on professional practice and healthcare outcomes. Cochrane Database Syst Rev. 2012 Jun 13;2012(6):CD000259. doi: 10.1002/14651858.CD000259.pub3. |
| 11101705 | Background | Grogan S, Conner M, Norman P, Willits D, Porter I. Validation of a questionnaire measuring patient satisfaction with general practitioner services. Qual Health Care. 2000 Dec;9(4):210-5. doi: 10.1136/qhc.9.4.210. |
| 21775313 | Background | Nabbuye-Sekandi J, Makumbi FE, Kasangaki A, Kizza IB, Tugumisirize J, Nshimye E, Mbabali S, Peters DH. Patient satisfaction with services in outpatient clinics at Mulago hospital, Uganda. Int J Qual Health Care. 2011 Oct;23(5):516-23. doi: 10.1093/intqhc/mzr040. Epub 2011 Jul 19. |
| 22853820 | Background | Ivers NM, Halperin IJ, Barnsley J, Grimshaw JM, Shah BR, Tu K, Upshur R, Zwarenstein M. Allocation techniques for balance at baseline in cluster randomized trials: a methodological review. Trials. 2012 Aug 1;13:120. doi: 10.1186/1745-6215-13-120. |
| 18697846 | Background | Sismanidis C, Moulton LH, Ayles H, Fielding K, Schaap A, Beyers N, Bond G, Godfrey-Faussett P, Hayes R. Restricted randomization of ZAMSTAR: a 2 x 2 factorial cluster randomized trial. Clin Trials. 2008;5(4):316-27. doi: 10.1177/1740774508094747. |
| 22745362 | Background | Sandelowski M, Leeman J. Writing usable qualitative health research findings. Qual Health Res. 2012 Oct;22(10):1404-13. doi: 10.1177/1049732312450368. Epub 2012 Jun 28. |
| 18288640 | Background | Sandelowski MJ. Justifying qualitative research. Res Nurs Health. 2008 Jun;31(3):193-5. doi: 10.1002/nur.20272. No abstract available. |
| 18677415 | Background | Voils CI, Sandelowski M, Barroso J, Hasselblad V. Making Sense of Qualitative and Quantitative Findings in Mixed Research Synthesis Studies. Field methods. 2008;20(1):3-25. doi: 10.1177/1525822X07307463. |
| 25025235 | Background | Salje H, Andrews JR, Deo S, Satyanarayana S, Sun AY, Pai M, Dowdy DW. The importance of implementation strategy in scaling up Xpert MTB/RIF for diagnosis of tuberculosis in the Indian health-care system: a transmission model. PLoS Med. 2014 Jul 15;11(7):e1001674. doi: 10.1371/journal.pmed.1001674. eCollection 2014 Jul. |
| 23262515 | Background | Dowdy DW, Basu S, Andrews JR. Is passive diagnosis enough? The impact of subclinical disease on diagnostic strategies for tuberculosis. Am J Respir Crit Care Med. 2013 Mar 1;187(5):543-51. doi: 10.1164/rccm.201207-1217OC. Epub 2012 Dec 21. |
| 25186263 | Background | Sun AY, Denkinger CM, Dowdy DW. The impact of novel tests for tuberculosis depends on the diagnostic cascade. Eur Respir J. 2014 Nov;44(5):1366-9. doi: 10.1183/09031936.00111014. Epub 2014 Sep 3. |
| Background | Chandrasekaran V, Ramachandran R, Cunningham J, Balasubramaniun R, Thomas A, Sudha G, et al. Factors leading to tuberculosis diagnostic drop-out and delayed treatment initiation in Chennai, India. Int J Tuberc Lung Dis. 2005;9:172. |
| Background | Den Boon S, Semitala F, Cattamanchi A, Walter N, Worodria W, Joloba M, Huang L, Davis JL. Impact of patient drop-out on the effective sensitivity of smear microscopy strategies. Am J Respir Crit Care Med 2010;181:A2258. |
| Background | Miller C, Haguma P, Ochom E, Ross J, Davis JL, Cattamanchi A, Katamba A. Costs associated with tuberculosis evaluation in rural Uganda. 43rd Union World Conference on Lung Health; Kuala Lumpur, Malaysia 2012. |
| Background | WHO. Global strategy and targets for tuberculosis prevention, care and control after 2015. Geneva, Switzerland: World Health Organization, 2013 EB134/12. |
| Background | WHO. WHO monitoring of Xpert MTB/RIF roll-out. Available at: http://www.who.int/tb/areas-of-work/laboratory/mtb-rif-rollout/en/ [cited 2015 January 15]. |
| Background | Churchyard GJ, on behalf of the Xtend study team. Xpert MTB/RIF vs microscopy as the first line TB test in South Africa: mortality, yield, initial loss to follow up and proportion treated. The Xtend Study. Conference on Retroviruses and Opportunistic Infections; Boston, USA: Available at: http://www.stoptb.org/wg/gli/assets/documents/M6/Churchyard%20-%20XTEND%20study.pdf; 2014. |
| Background | Cepheid. GeneXpert Omni: The True Point of Care Molecular Diagnostic System: Cepheid Inc; 2015. Available from: http://www.cepheid.com/us/genexpert-omni. |
| Background | Ajzen I. The theory of planned behavior. Organizational Behavior and Human Decision Processes. 1991;50:179-211. |
| Background | Green LW, Krueter M. Health Program Planning - An Educational and Ecological Approach. 4th ed. Philadelphia, USA: McGraw-Hill; 2005. |
| Background | Hayes RJ, Moulton LH. Cluster Randomized Trials. Boca Raton, Florida, USA: CRC Press; 2009. |
| 34936740 | Derived | Cattamanchi A, Reza TF, Nalugwa T, Adams K, Nantale M, Oyuku D, Nabwire S, Babirye D, Turyahabwe S, Tucker A, Sohn H, Ferguson O, Thompson R, Shete PB, Handley MA, Ackerman S, Joloba M, Moore DAJ, Davis JL, Dowdy DW, Fielding K, Katamba A. Multicomponent Strategy with Decentralized Molecular Testing for Tuberculosis. N Engl J Med. 2021 Dec 23;385(26):2441-2450. doi: 10.1056/NEJMoa2105470. |
| 32316993 | Derived | Reza TF, Nalugwa T, Farr K, Nantale M, Oyuku D, Nakaweesa A, Musinguzi J, Vangala M, Shete PB, Tucker A, Ferguson O, Fielding K, Sohn H, Dowdy D, Moore DAJ, Davis JL, Ackerman SL, Handley MA, Katamba A, Cattamanchi A. Study protocol: a cluster randomized trial to evaluate the effectiveness and implementation of onsite GeneXpert testing at community health centers in Uganda (XPEL-TB). Implement Sci. 2020 Apr 21;15(1):24. doi: 10.1186/s13012-020-00988-y. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols |
| BG001 | Intervention | Onsite molecular testing for TB with GeneXpert + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback GeneXpert: Onsite molecular testing with GeneXpert as a replacement for microscopy Process re-design: Research and Uganda NTLP staff will engage health center staff in a discussion of how to re-organize clinical, laboratory and pharmacy services to enable same-day TB diagnosis and treatment. Performance Feedback: Feedback of TB diagnostic evaluation quality indicators to health center staff |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| HIV infection | Excludes participants with unknown HIV status | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number Treated for Microbiologically-confirmed TB Within 14 Days After Presentation to the Health Center for TB Evaluation | Effectiveness outcome. | Posted | Count of Participants | Participants | Within 14 days after presentation to the health center for tuberculosis evaluation |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number Diagnosed With Microbiologically-confirmed TB | Effectiveness outcome. | Posted | Count of Participants | Participants | Within 14 days after presentation to the health center for tuberculosis evaluation |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Microbiologically-confirmed TB | Effectiveness outcome. Time-to-diagnosis if microbiologically-confirmed TB. | All participants' data was analyzed to determine who had confirmed TB. | Posted | Median | Inter-Quartile Range | days | Within 6 months of presentation to the health center for tuberculosis evaluation |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number Treated for TB | Effectiveness outcome. | Posted | Count of Participants | Participants | Within 14 days of presentation to the health center for tuberculosis evaluation |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time-to-treatment of Microbiologically-confirmed TB | Effectiveness outcome. Time-to-treatment if microbiologically-confirmed TB and treated. | All participants' data was analyzed to determine who had confirmed TB and treatment initiated. | Posted | Median | Inter-Quartile Range | days | Days from initial health center visit to initiation of treatment if diagnosed, up to 6 months. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number Who Died Within 6 Months | Effectiveness outcome. | Includes those with vital status follow-up at six months post-visit to health center | Posted | Count of Participants | Participants | Within 6 months of presentation to the health center for tuberculosis evaluation |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Enrolled | Effectiveness outcome. | All eligible were enrolled as there was a waiver of informed consent | Posted | Count of Participants | Participants | Presentation to the health center for tuberculosis evaluation during the 16-month study time frame |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number Tested for TB According to National Guidelines | Effectiveness outcome. | Posted | Count of Participants | Participants | Within 6 months of presentation to the health center for tuberculosis evaluation |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number Suspected/Diagnosed With Rifampin-resistant TB | Effectiveness outcome. | The data analyzed included all adult patients in the target population. Those with rifampin-resistant tuberculosis, extrapulmonary tuberculosis and/or missing age data were excluded from the trial population. Therefore, the number of participants analyzed for this measure differs from other parts of the record. | Posted | Count of Participants | Participants | Within 6 months of presentation to the health center for tuberculosis evaluation |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number Diagnosed and Treated for Microbiologically-confirmed TB | Effectiveness outcome. | Posted | Count of Participants | Participants | On the same-day of presentation to the health center for tuberculosis evaluation |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number Diagnosed AND Treated for TB | Effectiveness outcome. | Posted | Count of Participants | Participants | On the same-day of presentation to the health center for tuberculosis evaluation |
|
|
Vital status was assessed up to 18 months following health center visit
For all-cause mortality, the denominator excludes those with unknown vital status and unknown HIV status. Vital status was ascertained through review of TB treatment registers, phone calls, and home visits.
Serious and Other [Not Including Serious] Adverse Events were not monitored/assessed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Onsite ZN or LED fluorescence microscopy + hub-based GeneXpert testing per existing protocols | 154 | 3,857 | 0 | 0 | 0 | 0 |
| EG001 | Intervention | Onsite molecular testing for TB with GeneXpert + process redesign to facilitate same-day TB diagnosis and treatment + performance feedback GeneXpert: Onsite molecular testing with GeneXpert as a replacement for microscopy Process re-design: Research and Uganda NTLP staff will engage health center staff in a discussion of how to re-organize clinical, laboratory and pharmacy services to enable same-day TB diagnosis and treatment. Performance Feedback: Feedback of TB diagnostic evaluation quality indicators to health center staff | 145 | 4,556 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adithya Cattamanchi | University of California Irvine | 714-456-2959 | Adithya.Cattamanchi@uci.edu |
| Apr 30, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 22, 2020 | May 2, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D014397 | Tuberculosis, Pulmonary |
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|