Study protocol: a cluster randomized trial to evaluate the effectiveness and implementation of onsite GeneXpert testing at community health centers in Uganda (XPEL-TB).
Cluster randomized trial
Effectiveness-implementation design
Pragmatic trial
Tuberculosis
Xpert MTB/RIF
Journal
Implementation science : IS
ISSN: 1748-5908
Titre abrégé: Implement Sci
Pays: England
ID NLM: 101258411
Informations de publication
Date de publication:
21 04 2020
21 04 2020
Historique:
received:
17
03
2020
accepted:
03
04
2020
entrez:
23
4
2020
pubmed:
23
4
2020
medline:
25
5
2021
Statut:
epublish
Résumé
Delays in diagnosis and treatment of tuberculosis (TB) remain common in high-burden countries. To improve case detection, substantial investments have been made to scale-up Xpert MTB/RIF (Xpert), a cartridge-based nucleic acid amplification test that can detect TB within 2 hours, as a replacement for sputum smear microscopy. However, the optimal strategy for implementation of Xpert testing remains unclear. The Xpert Performance Evaluation for Linkage to Tuberculosis Care (XPEL-TB) trial uses an ultra-pragmatic, hybrid type II effectiveness-implementation design to assess the effectiveness and implementation of a streamlined strategy for delivery of Xpert testing in real-world settings. Twenty health centers with TB microscopy units were selected to participate in the trial, with ten health centers randomized to the intervention strategy (onsite molecular testing using GeneXpert Edge, process redesign to facilitate same-day TB diagnosis and treatment, and performance feedback) or routine care (onsite sputum smear microscopy plus referral of sputum samples to Xpert testing sites). The primary outcome is the number of patients with microbiologically confirmed TB who were initiated on treatment within 14 days of presentation to the health center, which reflects successful completion of the TB diagnostic evaluation process. Secondary outcomes include health outcomes (6-month vital status), as well as measures of the reach, adoption, and implementation of the intervention strategy. The design elements and implementation approach for the XPEL-TB trial were intentionally selected to minimize disruptions to routine care procedures, with the goal of limiting their influence on key primary and secondary outcomes. Trial findings may result in increased support and funding for rapid, onsite molecular testing as the standard-of-care for all patients being evaluated for TB. US National Institutes of Health's ClinicalTrials.gov, NCT03044158. Registered 06 February 2017. Pan African Clinical Trials Registry, PACTR201610001763265. Registered 03 September 2016.
Sections du résumé
BACKGROUND
Delays in diagnosis and treatment of tuberculosis (TB) remain common in high-burden countries. To improve case detection, substantial investments have been made to scale-up Xpert MTB/RIF (Xpert), a cartridge-based nucleic acid amplification test that can detect TB within 2 hours, as a replacement for sputum smear microscopy. However, the optimal strategy for implementation of Xpert testing remains unclear.
METHODS
The Xpert Performance Evaluation for Linkage to Tuberculosis Care (XPEL-TB) trial uses an ultra-pragmatic, hybrid type II effectiveness-implementation design to assess the effectiveness and implementation of a streamlined strategy for delivery of Xpert testing in real-world settings. Twenty health centers with TB microscopy units were selected to participate in the trial, with ten health centers randomized to the intervention strategy (onsite molecular testing using GeneXpert Edge, process redesign to facilitate same-day TB diagnosis and treatment, and performance feedback) or routine care (onsite sputum smear microscopy plus referral of sputum samples to Xpert testing sites). The primary outcome is the number of patients with microbiologically confirmed TB who were initiated on treatment within 14 days of presentation to the health center, which reflects successful completion of the TB diagnostic evaluation process. Secondary outcomes include health outcomes (6-month vital status), as well as measures of the reach, adoption, and implementation of the intervention strategy.
DISCUSSION
The design elements and implementation approach for the XPEL-TB trial were intentionally selected to minimize disruptions to routine care procedures, with the goal of limiting their influence on key primary and secondary outcomes. Trial findings may result in increased support and funding for rapid, onsite molecular testing as the standard-of-care for all patients being evaluated for TB.
TRIAL REGISTRATION
US National Institutes of Health's ClinicalTrials.gov, NCT03044158. Registered 06 February 2017. Pan African Clinical Trials Registry, PACTR201610001763265. Registered 03 September 2016.
Identifiants
pubmed: 32316993
doi: 10.1186/s13012-020-00988-y
pii: 10.1186/s13012-020-00988-y
pmc: PMC7171793
doi:
Banques de données
ClinicalTrials.gov
['NCT03044158']
PACTR
['PACTR201610001763265']
Types de publication
Clinical Trial Protocol
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
24Subventions
Organisme : Medical Research Council
ID : MR/R010161/1
Pays : United Kingdom
Organisme : NHLBI NIH HHS
ID : R01 HL130192
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR001863
Pays : United States
Organisme : NHLBI NIH HHS
ID : 5R01HL130192
Pays : United States
Références
J Biomed Inform. 2009 Apr;42(2):377-81
pubmed: 18929686
Gates Open Res. 2018 Jul 25;2:35
pubmed: 30234198
J Clin Tuberc Other Mycobact Dis. 2019 Apr 12;15:100099
pubmed: 31720425
PeerJ. 2017 Jul 14;5:e3567
pubmed: 28717600
Int J Qual Health Care. 2011 Oct;23(5):516-23
pubmed: 21775313
Am J Public Health. 1999 Sep;89(9):1322-7
pubmed: 10474547
J Biomed Inform. 2019 Jul;95:103208
pubmed: 31078660
PLoS One. 2012;7(11):e48599
pubmed: 23139799
Lancet Glob Health. 2015 Aug;3(8):e450-e457
pubmed: 26187490
Nature. 2006 Nov 23;444 Suppl 1:49-57
pubmed: 17159894
BMJ. 2015 May 08;350:h2147
pubmed: 25956159
Med Care. 2012 Mar;50(3):217-26
pubmed: 22310560
Lancet Respir Med. 2013 Aug;1(6):462-70
pubmed: 24429244
PLoS One. 2018 Aug 10;13(8):e0201731
pubmed: 30096174
J Infect Dis. 2017 Nov 6;216(suppl_7):S714-S723
pubmed: 29117349
Open Forum Infect Dis. 2014 Jun 25;1(1):ofu038
pubmed: 25734106
PLoS One. 2012;7(5):e36966
pubmed: 22693561
Lancet. 2014 Feb 1;383(9915):424-35
pubmed: 24176144
BMC Health Serv Res. 2015 Jan 22;15:10
pubmed: 25609495
Int J Tuberc Lung Dis. 2015 Aug;19(8):912-7
pubmed: 26162356
PLoS Med. 2017 Feb 21;14(2):e1002238
pubmed: 28222095