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Table 3 XPEL-TB PRECIS-2 domains

From: Study protocol: a cluster randomized trial to evaluate the effectiveness and implementation of onsite GeneXpert testing at community health centers in Uganda (XPEL-TB)

PRECIS-2 domainAssessment of XPEL-TBRating (1–5, where 5 is very pragmatic)
EligibilityNearly all adults who would have been offered Xpert testing if available in routine care are included in the trial. Only patients with a previous history of TB are excluded (to not falsely increase the primary outcome).5
RecruitmentNo formal recruitment procedures are used. A waiver of consent was obtained to enable automatic inclusion of data on all adults undergoing TB evaluation at trial sites. No incentives given to patients in either arm.5
SettingThe trial is implemented at 20 sites at the lowest level of the health system where TB diagnostic services (sputum smear microscopy) are provided—the sites targeted for expansion of Xpert testing using next-generation platforms.5
OrganizationXpert testing is implemented using existing healthcare staff and infrastructure at trial sites.5
Flexibility: deliveryProcess re-design and performance feedback were adapted by each trial site to suit its needs and processes of care and supervision.5
Flexibility: adherenceNo additional incentives or procedures are in place to encourage patients in the intervention arm with microbiologically-confirmed TB to initiate on treatment.5
Follow-upProcess and outcome data are collected from routine clinic records. No onsite research staff to conduct patient enrollment, data collection, or follow-up, with the exception of vital status assessment.5
Primary outcomeThe primary outcome is relevant to TB patients, their relatives, clinic staff, and the Uganda NTLP5
Primary analysisNo special allowances will be made in the primary analysis for non-adherence or variability in implementation by site5