TB investigations, treatment initiation and vital status at 6 months follow up of XTEND participants with negative sputum tests for tuberculosis by smear microscopy or Xpert who were subsequently started on TB treatment during the 6-month follow-up (n = 167).

<p>Sub-groups 1 (empirically treated participants) and sub-group 2 (participants with microbiologically-confirmed TB) are not mutually exclusive as some participants who were started on empiric TB treatment were subsequently found to have microbiologically confirmed TB.</p

Consultations en route to TB treatment initiation amongst 167 XTEND participants with negative smear microscopy tests for TB at enrolment, reconstructed from data obtained from patient interviews, case note abstractions and laboratory results and stratified by TB treatment start.

<p>Sequential visits to the same provider are not shown. A: Pathways for entire cohort (n = 167). B: Pathways for persons started on TB treatment empirically (n = 82).</p

A study profile illustrating the reason for TB treatment start and results of subsequent sputum TB tests amongst persons investigated for TB whose index (enrolment) sputum was negative for TB when tested by Xpert or smear microscopy.

<p>A study profile illustrating the reason for TB treatment start and results of subsequent sputum TB tests amongst persons investigated for TB whose index (enrolment) sputum was negative for TB when tested by Xpert or smear microscopy.</p

Characteristics of XTEND participants with negative sputum tests for tuberculosis by smear microscopy or Xpert at enrolment into XTEND who were subsequently started on TB treatment during the 6-month follow-up (n = 167).

<p>Sub-groups 1 (empirically treated participants) and sub-group 2 (participants with microbiologically-confirmed TB) are not mutually exclusive as some participants who were started on empiric TB treatment were subsequently found to have microbiologically confirmed TB.</p

Criteria used to infer the reason for TB treatment start amongst persons enrolled in the XTEND trial who had a negative sputum test for TB at enrolment by Xpert or smear microscopy, but who were started on TB treatment during the six month period after enrolment.

<p>Criteria used to infer the reason for TB treatment start amongst persons enrolled in the XTEND trial who had a negative sputum test for TB at enrolment by Xpert or smear microscopy, but who were started on TB treatment during the six month period after enrolment.</p

Participant flow for the exit interview substudy.

<p>Legend: *Participant enrolment errors, Xpert arm: did not complete survey n = 2; underage n = 10; attending clinic for TB care n = 66. **Participant enrolment errors, Microscopy arm: did not complete survey n = 2; underage n = 4; attending clinic for TB care n = 49.</p

Factors associated with having sputum requested for TB investigations among clients attending clinic because of symptoms suggestive of TB (Xpert and microscopy arms combined, n = 1267).

<p>* controlling for clinic using a random effects model</p><p>Factors associated with having sputum requested for TB investigations among clients attending clinic because of symptoms suggestive of TB (Xpert and microscopy arms combined, n = 1267).</p

Characteristics of participants by arm.

<p>¹Total number of symptoms based on current cough, night sweats, fever and weight loss; TB = tuberculosis; ART = antiretroviral therapy; ANC = antenatal clinic attendance</p><p>² Percentage HIV positive out of those willing to share HIV status 52.6% (647/1232) and 54.5% (749/1375) in the Xpert and microscopy arms, respectively.</p><p>³Attending clinic for other routine chronic disease follow-up, such as diabetes and hypertension</p><p>Characteristics of participants by arm.</p

Effect of Xpert on primary and secondary outcomes.

<p>CI = confidence interval</p><p>*summary ignores cluster</p><p>¹Adjusted for age group, gender, duration of cough, duration of night sweats, number of WHO TB symptoms, and HIV status with ART</p><p>²Adjusted for age group, gender, duration of cough, duration of night sweats, number of WHO TB symptoms, reason for attending clinic and HIV status with ART</p><p>Effect of Xpert on primary and secondary outcomes.</p

Flow diagram starting with the total number of patients in the ART management cohort, reasons for exclusion, and final sample for this study.

<p>Flow diagram starting with the total number of patients in the ART management cohort, reasons for exclusion, and final sample for this study.</p