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Kenya iTARA Data Summary (as of 2026-05-07)

Below is a summary of the iTARA Data and Plots which highlights the main data points of the study.

  • Recruiting sites 3 : Rhodes, Karen & Riruta

Total Number of Participants Screened in the Study.

screen_phc_ke n percent
Rhodes 1045 52.4%
Karen 493 24.7%
Riruta 458 22.9%
Total 1996 100.0%

Participants Gender & Site Data

screen_phc_ke Female Male
Rhodes 42.4% (443) 57.6% (602)
Karen 54.4% (268) 45.6% (225)
Riruta 63.5% (291) 36.5% (167)
Total 50.2% (1,002) 49.8% (994)

Screening Eligibility

screen_eligible_conf Rhodes Karen Riruta Total
Yes 255 159 196 610
No 790 334 262 1386

ELigible and Consented partcipants

screen_consent_yn Rhodes Karen Riruta Total
Yes 255 150 181 586
No 0 9 15 24
NA 790 334 262 1386

Removed all NAs from the data above

screened$screen_consent_yn n percent
Yes 586 96.1%
No 24 3.9%
Total 610 -

Baseline Enrollment Summary Plots

  • Monthly Sites Participant Enrollment

Monthly Site Baseline total Numbers

enrol_phc_ke Jun 2025 Jul 2025 Aug 2025 Sept 2025 Oct 2025 Nov 2025 Dec 2025 Jan 2026 Feb 2026 Mar 2026 Apr 2026 Total
Karen 27 25 9 11 10 8 3 4 14 23 16 150
Rhodes 14 38 19 21 17 12 12 12 29 42 39 255
Riruta 0 0 0 14 11 12 2 4 50 43 45 181
Total 41 63 28 46 38 32 17 20 93 108 100 586
  • Sites Participant Enrollment Against the Monthly Target
  • Monthly cumulative total participants enrollment.

Xpert Data and Summary

enrol_phc_ke Positive Negative Trace Indeterminate No sputum
Rhodes 118 131 0 0 6
Karen 4 137 0 0 9
Riruta 31 141 0 0 9
Total 153 409 0 0 24
xpert_result n percent
Positive 153 26%
Negative 409 70%
Trace 0 0%
Indeterminate 0 0%
No sputum 24 4%
Total 586 -
Positive Negative Trace Indeterminate No sputum
Rhodes
46.3% (118) 51.4% (131) 0.0% (0) 0.0% (0) 2.4% (6)
Karen
2.7% (4) 91.3% (137) 0.0% (0) 0.0% (0) 6.0% (9)
Riruta
17.1% (31) 77.9% (141) 0.0% (0) 0.0% (0) 5.0% (9)
Total
26.1% (153) 69.8% (409) 0.0% (0) 0.0% (0) 4.1% (24)

Xpert Summary and Plot of Results

Baseline Participants

enrol_phc_ke n percent
Rhodes 255 43.5%
Karen 150 25.6%
Riruta 181 30.9%
Total 586 100.0%

Cohort Participants

obs_phc_ke n percent
Rhodes 129 32.2%
Karen 127 31.8%
Riruta 144 36.0%
Total 400 100.0%

Site Cohort recruitment numbers over time

Monthly Site Cohort Enrollment bar plots

Monthly Site Cohort total Numbers

obs_phc_ke Jun 2025 Jul 2025 Aug 2025 Sept 2025 Oct 2025 Nov 2025 Dec 2025 Jan 2026 Feb 2026 Mar 2026 Apr 2026 May 2026 Total
Karen 12 24 10 6 11 7 3 4 14 19 17 0 127
Rhodes 6 19 7 11 13 2 3 8 15 15 30 0 129
Riruta 0 0 0 6 12 5 3 2 49 33 33 1 144
Total 18 43 17 23 36 14 9 14 78 67 80 1 400

Monthly Sites cohort enrollment against the target

Monthly Cummulative Site Cohort Enrolment Against the Target.

Number of participant who have had 26 week follow up visit done

Facility Number
Rhodes 41
Karen 46
Riruta 16
Total 103

Weekly 26 week follow up Summary (as of 2026-05-07)

Facility Number
Total 0

Participants Exited from the Study, (as of 2026-05-07)

Total Number of exited participants with reasons

exit_reason n
Completed all follow up (26 week visit and MGIT result feedback) 59
Study withdrawal 8
Lost to follow up (missed visit procedures completed) 18
Notified of participant death 5
Other 24
No longer eligible (baseline Xpert positive) 152
Not selected for cohort 1
No longer eligible (baseline MGIT positive) 7
Total 274

Number of exited participants with Other reasons

exit_reason exit_reason_detail n
Other LAM positive results 1
Other LAM positive results 1
Other Missed baselines cohort visit within study window 1
Other Out of window period 3
Other Outside the window period 1
Other Outside the window period 8
Other Outside window period 1
Other Participant could not attend the baseline cohort visit within the study window 1
Other Participant moved due to work related issues 1
Other Participant no longer able to complete week 26 visit, she's still admitted at KNH with Hodgkin Lymphoma and she's out of the window period 1
Other Participant realised later that she was pregnant 1
Other Participant urine lam turned positive 1
Other Participant was not feeling well during the window period of cohort enrollment 1
Other The husband refused the participant to continue with the study 1
Other Work related matters 1
Total - 24

Updated Cohort list after participants Exit

Exited cohort participants

exit_reason n percent
Completed all follow up (26 week visit and MGIT result feedback) 59 64.8%
Study withdrawal 1 1.1%
Lost to follow up (missed visit procedures completed) 14 15.4%
Notified of participant death 5 5.5%
Other 5 5.5%
No longer eligible (baseline Xpert positive) 0 0.0%
Not selected for cohort 0 0.0%
No longer eligible (baseline MGIT positive) 7 7.7%
Total 91 100.0%

Exited cohort participants with Other Reasons

exit_reason exit_reason_detail n
Other LAM positive results 1
Other LAM positive results 1
Other Participant moved due to work related issues 1
Other Participant no longer able to complete week 26 visit, she's still admitted at KNH with Hodgkin Lymphoma and she's out of the window period 1
Other Participant urine lam turned positive 1
Total - 5

Remaining Cohort Participants After exited participants

obs_phc_ke n
Rhodes 91
Karen 77
Riruta 141
Total 309