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Kenya iTARA Data Summary (as of 2026-04-09)

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 955 52.7%
Karen 465 25.7%
Riruta 392 21.6%
Total 1812 100.0%

Participants Gender & Site Data

screen_phc_ke Female Male
Rhodes 42.5% (406) 57.5% (549)
Karen 55.7% (259) 44.3% (206)
Riruta 63.8% (250) 36.2% (142)
Total 50.5% (915) 49.5% (897)

The table below show the total number of participnats screened this week

screen_phc_ke n percent
Rhodes 14 46.7%
Karen 6 20.0%
Riruta 10 33.3%
Total 30 100.0%

Screening Eligibility

screen_eligible_conf Rhodes Karen Riruta Total
Yes 224 147 159 530
No 731 318 233 1282

The table below show the total number of participants screened, eligible and those not eligible this week

screen_eligible_conf Rhodes Karen Riruta Total
Yes 5 4 8 17
No 9 2 2 13

ELigible and Consented partcipants

screen_consent_yn Rhodes Karen Riruta Total
Yes 224 138 146 508
No 1 9 50 60
NA 730 318 196 1244

Removed all NAs from the data above

screened$screen_consent_yn n percent
Yes 508 89.4%
No 60 10.6%
Total 568 -

The table below show the total number of participnats consented to the study this week

screen_consent_yn Rhodes Karen Riruta Total
Yes 5 4 6 15
No 0 0 2 2
NA 9 2 2 13

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 4 138
Rhodes 14 38 19 21 17 12 12 12 29 42 8 224
Riruta 0 0 0 14 11 12 2 4 50 43 10 146
Total 41 63 28 46 38 32 17 20 93 108 22 508
  • 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 NA_
Rhodes 113 110 0 0 1 0
Karen 4 127 0 0 7 0
Riruta 21 116 0 0 7 2
Total 138 353 0 0 15 2
xpert_result n percent valid_percent
Positive 138 27% 27%
Negative 353 69% 70%
Trace 0 0% 0%
Indeterminate 0 0% 0%
No sputum 15 3% 3%
NA 2 0% -
Total 508 - -
Positive Negative Trace Indeterminate No sputum NA_
Rhodes
50.4% (113) 49.1% (110) 0.0% (0) 0.0% (0) 0.4% (1) 0.0% (0)
Karen
2.9% (4) 92.0% (127) 0.0% (0) 0.0% (0) 5.1% (7) 0.0% (0)
Riruta
14.4% (21) 79.5% (116) 0.0% (0) 0.0% (0) 4.8% (7) 1.4% (2)
Total
27.2% (138) 69.5% (353) 0.0% (0) 0.0% (0) 3.0% (15) 0.4% (2)

Xpert Summary and Plot of Results

Baseline Participants

enrol_phc_ke n percent
Rhodes 224 40.0%
Karen 138 30.0%
Riruta 146 30.0%
Total 508 100.0%

Weekly baseline Participants Number

enrol_phc_ke n percent
Rhodes 5 33.3%
Karen 4 26.7%
Riruta 6 40.0%
Total 15 100.0%

Cohort Participants

obs_phc_ke n percent
Rhodes 104 30.6%
Karen 116 34.1%
Riruta 120 35.3%
Total 340 100.0%

Weekly Cohort Participants

obs_phc_ke n percent
Rhodes 4 40.0%
Karen 3 30.0%
Riruta 3 30.0%
Total 10 100.0%

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 Total
Karen 12 24 10 6 11 7 3 4 14 19 6 116
Rhodes 6 19 7 11 13 2 3 8 15 15 5 104
Riruta 0 0 0 6 12 5 3 2 49 33 10 120
Total 18 43 17 23 36 14 9 14 78 67 21 340

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 34
Karen 42
Riruta 8
Total 84

Weekly 26 week follow up Summary (as of 2026-04-09)

Facility Number
Rhodes 2
Karen 3
Riruta 3
Total 8

Participants Exited from the Study, (as of 2026-04-09)

Total Number of exited participants with reasons

exit_reason n
Completed all follow up (26 week visit and MGIT result feedback) 33
Study withdrawal 13
Lost to follow up (missed visit procedures completed) 8
Notified of participant death 5
Other 23
No longer eligible (baseline Xpert positive) 123
No longer eligible (baseline MGIT positive) 7
Total 212

Number of exited participants with Other reasons

exit_reason exit_reason_detail n
Other Failed to attend study visit within stipulated timeline 1
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 7
Other Outside window period 1
Other Outside window period 1
Other Participant could not attend the baseline cohort visit within the study window 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 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 Work related matters 1
Total - 23

Updated Cohort list after participants Exit

Exited cohort participants

exit_reason n percent
Completed all follow up (26 week visit and MGIT result feedback) 33 53.2%
Study withdrawal 6 9.7%
Lost to follow up (missed visit procedures completed) 7 11.3%
Notified of participant death 5 8.1%
Other 4 6.5%
No longer eligible (baseline Xpert positive) 0 0.0%
Not selected for cohort 0 0.0%
No longer eligible (baseline MGIT positive) 7 11.3%
Total 62 100.0%

Exited cohort participants with Other Reasons

exit_reason exit_reason_detail n
Other LAM positive results 1
Other LAM positive results 1
Other Participant 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 - 4

Remaining Cohort Participants After exited participants

obs_phc_ke n
Rhodes 87
Karen 73
Riruta 118
Total 278