Project CN001: Cervical Cancer Prevention Clinical Services Utilization Mapping Initiative

A Preliminary Analysis

Author

Lu Mao (CNCC)

Published

June 30, 2026

1 Overview

Project CN001 is a CASCADE network-wide initiative aimed at evaluating clinical service utilization and outcomes of cervical cancer prevention programs among Women Living with HIV (WLWH) at participating CASCADE Clinical Sites (CSs).

As of 2026-06-29, Project CN001 has enrolled n=18085 WLWH across multiple CASCADE Clinical Sites.

Table 1: Current enrollment totals by site and clinic
Clinical Site N
CS2 – Kenya (Coptic Hope Center) 1706
CS4 – Georgia, US (Emory) 697
CS6 – Kenya (KEMRI / JKUAT) 961
CS7 – Zimbabwe 14452
CS9 – South Africa (CAPRISA) 269
Total 18085
Figure 1: Cumulative enrollment by site over HX visit date

All analyses are restricted to n=17942 HIV positive participants.

2 HX - Clinical History

Table 2: Summary of key variables from HX instrument
Characteristic CS2 – Kenya (Coptic Hope Center)
N = 1,7061		 CS4 – Georgia, US (Emory)
N = 6921		 CS6 – Kenya (KEMRI / JKUAT)
N = 9561		 CS7 – Zimbabwe
N = 14,3191		 CS9 – South Africa (CAPRISA)
N = 2691		 Overall
N = 17,9421
Age (years) 41 (35, 45) 51 (39, 59) 45 (36, 53) 40 (34, 45) 38 (31, 43) 40 (34, 45)
    Unknown 0 0 0 1 0 1
Meets CN001 eligibility 1,706 (100%) 690 (100%) 952 (100%) 14,260 (100%) 267 (99%) 17,875 (100%)
    Unknown 0 0 0 8 0 8
Prior cervical screening 1,298 (78%) 688 (99%) 574 (60%) 12,522 (88%) 82 (31%) 15,164 (85%)
    Unknown 33 0 2 26 1 62
Result of last screening





    Normal 1,244 (98%) 462 (68%) 488 (92%) 12,195 (98%) 61 (75%) 14,450 (96%)
    Abnormal 27 (2.1%) 219 (32%) 43 (8.1%) 271 (2.2%) 20 (25%) 580 (3.9%)
    Unknown 435 11 425 1,853 188 2,912
Prior cervical precancer 33 (2.0%) 259 (37%) 36 (3.8%) 1,064 (7.5%) 9 (3.4%) 1,401 (7.9%)
    Unknown 30 1 2 112 3 148
Prior precancer treatment 20 (63%) 115 (44%) 23 (66%) 498 (47%) 1 (11%) 657 (47%)
    Unknown 1,674 433 921 13,265 260 16,553
Currently pregnant 1 (<0.1%) 19 (2.8%) 14 (1.5%) 46 (0.3%) 3 (1.1%) 83 (0.5%)
    Unknown 3 4 3 55 1 66
History of hysterectomy 2 (0.1%) 67 (12%) 20 (2.1%) 5 (<0.1%) 0 (0%) 94 (0.5%)
    Unknown 1 146 2 80 1 230
Year of HIV diagnosis known 1,648 (97%) 493 (71%) 938 (98%) 14,139 (99%) 267 (99%) 17,485 (97%)
hx_year_hiv_diag 2,015.0 (2,009.0, 2,020.0) 2,009.0 (2,001.0, 2,016.0) 2,013.0 (2,009.0, 2,018.0) 2,017.0 (2,014.0, 2,021.0) 2,014.0 (2,010.0, 2,018.0) 2,017.0 (2,013.0, 2,021.0)
    Unknown 58 199 18 214 2 491
1 Median (Q1, Q3); n (%)

3 HI - HIV RNA Viral Load

Figure 2: HIV RNA detection reported by HI (viral load number available for those with RNA detected)
Table 3: HIV RNA detection status by site (at first visit reported in HI instrument)
Characteristic CS2 – Kenya
N = 1,7051		 CS4 – Georgia, US
N = 6911		 CS6 – Kenya
N = 9021		 CS7 – Zimbabwe
N = 13,7601		 CS9 – South Africa
N = 2381
HIV RNA Detected 310 (19%) 161 (23%) 130 (14%) 958 (7.0%) 68 (29%)
    Unknown 92 0 1 84 3
1 n (%)
Table 4: HIV RNA viral load (copies/mL) among those with detected RNA, by site
Characteristic CS2 – Kenya
N = 3101		 CS4 – Georgia, US
N = 1611		 CS6 – Kenya
N = 1301		 CS7 – Zimbabwe
N = 9581		 CS9 – South Africa
N = 681
HIV RNA Viral Load (copies/mL) 30 (20, 81) 46 (20, 1,300) 105 (44, 696) 30 (20, 40) 50 (29, 156)
1 Median (Q1, Q3)
Figure 3: Boxplot of HIV RNA viral load (copies/mL) among those with detected RNA, by site

Set

  • Viral load \(=0\) if RNA not detected
Table 5: HIV RNA viral load (log(1 + copies/mL), VL=0 if not detected) by site
Characteristic CS2 – Kenya
N = 1,7051		 CS4 – Georgia, US
N = 6911		 CS6 – Kenya
N = 9021		 CS7 – Zimbabwe
N = 13,7601		 CS9 – South Africa
N = 2381
HIV RNA Viral Load (log(1 + copies/mL), VL=0 if not detected) 0.35 (0.81) 0.52 (1.10) 0.35 (0.95) 0.12 (0.45) 0.58 (1.01)
    Unknown 92 0 1 84 3
1 Mean (SD)

4 CD - CD4 Value

Figure 4: Participant count reported by CD (with CD4 count measured)
Figure 5: CD4 measurement status (1st report) by HIV RNA detection status and site
Table 6: CD4 count (cells/µL) among those with CD4 measured (at first report) by site and HIV RNA detection status
Characteristic
CS2 – Kenya (Coptic Hope Center)
CS4 – Georgia, US (Emory)
CS6 – Kenya (KEMRI / JKUAT)
CS7 – Zimbabwe
CS9 – South Africa (CAPRISA)
Yes
N = 2451		 No
N = 9701		 Unknown
N = 261		 Yes
N = 1611		 No
N = 5301		 Unknown
N = 01		 Yes
N = 761		 No
N = 3961		 Unknown
N = 131		 Yes
N = 131		 No
N = 691		 Unknown
N = 1601		 Yes
N = 561		 No
N = 1241		 Unknown
N = 41
CD4 Count (cells/µL) 391 (247, 580) 478 (286, 671) 361 (294, 415) 474 (192, 706) 679 (473, 980) NA (NA, NA) 445 (304, 595) 464 (311, 672) 200 (131, 450) 300 (179, 421) 229 (200, 355) 200 (200, 250) 522 (348, 791) 648 (426, 850) 943 (557, 1,317)
1 Median (Q1, Q3)
Figure 6: Boxplot of CD4 count (cells/µL) among those with CD4 measured (at first report) by site and HIV RNA detection status

5 AT - ART Regimen

Figure 7: Participant count by number of ART regimen started

6 SC - Screening Visit

Figure 8: Screening modalities performed by SC visit

6.1 Overall Screening by Site

Figure 9: Screening modalities performed at first SC visit, by site
Table 7: Screening modality combinations performed at first SC visit, by site
Characteristic
CS2 – Kenya
CS4 – Georgia, US
CS6 – Kenya
CS7 – Zimbabwe
N = 1,6511 N = 6871 N = 951 N = 13,9671
Screening Modality Combination



    HPV only 125 (7.6%) 15 (2.2%) 54 (57%) 864 (6.2%)
    Cytology only 2 (0.1%) 44 (6.4%) 0 (0%) 0 (0%)
    VIA only 1,511 (92%) 0 (0%) 40 (42%) 11,171 (80%)
    AI only 0 (0%) 0 (0%) 0 (0%) 1 (<0.1%)
    HPV + Cytology 1 (<0.1%) 628 (91%) 1 (1.1%) 0 (0%)
    HPV + VIA 12 (0.7%) 0 (0%) 0 (0%) 1,926 (14%)
    Other 0 (0%) 0 (0%) 0 (0%) 5 (<0.1%)
1 n (%)

6.2 VIA

Table 8: VIA test results at first SC visit, among those with VIA performed, by site
Characteristic CS2 – Kenya
N = 1,5231		 CS6 – Kenya
N = 401		 CS7 – Zimbabwe
N = 13,1021
VIA Test Results


    Negative 1,439 (94%) 36 (90%) 12,502 (95%)
    Positive 77 (5.1%) 4 (10%) 549 (4.2%)
    Suspiciousforcancer 4 (0.3%) 0 (0%) 32 (0.2%)
    Other 3 (0.2%) 0 (0%) 18 (0.1%)
    Unknown 0 0 1
1 n (%)
Table 9: Treatment and referral among those with non-negative VIA results at first SC visit, by site
Characteristic
CS2 – Kenya
CS6 – Kenya
CS7 – Zimbabwe
Other
N = 31		 Positive
N = 771		 Suspiciousforcancer
N = 41		 Positive
N = 41		 Other
N = 181		 Positive
N = 5491		 Suspiciousforcancer
N = 321
Patient treated at visit






    No 3 (100%) 30 (39%) 4 (100%) 1 (25%) 15 (83%) 274 (50%) 26 (81%)
    Unknown 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 42 (7.7%) 1 (3.1%)
    Yes 0 (0%) 47 (61%) 0 (0%) 3 (75%) 3 (17%) 231 (42%) 5 (16%)
Type of treatment provided at visit






    Thermal ablation 0 (NA%) 47 (100%) 0 (NA%) 3 (100%) 0 (0%) 193 (84%) 0 (0%)
    Cryotherapy 0 (NA%) 0 (0%) 0 (NA%) 0 (0%) 0 (0%) 2 (0.9%) 0 (0%)
    LEEP/LLETZ 0 (NA%) 0 (0%) 0 (NA%) 0 (0%) 0 (0%) 33 (14%) 0 (0%)
    Other 0 (NA%) 0 (0%) 0 (NA%) 0 (0%) 3 (100%) 3 (1.3%) 4 (80%)
    Unknown 0 (NA%) 0 (0%) 0 (NA%) 0 (0%) 0 (0%) 0 (0%) 1 (20%)
Referred for evaluation






    No 3 (100%) 47 (61%) 0 (0%) 3 (75%) 13 (72%) 456 (83%) 24 (75%)
    Unknown 0 (0%) 0 (0%) 0 (0%) 0 (0%) 2 (11%) 26 (4.7%) 0 (0%)
    Yes 0 (0%) 30 (39%) 4 (100%) 1 (25%) 3 (17%) 66 (12%) 8 (25%)
Referred for treatment






    No 2 (67%) 52 (68%) 1 (25%) 3 (75%) 15 (83%) 380 (69%) 15 (47%)
    Unknown 0 (0%) 2 (2.6%) 0 (0%) 0 (0%) 0 (0%) 24 (4.4%) 0 (0%)
    Yes 1 (33%) 23 (30%) 3 (75%) 1 (25%) 3 (17%) 144 (26%) 17 (53%)
1 n (%)

6.3 HPV

Table 10: HPV test results at first SC visit, among those with HPV testing performed, by site
Characteristic CS2 – Kenya
N = 1381		 CS4 – Georgia, US
N = 6431		 CS6 – Kenya
N = 551		 CS7 – Zimbabwe
N = 2,7901
HPV Test Assay



    AbbottAlinity 137 (99%) 0 (0%) 0 (0%) 25 (0.9%)
    XpertHPV 1 (0.7%) 0 (0%) 21 (38%) 880 (32%)
    Other 0 (0%) 640 (100%) 34 (62%) 1,800 (65%)
    Unknown 0 (0%) 3 (0.5%) 0 (0%) 80 (2.9%)
    Unknown 0 0 0 5
HPV test results



    Negative 105 (76%) 505 (79%) 9 (16%) 612 (22%)
    Positive 33 (24%) 130 (20%) 11 (20%) 393 (14%)
    Other/Unknown 0 (0%) 8 (1.2%) 35 (64%) 1,785 (64%)
1 n (%)
Table 11: HPV test assay at first SC visit, among those with HPV testing performed, by site
Characteristic
CS2 – Kenya
CS4 – Georgia, US
CS6 – Kenya
CS7 – Zimbabwe
Positive
N = 331		 Positive
N = 1301		 Other/Unknown
N = 81		 Positive
N = 111		 Other/Unknown
N = 351		 Positive
N = 3931		 Other/Unknown
N = 1,7851
Patient treated at visit






    No 17 (94%) 129 (99%) 7 (100%) 11 (100%) 35 (100%) 370 (94%) 1,744 (98%)
    Yes 1 (5.6%) 1 (0.8%) 0 (0%) 0 (0%) 0 (0%) 23 (5.9%) 34 (1.9%)
Type of treatment provided at visit






    LEEPLLETZ 0 (0%) 1 (100%) 0 (NA%) 0 (NA%) 0 (NA%) 2 (8.7%) 5 (15%)
    Other 0 (0%) 0 (0%) 0 (NA%) 0 (NA%) 0 (NA%) 3 (13%) 1 (2.9%)
    Thermalablation 1 (100%) 0 (0%) 0 (NA%) 0 (NA%) 0 (NA%) 18 (78%) 28 (82%)
Referred for evaluation






    No 15 (79%) 38 (30%) 4 (57%) 10 (91%) 35 (100%) 382 (98%) 1,759 (99%)
    Yes 4 (21%) 90 (70%) 3 (43%) 1 (9.1%) 0 (0%) 9 (2.3%) 13 (0.7%)
Referred for treatment






    No 19 (100%) 113 (88%) 7 (100%) 10 (91%) 35 (100%) 366 (94%) 1,756 (99%)
    Yes 0 (0%) 15 (12%) 0 (0%) 1 (9.1%) 0 (0%) 24 (6.2%) 23 (1.3%)
1 n (%)

6.4 Cytology

Table 12: Cytology test results at first SC visit, among those with Cytology testing performed, by site
Characteristic CS2 – Kenya
N = 31		 CS4 – Georgia, US
N = 6721		 CS6 – Kenya
N = 11
Cytology Test Results


    NILM 3 (100%) 456 (68%) 1 (100%)
    HSILCIN 0 (0%) 5 (0.7%) 0 (0%)
    ASCUS 0 (0%) 102 (15%) 0 (0%)
    LSILCIN1 0 (0%) 70 (10%) 0 (0%)
    ASCH 0 (0%) 10 (1.5%) 0 (0%)
    HSILCIN2 0 (0%) 1 (0.1%) 0 (0%)
    HSILNotspecified 0 (0%) 5 (0.7%) 0 (0%)
    Unknown 0 (0%) 2 (0.3%) 0 (0%)
    Other 0 (0%) 21 (3.1%) 0 (0%)
1 n (%)
Table 13: Treatment and referral among those with abnormal Cytology results at first SC visit, by site
Characteristic
CS4 – Georgia, US
Non-NILM
N = 1951		 Other
N = 211
Patient treated at visit 2 (1.0%) 0 (0%)
Type of treatment provided at visit

    LEEPLLETZ 1 (50%) 0 (NA%)
    Other 1 (50%) 0 (NA%)
Referred for evaluation 121 (63%) 4 (19%)
Referred for treatment 19 (9.9%) 0 (0%)
1 n (%)