Project CN001: Cervical Cancer Prevention Clinical Services Utilization Mapping Initiative

A Preliminary Analysis

Author

Lu Mao (CNCC)

Published

March 11, 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 2026-03-11, Project CN001 has enrolled n=4591 WLWH across multiple CASCADE Clinical Sites.

Table 1: Current enrollment totals by site and clinic
Clinical Site Clinic N
CS2 – Kenya (Coptic Hope Center) Coptic Hope Center, Nairobi 1222
CS4 – Georgia, US (Emory) Ponce de Leon Center, Atlanta 529
CS6 – Kenya (KEMRI / JKUAT) Embu Referral Hospital 211
Murang’a Level 5 Hospital 161
Ruiru Level 4 Hospital 199
Thika Level 5 Hospital 196
CS7 – Zimbabwe Budiriro Polyclinic 287
Epworth Polyclinic 210
Glen View Polyclinic 90
Hatcliffe Polyclinic 91
Hatfield Clinic 10
Hopley Clinic 3
Kambuzuma Polyclinic 109
Kunaka Rural Health Center 2
Kuwadzana Phase Clinic 80
Kuwadzana Polyclinic 78
Mabvuku Polyclinic 28
Makumbe District Hospital 1
Marlborough Clinic 69
Mbare Polyclinic 77
Mufakose Polyclinic 89
Rujeko Polyclinic 109
Rutsanana Polyclinic 219
Ruwa Polyclinic 2
Seke North Clinic 118
Seke South Clinic 49
St Mary’s Clinic 78
Warren Park Clinic 45
Wilkins Infectious Diseases Hospital 3
Zengeza Clinic 110
CS9 – Botswana Centre for Infectious Disease Research 116
Total 4591
Figure 1: Cumulative enrollment by site over HX visit date

All analyses are restricted to n=4575 HIV positive participants.

2 HX - Clinical History

Table 2: Summary of key variables from HX instrument
Characteristic CS2 – Kenya (Coptic Hope Center), N = 1,2211 CS4 – Georgia, US (Emory), N = 5261 CS6 – Kenya (KEMRI / JKUAT), N = 7631 CS7 – Zimbabwe, N = 1,9491 CS9 – Botswana, N = 1161 Overall, N = 4,5751
Age (years) 41 (35, 45) 50 (39, 59) 44 (36, 52) 40 (34, 45) 38 (32, 43) 41 (35, 47)
    Unknown 0 0 0 1 0 1
Meets CN001 eligibility 1,220 (100%) 524 (100%) 759 (99%) 1,946 (100%) 114 (98%) 4,563 (100%)
    Unknown 0 0 0 2 0 2
Prior cervical screening 918 (77%) 522 (99%) 469 (62%) 1,757 (90%) 2 (1.7%) 3,668 (81%)
    Unknown 24 0 6 7 1 38
Result of last screening





    Normal 877 (98%) 353 (68%) 396 (92%) 1,713 (98%) 1 (50%) 3,340 (93%)
    Abnormal 16 (1.8%) 165 (32%) 35 (8.1%) 34 (1.9%) 1 (50%) 251 (7.0%)
    Unknown 328 8 332 202 114 984
Prior cervical precancer 25 (2.1%) 196 (37%) 30 (4.0%) 152 (7.9%) 0 (0%) 403 (8.9%)
    Unknown 23 1 6 34 2 66
Prior precancer treatment 12 (50%) 91 (46%) 20 (69%) 44 (29%) 0 (NA%) 167 (42%)
    Unknown 1,197 330 734 1,797 116 4,174
Currently pregnant 1 (<0.1%) 16 (3.1%) 10 (1.3%) 5 (0.3%) 0 (0%) 32 (0.7%)
    Unknown 3 4 7 13 0 27
History of hysterectomy 2 (0.2%) 57 (14%) 15 (2.0%) 1 (<0.1%) 0 (0%) 75 (1.7%)
    Unknown 1 128 7 13 1 150
Year of HIV diagnosis known 1,181 (97%) 404 (77%) 739 (97%) 1,911 (98%) 115 (99%) 4,350 (95%)
    Unknown 0 0 5 0 0 5
Year of HIV diagnosis 2,014.0 (2,009.0, 2,020.0) 2,009.0 (2,001.0, 2,017.0) 2,013.0 (2,009.0, 2,018.0) 2,017.0 (2,014.0, 2,020.0) 2,013.0 (2,009.5, 2,017.0) 2,015.0 (2,011.0, 2,020.0)
    Unknown 40 122 24 46 1 233
1 Median (IQR); 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 = 1,2211 CS4 – Georgia, US, N = 5261 CS6 – Kenya, N = 7061 CS7 – Zimbabwe, N = 1,8881 CS9 – Botswana, N = 931
HIV RNA Detected 221 (19%) 126 (24%) 96 (14%) 89 (4.8%) 22 (24%)
    Unknown 63 0 0 25 0
1 n (%)
Table 4: HIV RNA viral load (copies/mL) among those with detected RNA, by site
Characteristic CS2 – Kenya, N = 2211 CS4 – Georgia, US, N = 1261 CS6 – Kenya, N = 961 CS7 – Zimbabwe, N = 891 CS9 – Botswana, N = 221
HIV RNA Viral Load (copies/mL) 29 (20, 75) 39 (20, 428) 86 (46, 452) 30 (20, 30) 56 (41, 166)
1 Median (IQR)
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 = 1,2211 CS4 – Georgia, US, N = 5261 CS6 – Kenya, N = 7061 CS7 – Zimbabwe, N = 1,8881 CS9 – Botswana, N = 931
HIV RNA Viral Load (log(1 + copies/mL), VL=0 if not detected) 0.34 (0.80) 0.51 (1.05) 0.32 (0.89) 0.07 (0.35) 0.48 (0.96)
    Unknown 63 0 0 25 0
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 – Botswana
Yes, N = 1761 No, N = 6961 Unknown, N = 241 Yes, N = 1261 No, N = 4001 Unknown, N = 01 Yes, N = 531 No, N = 2901 Unknown, N = 111 Yes, N = 51 No, N = 221 Unknown, N = 61 Yes, N = 141 No, N = 541 Unknown, N = 31
CD4 Count (cells/µL) 388 (258, 574) 469 (286, 671) 373 (298, 455) 509 (261, 747) 679 (481, 987) NA (NA, NA) 450 (307, 596) 460 (309, 653) 289 (141, 572) 179 (172, 185) 200 (185, 358) 200 (200, 350) 607 (411, 814) 667 (390, 889) 1,228 (943, 1,317)
1 Median (IQR)
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 = 1,2061 N = 5221 N = 821 N = 1,9021
Screening Modality Combination



    HPV only 126 (10%) 8 (1.5%) 50 (61%) 229 (12%)
    Cytology only 1 (<0.1%) 33 (6.3%) 0 (0%) 0 (0%)
    VIA only 1,068 (89%) 0 (0%) 32 (39%) 1,372 (72%)
    HPV + Cytology 0 (0%) 481 (92%) 0 (0%) 0 (0%)
    HPV + VIA 11 (0.9%) 0 (0%) 0 (0%) 301 (16%)
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 = 1,0791 CS6 – Kenya, N = 321 CS7 – Zimbabwe, N = 1,6731
VIA Test Results


    Negative 1,006 (93%) 29 (91%) 1,599 (96%)
    Positive 67 (6.2%) 3 (9.4%) 61 (3.6%)
    Suspiciousforcancer 4 (0.4%) 0 (0%) 5 (0.3%)
    Other 2 (0.2%) 0 (0%) 7 (0.4%)
    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
Positive, N = 671 Suspiciousforcancer, N = 41 Other, N = 21 Positive, N = 31 Positive, N = 611 Suspiciousforcancer, N = 51 Other, N = 71
Patient treated at visit 42 (63%) 0 (0%) 0 (0%) 2 (67%)


    No



33 (54%) 3 (60%) 6 (86%)
    Unknown



5 (8.2%) 0 (0%) 0 (0%)
    Yes



23 (38%) 2 (40%) 1 (14%)
Type of treatment provided at visit






    Thermalablation 42 (100%) 0 (NA%) 0 (NA%) 2 (100%) 21 (91%) 0 (0%) 0 (0%)
    Cryotherapy



1 (4.3%) 0 (0%) 0 (0%)
    LEEPLLETZ



1 (4.3%) 0 (0%) 0 (0%)
    Other



0 (0%) 2 (100%) 1 (100%)
Referred for evaluation 25 (37%) 4 (100%) 0 (0%) 1 (33%)


    No



48 (79%) 5 (100%) 6 (86%)
    Unknown



2 (3.3%) 0 (0%) 1 (14%)
    Yes



11 (18%) 0 (0%) 0 (0%)
Referred for treatment 20 (30%) 3 (75%) 1 (50%) 1 (33%) 16 (27%) 1 (20%) 3 (43%)
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 = 1371 CS4 – Georgia, US, N = 4891 CS6 – Kenya, N = 501 CS7 – Zimbabwe, N = 5301
HPV Test Assay



    AbbottAlinity 137 (100%) 0 (0%) 0 (0%) 9 (1.7%)
    XpertHPV 0 (0%) 0 (0%) 19 (38%) 72 (14%)
    Other 0 (0%) 486 (99%) 31 (62%) 447 (85%)
    Unknown 0 (0%) 3 (0.6%) 0 (0%) 0 (0%)
    Unknown 0 0 0 2
HPV test results



    Negative 104 (76%) 392 (80%) 9 (18%) 107 (20%)
    Positive 33 (24%) 91 (19%) 8 (16%) 65 (12%)
    Other/Unknown 0 (0%) 6 (1.2%) 33 (66%) 358 (68%)
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 = 911 Other/Unknown, N = 61 Positive, N = 81 Other/Unknown, N = 331 Positive, N = 651 Other/Unknown, N = 3581
Patient treated at visit 1 (5.6%) 1 (1.1%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 4 (1.1%)
Type of treatment provided at visit


0 (NA%) 0 (NA%)

    Thermalablation 1 (100%)



0 (NA%) 4 (100%)
    LEEPLLETZ
1 (100%) 0 (NA%)



Referred for evaluation 4 (21%) 66 (74%) 3 (50%) 0 (0%) 0 (0%) 5 (7.7%) 5 (1.4%)
Referred for treatment 0 (0%) 13 (15%) 0 (0%) 0 (0%) 0 (0%) 4 (6.2%) 4 (1.1%)
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 = 11 CS4 – Georgia, US, N = 5141
Cytology Test Results

    NILM 1 (100%) 356 (69%)
    HSILCIN 0 (0%) 5 (1.0%)
    ASCUS 0 (0%) 75 (15%)
    LSILCIN1 0 (0%) 51 (9.9%)
    ASCH 0 (0%) 10 (1.9%)
    HSILCIN2 0 (0%) 1 (0.2%)
    HSILNotspecified 0 (0%) 3 (0.6%)
    Other 0 (0%) 13 (2.5%)
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 = 1451 Other, N = 131
Patient treated at visit 2 (1.4%) 0 (0%)
Type of treatment provided at visit

    LEEPLLETZ 1 (50%) 0 (NA%)
    Other 1 (50%) 0 (NA%)
Referred for evaluation 91 (64%) 2 (15%)
Referred for treatment 17 (12%) 0 (0%)
1 n (%)