The Use of Self-Sampling Devices via a Smartphone Application to Encourage Participation in Cervical Cancer Screening: A Pilot Study
Abstract
1. Introduction
- HPV DNA detection in a screen-and-treat approach, commencing at the age of 30 years, with regular screening every 5 to 10 years.
- HPV DNA detection in a screen, triage, and treat approach, also starting at the age of 30 years, with regular screening intervals of 5 to 10 years.
2. Materials and Methods
2.1. Study Design
2.2. Home Self-Sampling
2.3. HPV Testing
2.4. Statistical Analysis
3. Results
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Patients | N (%) |
---|---|
Age (Mean ± SD) | 36.89 ± 13.22 |
BMI | |
<18.5, n (%) | 16 (7.1) |
18.5–24.9, n (%) | 146 (64.6) |
>25, n (%) | 50 (22.1) |
N.A., n (%) | 14 (6.2) |
Number of pregnancies, (Mean ± SD) | 1.10 ± 1.34 |
Menopause, n (%) | 20 (8.8) |
Oral contraceptive, (Mean ± SD) | 39 (17.3) |
Smoking | |
-Smoker, n (%) | 14 (6.2) |
-Non-Smoker, n (%) | 212 (93.8) |
HPV Vaccination | |
-Not vaccinated | 190 (84.1) |
-Vaccinated | 36 (15.9) |
-Cervarix® | 7 (19.4) |
-Gardasil-4® | 26 (72.2) |
-Gardasil-9® | 2 (5.6) |
Education level | |
-Middle school certificate, n (%) | 23 (8.3) |
-Higher education, n (%) | 111 (40.1) |
-University degree, n (%) | 121 (43.7) |
-Not indicated, n (%) | 22 (7.9) |
Sample sent back for analysis: | |
-unsuccessful, n (%) | 51 (18.4) |
-successful, n (%) | 226 (81.6) |
-Traditional mailbox | 196 (86.7) |
-Courier company | 30 (13.3) |
Digital activation of Kit | |
-Unsuccessful activation, n (%) | 62 (22.4) |
-Successful activation, n (%) | 215 (77.6) |
-Immediately | 165 (77) |
-Within 7 days | 39 (18) |
-Between 8 and 18 days | 11 (5) |
Self-Sampling Vaginal Swab (N = 190) | Medical Sampling Vaginal Swab (N = 190) | CLART (N = 190) | |
---|---|---|---|
HPV-HR positivity | 33 (17.4) | 38 (20) | 36 (18.9) |
HPV-negativity | 157 (82.6) | 152 (80) | 154 (81.1) |
Coinfected HPV | 10 | 11 | 18 |
Genotype of HPV-HR | |||
-Type 16 | 6 (3.1) | 8 (4.2) | 5 (2.6) |
-Type 18 | 0 (0) | 1 (0.5) | 0 (0) |
-Type 31 | 8 (4.2) | 10 (5.2) | 7 (3.7) |
-Type 33 | 0 (0) | 0 (0) | 1 (0.5) |
-Type 35 | 0 (0) | 0 (0) | 0 (0) |
-Type 39 | 5 (2.6) | 4 (2.1) | 1 (0.5) |
-Type 45 | 1 (0.5) | 1 (0.5) | 1 (0.5) |
-Type 51 | 4 (2.1) | 5 (2.6) | 5 (2.6) |
-Type 52 | 3 (1.6) | 2 (1.0) | 3 (1.6) |
-Type 56 | 3 (1.6) | 3 (1.6) | 1 (0.5) |
-Type 58 | 8 (4.2) | 7 (3.7) | 8 (4.2) |
-Type 59 | 2 (1.0) | 2 (1.0) | 2 (1.0) |
-Type 66 | 4 (2.1) | 5 (2.6) | 9 (4.7) |
-Type 68 | 2 (1.0) | 3 (1.6) | 0 (0) |
CLART 1 vs. HPV Selfy 1 | CLART 1 vs. HPV Selfy 2 | HPV 2 vs. HPV Selfy 1 | |
---|---|---|---|
Sensitivity | 86.1% (95%CI: 70.50–95.33%) | 77.8% (95%CI: 60.85–89.88%) | 81.5% (95%CI: 65.67–92.26%) |
Specificity | 95.4% (95%CI: 90.86–98.15%) | 96.8% (95%CI: 92.59–98.94%) | 98.7% (95%CI: 95.33–99.84%) |
Accuracy | 93.7% (95%CI: 89.23–96.69%) | 93.2% (95%CI: 88.58–96.31%) | 95.3% (95%CI: 91.20–97.81%) |
PPV | 81.6% (95%CI: 67.97–90.24%) | 84.8% (95%CI: 69.91–93.10%) | 93.9% (95%CI: 79.51–98.41%) |
NPV | 96.7% (95%CI: 92.87–98.52%) | 94.9% (95%CI: 90.99–97.17%) | 95.5% (95%CI: 91.65–97.67%) |
K Cohen | 79.9% (95%CI: 68.90–90.80%) | 77.0% (95%CI: 65.10–88.90%) | 84.4% (95%CI: 74.60–94.30%) |
OA agrement | 93.7% | 93.2% | 95.0% |
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Plotti, F.; Ficarola, F.; Fais, G.; De Cicco Nardone, C.; Montera, R.; Luvero, D.; Cundari, G.B.; Avian, A.; Riva, E.; Castriciano, S.; et al. The Use of Self-Sampling Devices via a Smartphone Application to Encourage Participation in Cervical Cancer Screening: A Pilot Study. J. Clin. Med. 2025, 14, 5569. https://doi.org/10.3390/jcm14155569
Plotti F, Ficarola F, Fais G, De Cicco Nardone C, Montera R, Luvero D, Cundari GB, Avian A, Riva E, Castriciano S, et al. The Use of Self-Sampling Devices via a Smartphone Application to Encourage Participation in Cervical Cancer Screening: A Pilot Study. Journal of Clinical Medicine. 2025; 14(15):5569. https://doi.org/10.3390/jcm14155569
Chicago/Turabian StylePlotti, Francesco, Fernando Ficarola, Giuseppina Fais, Carlo De Cicco Nardone, Roberto Montera, Daniela Luvero, Gianna Barbara Cundari, Alice Avian, Elisabetta Riva, Santina Castriciano, and et al. 2025. "The Use of Self-Sampling Devices via a Smartphone Application to Encourage Participation in Cervical Cancer Screening: A Pilot Study" Journal of Clinical Medicine 14, no. 15: 5569. https://doi.org/10.3390/jcm14155569
APA StylePlotti, F., Ficarola, F., Fais, G., De Cicco Nardone, C., Montera, R., Luvero, D., Cundari, G. B., Avian, A., Riva, E., Castriciano, S., Angeletti, S., Ciccozzi, M., Angioli, R., & Terranova, C. (2025). The Use of Self-Sampling Devices via a Smartphone Application to Encourage Participation in Cervical Cancer Screening: A Pilot Study. Journal of Clinical Medicine, 14(15), 5569. https://doi.org/10.3390/jcm14155569