Addition of digital VIA/VILI to conventional naked-eye examination for triage of HPV-positive women: A study conducted in a low-resource setting

Abstract

Background World Health Organization guidelines for cervical cancer screening recommend HPV testing followed by visual inspection with acetic acid (VIA) for triage if HPV positive. In order to improve visual assessment and identification of cervical intraepithelial neoplasia grade 2 and worse (CIN2+), providers may use visual aids such as digital cameras. Objectives To determine whether combined examination by naked-eye and digital VIA (D-VIA) and VILI (D-VILI) improves detection of CIN2+ as compared to the conventional evaluation. Materials and methods Women (30–49 years) living in Dschang (West Cameroon) were prospectively invited to a cervical cancer screening campaign. Primary HPV-based screening was followed by VIA/VILI and D-VIA/VILI if HPV-positive. Health care providers independently defined diagnosis (pathological or non-pathological) based on naked-eye VIA/VILI and D-VIA/VILI. Decision to treat was based on combined examination (VIA/VILI and D-VIA/VILI). Cervical biopsy and endocervical curettage were performed in all HPV-positive participants and considered as reference standard. Diagnostic performance of individual and combined naked-eye VIA/VILI and D-VIA/VILI was evaluated. A sample size of 1,500 women was calculated assuming a prevalence of 20% HPV positivity and 10% CIN2+ in HPV-positive women. Results Due to the COVID-19 pandemic, the study had to terminate prematurely. A total of 1,081 women with a median age of 40 (IQR 35.5–45) were recruited. HPV positivity was 17.4% (n = 188) and 26 (14.4%) had CIN2+. Naked-eye VIA and D-VIA sensitivities were 80.8% (95% CI 60.6–93.4) and 92.0% (95% CI 74.0–99.0), and specificities were 31.2% (95% CI 24–39.1) and 31.6% (95% CI 24.4–39.6), respectively. The combination of both methods yielded a sensitivity of 92.3% (95% CI 74.9–99.1) and specificity of 23.2% (95% CI 16.8–30.7). A trend towards improved sensitivity was observed, but did not reach statistical significance. Conclusion Addition of D-VIA/VILI to conventional naked-eye examination may be associated with improved CIN2+ identification. Further studies including a larger sample size are needed to confirm these results.

Performance of visual inspection of the cervix with acetic acid (VIA) for triage of HPV screen‐positive women: results from the ESTAMPA study

“…As discussed above, this highlights the potential for VIA to be improved by adopting proficiency schemes based on training and increased expert interaction and supervision. Also, adding more objective tests such as partial HPV16/18 genotyping and/or HPV viral load and/or computer‐based aids may further improve the methodology 13,30,43 . Our results are based on local diagnoses.…”

“…Several studies have evidenced high variability of VIA to detect high‐grade cervical lesions with sensitivities ranging between 17%‐96% in primary screening, 4 , 6 , 13 , 14 , 15 , 16 , 17 and between 25%–92% in HPV‐positive women. 13 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 Only five studies in HPV‐positive women, characterised by including intensive training, report sensitivities ≥80%. 20 , 23 , 24 , 27 , 30 VIA positivity, which is a useful indicator in triage scenarios, has also shown to be highly variable.…”

“… 13 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 Only five studies in HPV‐positive women, characterised by including intensive training, report sensitivities ≥80%. 20 , 23 , 24 , 27 , 30 VIA positivity, which is a useful indicator in triage scenarios, has also shown to be highly variable. 5 It is worth noting that in the context of triage, knowledge of HPV status may increase the positivity rate of observer‐depended techniques, as reported for cytology, increasing the sensitivity.…”

“…As observed by others, 27 our results suggest that adopting proficiency schemes based on training and supervision is desirable to improve VIA. Consequently, alternatives such as computer tools based on remote support from external experts and/or artificial intelligence algorithms (AI) that can offer permanent supervision and training 30 , 37 , 38 , 39 , 40 may be useful. The use of AI algorithms incorporated to portable devices such as smartphones will represent a more objective assessment of the presence or not of cervical precancerous lesions contributing to reduction of variability attributed to VIA examiners.…”

“…Also, adding more objective tests such as partial HPV16/18 genotyping and/or HPV viral load and/or computer‐based aids may further improve the methodology. 13 , 30 , 43 Our results are based on local diagnoses. Among analysed participants, 2248 had results based on histology, of which 68% have been reviewed by external pathologists using the LAST nomenclature; 44 , 45 355 high‐grade cervical lesions (CIN2 p16‐positive, CIN3, or cancer) have been confirmed.…”