Feasibility and Acceptability of Smartphone-Based Cervical Cancer Screening Among HIV-Positive Women in Western Kenya

Abstract

PURPOSE Adjunct cervical cancer screening methods are under evaluation to improve the diagnostic accuracy of human papillomavirus (HPV)-based screening in low- and middle-income countries. We evaluated the feasibility and acceptability of smartphone-based cervicography among HPV-positive women living with HIV (WLWH) in Western Kenya. METHODS HPV-positive WLWH of 25-49 years of age enrolled in a clinical trial (ClinicalTrials.gov identifier: NCT04191967 ) had digital images of the cervix taken using a smartphone by a nonphysician provider following visual inspection with acetic acid. All participants had colposcopy-directed biopsy before treatment. Cervical images were evaluated by three off-site colposcopists for quality, diagnostic utility, and assigned a presumed diagnosis. We determined the proportion of images rates as low, medium, or high quality, interobserver agreement using Cohen’s Kappa statistic, and the off-site colposcopist’s sensitivity and specificity for diagnosis of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) compared with histopathology. Acceptability was evaluated using a questionnaire. RESULTS One hundred sixty-four HPV-positive WLWH underwent cervicography during the study period. Mean age was 37.3 years. Images from the first 94 participants were evaluated by off-site colposcopists, with a majority (70.9%) rated as high quality. Off-site colposcopists had a sensitivity ranging from 21.4% (95% CI, 0.06 to 0.43) to 35.7% (95% CI, 0.26 to 0.46) and a specificity between 85.5% (95% CI, 0.81 to 0.90) to 94.9% (95% CI, 0.92 to 0.98) for diagnosis of CIN2+ based compared with histopathology. The majority of women, 99.4%, were comfortable having an image of their cervix taken as part of screening. CONCLUSION Cervicography by a nonphysician provider as an adjunct to HPV-based screening among WLWH in a low- and middle-income country setting is feasible and acceptable. However, low sensitivity for diagnosis of CIN2+ by off-site expert colposcopists highlights the limitations of cervicography.

Diagnostic accuracy of cervical cancer screening strategies for high-grade cervical intraepithelial neoplasia (CIN2+/CIN3+) among women living with HIV: A systematic review and meta-analysis

“…Thirteen studies enrolled WLHIV attending cervical cancer screening in outpatient gynaecology clinics, 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 whereas 21 studies recruited WLHIV attending HIV clinics. 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 Two studies recruited WLHIV with a prior positive screen-test (HPV-positive) 58 , 59 and two studies included a combination of women attending primary care and women referred to colposcopy because of positive HPV test and/or abnormal cytology. 60 , 61 The median age of enrolled women within studies ranged from 30 to 50 years (age range: 19 to 68 years).…”

“… c ART status not reported for 9 studies. d Studies enrolling WLHIV with a prior positive screen-test (HPV-positive) 58 , 59 and two studies included a combination of women attending primary care and women referred to colposcopy because of positive HPV test and/or abnormal cytology. 60 , 61 excluded from pooled estimates.…”

“…Twenty studies 24 , 25 , 29 , 31 , 32 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 47 , 51 , 53 , 58 , 59 evaluated any visual inspection strategy (VIA, VIA-DC or VILI) for CIN2+ detection ( Table 1 ) and 12 for CIN3+ 29 , 36 , 37 , 38 , 39 , 42 , 45 , 47 , 51 , [ 53 ] the majority were conducted in SSA. No studies evaluated automated visual evaluation (AVE) methods.…”

Digital cervicography for cervical cancer screening in low-resource settings: A scoping review

“…They concluded improved training support and better communication with patients for targeted education improve adherence ( Asgary et al, 2019 ). Similarly, in a 2018 study by Quercia et al, using a smartphone reported that DC helped HCWs with decision making and management options, including image sharing during the time of referral ( Mungo et al, 2021 ). Using same-day screen-and-treat models was also demonstrated in many studies.…”

Acting on the call for cervical cancer elimination: Planning tools for low- and middle- income countries to increase the coverage and effectiveness of screening and treatment

“…Extended HPV genotyping, viral and host methylation of genes, dual staining for p16/Ki67, and detection of viral oncoproteins E6/E7 are examples of promising approaches to further identify HPV positive women at highest risk of cervical cancer [31,32]. An additional approach currently under evaluation that may be especially suited for low-cost point-of-care screening in LMIC settings combines advances in digital images captured by a smartphone [33] or other dedicated device with the automated reading and scoring of cervical cancer risk through the application of artificial intelligence algorithms to cervical cancer images [34]. Preliminary data suggests this automated visual evaluation (AVE) approach demonstrates high performance when using high quality images such as cervigram images [35,36].…”