Purpose: Adjunct cervical cancer screening methods, including cervicography, are under evaluation to improve the accuracy of HPV-based screening in low- and middle-income countries (LMICs). 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 age 25-49 years enrolled in a clinical trial (NCT04191967) had digital images of the cervix taken using a smartphone by a nonphysician provider following visual inspection with acetic acid (VIA). All participants had colposcopy-directed biopsy prior to treatment. A questionnaire was administered to assess acceptability of cervicography. Cervical images were evaluated by three off-site colposcopists for quality, diagnostic utility, and assigned a presumed diagnosis. We determined the proportion of images rated as low, medium, or high quality, the interobserver agreement using Cohen's Kappa statistic, and the colposcopist's sensitivity and specificity for diagnosis of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) compared with histopathology. Results: One hundred and sixty-four HPV-positive WLWH underwent cervicography during the study period. Mean age was 37.3 years. The vast majority of women, 99.4%, were comfortable having an image of their cervix taken as part of screening. Images from the first 94 participants were evaluated by off-site colposcopists, with a majority (70.9%) rated as high quality, and 86.9% of sufficient quality for diagnosis. Off-site colposcopists had a sensitivity ranging from 21.4% (95% CI 0.06-0.43) to 35.7% (95% CI 0.26-0.46), and specificity between 85.5% (95% CI 0.81-0.90) to 94.9% (95% CI 0.92-0.98) for diagnosis of CIN2+ compared to histopathology. Conclusion: Cervicography by a nonphysician provider as an adjunct to HPV-based screening among WLWH in an LMIC setting is feasible and acceptable. However, low sensitivity for diagnosis of CIN2+ from cervical images by off-site expert colposcopists highlights the limitations of cervicography and need for a better triage test in this population. Citation Format: Chemtai Mungo, Cyrillus Ogollah, Jennifer Ambaka, Magdalene Randa, Anagha Guliam, Craig Cohen. Feasibility and Acceptability of Smartphone-Based Cervical Cancer Screening among HIV-Positive Women in Western Kenya [abstract]. In: Proceedings of the 9th Annual Symposium on Global Cancer Research; Global Cancer Research and Control: Looking Back and Charting a Path Forward; 2021 Mar 10-11. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2021;30(7 Suppl):Abstract nr 90.
Purpose: The World Health Organization (WHO) recommends human papillomavirus (HPV) as a primary screening test within "screen-and-treat" cervical cancer programs in low- and middle-income countries (LMICs). Following a positive test, two alternative strategies are endorsed within the single-visit approach. All HPV positive women can be offered immediate treatment, or visual inspection with acetic acid (VIA) is used to triage. Thus, we calculated the positive predictive value (PPV) of VIA for histologically confirmed CIN2+ among HPV-positive women living with HIV (WLWH). Methods: Between August 2019 and March 2020, as part of a clinical trial (NCT04191967) in western Kenya, high-risk HPV-positive WLWH age 25-65 years underwent VIA and colposcopy-directed biopsies regardless of VIA result. All women received treatment. The PPV of VIA for CIN2+ was determined. Results: Three hundred and sixty-six HPV-positive WLWH were evaluated during the study period. Mean age was 40.2 years (SD 8.5), median CD4 count was 420 (IQR 359), and 94.5% were virally suppressed. Seventy-four (20.2%) women had CIN2+ on histology (14 CIN2, 54 CIN3, six microinvasive carcinoma), of whom only 33 were also VIA-positive. The PPV of VIA for diagnosis of CIN2+ was 44.6% (95% CI 33.0 – 56.6) and was similar when limited to CIN3+. The PPV decreased with age, ranging from 72.7% (95% CI 54.5–86.7), to 24.2% (95% CI 11.1 – 42.3) to 3.0% (95% CI 0.1 – 15.8) among ages 30-39 years, 40-49 years, and 50 years and greater, respectively. Conclusions: While HPV testing has low specificity among WLWH, triage with VIA has a low positive predictive value for CIN2+ and would result in missed opportunities for treatment in this high-risk population. This highlights the need for more objective, affordable, and accessible triage tests, e.g. artificial intelligence-assisted cervicography or biomarkers of dysplasia to improve the PPV of the HPV-based screen-and-treat single-visit approach in LMICs. Citation Format: Chemtai Mungo, Cyrillus Ogollah, Jennifer Ambaka, Magdalene Randa, Jackton Omoto, Craig Cohen. To Triage or Not? Positive Predictive Value of Visual Inspection with Acetic Acid for Diagnosis of Cervical Intraepithelial Neoplasia Grade 2 or Worse (CIN2+) among HIV-Positive Women in a Low-Resource Setting [abstract]. In: Proceedings of the 9th Annual Symposium on Global Cancer Research; Global Cancer Research and Control: Looking Back and Charting a Path Forward; 2021 Mar 10-11. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2021;30(7 Suppl):Abstract nr 69.
PURPOSE In 2019, the World Health Organization (WHO) endorsed thermal ablation (TA) for use within “screen-and-treat” cervical cancer prevention programs in low- and middle-income countries (LMICs), including among women living with HIV (WLWH). We evaluated TA efficacy for treatment of biopsy-confirmed cervical intraepithelial neoplasia grades 2 and 3 (CIN2/3) among WLWH in western Kenya (ClinicalTrials.gov NCT04191967). METHODS Between August 2019 and November 2020, WLWH age 25-65 years underwent high-risk human papillomavirus (hrHPV) self-collection. hrHPV-positive women underwent colposcopy-directed biopsies, and thermal ablation treatment if eligible per WHO guidelines. Women with biopsy-confirmed CIN2/3 had colposcopy-directed biopsies at 12-months to determine treatment efficacy. RESULTS Sixty-eight hrHPV-positive WLWH with biopsy-confirmed CIN2/3 at baseline; 14 CIN2, 54 CIN3, underwent thermal ablation. Mean age and parity were 41.2 years and 4, respectively. The mean CD4 count was 473.98 cells/mm3 and 96.9% had HIV viral suppression. Fifty-eight women (83.8%) have been seen for a 12-month follow-up visit, and pathology results are available for 54 (79.4%). Of these, 35 (66.0%) had successful treatment, defined as biopsy-confirmed CIN1 or normal findings 12-months following treatment, while 18 (34.0%) had treatment failure - persistent biopsy-confirmed CIN2/3. Treatment failure was 23.1% 95% CI (13.0 to 45.9) and 37.5%, 95% CI (22.1 to 52.0) among women with CIN2 and CIN3 at baseline, respectively. CONCLUSION Hand-held thermal ablation devices are affordable, portable, easy to use, and hence highly scaleable within screen-and-treat programs in LMICs. However, our preliminary results, with rigorous disease status verification at both baseline and follow-up find higher than previously reported treatment failure rates for CIN3 among WLWH, a high-risk population for cervical cancer. If replicated by larger studies, this highlights a potential limitation of the current WHO cervical cancer elimination strategy, calling for better risk stratification in this population, and/or consideration of adjuvant therapy to prevent CIN2/3 recurrence following thermal ablation.
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