Design and feasibility of a novel program of cervical screening in Nigeria: self-sampled HPV testing paired with visual triage

Abstract

Background Accelerated global control of cervical cancer would require primary prevention with human papillomavirus (HPV) vaccination in addition to novel screening program strategies that are simple, inexpensive, and effective. We present the feasibility and outcome of a community-based HPV self-sampled screening program. Methods In Ile Ife, Nigeria, 9406 women aged 30–49 years collected vaginal self-samples, which were tested for HPV in the local study laboratory using Hybrid Capture-2 (HC2) (Qiagen). HPV-positive women were referred to the colposcopy clinic. Gynecologist colposcopic impression dictated immediate management; biopsies were taken when definite acetowhitening was present to produce a histopathologic reference standard of precancer (and to determine final clinical management). Retrospective linkage to the medical records identified 442 of 9406 women living with HIV (WLWH). Results With self-sampling, it was possible to screen more than 100 women per day per clinic. Following an audio-visual presentation and in-person instructions, overall acceptability of self-sampling was very high (81.2% women preferring self-sampling over clinician collection). HPV positivity was found in 17.3% of women. Intensive follow-up contributed to 85.9% attendance at the colposcopy clinic. Of those referred, 8.2% were initially treated with thermal ablation and 5.6% with large loop excision of transformation zone (LLETZ). Full visibility of the squamocolumnar junction, necessary for optimal visual triage and ablation, declined from 68.5% at age 30 to 35.4% at age 49. CIN2+ and CIN3+ (CIN- Cervical intraepithelial neoplasia), including five cancers, were identified by histology in 5.9 and 3.2% of the HPV-positive women, respectively (0.9 and 0.5% of the total screening population), leading to additional treatment as indicated. The prevalences of HPV infection and CIN2+ were substantially higher (40.5 and 2.5%, respectively) among WLWH. Colposcopic impression led to over- and under-treatment compared to the histopathology reference standard. Conclusion A cervical cancer screening program using self-sampled HPV testing, with colposcopic immediate management of women positive for HPV, proved feasible in Nigeria. Based on the collected specimens and images, we are now evaluating the use of a combination of partial HPV typing and automated visual evaluation (AVE) of cervical images to improve the accuracy of the screening program.

A Framework for Cervical Cancer Elimination in Low-and-Middle-Income Countries: A Scoping Review and Roadmap for Interventions and Research Priorities

“…Devices which could be inserted by the women herself for remote visualization of the cervix are also being developed and tested ( 158 ). However, a large ( n = 9,406) ongoing study in Nigeria noted that the squamocolumnar junction where cancers arise was not fully visible for almost 64.6% of women by age 49 using enhanced visual assessment (MobileODT, Israel) ( 159 ). Challenges to adequate visualization of the cervix have pertinent implications for both ablative treatments and visual screening or triage efforts ( 159 ).…”

The development of “automated visual evaluation” for cervical cancer screening: The promise and challenges in adapting deep‐learning for clinical testing

“…For colposcopic biopsy to be sensitive, multiple biopsies of all F I G U R E 3 The AVE classification categories are expected to be consonant with the four biological distinct stages in the natural history and pathogenesis of cervical cancer. Reprinted with permission from Schiffman et al 21 ; Histopathology image source: Desai et al 20 [Color figure can be viewed at wileyonlinelibrary.com] visible lesions (based on turning white after application of vinegar, called acetowhitening) is necessary, rather than targeting of the most severe appearing lesion. Clinician colposcopic impressions, even when performed by experienced gynecologists, are subjective and variable in distinguishing precancer from benign HPV-related changes and "lookalike" conditions.…”

“…Without a quality check, AVE will provide a prediction for any image given to it as an input, including images not even recognizable as cervix and images with a completely obstructed region of interest (ROI) (ie, SCJ) (Figure 2B,C). 20,56 Therefore, a manual or automated gatekeeping mechanism should be in place to exclude poor-quality images from training and evaluation to minimize false predictions.…”

Moving towards a strategy to accelerate cervical cancer elimination in a high-burden city—Lessons learned from the Amazon city of Manaus, Brazil

“…HPV testing using a self-collection strategy is well-suited for high-volume screening campaigns and can even be conducted outside clinical settings, bringing screening closer to women in community locations [48,49]. The logistics of sample transportation and processing in laboratories are much easier compared with cytology, allowing for quicker processing and provision of results.…”