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iThe World Health Organization has recommended that testing for high-risk human papillomavirus (HPV) (hrHPV) infection be incorporated into cervical screening programs in all settings worldwide. In many high-burden, low-income countries, it will not be feasible to achieve high cervical screening coverage using hrHPV assays that require clinician-collected samples. We conducted the first evaluation of self-collected vaginal specimens compared with clinician-collected cervical specimens for the detection of hrHPV infection using the Xpert HPV test. Women aged 30 to 54 years attending two well-woman clinics in Papua New Guinea were invited to participate and provided self-collected vaginal and clinician-collected cervical cytobrush specimens. Both specimen types were tested at the point of care by using the Xpert HPV test. T he recognition that infection with certain high-risk types of human papillomavirus (HPV) (hrHPV) is the primary cause of both cervical precancer and cancer led to the development of new technologies that would allow hrHPV DNA to be detected as part of population-based screening. These tests are more sensitive than cytology for the detection of high-grade cervical intraepithelial neoplasia (CIN) and invasive disease and have comparable specificities (1, 2), and their potential efficacy for populationbased cervical screening has been conclusively demonstrated in large-scale randomized trials and prospective studies (3-5). These findings led to recommendations in Europe, the United States, Australia, and other high-income settings for cervical screening programs to incorporate hrHPV DNA testing (2, 5-7). In this rapidly developing environment, and based on trials directly comparing HPV screening with cytology (3-5), the World Health Organization recently recommended that hrHPV testing be incorporated into cervical screening programs in low-and middle-income countries (LIMCs), particularly where cytological testing is not available and where visual inspection of the cervix after the application of acetic acid (VIA) or visual inspection after the application of Lugol's iodine (VILI) is the principal cervical screening strategy (8).The Xpert HPV test (GeneXpert; Cepheid, Sunnyvale, CA) is a newly available, rapid, fully automated, and easy-to-use nonbatch test for hrHPV infection that is as accurate as laboratory-based nucleic acid amplification tests (NAATs) (2, 9). Xpert HPV compared favorably to the FDA-approved Cobas 4800 (Roche Molecular Systems, Pleasanton, CA) and Hybrid Capture 2 (hc2; Qiagen, Germantown, MD) assays for the detection of hrHPV using clinician-collected cervical specimens (2, 9) and had sensitivity, specificity, and positive predictive values comparable to those of the above-mentioned assays for high-grade CIN (2). Disposable cartridges hold the reagents, primers, and probes for the simultaneous detection of 14 hrHPV types responsible for over 95% of cervical cancers ; a human reference gene; and an internal probe check control (PCC) (2). The system monitors the presence of inh...

The performance of different clinical screening algorithms comprising point-of-care HPV-DNA testing using self-collected vaginal (‘V’) specimens, and visual inspection of the cervix with acetic acid (VIA) was evaluated in Papua New Guinea.Women aged 30–59 years provided V specimens that were tested at point-of-care using the Xpert HPV Test (Cepheid, Sunnyvale, CA). A clinician-collected cervical (‘C’) specimen was then collected for point-of-care Xpert testing, and liquid-based cytology (LBC). Following this, VIA examination was conducted, blind to HPV test results, and ablative cervical cryotherapy provided if indicated. Detection of high-grade squamous intraepithelial lesion (HSIL) by LBC was the reference standard used to evaluate clinical screening algorithms.Of 1005 women, 36 had HSIL+. Xpert HPV Test performance using V specimens (sensitivity 91.7%, specificity 87.0%, PPV 34.0%, NPV 99.3%) was superior to VIA examination alone (51.5%, 81.4%, 17.5%, 95.6% respectively) in predicting underlying HSIL+. A screening algorithm comprising V specimen HPV testing followed by VIA examination had low sensitivity (45.5%) but comparable specificity, PPV and NPV to HPV testing alone (96.3%, 45.5%, 96.3% respectively).A ‘test-and-treat’ screening algorithm based on point-of-care HPV testing of V specimens had superior performance compared with either VIA examination alone, or a combined screening algorithm comprising HPV testing plus VIA.

Background Cervical cancer is the fourth most common cancer affecting women worldwide, with 85% of the burden estimated to occur among women in low and middle-income countries (LMICs). Recent developments in cervical cancer screening include a novel self-collection method for the detection of oncogenic HPV strains in the collected samples. The purpose of this review is to synthesise qualitative research on self-collection for HPV-based testing for cervical screening and identify strategies to increase acceptability and feasibility in different settings, to alleviate the burden of disease. Methods This review includes qualitative studies published between 1986 and 2020. A total of 10 databases were searched between August 2018 and May 2020 to identify qualitative studies focusing on the perspectives and experiences of self-collection for HPV-based cervical screening from the point of view of women, health care workers and other key stakeholders (i.e., policymakers). Two authors independently assessed studies for inclusion, quality, and framework thematic synthesis findings. The Socio-Ecological Model (SEM) was used to synthesize the primary studies. Results A total of 1889 publications were identified, of which 31 qualitative studies were included. Using an adapted version of SEM, 10 sub-themes were identified and classified under each of the adapted model’s constructs: (a) intrapersonal, (b) interpersonal, and (c) health systems/public policy. Some of the themes included under the intrapersonal (or individual) construct include the importance of self-efficacy, and values attributed to self-collection. Under the intrapersonal construct, the findings centre around the use of self-collection and its impact on social relationships. The last construct of health systems focuses on needs to ensure access to self-collection, the need for culturally sensitive programs to improve health literacy, and continuum of care. Conclusion This review presents the global qualitative evidence on self-collection for HPV-based testing and details potential strategies to address socio-cultural and structural barriers and facilitators to the use of self-collection. If addressed during the design of an HPV-based cervical cancer screening testing intervention program, these strategies could significantly increase the acceptability and feasibility of the intervention and lead to more effective and sustainable access to cervical screening services for women worldwide.