Self-collection for high-risk HPV-RNA detection among HIV-seropositive and HIV-seronegative women engaged in sex work in Kenya.

Background: Evidence of self-collection human papillomavirus (HPV)-RNA testing in cervical cancer screening is limited among women with HIV (WHIV). Most studies are in low-risk patient populations in high-income countries. We examine the prevalence of high-risk HPV (hrHPV) using the APTIMA HPV-RNA assay on self-collected versus provider-collected specimens, and the associated risk factors for high-grade cervical intraepithelial neoplasia (CIN2/3) among women engaged in sex work in Kenya. Among WHIV, we examine the performance of both collection methods for the detection of CIN2/3.

Methods: Participants were aged ≥18 years, non-pregnant and had no previous treatment for cervical precancer. The screening process included self-collection of cervicovaginal samples using a Viba cytobrush (Rovers), provider-collected cervical samples, visual inspection with acetic acid (VIA) and Pap smear. The APTIMA HPV Assay (Hologic) was used to detect E6/E7 oncogene RNA of 14 hrHPV types in both self-collected and on provider-collected samples. Risk factors for CIN2/3 were determined via multivariable logistic regression. We estimated test characteristics for each screening method for CIN2/3 detection.

Results: A total of 400 women (194 WHIV, 206 women without HIV) underwent screening between 2013 and 2018, with 399 valid HPV results. WHIV had a higher prevalence of hrHPV by self-collection compared with women without HIV (44.0% vs 29.6%, p<0.05) and CIN2/3 (19.0% vs 9.7%, p<0.05). After adjusting for age and HIV status, hrHPV-positivity increased the risk of CIN2/3 by 13 to 20 times. Among WHIV, the sensitivity for CIN2/3 detection was similar between self-collection (85% (66-96)) and provider-collection (93% (76-99)), both of which were higher than the sensitivity of high-grade cytology (high-grade squamous intraepithelial lesion cut-off) (47% (95% CI 23 to 72)). The specificity for both collection methods (self: 66% (95% CI 57 to 75) and provider: 67% (95% CI 58 to 75)) was lower than cytology (85% (95% CI 78 to 91)).

Conclusion: Self-collection for HPV-RNA testing performed similarly to provider-collection among WHIV. For WHIV, while the higher sensitivity of HPV-RNA testing compared with cytology for the detection of clinically relevant cervical disease is important, the lower specificity supports the inclusion of a triage test in the screening algorithm.