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Original research
Self-collection for high-risk HPV-RNA detection among HIV-seropositive and HIV-seronegative women engaged in sex work in Kenya
  1. Fan Lee1,
  2. Jessica Yasmine Islam2,
  3. Michael Musila Mutua3,4,
  4. Emmanuel Kabare3,4,
  5. Griffins Manguro5,
  6. Wairimu Waweru3,4,
  7. Kishor N Mandaliya6,
  8. Juma Shafi3,4,
  9. R Scott McClelland3,4,7,
  10. Jennifer S Smith8,9
  1. 1Obstetrics and Gynecology, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania, USA
  2. 2Cancer Epidemiology Program, H Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA
  3. 3Department of Medical Microbiology, University of Nairobi, Nairobi, Kenya
  4. 4Department of Medicine, University of Washington, Seattle, Washington, USA
  5. 5Ghent University Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium
  6. 6Pathcare Laboratories, Mombasa, Kenya
  7. 7Department of Global Health, University of Washington, Seattle, Washington, USA
  8. 8Department of Epidemiology, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
  9. 9The University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, USA
  1. Correspondence to Dr Fan Lee; fan.lee{at}jefferson.edu

Abstract

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.

  • screening
  • HIV
  • human papillomavirus
  • cervical intraepithelial neoplasia

Data availability statement

Data are available upon reasonable request.

https://doi.org/10.1136/sextrans-2024-056159

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    Data availability statement

    Data are available upon reasonable request.

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    Footnotes

    • Handling editor Jane S Hocking

    • Contributors FL performed data interpretation and analysis, designed tables/figures and led the writing of the manuscript. JYI jointly conceived the study, conducted literature search, performed data analysis and data interpretation, designed tables/figures and contributed to the writing of the manuscript. MMM designed the study protocol, led the data collection at Ganjoni Clinic in Kenya and commented on the manuscript. EK performed human papillomavirus messenger RNA laboratory testing and commented on the manuscript. GM co-designed the study protocol, co-led the data collection at Ganjoni Clinic in Kenya and commented on the manuscript. WW contributed to the design of the study protocol, led the data collection and commented on the manuscript. KNM led the pathology review and commented on the manuscript. JS led the data collection and commented on the manuscript. RSM jointly conceived the study, and gave input on data analysis and the writing of the manuscript. JSS jointly conceived the study, designed the study protocol and gave input on data analysis and the writing of the manuscript. JSS is the guarantor.

    • Funding Specimen collection and processing was supported by a grant from Hologic (Boston, Massachusetts, USA), and the UNC Gillings Innovation Laboratory through JSS. HPV self-collection kits were donated by Rovers Medical Devices (Amsterdam, The Netherlands). Trainee support for FL was provided by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (T32 HD075731) and Fogarty International Center (D43 TW009340). Infrastructure and logistical support for the Mombasa research site was received from the University of Washington & Fred Hutchinson Cancer Research Center for AIDS Research (NIH grant P30-AI27757).

    • Disclaimer The study funders were not involved in the collection, analysis and interpretation of data; in the writing of the report and in the decision to submit the article for publication.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.