Comparative Assessment of p16/Ki-67 Dual Staining Technology for cervical cancer screening in women living with HIV (COMPASS-DUST)-Study protocol.

Autor: Okunade KS; Department of Obstetrics & Gynaecology, College of Medicine, University of Lagos, Lagos, Nigeria.; Department of Obstetrics & Gynaecology, Lagos University Teaching Hospital, Lagos, Nigeria.; Center for Clinical Trial, Research, and Implementation science (CCTRIS), College of Medicine, University of Lagos, Lagos, Nigeria., Badmos KB; Department of Anatomic and Molecular Pathology, College of Medicine, University of Lagos, Lagos, Nigeria., Okoro AC; Department of Obstetrics & Gynaecology, Lagos University Teaching Hospital, Lagos, Nigeria., Ademuyiwa IY; Department of Nursing Science, College of Medicine, University of Lagos, Lagos, Nigeria., Oshodi YA; Department of Obstetrics & Gynaecology, Lagos State University College of Medicine, Lagos, Nigeria., Adejimi AA; Department of Community Health & Primary Care, College of Medicine, University of Lagos, Lagos, Nigeria., Awolola NA; Department of Anatomic and Molecular Pathology, College of Medicine, University of Lagos, Lagos, Nigeria., Ozonu O; Department of Obstetrics & Gynaecology, Lagos University Teaching Hospital, Lagos, Nigeria., Adelabu H; Center for Clinical Trial, Research, and Implementation science (CCTRIS), College of Medicine, University of Lagos, Lagos, Nigeria., Olorunfemi G; Division of Epidemiology and Biostatistics, School of Public Health, University of Witwatersrand, Johannesburg, South Africa., Akanmu AS; Department of Haematology & Blood Transfusion, College of Medicine, University of Lagos, Lagos, Nigeria., Banjo AA; Department of Anatomic and Molecular Pathology, College of Medicine, University of Lagos, Lagos, Nigeria., Anorlu RI; Department of Obstetrics & Gynaecology, College of Medicine, University of Lagos, Lagos, Nigeria.; Department of Obstetrics & Gynaecology, Lagos University Teaching Hospital, Lagos, Nigeria., Berek JS; Department of Obstetrics & Gynaecology, Stanford University School of Medicine, Stanford, United States of America.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2023 Jan 26; Vol. 18 (1), pp. e0278077. Date of Electronic Publication: 2023 Jan 26 (Print Publication: 2023).
DOI: 10.1371/journal.pone.0278077
Abstrakt: The risk of progression of low-grade (CIN1) to high-grade cervical intraepithelial neoplasia (CIN2/3) is 3-5 times higher for women living with HIV (WLHIV) than for HIV-negative women. Evidence suggests that the current cervical cancer screening methods perform less effectively in WLHIV. An emerging screening method-p16/Ki-67 dual staining technology (DUST) is a safe and rapid assay that could be used to detect CIN2/3 with higher sensitivity and specificity. The study in this protocol will evaluate the performance of DUST in cervical cancer screening among WLHIV. We will conduct an intra-participant comparative study (Phase 1) to enrol n = 1,123 sexually active WLHIV aged 25-65 years at two accredited adult HIV treatment centres in Lagos, Nigeria to compare the performance of DUST to the currently used screening methods (Pap smear, hr-HPV DNA, or VIA testing) in detecting high-grade CIN and cancer (CIN2+). Subsequently, a prospective cohort study (Phase 2) will be conducted by enrolling all the WLHIV who are diagnosed as having low-grade CIN (CIN1) in Phase 1 for a 6-monthly follow-up for 2 years to detect the persistence and progression of CIN1 to CIN2+. The findings of this study may provide evidence of the existence of a better performance screening method for the primary and triage detection of CIN2+ in WLHIV. It may also demonstrate that this high-performance test can improve the long-term predictive accuracy of screening by extending the intervals between evaluations and thus decrease the overall cost and increase screening uptake and follow-up compliance in WLHIV.
Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: KSO and GO are both editorial board members of PLoS One. This does not alter our adherence to PLOS ONE policies on sharing data and materials.
(Copyright: © 2023 Okunade et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
Databáze: MEDLINE
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