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

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...

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Autores principales: Okunade, Kehinde S., Badmos, Kabir B., Okoro, Austin C., Ademuyiwa, Iyabo Y., Oshodi, Yusuf A., Adejimi, Adebola A., Awolola, Nicholas A., Ozonu, Oluchi, Adelabu, Hameed, Olorunfemi, Gbenga, Akanmu, Alani S., Banjo, Adekunbiola A., Anorlu, Rose I., Berek, Jonathan S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9879465/
https://www.ncbi.nlm.nih.gov/pubmed/36701329
http://dx.doi.org/10.1371/journal.pone.0278077
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author Okunade, Kehinde S.
Badmos, Kabir B.
Okoro, Austin C.
Ademuyiwa, Iyabo Y.
Oshodi, Yusuf A.
Adejimi, Adebola A.
Awolola, Nicholas A.
Ozonu, Oluchi
Adelabu, Hameed
Olorunfemi, Gbenga
Akanmu, Alani S.
Banjo, Adekunbiola A.
Anorlu, Rose I.
Berek, Jonathan S.
author_facet Okunade, Kehinde S.
Badmos, Kabir B.
Okoro, Austin C.
Ademuyiwa, Iyabo Y.
Oshodi, Yusuf A.
Adejimi, Adebola A.
Awolola, Nicholas A.
Ozonu, Oluchi
Adelabu, Hameed
Olorunfemi, Gbenga
Akanmu, Alani S.
Banjo, Adekunbiola A.
Anorlu, Rose I.
Berek, Jonathan S.
author_sort Okunade, Kehinde S.
collection PubMed
description 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.
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spelling pubmed-98794652023-01-27 Comparative Assessment of p16/Ki-67 Dual Staining Technology for cervical cancer screening in women living with HIV (COMPASS-DUST)–Study protocol Okunade, Kehinde S. Badmos, Kabir B. Okoro, Austin C. Ademuyiwa, Iyabo Y. Oshodi, Yusuf A. Adejimi, Adebola A. Awolola, Nicholas A. Ozonu, Oluchi Adelabu, Hameed Olorunfemi, Gbenga Akanmu, Alani S. Banjo, Adekunbiola A. Anorlu, Rose I. Berek, Jonathan S. PLoS One Study Protocol 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. Public Library of Science 2023-01-26 /pmc/articles/PMC9879465/ /pubmed/36701329 http://dx.doi.org/10.1371/journal.pone.0278077 Text en © 2023 Okunade et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Study Protocol
Okunade, Kehinde S.
Badmos, Kabir B.
Okoro, Austin C.
Ademuyiwa, Iyabo Y.
Oshodi, Yusuf A.
Adejimi, Adebola A.
Awolola, Nicholas A.
Ozonu, Oluchi
Adelabu, Hameed
Olorunfemi, Gbenga
Akanmu, Alani S.
Banjo, Adekunbiola A.
Anorlu, Rose I.
Berek, Jonathan S.
Comparative Assessment of p16/Ki-67 Dual Staining Technology for cervical cancer screening in women living with HIV (COMPASS-DUST)–Study protocol
title Comparative Assessment of p16/Ki-67 Dual Staining Technology for cervical cancer screening in women living with HIV (COMPASS-DUST)–Study protocol
title_full Comparative Assessment of p16/Ki-67 Dual Staining Technology for cervical cancer screening in women living with HIV (COMPASS-DUST)–Study protocol
title_fullStr Comparative Assessment of p16/Ki-67 Dual Staining Technology for cervical cancer screening in women living with HIV (COMPASS-DUST)–Study protocol
title_full_unstemmed Comparative Assessment of p16/Ki-67 Dual Staining Technology for cervical cancer screening in women living with HIV (COMPASS-DUST)–Study protocol
title_short Comparative Assessment of p16/Ki-67 Dual Staining Technology for cervical cancer screening in women living with HIV (COMPASS-DUST)–Study protocol
title_sort comparative assessment of p16/ki-67 dual staining technology for cervical cancer screening in women living with hiv (compass-dust)–study protocol
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9879465/
https://www.ncbi.nlm.nih.gov/pubmed/36701329
http://dx.doi.org/10.1371/journal.pone.0278077
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