Comparative Assessment of p16/Ki-67 Dual Staining Technology for Cervical Cancer Screening in Women Living with HIV (COMPASS-DUST) - Study Protocol

Abstract

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. Molecular-based 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 p16/Ki-67 dual staining technology (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 Interest Statement

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.

Funding Statement

The lead author (KSO) received support for the research proposed in this publication from the National Cancer Institute and Fogarty International Center of the National Institutes of Health under Award Number K43TW011930. The content of this paper is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute, Fogarty International Center, or the National Institutes of Health.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Not Applicable

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Health Research Ethics Committees of the Lagos University Teaching Hospital with approval number ADM/DSCST/HREC/APP/5204 and the College of Medicine, University of Lagos with approval number CMUL/HREC/07/22/1075.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

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I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

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Data Availability

No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion.

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