{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T18:02:57Z","timestamp":1772215377265,"version":"3.50.1"},"reference-count":36,"publisher":"Public Library of Science (PLoS)","issue":"1","license":[{"start":{"date-parts":[[2023,1,26]],"date-time":"2023-01-26T00:00:00Z","timestamp":1674691200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000061","name":"Fogarty International Center","doi-asserted-by":"publisher","award":["K43TW011930"],"award-info":[{"award-number":["K43TW011930"]}],"id":[{"id":"10.13039\/100000061","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:p>\n                    The risk of progression of low-grade (CIN1) to high-grade cervical intraepithelial neoplasia (CIN2\/3) is 3\u20135 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\u2013p16\/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 (\n                    <jats:italic>Phase 1<\/jats:italic>\n                    ) to enrol n = 1,123 sexually active WLHIV aged 25\u201365 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 (\n                    <jats:italic>Phase 2<\/jats:italic>\n                    ) will be conducted by enrolling all the WLHIV who are diagnosed as having low-grade CIN (CIN1) in\n                    <jats:italic>Phase 1<\/jats:italic>\n                    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.\n                  <\/jats:p>","DOI":"10.1371\/journal.pone.0278077","type":"journal-article","created":{"date-parts":[[2023,1,26]],"date-time":"2023-01-26T13:37:37Z","timestamp":1674740257000},"page":"e0278077","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":5,"title":["Comparative Assessment of p16\/Ki-67 Dual Staining Technology for cervical cancer screening in women living with HIV (COMPASS-DUST)\u2013Study protocol"],"prefix":"10.1371","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0957-7389","authenticated-orcid":true,"given":"Kehinde S.","family":"Okunade","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kabir B.","family":"Badmos","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Austin C.","family":"Okoro","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Iyabo Y.","family":"Ademuyiwa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yusuf A.","family":"Oshodi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adebola A.","family":"Adejimi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicholas A.","family":"Awolola","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Oluchi","family":"Ozonu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1834-6291","authenticated-orcid":true,"given":"Hameed","family":"Adelabu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gbenga","family":"Olorunfemi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7424-6060","authenticated-orcid":true,"given":"Alani S.","family":"Akanmu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adekunbiola A.","family":"Banjo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rose I.","family":"Anorlu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jonathan S.","family":"Berek","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2023,1,26]]},"reference":[{"issue":"3","key":"pone.0278077.ref001","doi-asserted-by":"crossref","first-page":"209","DOI":"10.3322\/caac.21660","article-title":"Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries","volume":"71","author":"H Sung","year":"2021","journal-title":"CA Cancer J Clin"},{"issue":"4","key":"pone.0278077.ref002","doi-asserted-by":"crossref","first-page":"505","DOI":"10.1001\/jamaoncol.2015.0735","article-title":"The Global Burden of Cancer 2013","volume":"1","author":"Global Burden of Disease Cancer Collaboration","year":"2015","journal-title":"JAMA Oncol"},{"key":"pone.0278077.ref003","article-title":"Centers for Disease Control and Prevention Idiopathic CD4+. From the Centers for Disease Control and Prevention. 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults","author":"DK Smith","year":"1993"},{"key":"pone.0278077.ref004","volume-title":"AIDS epidemic update.","author":"World Health Organisation","year":"2004"},{"key":"pone.0278077.ref005","first-page":"602","volume-title":"Journal of Obstetrics and Gynaecology","author":"KS Okunade","year":"2020"},{"issue":"6","key":"pone.0278077.ref006","doi-asserted-by":"crossref","first-page":"545","DOI":"10.1097\/CEJ.0b013e3282f75ea1","article-title":"HIV, human papillomavirus, and cervical neoplasia and cancer in the era of highly active antiretroviral therapy","volume":"17","author":"H de Vuyst","year":"2008","journal-title":"Eur J Cancer Prev"},{"issue":"18","key":"pone.0278077.ref007","doi-asserted-by":"crossref","first-page":"2337","DOI":"10.1097\/01.aids.0000253361.63578.14","article-title":"HPV and HIV Study Group. Human papillomavirus types among women infected with HIV: a meta-analysis","volume":"20","author":"GM Clifford","year":"2006","journal-title":"AIDS"},{"key":"pone.0278077.ref008","first-page":"18","article-title":"A description of HIV prevalence trends in Nigeria from 2001 to 2010: what is the progress, where is the problem?","volume":"1","author":"A Bashorun","year":"2014","journal-title":"Pan Afr Med J"},{"key":"pone.0278077.ref009","doi-asserted-by":"crossref","first-page":"101","DOI":"10.1016\/j.gore.2017.07.009","article-title":"Cervical cancer control in HIV-infected women: Past, present and future","volume":"21","author":"RG Ghebre","year":"2017","journal-title":"Gynecol Oncol Rep"},{"key":"pone.0278077.ref010","author":"TD Moon","year":"2012","journal-title":"Implementation of cervical cancer screening using visual inspection with acetic acid in rural Mozambique: successes and challenges using HIV care and treatment programme investments in Zamb\u00e9 zia Province"},{"key":"pone.0278077.ref011","author":"WHO","year":"2020","journal-title":"Global strategy to accelerate the elimination of cervical cancer as a public health problem [Internet]"},{"key":"pone.0278077.ref012","author":"World Health Organisation","year":"2020","journal-title":"Costing the National Strategic Plan on Prevention and Control of Cervical Cancer: Nigeria"},{"key":"pone.0278077.ref013","doi-asserted-by":"crossref","DOI":"10.1097\/01.aids.0000432472.92120.1b","article-title":"Comparing Papanicolau smear, visual inspection with acetic acid and human papillomavirus cervical cancer screening methods among HIV-positive women by immune status and antiretroviral therapy","author":"MH Chung","year":"2013"},{"key":"pone.0278077.ref014","doi-asserted-by":"crossref","first-page":"1823","DOI":"10.2147\/RMHP.S296914","article-title":"An Overview of HPV Screening Tests to Improve Access to Cervical Cancer Screening Amongst Underserved Populations: From Development to Implementation","volume":"15","author":"KS Okunade","year":"2022","journal-title":"Risk Manag Healthc Policy [Internet]."},{"key":"pone.0278077.ref015","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0053494","article-title":"Validation of Cervical Cancer Screening Methods in HIV Positive Women from Johannesburg South Africa","volume":"8","author":"C Firnhaber","year":"2013","journal-title":"PLoS ONE"},{"issue":"1","key":"pone.0278077.ref016","doi-asserted-by":"crossref","first-page":"127","DOI":"10.1002\/ijc.29353","article-title":"Cervical cancer screening in sub-Saharan Africa: A randomized trial of VIA versus cytology for triage of HPV-positive women","volume":"137","author":"J Bigoni","year":"2015","journal-title":"Int J Cancer"},{"issue":"6","key":"pone.0278077.ref017","doi-asserted-by":"crossref","first-page":"235","DOI":"10.1258\/1356262011928635","article-title":"Limitations of the cervical smear test as a method of detecting women at risk of cervical cancer","volume":"7","author":"D. Coleman","year":"2001","journal-title":"Clin Risk"},{"key":"pone.0278077.ref018","doi-asserted-by":"crossref","article-title":"Cervical surveillance in HIV-positive women: a genitourinary medicine clinic experience","author":"FW Ibrahim","DOI":"10.1783\/147118909787931735"},{"key":"pone.0278077.ref019","doi-asserted-by":"crossref","first-page":"651","DOI":"10.1086\/605292","article-title":"Primary care guidelines for the management of persons infected with human immunodeficiency virus: 2009 update by the HIV medicine Association of the Infectious Diseases Society of America","volume":"49","author":"JA Aberg","year":"2009","journal-title":"Clinical Infectious Diseases [Internet]."},{"issue":"5","key":"pone.0278077.ref020","doi-asserted-by":"crossref","first-page":"463","DOI":"10.1097\/00126334-200108150-00007","article-title":"Screening for cervical cancer in HIV-infected women receiving care in the United States","volume":"27","author":"MD Stein","year":"2001","journal-title":"J Acquir Immune Defic Syndr"},{"issue":"5","key":"pone.0278077.ref021","doi-asserted-by":"crossref","first-page":"550","DOI":"10.1097\/01.qai.0000245884.66509.7a","article-title":"Frequency of Gynecologic Follow-Up and Cervical Cancer Screening in the Swiss HIV Cohort Study","volume":"43","author":"O Keiser","year":"2006","journal-title":"JAIDS Journal of Acquired Immune Deficiency Syndromes"},{"issue":"12","key":"pone.0278077.ref022","doi-asserted-by":"crossref","first-page":"2654","DOI":"10.7150\/jca.32743","article-title":"Application of p16\/Ki-67 dual-staining cytology in cervical cancers","volume":"10","author":"Y Li","year":"2019","journal-title":"J Cancer [Internet]."},{"key":"pone.0278077.ref023","doi-asserted-by":"crossref","first-page":"388","DOI":"10.1002\/ijc.26017","article-title":"Evaluation of cervical cone biopsies for coexpression of p16 INK4a and Ki-67 in epithelial cells","author":"M Reuschenbach","year":"2012","journal-title":"Int J Cancer"},{"issue":"3","key":"pone.0278077.ref024","doi-asserted-by":"crossref","first-page":"505","DOI":"10.1016\/j.ygyno.2011.02.033","article-title":"Triaging Pap cytology negative, HPV positive cervical cancer screening results with p16\/Ki-67 Dual-stained cytology","volume":"121","author":"KU Petry","year":"2011","journal-title":"Gynecol Oncol"},{"key":"pone.0278077.ref025","author":"J Ordi","journal-title":"Usefulness of p16\/Ki67 Immunostaining in the Triage of Women Referred to Colposcopy"},{"key":"pone.0278077.ref026","doi-asserted-by":"crossref","first-page":"870","DOI":"10.1038\/modpathol.2016.80","article-title":"p16\/Ki-67 dual-stained cytology for detecting cervical (pre)cancer in a HPV-positive gynecologic outpatient population","volume":"29","author":"R Luttmer","year":"2016","journal-title":"Modern Pathology [Internet]."},{"issue":"16","key":"pone.0278077.ref027","doi-asserted-by":"crossref","first-page":"21181","DOI":"10.18632\/oncotarget.8307","article-title":"Evaluation of p16\/Ki-67 dual staining in detection of cervical precancer and cancers: a multicenter study in China","volume":"7","author":"LL Yu","year":"2016","journal-title":"Oncotarget"},{"issue":"5","key":"pone.0278077.ref028","doi-asserted-by":"crossref","first-page":"321","DOI":"10.3322\/caac.21628","article-title":"Cervical cancer screening for individuals at average risk: 2020 guideline update from the American Cancer Society","volume":"70","author":"ETH Fontham","year":"2020","journal-title":"CA Cancer J Clin"},{"issue":"2","key":"pone.0278077.ref029","doi-asserted-by":"crossref","first-page":"172","DOI":"10.1016\/j.ygyno.2014.03.008","article-title":"Liquid-based cytology and human papillomavirus testing: A pooled analysis using the data from 13 population-based cervical cancer screening studies from China","volume":"133","author":"Q jing Pan","year":"2014","journal-title":"Gynecol Oncol"},{"key":"pone.0278077.ref030","first-page":"28","article-title":"Prevalence and risk factors for genital high-risk human papillomavirus infection among women attending the outpatient clinics of a university teaching hospital in Lagos","author":"KS Okunade","year":"2017","journal-title":"Nigeria. Pan African Medical Journal"},{"key":"pone.0278077.ref031","author":"World Health Organisation","year":"2013","journal-title":"WHO guidelines for screening and treatment of precancerous lesions for cervical cancer prevention"},{"key":"pone.0278077.ref032","author":"R Sankaranarayanan","year":"2003","journal-title":"World Health Organization-International Agency for Research on Cancer (IARC) [Internet]"},{"key":"pone.0278077.ref033","author":"RB Perkins","year":"2020","journal-title":"2019 ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors ASCCP Risk-Based Management Consensus Guidelines Committee"},{"issue":"3","key":"pone.0278077.ref034","doi-asserted-by":"crossref","first-page":"292","DOI":"10.1016\/j.jogc.2018.06.021","article-title":"Post-Colposcopy Management and Progression Predictors of Biopsy-Proven CIN1 in Women Under 25 Years","volume":"41","author":"DL Loopik","year":"2019","journal-title":"Journal of Obstetrics and Gynaecology Canada"},{"issue":"5","key":"pone.0278077.ref035","doi-asserted-by":"crossref","first-page":"271","DOI":"10.1002\/cncy.21521","article-title":"The Pap test and Bethesda 2014","volume":"123","author":"R Nayar","year":"2015","journal-title":"Cancer Cytopathol"},{"issue":"4","key":"pone.0278077.ref036","doi-asserted-by":"crossref","first-page":"317","DOI":"10.1037\/1082-989X.6.4.317","article-title":"The use of multiple imputation for the analysis of missing data","volume":"6","author":"S Sinharay","year":"2001","journal-title":"Psychol Methods"}],"container-title":["PLOS ONE"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0278077","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,1,26]],"date-time":"2023-01-26T13:38:11Z","timestamp":1674740291000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0278077"}},"subtitle":[],"editor":[{"given":"Richard","family":"Ali","sequence":"first","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2023,1,26]]},"references-count":36,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2023,1,26]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0278077","relation":{"has-preprint":[{"id-type":"doi","id":"10.1101\/2022.11.10.22282170","asserted-by":"object"}]},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,1,26]]}}}