{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,21]],"date-time":"2026-02-21T08:01:08Z","timestamp":1771660868044,"version":"3.50.1"},"reference-count":35,"publisher":"BMJ","issue":"9","funder":[{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["KL2 RR024130"],"award-info":[{"award-number":["KL2 RR024130"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["P30-AI027763"],"award-info":[{"award-number":["P30-AI027763"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2016,7,13]]},"published-print":{"date-parts":[[2016,9]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>\n                      A biomarker with increased specificity for cervical dysplasia compared with human papillomavirus (HPV) testing would be an attractive option for cervical cancer screening among HIV-infected women in resource-limited settings. p16\n                      <jats:sup>INK4a<\/jats:sup>\n                      has been explored as a biomarker for screening in general populations.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>A 2-year cross-sectional study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>2 large HIV primary care clinics in western Kenya.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>1054 HIV-infected women in western Kenya undergoing cervical cancer screening as part of routine HIV care from October 2010 to November 2012.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Interventions<\/jats:title>\n                    <jats:p>\n                      Participants underwent p16\n                      <jats:sup>INK4a<\/jats:sup>\n                      specimen collection and colposcopy. Lesions with unsatisfactory colposcopy or suspicious for cervical intraepithelial neoplasia 2+ (CIN2+; including CIN2\/3 or invasive cervical cancer) were biopsied. Following biopsy, disease status was determined by histopathological diagnosis.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Primary and secondary outcome measures<\/jats:title>\n                    <jats:p>\n                      We measured the sensitivity, specificity and predictive values of p16\n                      <jats:sup>INK4a<\/jats:sup>\n                      ELISA for CIN2+ detection among HIV-infected women and compared them to the test characteristics of current screening methods used in general as well as HIV-infected populations.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Average p16\n                      <jats:sup>INK4a<\/jats:sup>\n                      concentration in cervical samples was 37.4\u2005U\/mL. After colposcopically directed biopsy, 127 (12%) women were determined to have CIN2+. Receiver operating characteristic analysis showed an area under the curve of 0.664 for p16\n                      <jats:sup>INK4a<\/jats:sup>\n                      to detect biopsy-proven CIN2+. At a p16\n                      <jats:sup>INK4a<\/jats:sup>\n                      cut-off level of 9\u2005U\/mL, sensitivity, specificity, positive and negative predictive values were 89.0%, 22.9%, 13.6% and 93.8%, respectively. The overall p16\n                      <jats:sup>INK4a<\/jats:sup>\n                      positivity at a cut-off level of 9\u2005U\/mL was 828 (78.6%) women. There were 325 (30.8%) cases of correct p16\n                      <jats:sup>INK4a<\/jats:sup>\n                      prediction to detect or rule out CIN2+, and 729 (69.2%) cases of incorrect p16\n                      <jats:sup>INK4a<\/jats:sup>\n                      prediction.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      p16\n                      <jats:sup>INK4a<\/jats:sup>\n                      ELISA did not perform well as a screening test for CIN2+ detection among HIV-infected women due to low specificity. Our study contributes to the ongoing search for a more specific alternative to HPV testing for CIN2+ detection.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2016-012547","type":"journal-article","created":{"date-parts":[[2016,9,13]],"date-time":"2016-09-13T20:48:52Z","timestamp":1473799732000},"page":"e012547","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":7,"title":["Performance of p16\n                    <sup>INK4a<\/sup>\n                    ELISA as a primary cervical cancer screening test among a large cohort of HIV-infected women in western Kenya: a 2-year cross-sectional study"],"prefix":"10.1136","volume":"6","author":[{"given":"Tara J","family":"Wu","sequence":"first","affiliation":[{"name":"School of Medicine, University of California San Francisco, San Francisco, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karen","family":"Smith-McCune","sequence":"additional","affiliation":[{"name":"Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Miriam","family":"Reuschenbach","sequence":"additional","affiliation":[{"name":"Department of Applied Tumor Biology, Clinical Cooperation Unit, Institute of Pathology, University of Heidelberg, German Cancer Research Cancer (DKFZ), Heidelberg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Magnus","family":"von Knebel Doeberitz","sequence":"additional","affiliation":[{"name":"Department of Applied Tumor Biology, Clinical Cooperation Unit, Institute of Pathology, University of Heidelberg, German Cancer Research Cancer (DKFZ), Heidelberg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"May","family":"Maloba","sequence":"additional","affiliation":[{"name":"Family AIDS Care and Education Services, Kenya Medical Research Institute, Kisumu, Kenya"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Megan J","family":"Huchko","sequence":"additional","affiliation":[{"name":"Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2016,9,13]]},"reference":[{"key":"2025121404311902000_6.9.e012547.1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0b013e31828177d7"},{"key":"2025121404311902000_6.9.e012547.2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199711063371903"},{"key":"2025121404311902000_6.9.e012547.3","doi-asserted-by":"publisher","DOI":"10.1097\/COH.0b013e32831a7246"},{"key":"2025121404311902000_6.9.e012547.4","doi-asserted-by":"publisher","DOI":"10.1006\/gyno.2001.6244"},{"key":"2025121404311902000_6.9.e012547.5","unstructured":"UNAIDS, The Joint United Nations Programme on HIV\/AIDS. 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