{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,13]],"date-time":"2026-01-13T15:03:51Z","timestamp":1768316631328,"version":"3.49.0"},"reference-count":49,"publisher":"BMJ","issue":"8","license":[{"start":{"date-parts":[[2020,8,11]],"date-time":"2020-08-11T00:00:00Z","timestamp":1597104000000},"content-version":"unspecified","delay-in-days":10,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2020,6,18]]},"published-print":{"date-parts":[[2020,8]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Human papillomavirus (HPV) is a causal agent of malignancies including cervical, vulvar, vaginal, penile, anal and oropharyngeal cancer, as well as benign conditions such as anogenital warts. HPV vaccination protects individuals against infections with the target HPV types and their clinical outcomes. However, little is known about the protection an immunised individual confers to their sexual partner or its impact on HPV transmission dynamics. In this context, the Transmission Reduction and Prevention with HPV vaccination (TRAP-HPV) study was designed to determine the efficacy of an HPV vaccine in reducing transmission of genital and oral HPV infection in sexual partners of vaccinated individuals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>The TRAP-HPV study is an ongoing randomised controlled trial among heterosexual couples living in Montreal, Canada. Sexually active couples, aged between 18 and 45 years, who have been in a relationship no longer than 6 months are considered eligible. Participants are independently randomised to receive either the intervention HPV vaccine, Gardasil 9, or a placebo hepatitis A vaccine, Avaxim, creating four vaccination groups among couples: intervention\u2013intervention, intervention\u2013placebo, placebo\u2013intervention and the placebo\u2013placebo. Participants provide genital (vaginal\/penile) and oral samples at baseline and five follow-up visits over a 1-year duration. Linear Array HPV genotyping is used to detect 36 HPV types. Cox proportional hazard regression models will be used to estimate the effect of vaccination on HPV transmission.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The TRAP-HPV study received ethical approval by institutional review boards McGill University, Concordia University and Centre Hospitalier de l\u2019Universit\u00e9 de Montr\u00e9al. Before enrolment, all participants provide informed written consent. Results will be published in peer-reviewed journals and presented at national and international conferences. The generated empirical evidence could be used in mathematical models of vaccination to inform policymakers in Canada and elsewhere.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial pre-results\" xlink:href=\"NCT01824537\">NCT01824537<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2020-039383","type":"journal-article","created":{"date-parts":[[2020,8,12]],"date-time":"2020-08-12T02:47:08Z","timestamp":1597200428000},"page":"e039383","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":11,"title":["Transmission reduction and prevention with HPV vaccination (TRAP-HPV) study protocol: a randomised controlled trial of the efficacy of HPV vaccination in preventing transmission of HPV infection in heterosexual couples"],"prefix":"10.1136","volume":"10","clinical-trial-number":[{"clinical-trial-number":"nct01824537","registry":"10.18810\/clinical-trials-gov","type":"preResults"}],"author":[{"given":"Aaron","family":"MacCosham","sequence":"first","affiliation":[{"name":"Division of Cancer Epidemiology, McGill University, Montreal, Quebec, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mariam","family":"El-Zein","sequence":"additional","affiliation":[{"name":"Division of Cancer Epidemiology, McGill University, Montreal, Quebec, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ann N","family":"Burchell","sequence":"additional","affiliation":[{"name":"Department of Family and Community Medicine and Centre for Research on Inner City Health, Li Ka Shing Knowledge Institute, St. Michael\u2019s Hospital, Unity Health Toronto, Toronto, Ontario, Canada"},{"name":"Department of Family and Community Medicine, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pierre-Paul","family":"Tellier","sequence":"additional","affiliation":[{"name":"Family Medicine, McGill University, Montreal, Quebec, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fran\u00e7ois","family":"Coutl\u00e9e","sequence":"additional","affiliation":[{"name":"Service de Microbiologie M\u00e9dicale et Service d\u2019Infectiologie, D\u00e9partements de M\u00e9decine et de M\u00e9decine de Laboratoire, Centre Hospitalier de L'Universite de Montreal, Montreal, Quebec, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4409-8084","authenticated-orcid":false,"given":"Eduardo L","family":"Franco","sequence":"additional","affiliation":[{"name":"Division of Cancer Epidemiology, McGill University, Montreal, Quebec, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2020,8,11]]},"reference":[{"key":"2025121602462234000_10.8.e039383.1","first-page":"468","article-title":"Human papillomaviruses","volume":"90","year":"2007","journal-title":"IARC Monogr. Eval. Carcinog. risks to humans"},{"key":"2025121602462234000_10.8.e039383.2","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1096-9896(199909)189:1<12::AID-PATH431>3.0.CO;2-F"},{"key":"2025121602462234000_10.8.e039383.3","doi-asserted-by":"crossref","first-page":"S52","DOI":"10.1016\/j.vaccine.2006.05.031","article-title":"Chapter 6: epidemiology and transmission dynamics of genital HPV infection","volume":"24 Suppl 3","author":"Burchell","year":"2006","journal-title":"Vaccine"},{"key":"2025121602462234000_10.8.e039383.4","doi-asserted-by":"publisher","DOI":"10.1158\/1055-9965.EPI-19-0618"},{"key":"2025121602462234000_10.8.e039383.5","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(04)17398-4"},{"key":"2025121602462234000_10.8.e039383.6","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa061760"},{"key":"2025121602462234000_10.8.e039383.7","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1405044"},{"key":"2025121602462234000_10.8.e039383.8","doi-asserted-by":"publisher","DOI":"10.1016\/j.ygyno.2007.07.076"},{"key":"2025121602462234000_10.8.e039383.9","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa021641"},{"key":"2025121602462234000_10.8.e039383.10","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(07)61416-0"},{"key":"2025121602462234000_10.8.e039383.11","first-page":"1501","article-title":"Spirit 2013 statement: defining standard protocol items for clinical trials","volume":"13","author":"Chan","year":"2013","journal-title":"Ann Intern Med"},{"key":"2025121602462234000_10.8.e039383.12","doi-asserted-by":"publisher","DOI":"10.2307\/350547"},{"key":"2025121602462234000_10.8.e039383.13","doi-asserted-by":"publisher","DOI":"10.1111\/j.1741-3737.2006.00284.x"},{"key":"2025121602462234000_10.8.e039383.14","first-page":"25","article-title":"Traduction fran\u00e7aise de l\u2019\u00c9chelle d\u2019ajustement dyadique [French translation of the Dyadic Adjustment Scale]","volume":"18","author":"Baillargeon","year":"1986","journal-title":"Rev Can des Sci du Comport"},{"key":"2025121602462234000_10.8.e039383.15","doi-asserted-by":"crossref","first-page":"959","DOI":"10.1128\/CDLI.12.8.959-969.2005","article-title":"Optimization and validation of a multiplexed Luminex assay to quantify antibodies to neutralizing epitopes on human papillomaviruses 6, 11, 16, and 18","volume":"12","author":"Dias","year":"2005","journal-title":"CVI"},{"key":"2025121602462234000_10.8.e039383.16","doi-asserted-by":"publisher","DOI":"10.1128\/CDLI.10.1.108-115.2003"},{"key":"2025121602462234000_10.8.e039383.17","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/djg107"},{"key":"2025121602462234000_10.8.e039383.18","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/kwf212"},{"key":"2025121602462234000_10.8.e039383.19","first-page":"95","article-title":"Evaluation of self-collected cervicovaginal cell samples for human papillomavirus testing by polymerase chain reaction","volume":"10","author":"Gravitt","year":"2001","journal-title":"Cancer Epidemiol Biomarkers Prev"},{"key":"2025121602462234000_10.8.e039383.20","doi-asserted-by":"publisher","DOI":"10.1001\/jama.283.1.81"},{"key":"2025121602462234000_10.8.e039383.21","doi-asserted-by":"publisher","DOI":"10.1067\/mjd.2002.122198"},{"key":"2025121602462234000_10.8.e039383.22","doi-asserted-by":"publisher","DOI":"10.1086\/381395"},{"key":"2025121602462234000_10.8.e039383.23","doi-asserted-by":"publisher","DOI":"10.1086\/368220"},{"key":"2025121602462234000_10.8.e039383.24","doi-asserted-by":"crossref","first-page":"492","DOI":"10.1158\/1055-9965.492.13.3","article-title":"Molecular quality of exfoliated cervical cells: implications for molecular epidemiology and biomarker discovery","volume":"13","author":"Habis","year":"2004","journal-title":"Cancer Epidemiol Biomarkers Prev"},{"key":"2025121602462234000_10.8.e039383.25","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00104-06"},{"key":"2025121602462234000_10.8.e039383.26","doi-asserted-by":"publisher","DOI":"10.1080\/00949657808810249"},{"key":"2025121602462234000_10.8.e039383.27","doi-asserted-by":"publisher","DOI":"10.1097\/OLQ.0b013e3181b35693"},{"key":"2025121602462234000_10.8.e039383.28","doi-asserted-by":"publisher","DOI":"10.1097\/EDE.0b013e3181c1e70b"},{"key":"2025121602462234000_10.8.e039383.29","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jir644"},{"key":"2025121602462234000_10.8.e039383.30","doi-asserted-by":"publisher","DOI":"10.1093\/biomet\/73.1.13"},{"key":"2025121602462234000_10.8.e039383.31","doi-asserted-by":"publisher","DOI":"10.1158\/1055-9965.EPI-09-0546"},{"key":"2025121602462234000_10.8.e039383.32","doi-asserted-by":"crossref","first-page":"2219","DOI":"10.1002\/sim.4780122307","article-title":"Use of spending functions for occasional or continuous monitoring of data in clinical trials","volume":"12","author":"Lan","year":"1993","journal-title":"Stat Med"},{"key":"2025121602462234000_10.8.e039383.33","doi-asserted-by":"publisher","DOI":"10.2307\/2530245"},{"key":"2025121602462234000_10.8.e039383.34","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jit018"},{"key":"2025121602462234000_10.8.e039383.35","doi-asserted-by":"publisher","DOI":"10.1016\/j.jinf.2013.03.009"},{"key":"2025121602462234000_10.8.e039383.36","doi-asserted-by":"publisher","DOI":"10.3201\/eid1406.070616.2"},{"key":"2025121602462234000_10.8.e039383.37","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jit615"},{"key":"2025121602462234000_10.8.e039383.38","doi-asserted-by":"crossref","first-page":"980","DOI":"10.1093\/infdis\/jiz224","article-title":"Prevalence, concordance, and transmission of human papillomavirus infection among heterosexual couples in Liuzhou, China: an observational perspective study","volume":"220","author":"Su","year":"2019","journal-title":"J Infect Dis"},{"key":"2025121602462234000_10.8.e039383.39","doi-asserted-by":"publisher","DOI":"10.1038\/srep08026"},{"key":"2025121602462234000_10.8.e039383.40","doi-asserted-by":"crossref","DOI":"10.2196\/11284","article-title":"Human papillomavirus infection and transmission among couples through heterosexual activity (Hitch) cohort study: protocol describing design, methods, and research goals","volume":"8","author":"El-Zein","year":"2019","journal-title":"JMIR Res Protoc"},{"key":"2025121602462234000_10.8.e039383.41","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2007.04.086"},{"key":"2025121602462234000_10.8.e039383.42","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/djh104"},{"key":"2025121602462234000_10.8.e039383.43","doi-asserted-by":"publisher","DOI":"10.1097\/00001648-200211000-00006"},{"key":"2025121602462234000_10.8.e039383.44","doi-asserted-by":"publisher","DOI":"10.1038\/sj.bjc.6604462"},{"key":"2025121602462234000_10.8.e039383.45","doi-asserted-by":"publisher","DOI":"10.3201\/eid1301.060438"},{"key":"2025121602462234000_10.8.e039383.46","doi-asserted-by":"publisher","DOI":"10.3201\/eid1011.040222"},{"key":"2025121602462234000_10.8.e039383.47","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jir285"},{"key":"2025121602462234000_10.8.e039383.48","doi-asserted-by":"crossref","first-page":"F3","DOI":"10.1016\/j.vaccine.2008.02.004","article-title":"Evolution of the health economics of cervical cancer vaccination","volume":"26 Suppl 5","author":"Ferko","year":"2008","journal-title":"Vaccine"},{"key":"2025121602462234000_10.8.e039383.49","doi-asserted-by":"publisher","DOI":"10.1038\/bjc.2011.185"}],"updated-by":[{"DOI":"10.1136\/bmjopen-2020-039383corr1","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2020,8,24]],"date-time":"2020-08-24T00:00:00Z","timestamp":1598227200000}}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2020-039383","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T10:46:31Z","timestamp":1765881991000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2020-039383"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,8]]},"references-count":49,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2020,8,11]]},"published-print":{"date-parts":[[2020,8]]}},"alternative-id":["10.1136\/bmjopen-2020-039383"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2020-039383","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,8]]}}}