About: 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

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About: 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 Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : covidontheweb.inria.fr associated with source document(s)

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has 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
Creator	Li, Ka
Source	PMC
abstract	INTRODUCTION: 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. METHODS AND ANALYSIS: 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–intervention, intervention–placebo, placebo–intervention and the placebo–placebo. 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. ETHICS AND DISSEMINATION: The TRAP-HPV study received ethical approval by institutional review boards McGill University, Concordia University and Centre Hospitalier de l’Université de Montréal. 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. TRIAL REGISTRATION NUMBER: NCT01824537.
has issue date	2020-08-11(xsd:dateTime)
bibo:doi	10.1136/bmjopen-2020-039383
bibo:pmid	32788190
has license	cc-by-nc
sha1sum (hex)	b0ca7bd6e529244ae76158bcdcc2c70af64fe024
schema:url	https://doi.org/10.1136/bmjopen-2020-039383
resource representing a document's 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
has PubMed Central identifier	PMC7422656
has PubMed identifier	32788190
schema:publication	BMJ Open
resource representing a document's body	covid:b0ca7bd6e529244ae76158bcdcc2c70af64fe024#body_text
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