Lubricant Investigation in Men to Inhibit Transmission of HPV Infection (LIMIT-HPV): design and methods for a randomised controlled trial
Introduction Gay, bisexual and other men who have sex with men (gbMSM) have an increased risk of human papillomavirus (HPV) infection and HPV-associated diseases, such as anal cancer and anogenital warts. A carrageenan-based lubricant could prevent HPV infection, thereby reducing the disease burden...
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| Main Authors: | , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2020-03-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/3/e035113.full |
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| author | François Coutlée Julie Guenoun Cassandra Laurie Mariam El-Zein Joseph Tota Pierre-Paul Tellier Alexandra de Pokomandy Allita Rodrigues Natalia Morykon Raphaela Rodrigues Sheila Boutenm Samantha Shapiro Roger Leblanc Benoit Trottier Christina de Castro Karène Proulx-Boucher Guillaume Theriault Eduardo L Franco |
| author_facet | François Coutlée Julie Guenoun Cassandra Laurie Mariam El-Zein Joseph Tota Pierre-Paul Tellier Alexandra de Pokomandy Allita Rodrigues Natalia Morykon Raphaela Rodrigues Sheila Boutenm Samantha Shapiro Roger Leblanc Benoit Trottier Christina de Castro Karène Proulx-Boucher Guillaume Theriault Eduardo L Franco |
| author_sort | François Coutlée |
| collection | DOAJ |
| description | Introduction Gay, bisexual and other men who have sex with men (gbMSM) have an increased risk of human papillomavirus (HPV) infection and HPV-associated diseases, such as anal cancer and anogenital warts. A carrageenan-based lubricant could prevent HPV infection, thereby reducing the disease burden in this population. This paper describes the protocol for the Lubricant Investigation in Men to Inhibit Transmission of HPV Infection (LIMIT-HPV) study, an ongoing randomised controlled trial (RCT), evaluating efficacy of a carrageenan-based personal lubricant in reducing type-specific anal HPV incidence and prevalence among sexually active gbMSM, efficacy by HIV status, safety and tolerability of the gel and participant adherence to the intervention.Methods and analysis The study is a double-blinded, placebo-controlled RCT. Volunteer gbMSM 18 years and older are randomly assigned 1:1 to receive the treatment (a self-applied anal microbicide gel with carrageenan) or placebo (a self-applied placebo gel). At each visit, computerised questionnaires are used to collect data on sociodemographic and clinical variables, lifestyle, sexual behaviour and the gels’ safety and tolerability. At baseline and each follow-up visit (months 1, 2, 3, 6, 9 and 12), nurses collect anal specimens tested for 36 HPV types (linear array assay). HIV status is determined at baseline and 12 months. The primary outcome is incidence of type-specific anal HPV infection(s) undetected at baseline. Secondary outcomes are prevalence of type-specific anal HPV infection, safety, tolerability and adherence. We aim to recruit 380 participants to attain the study’s objectives. Data will be analysed using intention-to-treat and per-protocol approaches with subgroup analyses by HIV status.Ethics and dissemination Ethics approval was obtained by the Research Ethics Boards of McGill University, the McGill University Health Centre, Concordia University and Centre Hospitalier de l’Université de Montréal. Trial results will be disseminated through peer-reviewed publications and conference presentations.Trial registration number NCT02354144. |
| format | Article |
| id | doaj-art-e9b9f6c1e3f74f6eac9f57336491dd38 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-03-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-e9b9f6c1e3f74f6eac9f57336491dd382024-12-06T00:15:10ZengBMJ Publishing GroupBMJ Open2044-60552020-03-0110310.1136/bmjopen-2019-035113Lubricant Investigation in Men to Inhibit Transmission of HPV Infection (LIMIT-HPV): design and methods for a randomised controlled trialFrançois Coutlée0Julie GuenounCassandra Laurie1Mariam El-Zein2Joseph Tota3Pierre-Paul Tellier4Alexandra de Pokomandy5Allita RodriguesNatalia MorykonRaphaela RodriguesSheila BoutenmSamantha ShapiroRoger LeblancBenoit TrottierChristina de CastroKarène Proulx-BoucherGuillaume TheriaultEduardo L Franco6Hôpital Notre-Dame du CHUM, Montréal, Québec, CanadaDivision of Cancer Epidemiology, McGill University, Montreal, Quebec, CanadaDivision of Cancer Epidemiology, McGill University, Montreal, Quebec, CanadaDivision of Cancer Epidemiology, McGill University, Montreal, Quebec, CanadaDepartment of Family Medicine, McGill University, Montreal, Quebec, CanadaChronic Viral Illness Service, McGill University Health Centre, Montreal, Quebec, CanadaDivision of Cancer Epidemiology, McGill University, Montreal, Quebec, CanadaIntroduction Gay, bisexual and other men who have sex with men (gbMSM) have an increased risk of human papillomavirus (HPV) infection and HPV-associated diseases, such as anal cancer and anogenital warts. A carrageenan-based lubricant could prevent HPV infection, thereby reducing the disease burden in this population. This paper describes the protocol for the Lubricant Investigation in Men to Inhibit Transmission of HPV Infection (LIMIT-HPV) study, an ongoing randomised controlled trial (RCT), evaluating efficacy of a carrageenan-based personal lubricant in reducing type-specific anal HPV incidence and prevalence among sexually active gbMSM, efficacy by HIV status, safety and tolerability of the gel and participant adherence to the intervention.Methods and analysis The study is a double-blinded, placebo-controlled RCT. Volunteer gbMSM 18 years and older are randomly assigned 1:1 to receive the treatment (a self-applied anal microbicide gel with carrageenan) or placebo (a self-applied placebo gel). At each visit, computerised questionnaires are used to collect data on sociodemographic and clinical variables, lifestyle, sexual behaviour and the gels’ safety and tolerability. At baseline and each follow-up visit (months 1, 2, 3, 6, 9 and 12), nurses collect anal specimens tested for 36 HPV types (linear array assay). HIV status is determined at baseline and 12 months. The primary outcome is incidence of type-specific anal HPV infection(s) undetected at baseline. Secondary outcomes are prevalence of type-specific anal HPV infection, safety, tolerability and adherence. We aim to recruit 380 participants to attain the study’s objectives. Data will be analysed using intention-to-treat and per-protocol approaches with subgroup analyses by HIV status.Ethics and dissemination Ethics approval was obtained by the Research Ethics Boards of McGill University, the McGill University Health Centre, Concordia University and Centre Hospitalier de l’Université de Montréal. Trial results will be disseminated through peer-reviewed publications and conference presentations.Trial registration number NCT02354144.https://bmjopen.bmj.com/content/10/3/e035113.full |
| spellingShingle | François Coutlée Julie Guenoun Cassandra Laurie Mariam El-Zein Joseph Tota Pierre-Paul Tellier Alexandra de Pokomandy Allita Rodrigues Natalia Morykon Raphaela Rodrigues Sheila Boutenm Samantha Shapiro Roger Leblanc Benoit Trottier Christina de Castro Karène Proulx-Boucher Guillaume Theriault Eduardo L Franco Lubricant Investigation in Men to Inhibit Transmission of HPV Infection (LIMIT-HPV): design and methods for a randomised controlled trial BMJ Open |
| title | Lubricant Investigation in Men to Inhibit Transmission of HPV Infection (LIMIT-HPV): design and methods for a randomised controlled trial |
| title_full | Lubricant Investigation in Men to Inhibit Transmission of HPV Infection (LIMIT-HPV): design and methods for a randomised controlled trial |
| title_fullStr | Lubricant Investigation in Men to Inhibit Transmission of HPV Infection (LIMIT-HPV): design and methods for a randomised controlled trial |
| title_full_unstemmed | Lubricant Investigation in Men to Inhibit Transmission of HPV Infection (LIMIT-HPV): design and methods for a randomised controlled trial |
| title_short | Lubricant Investigation in Men to Inhibit Transmission of HPV Infection (LIMIT-HPV): design and methods for a randomised controlled trial |
| title_sort | lubricant investigation in men to inhibit transmission of hpv infection limit hpv design and methods for a randomised controlled trial |
| url | https://bmjopen.bmj.com/content/10/3/e035113.full |
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