Official websites use. Share sensitive information only on official, secure websites. Correspondence to Dr Alexandra de Pokomandy; alexandra. 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.
The study is a double-blinded, placebo-controlled RCT. Volunteer gbMSM 18 years and older are randomly assigned to receive the treatment a self-applied anal microbicide gel with carrageenan or placebo a self-applied placebo gel. 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. Data will be analysed using intention-to-treat and per-protocol approaches with subgroup analyses by HIV status. Trial results will be disseminated through peer-reviewed publications and conference presentations.
First study to explore the efficacy of carrageenan as a topical microbicide for preventing anal human papillomavirus HPV acquisition in gay, bisexual and other men who have sex with men gbMSM. Randomised controlled trial design comparing carrageenan lubricant gel to placebo is optimal to evaluate the efficacy of carrageenan in gbMSM with and without HIV.
The proportion of incident infections that could be due to reactivation of previously acquired HPV types is unknown. Carrageenan, a gelling agent derived from red algae, is used as a stabiliser and emulsifier in food and cosmetic products. The primary objective is to evaluate the efficacy of carrageenan in reducing type-specific anal HPV incidence, that is, in preventing incident infections by HPV types undetected at baseline in sexually active gbMSM, overall and by HIV status.
