Clearing high risk HPV among men who have sex with men study

Men who have sex with men (MSM) living with HIV have a high prevalence and incidence of anal high-risk human papillomavirus (hrHPV) and anal cancer. Imiquimod cream is a treatment for anogenital warts caused by HPV. Between April 2018 and June 2020, we conducted the Clearing High Risk HPV Among Men who have sex with Men Pilot (CHAMP). This trial was registered at the Australian New Zealand Clinical Trials Registry ACTRN12617001355369.

The CHAMP study aimed to examine the tolerability of using imiquimod cream inside the anal canal. The participants were MSM aged 18 years or older, living with HIV, who tested positive for anal hrHPV at Melbourne Sexual Health Centre.

The CHAMP study involved 27 study participants. Study participants applied imiquimod inside and around their anus:

• Three times per week for 16 weeks (period one) and then
• Once per week for a further 48 weeks (period two)

Participants completed regular surveys to measure:

• how tolerable they found the medication
• whether they were able to apply the medication at the recommended schedule

We found that imiquimod use at three times per week caused adverse symptoms including irritation, itching and tenderness. Adverse symptoms caused participants to temporarily stop imiquimod use.

18 participants continued to period two. We found that imiquimod application once a week was well tolerated over 48 weeks. Participants reported no adverse symptoms that caused an interruption to treatment.