Grant: Project Grant - Priority Announcement: HIV/AIDS and STBBI

There are very little data on human papillomavirus (HPV) vaccination among the 18.8 million women living with HIV (WLWH) globally, who are a population most vulnerable to HPV and the resultant cervical cancer. Particularly, there are no data to date on whether or not less than three doses of the newest HPV vaccine, which protects against 9 types of HPV, can be used in WLWH. In fact, there is very little data on this vaccine in WLWH overall. It is critical to examine this vaccine in WLWH now because, in order to reach the World Health Organization's global goal of cervical cancer elimination, we must understand the role of various HPV prevention strategies in this important population including those like reducing the number of vaccine doses, which can drastically increase the feasibility of HPV vaccination programs globally. This randomized clinical trial will enrol WLWH aged 18-50 from across Canada who have not previously received any HPV vaccine. Participants will have a 50/50 chance of receiving 3 doses of the HPV vaccine that protects against 9 types of HPV at the usual timing of 0/2/6 months or over an expanded timeframe of 0/6/12 months. We will compare the immune response generated to two versus three doses of the vaccine and will follow participants for 2 years to examine the immune response to three doses of vaccine over time. This study, which builds upon our team's prior work on HPV vaccination in WLWH, will determine whether two doses of this HPV vaccine can be used in WLWH instead of three, and will examine additional aspects of HPV vaccination in WLWH including the immune response to three doses, vaccine safety, how well the vaccine protects against HPV infection, and attitudes towards self-collected HPV samples in this population. These data will inform global public health policy and programming and will inform the global strategy for cervical cancer elimination.