A double-blind, randomized, placebo-controlled trial to evaluate the ability to recruit and retain HIV-1 uninfected key populations from Nairobi by enrolment into a licensed HBV vaccine study

The success of any HIV prevention trial depends on the identification of a suitably large population of persons at high risk of HIV seroincidence that is willing to participate in the trial (Seage et al 2001). Studies in Kenya have demonstrated that men who have sex with men (MSM) and female sex workers (FSW) are at disproportionately high risk of HIV infection (Sanders et al 2007, McKinnon et al 2013). The purpose of this study is to evaluate if FSW and men who have sex with men (MSM) who sell sex (MSM-SW) are willing to participate in a simulated vaccine clinical trial. The trial is designed to mirror the procedures of an actual HIV vaccine trial but will use a registered hepatitis B vaccine as a proxy. This will enable assessment of volunteer compliance with protocol procedures while identifying potential barriers to participation in an actual vaccine trial. Retention of study volunteers is of critical importance in randomized clinical trials and this study will determine retention rates in this mixed cohort of MSM-SWand FSW.<br><br>