Clinical Study Review

WHO prequalification of a male circumcision device includes review of the clinical data regarding the safety of the device when used by providers in male circumcision programmes for HIV prevention.

The WHO Technical Advisory Group on Innovations in Male Circumcision has recommended that the following pivotal clinical studies be conducted independently from the manufacturer in at least two countries representative of the intended use setting.

Clinical study – Phase 1 (randomized controlled trial)

This phase includes a comparative study (at least 100 patients) that compares the performance of the device with a standard surgical procedure in a randomized controlled trial. This trial needs to be performed by surgeons skilled and equipped to offer either method.

Clinical study – Phase 2 (field study)

This study phase also called field study, is a non-comparative field trial of the device in settings of intended use, with procedures performed by trained mid-level providers (non-physicians). A cohort study of at least 500 patients in each country is enrolled and followed up.