Design:

An open-label demonstration project to evaluate the safety and effectiveness of the PrePex device for male circumcision in routine Kenyan service delivery sites.

Population:

425 adult men aged 18 to 49 years voluntarily seeking medical male circumcision.

Duration:

Approximately 2 months of recruitment plus 42 days of scheduled follow-up per participant; total expected study duration of approximately 4 months in the field.

Primary Objective:

To measure rates of moderate and severe adverse events during routine service delivery for PrePex circumcision procedures.

Primary Endpoint:

The incidence of moderate and severe adverse events in routine service delivery settings.

Secondary Objectives:

Sites:

The secondary objectives of this research study are to:

• Evaluate the acceptability of PrePex procedures among clients and providers in Kenya
• Determine the time to complete healing after a PrePex procedure
• Determine training needed for proficiency including usefulness of a penis/foreskin training model
• Determine costs of PrePex training and service delivery
• Document proportion of men ineligible for circumcision with PrePex
• Document proportion of men who do not return for removal at 7 days and level of effort and outcomes needed for their active follow-up
• Compare outcomes and acceptability in fixed sites versus those served by mobile teams.

Fixed clinics with on-site trained staff and sites served by trained mobile teams currently providing routine male circumcision services and able to recruit a total of 425 men within approximately 2 months.