A Model for the Roll-Out of Comprehensive Adult Male Circumcision Services in African Low-Income Settings of High HIV Incidence: The ANRS 12126 Bophelo Pele Project

Bertrand Auvert and colleagues describe the large-scale roll-out of adult male circumcision through a program in South Africa

Piloting PrePex for Adult and Adolescent Male Circumcision in South Africa--Pain Is an Issue.

The World Health Organisation and the Joint United Nations Programme on HIV/AIDS have recommended the scale-up of Medical Male Circumcision (MMC) in countries with high HIV and low MMC prevalence. PrePex device circumcision is proposed as an alternate method for scaling up MMC.Evaluate safety and feasibility of PrePex in South Africa.A multisite prospective cohort PrePex study in adults and adolescents at three MMC clinics. Participants were followed-up 8 times, up to 56 days after PrePex placement.In total, 398 PrePex circumcisions were performed (315 adults and 83 adolescents) their median ages were 26 (IQR: 22-30) and 16 years (IQR: 15-17), respectively. The median time for device placement across both groups was 6 minutes (IQR: 5-9) with the leading PrePex sizes being B (30%) and C (35%) for adults (18-45 years), and A (31%) and B (38%) for adolescents (14-17 years). Additional sizes (size 12-20) were rarely used, even in the younger age group. Pain of device application was minimal but that of removal was severe. However, described pain abated rapidly and almost no pain was reported 1 hour after removal. The Adverse Events rate were experienced by 2.7% (11/398) of all participants, three of which were serious (2 displacements and 1 self-removal requiring prompt surgery). None of the Adverse Events required hospitalization. The majority of participants returned to work within a day of device placement.Our study shows that PrePex is a safe MMC method, for males 14 years and above. PrePex circumcision had a similar adverse event rate to that reported for surgical MMC, but device removal caused high levels of pain, which subsided rapidly

Baseline Characteristics of PrePex Participants.

<p>Baseline Characteristics of PrePex Participants.</p

Pain during PrePex procedure.

<p>Adult and adolescent participants had little or no pain during the placement procedure. However, during the removal procedure they experienced moderate to severe pain which abated rapidly and virtually no pain was reported 1 hour after removal.</p

Flow chart of total PrePex participants assessed, screened and enrolled.

<p>A Total of 454 participants received information and 21 refused to participate. Among the 433 participants that were assessed for eligibility 35 (24 adults and 11 adolescents) were not suitable therefore a total of 398 (315 adults and 83 adolescents) participants were enrolled. We observed 8 adverse events in adults and 3 in adolescents.</p

Kaplan Meier Survival Analysis of time to healing after application by adults and Adolescents.

<p>At the day 42 (post-application) review, 15% (39/263) adults and 27% (19/70) adolescents were healed. Of the 171 adults who were assessed on day 56 review, 164 (96%) were considered healed. For adolescents, 91% (32/35) were healed on day 56 review.</p