The PrePex device used in male circumcision is safe, say experts. The decision follows a three month study to assess the safety and acceptability of device-assisted adult male circumcision in routine clinical settings in Kenya.
The study conducted by the Male Circumcision Consortium, National Aids/STI Control Programme and the Nyanza Reproductive Health Society raised no safety concerns over the use of the device.
A committee of independent experts conducted the review and recommended continuing the study. The device has shown promise in clinical studies conducted in Rwanda and Zimbabwe.
“Our study will provide the information that the Health ministry needs to decide whether to add PrePex to the national programme on voluntary medical male circumcision,” said Peter Cherutich, NASCOP deputy head and head of HIV prevention.
The first phase of the study was designed as a “safety run-in,” with an analysis and independent review of the data on the first 50 participants after 42 days of follow-up.
Trained professionals used the PrePex devise on 18 to 49-year-old men who were circumcised at the UNIM Research and Training Centre in Kisumu and consented to be in the study.
Elijah Odoyo, a lead researcher in the study, said most of the men returned for all of their follow-up visits. Only two men did not go for follow-up visits while more than 97 per cent of the scheduled visits were completed.
The study is now enroling another 375 men at the UNIM Research and Training Centre and at health centres in Rachuonyo where voluntary medical male circumcision is provided on specific days by outreach teams.
“Both service delivery approaches—fixed and outreach—are important components of the Kenyan VMMC programme and will provide essential data on how the device might be integrated into ongoing services,” said co-principal investigator Paul Feldblum of FHI 360.
The PrePex device consists of an elastic mechanism that fits closely around an inner ring, clamping the foreskin and cutting off its blood supply. The foreskin then dries up and is removed after a week.