By Agwanda Saye
Men are now enrolling in the second phase of a study of the PrePex™ device for performing adult male circumcision after a planned review of the data from the first phase raised no safety concerns.
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. But this study, conducted by the Male Circumcision Consortium (MCC) in collaboration with the National AIDS/STI Control Programme (NASCOP) and the Nyanza Reproductive Health Society (NRHS), is the first to assess the safety and acceptability of PrePex-assisted adult male circumcision in routine clinical settings in Kenya.
“Our study will provide the information that the Ministry of Health (MOH) needs to decide whether to add PrePex to the national programme on voluntary medical male circumcision (VMMC),” says Dr. Peter Cherutich, NASCOP deputy head and head of HIV prevention, who is a co-investigator for the study.
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. Men ages 18 to 49 who sought VMMC services at the UNIM Research and Training Centre run by NRHS in Kisumu and consented to be in the study were circumcised by trained providers using the PrePex device.
Each man was scheduled to return after seven days to have the PrePex device removed and for additional follow-up visits after nine, 14, 28, 35 and 42 days.
Dr. Elijah Odoyo-June of UNIM reports that most of the men returned for all of their follow-up visits. Only two men missed any visits at all, and more than 97 percent of the scheduled visits were complete
Enrolment in the study has also proceeded smoothly. The first 50 participants were recruited within three weeks.
Now the study is enroling another 375 men at the UNIM Research and Training Centre and at dispensaries or health centres in Rachuonyo where VMMC 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,” explains co-principal investigator Paul Feldblum of FHI 360.
In addition to getting circumcised, all participants receive the package of HIV prevention services recommended by the Kenyan MOH, including HIV testing and counseling, screening and treatment for any sexually transmitted infection, condoms and instructions in how to use them, and counseling on HIV-risk reduction and safer sex.
The men participating in the second phase of the study are asked to return after seven days to have the device removed and the circumcision wound assessed, and then for a final assessment 42 days after the procedure. They are encouraged to contact a study clinician or come to the clinic at any time should they have problems or questions related to care of the wound.
The main objective of the study is to assess the safety of PrePex procedure by measuring rates of complications and side effects and comparing them to the rates seen with the conventional surgery.
The researchers will also examine a range of other service delivery issues, such as client satisfaction with the procedure, providers’ perceptions of ease of use, return for follow-up visits, time to wound healing, the training required to achieve proficiency in the PrePex procedure and the cost of the procedure. Results are expected by September 2013.
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.
Use of PrePex dramatically reduces the time needed to perform a male circumcision. The procedure requires no stitches, involves minimal bleeding and can usually be performed without injected anaesthesia. These advantages could make male circumcision more accessible and acceptable to adult and adolescent men. Disadvantages include the need to wear the device for a week and possibly a longer healing period.
Several PrePex studies have been conducted in Rwanda, including a randomised controlled trial that documented the safety of the procedure. A randomised trial has also been completed in Zimbabwe; the results have not yet been published.
The World Health Organization’s Technical Advisory Group on Innovations in Male Circumcision has endorsed the use of PrePex only in Rwanda based on the results of the studies there. The Kenya implementation study will show how well the device performs in a wider variety of settings.
The MCC consists of FHI 360 and the University of Illinois at Chicago, working closely with the NRHS. It is funded by a grant to FHI 360 from the Bill & Melinda Gates Foundation.