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Study of male circumcision device informs policy in Kenya

July 22, 2014 —

In May 2013, a small plastic device known as PrePex became the first device for adult male circumcision to be prequalified by the World Health Organization, based on studies in Rwanda, Uganda and Zimbabwe.

Prequalification means that the device meets international standards, an action that paves the way for ministries of health to consider using it to provide voluntary medical male circumcision (VMMC) for HIV prevention. But, ministries of health need to assess local data to determine if PrePex-assisted male circumcision is a safe, acceptable and feasible complement to the conventional surgical procedure in their own countries. 

To provide data on PrePex, FHI 360 and its partners conducted a study titled, Safety, Effectiveness and Acceptability of the PrePex Device for Adult Male Circumcision in Kenya. The results of the study — the first to assess PrePex-assisted male circumcision in routine health care settings in Kenya — were published May 1, 2014, in the online journal PLoS ONE. 

The PrePex study was conducted in the Nyanza region of Kenya, which was also the site of one of the three pivotal clinical trials that provided conclusive evidence that circumcision reduced men’s risk of becoming infected with HIV through vaginal sex by about 60 percent.

FHI 360 and its partner in the Male Circumcision Consortium (MCC), the University of Illinois at Chicago, conducted the study in collaboration with the National AIDS and STI Control Programme (NASCOP) and the Nyanza Reproductive Health Society. The study involved 427 men ages 15–49 who sought VMMC services, consented to participate in the PrePex study and had the device placed.

The results show that PrePex is an effective and well-accepted method for adult male circumcision in routine service delivery in Kenya. The 5.9 percent rate of complications and side effects was higher than the rates seen in other PrePex studies — perhaps because the first 50 men in this study received intensive follow-up — but all were easily resolved with medical care.

The study also provided important insights that will inform program planning, training of providers and counseling of VMMC clients in Kenya.

“Kenya plans to introduce the PrePex device in several phases, beginning with active surveillance of the first 1,000 clients to monitor safety as we roll out the new procedure,” says Dr. Githuka George, NASCOP’s program manager for VMMC. “The results of the study influenced our decision to take this approach, and they are guiding our planning for PrePex introduction and scale-up.”