1.

Who funds the two adult male circumcision studies?

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), funds two adult male circumcision trials in Africa: one in Kenya and one in Uganda. The Canadian Institute of Health Research also supports the trial in Kenya.

2.

Where are the trials taking place?

The two clinical trials are being conducted in Rakai, Uganda, and Kisumu, Kenya.

3.

Who is conducting the studies?

The Ugandan study is led by Drs. Ron Gray and Maria Wawer of Johns Hopkins Bloomberg School of Public Health in Baltimore, and Drs. David Serwadda and Nelson Sewankambo of Makerere University in Kampala, Uganda.

The Kenyan trial, also known as the UNIM trial (Universities of Nairobi, Illinois and Manitoba trial), is conducted by a collaborative team of Kenyan, U.S. and Canadian researchers. They include Drs. Robert Bailey, University of Illinois at Chicago; Stephen Moses, University of Manitoba; J. Ndinya Achola, University of Nairobi; and Kwango Agot, UNIM.

4.

How are the studies designed?

Both trials recruited healthy, HIV-negative uncircumcised men who planned to remain near the study site for the duration of the trial. The trial in Uganda recruited men between 15 and 49 years old; the trial in Kenya recruited men between 18 and 24 years old.  Both trials are fully enrolled.

After an initial HIV screening and a medical exam, eligible men were assigned at random either to receive circumcision immediately or to wait two years before circumcision. All participants are closely followed for two years to collect important information and to check the HIV status of the volunteer. 
 
Participants in the Kenyan study are scheduled for six visits over the two-year follow-up, compared with four visits for the Ugandan trial participants. In addition to the study visits, men enrolled in the Kenyan trial are encouraged to receive all of their outpatient health care at the study clinics, which allows researchers to collect information on the safety of the procedure and the number of other sexually transmitted diseases the men have during follow-up.

5.

What are the objectives of the studies?

The primary objectives of these studies are to determine whether adult male circumcision 1) can be administered safely, and 2) reduce the risk of acquiring HIV infection through heterosexual contact.

6.

How many participants are involved?

The Ugandan study recruited 5,000 men since the trial began in August 2003; the Kenyan trial enrolled 2,784 participants since it opened in February 2002. 

7.

How was circumcision performed in the studies?

All circumcisions were performed in a surgical room with local anesthesia. The circumcision procedure used in the Kenyan trial was the foreskin clamp method. The Kenyan trial procedure took about 25 minutes and used stitches to control bleeding and improve incision closure. The circumcision procedure used in the Ugandan trial is known as the sleeve method and takes about 30 minutes. The Ugandan trial used cauterization of the blood vessels to control bleeding and stitches to close the incision. Both methods are commonly used throughout the world.

8.

When will the two trials be completed?

The trial in Uganda is currently scheduled to end in July 2007; the trial in Kenya is scheduled to end in September 2007.