Rationale: This study was designed to examine whether male circumcision is safe in HIV-positive men and men who do not know their status, and whether the procedure has an impact on rates of HIV transmission from circumcised, HIV-positive men to their partners.
Study question(s): This study enrolled HIV-positive men and men who did not wish to know their status, and randomized them to receive immediate or delayed circumcision. All of the participants received the standard prevention package (risk reduction counseling and condoms). Rates of adverse events and side effects were measured to examine whether they are comparable to those observed in HIV-negative men enrolled in a companion trial. Female partners of participants were also enrolled in the study to examine whether there is an impact on HIV transmission. The men and women were not enrolled as couples. They were recruited separately after being linked via data from a long-term cohort study conducted by Rakai Health Sciences Project.
Participants: At the time the trial was halted, enrollment was partially completed. The data analyzed to date reflect 922 men and 163 women.
Country: Uganda
Trial sponsors and collaborators: Bill & Melinda Gates Foundation, Johns Hopkins University, Rakai Health Sciences Project
When were results released? The trial stopped enrollment in December 2006. Circumcision of HIV-positive men did not reduce transmission of HIV to female partners, and men who resumed sex prior to wound healing were more likely to transmit HIV to their female partners. Results were announced in February 2008 and published in July 2009.
To learn more visit:
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2809%2960998-3/abstract
http://www.retroconference.org/2008/Abstracts/33461.htm
http://www.malecircumcision.org/