AIDSImpact.com:: - Santa Fe, USA 2011

Abstract #371 - Integrating non-surgical male circumcision into the Rwanda national MC roll-out plan
Authors: Presenting Author: Dr MUTABAZI Vincent - MINISTRY OF HEALTH
Additional Authors:
Aim: Major obstacles to adult MC in most sub-Saharan countries include lack of medical infrastructure and trained health professionals to perform the numbers of MCs planned. A Phase I trial of the PrePex device, requiring no surgery, sutures or anesthesia, was carried out. Testing of the PrePex device began in March 2010. Safety and efficacy of the device was validated in prior studies in Rwanda. This study, launched in February 2011, was meant to directly compare the PrePex device with one of the WHO approved methods of surgical circumcision, as a final step before defining the national MC scale up strategy
Method / Issue: The Rwandan National Ethics Committee approved the study to be conducted in the Nyamata district hospital. 179 adult male subjects ages 21 to 54 were screened and then randomly divided into two unbalanced study arms; one for surgical circumcision (60 subjects) and the other to have a circumcision performed by the PrePex device (119 subjects). The primary factor for comparison was the total procedural time of the circumcision using the PrePex device and one of the WHO approved methods of surgical circumcision,. Secondary factors included: preparation time and adverse events (AE). Follow-up appointments were scheduled for eight weeks post-removal (nine weeks total study duration
Results / Comments: All 179 subjects completed the circumcision and follow up stages. One hundred percent (100%) of the subjects in both arms achieved complete circumcision, with the glans fully exposed. Total procedural, preparation times and related adverse events are summarized below. The PrePex arm had 119 subjects compared to 60 subjects in the surgical arm. Average procedure times for PrePex and surgical arms were three minutes and ten seconds and fifteen minutes and thirty eight seconds respectively. Average preparation times for PrePex and surgical arms were three minutes and seven seconds and eight minutes and forty seconds respectively. The prepex arm had zero related adverse events while the surgical arm had one.
Discussion: Male circumcision performed with the PrePex device demonstrated significant superiority over surgical circumcision in a number of factors: procedure and preparation time, as well as a lower rate of Adverse Eventss and no device related incidents. Safety and efficacy of PrePex for male circumcision was demonstrated without any anesthesia, bleeding, sutures or sterile settings (standard consultation room). The device was officially approved for use in Rwanda. PrePex has the potential to facilitate rapid MC scale-up programs for HIV prevention, an imminent need in Sub Saharan Africa. The Rwanda government is now training health care workers to perform the procedure, while assessing the cost effectiveness, scalability training requirements and administrative infrastructure that will enable scaling up to achieve 2 million circumcisions in 2 years.
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