Bloodless circumcision procedure opens the way to HIV prevention in Rwanda

As three recent randomized control trials undertaken in Africa have shown, male circumcision can reduce risk of HIV transmission by 53-60%.  But sub-Saharan African countries will need to scale up voluntary male medical circumcision (VMMC) hugely if they are to achieve these preventative benefits.  (See our earlier blog: Costing the Scale-Up of Voluntary Male Medical Circumcision).  In these settings the availability and deployment of the necessary resources poses a great challenge.

The development of new medical technologies adapted to resource-limited settings may be the way to make such a scale-up achievable.  Last month saw the successful completion of safety and efficacy trials in Rwanda on a device – the Prepex – designed to achieve circumcision by non-surgical means.  This certainly brings Rwanda’s goal of circumcising 2 million men over the next two years a step closer (and with it the goal of reducing HIV transmission by a half); but is also good news for other sub-Saharan countries facing similar challenges.  Results of the three trials on the Prepex were presented to the 16th International  Conference on Aids and Sexually Transmitted Infections in Africa (ICASA) at Addis Ababa.  The importance of non-surgical circumcision can be imagined in a country with only 300 trained physicians for a population of 10 million, and 90% of them living in rural areas remote from surgical facilities. But such conditions are replicated in other sub-Saharan countries which share Rwanda’s ambition to achieve HIV reduction through circumcision, and the challenge which this poses for the availability and deployment of resources.

The device itself operates by controlled radial elastic pressure so as to cut off circulation to the foreskin distally.  The necrotic foreskin can be removed bloodlessly from 4 days after the fitting of the device.  The Prepex offers a number of advantages over surgical circumcision that are particularly relevant to resource-limited settings.  The Prepex device does not require anaesthetic or sutures, may consequently be deployed in non-sterile conditions by non-medically trained staff.  Total time required for the procedure is just over 8 minutes, as opposed to the 25-36 minutes required for surgical circumcision.

Of the three Prepex trials successfully undertaken in Rwanda, the first was a non-controlled study of the feasibility of the procedure in 55 adult males; the second was a randomized controlled study comparing the non-surgical Prepex with surgical male circumcision; the third set out to demonstrate that the procedure could be performed safely and effectively by nurses.

The only results as yet published (JAIDS (15th December 2011) relate to the first of these trials. Following the procedure the 55 subjects were monitored regularly for signs of bleeding, oedema and infection.  Levels of pain experienced at each stage of the procedure were assessed using VAS scores.  The paper makes detailed comparisons between the Prepex device and another circumcision devise – the Shang Ring.  The latter removes the live distal foreskin immediately after placement, and consequently requires anaesthesia and a sterile setting.

The Prepex procedure achieved complete circumcision in all cases with a median healing time of 21 days following removal of the device.  The only adverse event was a case of diffused oedema as a result of chronic urethritis from a belatedly reported STI.  This compares favourably with the six mild adverse events observed in a trial of 40 patients circumcised with the Shang Ring (M.A. Barone & F. Ndede et al., “The Shang Ring device for adult male circumcision: a proof of concept study in Kenya”, JAICS 2011;57: E7-E12).  The most serious issue with the Prepex device appears to be the experience of considerable pain during device removal (mean VAS score 5.4) which was not alleviated by paracetemol.

http://www.prepex.com/Scientific.aspx

Jean Paul Bitega, Agnes Binagwaho et al., “Safety and Efficacy of the PrePex Device for Rapid Scale-Up of Male Circumcision for HIV Prevention in Resource-Limited Settings”, JAIDS, Vol. 58, no. 5, December 15 2011

http://journals.lww.com/jaids/Fulltext/2011/12150/Safety_and_Efficacy_of_the_PrePex_Device_for_Rapid.16.aspx