Adverse events profile of PrePex a non-surgical device for adult male circumcision in a Ugandan urban setting.

BACKGROUND: Safe Male Circumcision is a proven approach for partial HIV prevention. Several sub Saharan African countries have plans to reach a prevalence of 80% of their adult males circumcised by 2015. These targets require out of ordinary organization, demand creation, timely execution and perhaps the use of SMC devices. OBJECTIVE: To profile Adverse Events rate and acceptance of PrePex, a non surgical device for adult male circumcision. METHODS: A prospective study, conducted at International Hospital Kampala, Uganda, between August and October 2012. Ethical approval was obtained from Uganda National Council of Science and Technology. RESULTS: Of 1,040 men received to undergo SMC, 678 opted for PrePex, 36 were excluded at an initial physical examination screening. 642 were enrolled and consented, and another 17 were excluded before device placement. 625 underwent the procedure. Average age was 24 years (± 7). Twelve moderate AEs occurred among 10 participants 12/625, (1.9%). These were all reversible. Five had device displacement, one had an everted foreskin; five had bleeding after the device was removed and one had voiding difficulties. The majority (279 out of 300) of men interviewed complained of some pain within the week of placement. Mean pain score at device placement (using visual analogue scale) was 0.5, at device removal 4.5 and within 2 min of removal the pain score was 1.4. Over 70% of the devices were placed and removed by non-physician clinicians. Presented with a choice, 60% of men chose PrePex over surgical SMC. Close to 90% would recommend the device to their friends. Odour from the necrotic skin was a concern. Removals done 1-2 days earlier than day 7 were beneficial and conferred no extra risk. CONCLUSION: AEs of a moderate or severe nature associated with PrePex were low and reversible. PrePex is feasible for mass safe male circumcision scaling up.

Mass safe male circumcision: early lessons from a Ugandan urban site - a case study.

INTRODUCTION: It has been proven in several randomized clinical trials that HIV transmission from female to male is reduced by 60% and more among circumcised males. The national target for Uganda by 2015 is to circumcise 4.2 million adult males, an unprecedented number requiring a pragmatic approach and effective model(s) to deliver this target. The objective of the study was to describe early lessons learnt at a start up of a mass safe male circumcision (SMC) program in an urban Ugandan site, implemented through task shifting and a private public partnership approach. METHODS: A case study of an urban SMC site in Uganda's capital, Kampala with a catchment population of approximately 0.8 million adult males aged between 15 and 49 years. Client enrollment was voluntary; mobilization was by word of mouth and through the media. Non Physician clinicians (NPC) carried out the majority of the SMCs. The SMC and voluntary counseling and testing (VCT), adverse events (AE) management and follow up were done as per set national guidelines. The supervision was by a public and private service provider. All clients were consented. RESULTS: A total of 3000 males were circumcised in 27 days spread over four months. The AE rate was 2.1% all AEs were mild and reversible. No deaths occurred. The work rate was 111 SMCs per day. There was sufficient demand for SMC despite minimal mobilization effort. The bulk of the SMC work was successfully carried out by the NPCs. CONCLUSION: Private Public Partnership and task shifting approaches were successful at the start up phase and we anticipate will be feasible for the scale up.