AIDSImpact.com:: - Santa Fe, USA 2011

Abstract #372 - Development and feasibility: Surgical and non-surgical concepts for delivery of adult male circumcision
Authors: Presenting Author: Mr. Scott Ulrich - Battelle
Additional Authors: Mr. Reade Harpham,
Aim: The goal of this project was to assess the feasibility of and develop new concepts for a low-cost, easy-to-train male circumcision (MC) device or method for implementation particularly targeting low resource settings.
Method / Issue: A review of adult male circumcision devices was conducted. Screening criteria were generated to aid in the evaluation and development of concepts for low-cost, easy-to-train male circumcision devices or methods.
Results / Comments: Criteria deemed important for devices and methods were: protection of glans, positioning of foreskin, guide for and control of tissue removal, hemostasis, easy to train/use, low AE rate, acceptable cosmetic result, low cost, sterile. 20 existing devices were identified and 10 were evaluated using the screening criteria. No candidate devices fully met the desired requirements. The task analysis, and device concept generation activities, confirmed proper hemostasis and wound closure would be critical in the successful implementation of any device or modified surgical method. Lessons Learned: Of the existing devices reviewed, and device concepts developed, ligature/necrosing ring concepts had the most potential to meet this need. The advantage of these devices is simplicity and providing for a bloodless procedure. However, due to possible issues related to patient/clinician acceptance and potential for complications during a patient erection, these concepts need further development and testing. Based on these conclusions, two paths for further study were recommended. A prototype of a ligature/necrosing ring concept should be evaluated by physicians and patients. This evaluation should encompass a study of patient comfort and acceptability, ease of use, and the pros/cons of a bloodless procedure.
Discussion: Next Steps: Prior to making decisions about these devices, opinions from qualified medical practitioners regarding the potential for infection or other risks to the patient are needed. In addition, after development of devices, safety and efficacy trials will be needed. Contextual observational research examining device use should focus on determining: 1) Basic Needs (basic requirements of the device), 2) Performance Needs (factors increasing or decreasing satisfaction during implementation), and 3) Unexpected Needs (unspoken or unanticipated needs of clinicians/patients), especially documenting forseeable misuse (FMU). Due to the range of needs (patient, provider), and necessity of achieving hemostatis and proper wound closure, a single device solution may not be practical for adult MC in SSA. Currently the guided forceps procedure has been simplified with task shifting and the MOVE model, but could be improved with alternative technologies for hemostasis and wound closure. In addition, a bloodless non-surgical option has been developed based on recommendations, and is currently in safety and efficacy trials in Rwanda and Zimbabwe. A three phase trial in Zimbabwe will test: 1) safety of the non-surgical device; 2) compare device and surgical circumcisions; and 3) document implementation in primary care settings. Demand creation and usability research will drive recommendations for improving device and surgical circumcisions increasing the chances of successful national roll-out of MC programs.
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