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Abstract
Background:Fourteen countries in East and Southern Africa have engaged in national programs to accelerate the provision of voluntary medical male circumcision (VMMC) since 2007. Devices have the potential to accelerate VMMC programs by making the procedure easier, quicker, more efficient, and widely accessible.Methods:Pilot Implementation studies were conducted in Mozambique, South Africa, and Zambia. The primary objective of the studies was to assess the safety of PrePex device procedures when conducted by nurses and clinical officers in adults and adolescent males (13–17 years, South Africa only) with the following end points: number and grade of adverse events (AEs); pain-related AEs measured using visual analog score; device displacements/self-removals; time to complete wound healing; and procedure times for device placement and removal.Results:A total of 1401 participants (1318 adult and 83 adolescent males) were circumcised using the PrePex device across the 3 studies. Rates of moderate/severe AEs were low (1.0%; 2.0%; and 2.8%) in the studies in Mozambique, Zambia, and South Africa, respectively. Eight early self-removals of 1401 (0.6%) were observed, all required corrective surgery. High rates of moderate/severe pain-related AEs were recorded especially at device removal in South Africa (34.9%) and Mozambique (59.5%). Ninety percent of participants were healed at day 56 postplacement.Discussion:The study results from the 3 countries suggest that the implementation of the PrePex device using nonphysician health care workers is both safe and feasible, but better pain control at device removal needs to be put in place to increase the comfort of VMMC clients using the PrePex device.
Highlights
Fourteen countries in East and Southern Africa have engaged in national programs to accelerate the provision of voluntary medical male circumcision (VMMC) since 2007
The study results from the 3 countries suggest that the implementation of the PrePex device using nonphysician health care workers is both safe and feasible, but better pain control at device removal needs to be put in place to increase the comfort of VMMC clients using the PrePex device
The studies were funded by the Bill & Melinda Gates Foundation (BMGF) through Population Services International (PSI) in all sites excluding Mozambique where additional support was provided through the President’s Emergency Plan for AIDS Relief (PEPFAR) through the US Department of Health and Human Services and the US Centers for Disease Control and Prevention (CDC) under the terms of Cooperative Agreement Number U2GPS001542 to Jhpiego
Summary
Fourteen countries in East and Southern Africa have engaged in national programs to accelerate the provision of voluntary medical male circumcision (VMMC) since 2007. Devices have the potential to accelerate VMMC programs by making the procedure easier, quicker, more efficient, and widely accessible. Three randomized controlled trials have demonstrated that male circumcision reduces the risk of heterosexually acquired HIV infection in men by 60%.1–3. VMMC is a 1-time intervention resulting in lifelong protection from HIV infection in men. Male circumcision devices have the potential to accelerate VMMC programs by making the procedure easier, quicker, more efficient, and widely accessible.[6,7,8]
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