Safety and efficacy of the prepex male circumcision device: Results from pilot implementation studies in Mozambique, South Africa, and Zambia

Paul Feldblum, Neil Martinson, Bruce Bvulani, Noah Taruberekera, Mehebub Mahomed, Namwinga Chintu, Minja Milovanovic, Catherine Hart, Scott Billy, Edgar Necochea, Alick Samona, Miriam Mhazo, Debora Bossemeyer, Jaim Jou Lai, Limakatso Lebinai, Tigistu A. Ashengo, Lucinda MacAringue, Valentine Veena, Karin Hatzold

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)S43-S48
JournalJournal of Acquired Immune Deficiency Syndromes
Volume72
DOIs
StatePublished - 2016
Externally publishedYes

Keywords

  • Male circumcision
  • Mozambique
  • PrePex
  • Safety
  • South Africa
  • Zambia

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)

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