title: Safety, Feasibility, and Acceptability of the PrePex Device for Adult Male Circumcision in Malawi.
abstract: BACKGROUND
  Nonsurgical adult male circumcision devices present an alternative to surgery where health resources are limited. This study aimed to assess the safety, feasibility, and acceptability of the PrePex device for adult male circumcision in Malawi.
  
  
  METHODS
  A prospective single-arm cohort study was conducted at 3 sites (1 urban static, 1 rural static, 1 rural tent) in Malawi. Adverse event (AE) outcomes were stratified to include/exclude pain, and confidence intervals (CIs) were corrected for clinic-level clustering.
  
  
  RESULTS
  Among 935 men screened, 131 (14.0%) were not eligible, 13 (1.4%) withdrew before placement, and 791 (84.6%) received the device. Moderate and severe AEs totaled 7.1% including pain [95% CI: 3.4-14.7] and 4.0% excluding pain (95% CI: 2.6 to 6.4). Severe AEs included pain (n = 3), insufficient skin removal (n = 4), and early removal (n = 4). Among early removals, 1 had immediate surgical circumcision, 1 had surgery after 48 hours of observation, 1 declined surgery, and 1 did not return to our site although presented at a nearby clinic. More than half of men (51.9%) reported odor; however, few (2.2%) stated they would not recommend the device to others because of odor. Median levels of reported pain (scale, 1-10) were 2 (interquartile range, 2-4) during application and removal, and 0 (interquartile range, 0-2) at all other time points.
  
  
  CONCLUSIONS
  Severe AEs were rare and similar to other programs. Immediate provision of surgical services after displacement or early removal proved a challenge. Cases of insufficient skin removal were linked to poor technique, suggesting provider training requires reinforcement and supervision.
authors.affiliation: *Department of Global Health, University of Washington, Seattle, WA; †Department of Psychosocial and Community Health, University of Washington, Seattle, WA; ‡Health Services, US Centers for Disease Control and Prevention, Lilongwe, Malawi; §Banja La Mtsogolo, Blantyre, Malawi; ‖Médecin Sans Frontières, Nsanje, Malawi; ¶International Training and Education Center for Health, Lilongwe, Malawi; #Malawi Ministry of Health, Lilongwe, Malawi; **US Centers for Disease Control and Prevention, Atlanta, Georgia; and ††Jhpiego, An affiliate of Johns Hopkins University, Washington, DC.
authors.forename: Pamela K
authors.initials: PK
authors.lastname: Kohler
authors.forename: Beth A
authors.initials: BA
authors.lastname: Tippett Barr
authors.forename: Anderson
authors.initials: A
authors.lastname: Kangʼombe
authors.forename: Carola
authors.initials: C
authors.lastname: Hofstee
authors.forename: Franklin
authors.initials: F
authors.lastname: Kilembe
authors.forename: Sean
authors.initials: S
authors.lastname: Galagan
authors.forename: David
authors.initials: D
authors.lastname: Chilongozi
authors.forename: Dorothy
authors.initials: D
authors.lastname: Namate
authors.forename: Medson
authors.initials: M
authors.lastname: Machaya
authors.forename: Khuliena
authors.initials: K
authors.lastname: Kabwere
authors.forename: Mwawi
authors.initials: M
authors.lastname: Mwale
authors.forename: Wezi
authors.initials: W
authors.lastname: Msunguma
authors.forename: Jason
authors.initials: J
authors.lastname: Reed
authors.forename: Frank
authors.initials: F
authors.lastname: Chimbwandira
mesh_terms: D000293:Adolescent; D000328:Adult; D002944:Circumcision, Male / Q000009:adverse effects / Q000706:statistics & numerical data*; D005240:Feasibility Studies; D006801:Humans; D008295:Malawi; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010342:Patient Acceptance of Health Care; D017060:Patient Satisfaction; D011446:Prospective Studies; D055815:Young Adult