Abstract

Objective:To assess participant experiences and perceptions of removal pain and odor associated with the PrePex device procedure.Methods:We analyzed data from a PrePex device pilot implementation study of 802 male participants aged 18–49 years at 2 clinics in Botswana, 2013. Study staff administered survey questions on device-related odor and assessed pain using visual analog scale scores categorized as no pain (0), mild (1–4), moderate (5–7), or severe pain (8–10).Results:Mean participant age was 27.7 (range = 18–48) years. Of the 802 participants, 751 (94%) reported to have noticed an unusual or unpleasant odor while wearing the device. Of these, 193 (26%) participants tried something to combat the odor. A total of 84 (10%) participants reported no pain, 655 (82%) mild pain, 48 (6%) moderate pain, and 15 (2%) severe pain at 2 minutes after device removal. Pain reports at 15 minutes after removal were 553 (69%) no pain, 247 (31%) mild pain, and 2 (0.25%) moderate pain, with no report of severe pain at this time point. Of 740 participants interviewed on day 42 after device placement, 678 (92%) were satisfied with the procedure and 681 (92%) would recommend it to another man considering circumcision, including 488 (66%) who would recommend it strongly.Conclusions:An unusual or unpleasant odor while wearing the PrePex device and mild self-limiting pain at device removal were common, but overall, these did neither seem to impair satisfaction nor deter participants from recommending PrePex to others, which could suggest good prospects for uptake of the device in this setting.

Highlights

  • The HIV prevention role of male circumcision has been demonstrated in several observational studies[1,2] and 3 landmark clinical trials.[3,4,5] The World Health Organization and Joint United Nations Programme on HIV/AIDS endorsed Voluntary Medical Male Circumcision (VMMC) for HIV prevention in 2007.6 Increasing data from longer posttrial follow-up studies show continued HIV protection.[7,8,9] Botswana faces an estimated 18.5% HIV prevalence in the general population, with male circumcision prevalence estimated at 24% in the 10- to 64-year age group.[10]

  • The PrePex device is one of a few adult male circumcision devices currently being studied in Africa

  • A key difference from other current adult devices is that necrotizing foreskin tissue distal to the PrePex device components remains in situ until device removal 5–7 days after placement

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Summary

Introduction

The HIV prevention role of male circumcision has been demonstrated in several observational studies[1,2] and 3 landmark clinical trials.[3,4,5] The World Health Organization and Joint United Nations Programme on HIV/AIDS endorsed Voluntary Medical Male Circumcision (VMMC) for HIV prevention in 2007.6 Increasing data from longer posttrial follow-up studies show continued HIV protection.[7,8,9] Botswana faces an estimated 18.5% HIV prevalence in the general population, with male circumcision prevalence estimated at 24% in the 10- to 64-year age group.[10]. To increase demand and ease supply of VMMC, the Botswana Ministry of Health considered introduction of PrePex device and assessed it for safety and acceptability in 2013. The PrePex device is one of a few adult male circumcision devices currently being studied in Africa. The device uses radial compression to cause ischemic necrosis of the foreskin. A key difference from other current adult devices is that necrotizing foreskin tissue distal to the PrePex device components remains in situ (attached) until device removal 5–7 days after placement. Placement and removal require 3– 5 minutes each. This procedure requires neither injectable anesthesia nor a sterile field

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