Participant Experiences and Views of Odor and PrePex Device Removal Pain in a VMMC Pilot Study in Botswana

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.

PrePex circumcision surveillance: Adverse events and analgesia for device removal

“…However, device removal was associated with moderate to severe pain that abated within half an hour[ 13 ]. Other studies have also reported on moderate and severe pain experienced during device removal for example: in Zimbabwe 28% of participants experienced mild to moderate pain during removal [ 21 ], in Botswana 6% and 2% had moderate to severe pain respectively [ 22 ], and in Mozambique 38% reported severe or unbearable pain and 22% had moderate pain during removal [ 18 ]. Although the manufacturer did not recommend analgesia for placement or removal, our findings indicate that providing analgesia prior to PrePex device removal reduced the proportion of participants reporting severe pain compared to no analgesia.…”

VMMC Devices—Introducing a New Innovation to a Public Health Intervention

“…Introduction studies of PrePex in adults in Malawi, Zambia, Zimbabwe, Mozambique, South Africa, and Botswana confirm that the device is safe, including in the context of routine service delivery by nurses, and that clients are satisfied and would recommend it to their peers. 14 – 19 A study of PrePex in Zimbabwean adolescents aged 13–17 years provides the first safety data in this important younger age group, constituting the largest number of clients who have sought VMMC services thus far. 20 Although a greater proportion of adolescents versus adults are anatomically ineligible for PrePex, adverse event rates, perceptions of pain, and healing time are all less than observed using PrePex in adults.…”

“…This supplement contains 16 articles from 8 countries examining different aspects of the introduction of devices into VMMC and focus on the following: Safety and acceptability of device introduction in Botswana, South Africa, Malawi, Zambia, Zimbabwe, Mozambique, and Kenya 14 – 20 , 22 – 24 The WHO-defined pathway for the evaluation of devices for VMMC programs for HIV prevention 13 Estimated unit costs of device-based VMMC and cost of device introduction 27 , 28 Impact of devices on demand for VMMC services 26 Provider training and client education. 21 , 25 …”

“…Safety and acceptability of device introduction in Botswana, South Africa, Malawi, Zambia, Zimbabwe, Mozambique, and Kenya 14 – 20 , 22 – 24 …”

“… 20 Reports of the nearly universal experience of pain at the time of PrePex removal and the development of odor while the device is in place present potential barriers to uptake and point to the need for better pain control with the use of this device and for appropriate client expectation setting concerning odor. 14 – 17 , 19 In response to these findings, studies to optimize pain and odor control are ongoing.…”