E one of the clients in the study returned 2 days earlier due to pain (anPLOS ONE | www.plosone.orgAdverse Events of PrePex in Ugandan Urban SettingOdourBad odout was not anticipated during the preparations for this study. Bad odour may be described as a discomfort occurring from use of the device and whether this is considered a mild AE or a side effect is subject to debate Bad odour could potentially make an otherwise excellent innovation less favourable. 63 (189/300) of the clients interviewed after removal reported bad odour. Exploring this further, only 3 out of the 300 participants interviewed indicated that another person had told them they `smelt bad’. When asked whether they would recommend the device to a friend 89.3 (268/300) responded in the affirmative suggesting that the odour and pain may not have had such a negative impact but, nonetheless, it remains important to seek means of mitigating both. The odour may have been caused by order Necrostatin-1 anaerobes harboring in the wet necrotic foreskin. Further research and study will be needed to verify this conjecture. In some cases device removal was performed 1 to 2 days earlier than originally scheduled due to complaints about bad odour. Removal at day 5 may be one possible solution to help mitigate client concerns about odour. Another plausible solution is to emphasize good hygiene, washing with soap and dabbing dry, at least twice a day. Use of metronidazole gel or powder is another option to be investigated.Screen NVP-AUY922 site failureIn total, 44 of 678 who had originally chosen PrePex were disqualified on clinical grounds making a screen failure rate of 6.5 . The implication of this is in program planning as a proportion of individuals would not be suitable for the device even if they originally chose to have it.Study limitationsThis study was conducted in an urban setting targeting young men aged between 18?9 years. It was conducted at a fixed site within a hospital setting with a surgically competent back up, team to handle AEs and screen failures and we need to extend this trial to rural settings and use the mobile operations model (SMC camps) in order to more fully explore acceptance and feasibility that would inform policy guidelines for such a device in Uganda’s national SMC program. Acceptance and choice between surgical male circumcision and PrePex may differ in rural settings. Attitudes and practices towards bad odour, hygiene and pain tolerance may be different too. Whereas we assumed that the study population was device naive, some men could have come because their friends recommended the device therefore causing an over estimation of PrePex preference. It was not possible to draw meangful inferences from the baseline characteristics of the men who had the moderate AEs as the number was small.Voiding difficultiesVoiding difficulties were encountered but these were mostly of transient nature. The drying or necrotizing prepuce gets in the `way’ and this ought to be considered in the pre-device placement counseling sessions to avoid clients taking it upon themselves to relieve real or perceived `obstructured’ as one did in this study using a razor blade.ConclusionPrePex as a non-surgical male circumcision device is a viable option for upscaling up of safe male circumcision with a low rate of AE and high acceptance rate by the clients (90 recommend its use). Use of Prepex would not exclude the conventional surgical circumcision since some may be screened out or may require surgical circumcis.E one of the clients in the study returned 2 days earlier due to pain (anPLOS ONE | www.plosone.orgAdverse Events of PrePex in Ugandan Urban SettingOdourBad odout was not anticipated during the preparations for this study. Bad odour may be described as a discomfort occurring from use of the device and whether this is considered a mild AE or a side effect is subject to debate Bad odour could potentially make an otherwise excellent innovation less favourable. 63 (189/300) of the clients interviewed after removal reported bad odour. Exploring this further, only 3 out of the 300 participants interviewed indicated that another person had told them they `smelt bad’. When asked whether they would recommend the device to a friend 89.3 (268/300) responded in the affirmative suggesting that the odour and pain may not have had such a negative impact but, nonetheless, it remains important to seek means of mitigating both. The odour may have been caused by anaerobes harboring in the wet necrotic foreskin. Further research and study will be needed to verify this conjecture. In some cases device removal was performed 1 to 2 days earlier than originally scheduled due to complaints about bad odour. Removal at day 5 may be one possible solution to help mitigate client concerns about odour. Another plausible solution is to emphasize good hygiene, washing with soap and dabbing dry, at least twice a day. Use of metronidazole gel or powder is another option to be investigated.Screen failureIn total, 44 of 678 who had originally chosen PrePex were disqualified on clinical grounds making a screen failure rate of 6.5 . The implication of this is in program planning as a proportion of individuals would not be suitable for the device even if they originally chose to have it.Study limitationsThis study was conducted in an urban setting targeting young men aged between 18?9 years. It was conducted at a fixed site within a hospital setting with a surgically competent back up, team to handle AEs and screen failures and we need to extend this trial to rural settings and use the mobile operations model (SMC camps) in order to more fully explore acceptance and feasibility that would inform policy guidelines for such a device in Uganda’s national SMC program. Acceptance and choice between surgical male circumcision and PrePex may differ in rural settings. Attitudes and practices towards bad odour, hygiene and pain tolerance may be different too. Whereas we assumed that the study population was device naive, some men could have come because their friends recommended the device therefore causing an over estimation of PrePex preference. It was not possible to draw meangful inferences from the baseline characteristics of the men who had the moderate AEs as the number was small.Voiding difficultiesVoiding difficulties were encountered but these were mostly of transient nature. The drying or necrotizing prepuce gets in the `way’ and this ought to be considered in the pre-device placement counseling sessions to avoid clients taking it upon themselves to relieve real or perceived `obstructured’ as one did in this study using a razor blade.ConclusionPrePex as a non-surgical male circumcision device is a viable option for upscaling up of safe male circumcision with a low rate of AE and high acceptance rate by the clients (90 recommend its use). Use of Prepex would not exclude the conventional surgical circumcision since some may be screened out or may require surgical circumcis.
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