Dverse Events of PrePex in Ugandan Urban SettingTable 1. Baseline characteristics of study participants, IHK Uganda PrePex trial study 2012.Variable Mean age Age range Education Tertiary Secondary Others HIV prevalence Occupation Students *Boda boda cyclists Others Penile sizes (24?6mm) A B C D E Missing data Screen failure Screen failure Clients excluded at initial physical screen before consent Narrow fore skin Frenulunm breve Client withdrawal Penile ulcer Penile wart Hypospadia Clients admitted to study but device not placed Lesion on glans Adhesions Narrow foreskin Repeated erections during procedure , size A Frenulum breve Withdrawals before placement Below age Withdrawals on request (changing their mind)Number (percentage) 24 sd 7 18?9 years212 (34 ) 312 (50 ) 101 (16 ) 3 (0.5 )63 (10 ) 6 (1 ) 556 (89 )61 (10 ) 171 (28 ) 224 (35.5 ) 113 (18 ) 52 (8 ) 4 (0.5 )51/678 (8 ) 36 27 4 ^ 2 1 11 1 4 1 11 ^*boda boda refers to motorcycles a common and popular two wheel means of transport for mostly short distances in the country^ Exclusions due to change of client mind not included in screen failure rates. doi:10.1371/journal.pone.0086631.tmanipulation included AZD0156 biological activity purposeful removal of the device or engaging in sex activities despite prior counseling. Device AKB-6548 chemical information displacement required surgical intervention to pre-empt further complication, on this basis a classification of severe AE was made. Out of the 300 exit interviews conducted immediately after the device removal, six participants admitted to attempting penetrative vaginal sex during the week of wearing the device. The number 6 out of 300 (2 ) may be an underestimate as men may have been reluctant to disclose this information. But also we did not follow up the sex resumption issue beyond 14 days. Studies inZambia and Kenya indicated a significant percentage (24?1 ) of circumcised men resuming sexual intercourse before the mandatory 6 weeks abstinence period recommended to allow full healing of the penis [16,17]. This early resumption of sex prior to healing raises the question, there could be an increased risk of HIV acquisition through a wound that is not completely healed, infections acquired during a short period of potential increased vulnerability are far outweighed by the number of HIV infections averted over subsequent years [16,17]. Fully understanding the factors that lead to early resumption of sex after circumcision would inform preventivePLOS ONE | www.plosone.orgAdverse Events of PrePex in Ugandan Urban SettingTable 2. Adverse events profile IHK PrePex Uganda study 2012.Timing Events during placementAdverse Event Pain n =Values 0.5 (average score ?in VAS 0?0) Nil NilComments Short lived ,2min (considered Mild AE).Bleeding n = 625 Others Events during wearing Pain n =Pain/discomfort was mostly tolerable. Scores of 10 were considered mild AE, clients were encouraged to carry on with analgesics previously givenVAS Pain scores 0 2 4 6 8 10 Odour n = 300 Odour complaints Smell by day of wearing Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Early removals n = 625 Day 4 Day 5 Day 6 Device displacement n = 625 SAE Transient voiding difficulties n = 300 (Mild-Moderate AEs)n ( ) 19 (6.3 ) 219 (73 ) 25 (8 ) 21 (7 ) 14 (5 ) 2 (0.7 )238/300 (79 ) Clients noticing smell 18 (8 ) 68 (28 ) 83 (35 ) 40 (17 ) 25 (10 ) 4 (2 )Not considered an AE but a side effect. Odour for the majority (63 ) was noticed on D3 and 4.Eight D4 removals were done in error when D4 was mistaken by the client and operator for D5 1.Dverse Events of PrePex in Ugandan Urban SettingTable 1. Baseline characteristics of study participants, IHK Uganda PrePex trial study 2012.Variable Mean age Age range Education Tertiary Secondary Others HIV prevalence Occupation Students *Boda boda cyclists Others Penile sizes (24?6mm) A B C D E Missing data Screen failure Screen failure Clients excluded at initial physical screen before consent Narrow fore skin Frenulunm breve Client withdrawal Penile ulcer Penile wart Hypospadia Clients admitted to study but device not placed Lesion on glans Adhesions Narrow foreskin Repeated erections during procedure , size A Frenulum breve Withdrawals before placement Below age Withdrawals on request (changing their mind)Number (percentage) 24 sd 7 18?9 years212 (34 ) 312 (50 ) 101 (16 ) 3 (0.5 )63 (10 ) 6 (1 ) 556 (89 )61 (10 ) 171 (28 ) 224 (35.5 ) 113 (18 ) 52 (8 ) 4 (0.5 )51/678 (8 ) 36 27 4 ^ 2 1 11 1 4 1 11 ^*boda boda refers to motorcycles a common and popular two wheel means of transport for mostly short distances in the country^ Exclusions due to change of client mind not included in screen failure rates. doi:10.1371/journal.pone.0086631.tmanipulation included purposeful removal of the device or engaging in sex activities despite prior counseling. Device displacement required surgical intervention to pre-empt further complication, on this basis a classification of severe AE was made. Out of the 300 exit interviews conducted immediately after the device removal, six participants admitted to attempting penetrative vaginal sex during the week of wearing the device. The number 6 out of 300 (2 ) may be an underestimate as men may have been reluctant to disclose this information. But also we did not follow up the sex resumption issue beyond 14 days. Studies inZambia and Kenya indicated a significant percentage (24?1 ) of circumcised men resuming sexual intercourse before the mandatory 6 weeks abstinence period recommended to allow full healing of the penis [16,17]. This early resumption of sex prior to healing raises the question, there could be an increased risk of HIV acquisition through a wound that is not completely healed, infections acquired during a short period of potential increased vulnerability are far outweighed by the number of HIV infections averted over subsequent years [16,17]. Fully understanding the factors that lead to early resumption of sex after circumcision would inform preventivePLOS ONE | www.plosone.orgAdverse Events of PrePex in Ugandan Urban SettingTable 2. Adverse events profile IHK PrePex Uganda study 2012.Timing Events during placementAdverse Event Pain n =Values 0.5 (average score ?in VAS 0?0) Nil NilComments Short lived ,2min (considered Mild AE).Bleeding n = 625 Others Events during wearing Pain n =Pain/discomfort was mostly tolerable. Scores of 10 were considered mild AE, clients were encouraged to carry on with analgesics previously givenVAS Pain scores 0 2 4 6 8 10 Odour n = 300 Odour complaints Smell by day of wearing Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Early removals n = 625 Day 4 Day 5 Day 6 Device displacement n = 625 SAE Transient voiding difficulties n = 300 (Mild-Moderate AEs)n ( ) 19 (6.3 ) 219 (73 ) 25 (8 ) 21 (7 ) 14 (5 ) 2 (0.7 )238/300 (79 ) Clients noticing smell 18 (8 ) 68 (28 ) 83 (35 ) 40 (17 ) 25 (10 ) 4 (2 )Not considered an AE but a side effect. Odour for the majority (63 ) was noticed on D3 and 4.Eight D4 removals were done in error when D4 was mistaken by the client and operator for D5 1.
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