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Abstract
ObjectivesTo assess the safety and acceptance of the PrePex device for medical male circumcision (MMC) in rural Uganda.MethodsIn an observational study, HIV-uninfected, uncircumcised men aged 18 and older who requested elective MMC were informed about the PrePex and dorsal slit methods and offered a free choice of their preferred procedure. 100 men received PrePex to assess preliminary safety (aim 1). An additional 329 men, 250 chose PrePex and 79 chose Dorsal slit, were enrolled following approval by the Safety Monitoring Committee (aim 2). Men were followed up at 7 days to assess adverse events (AEs) and to remove the PrePex device. Wound healing was assessed at 4 weeks, with subsequent weekly follow up until completed healing.ResultsThe PrePex device was contraindicated in 5.7% of men due to a tight prepuce or phimosis/adhesions. Among 429 enrolled men 350 (82.0%) got the PrePex device and 79 (18.0%) the dorsal slit procedure. 250 of 329 men (76.0%) who were invited to choose between the 2 procedures chose Prepex. There were 9 AEs (2.6%) with the PrePex, of which 5 (1.4%) were severe complications, 4 due to patient self-removal of the device leading to edema and urinary obstruction requiring emergency surgical circumcision, and one due to wound dehiscence following device removal. 71.8% of men reported an unpleasant odor prior to PrePex removal. Cumulative rates of completed wound healing with the PrePex were 56.7% at week 4, 84.8% week 5, 97.6% week 6 and 98.6% week 7, compared to 98.7% at week 4 with dorsal slit (p<0.0001).ConclusionThe PrePex device was well accepted, but healing was slower than with dorsal slit surgery. Severe complications, primarily following PrePex self-removal, required rapid access to emergency surgical facilities. The need to return for removal and delayed healing may increase Program cost and client burden.
Highlights
Medical male circumcision (MMC) reduces male HIV acquisition by 50–60% [1,2,3] and has been recommended by UNAIDS/WHO as a component of HIV prevention [4]
The World Health Organization Technical Advisory Group (WHO TAG) reviewed eight published and unpublished studies of the PrePex device in January, 2013, and concluded that in,7% of clients the PrePex device could not be used because a tight foreskin precluded placement, that adverse events were,1.7% and that severe adverse events, mainly due to displacement or self-removal of the elastic ring, required urgent surgical intervention in 0.4% of cases [12]
Statistical methods We present results from the PrePex training phase in which 136 devices were provided by trainees and during the research phase of the study when 350 PrePex devices and 79 dorsal slit MMCs were provided
Summary
Medical male circumcision (MMC) reduces male HIV acquisition by 50–60% [1,2,3] and has been recommended by UNAIDS/WHO as a component of HIV prevention [4]. The Shang Ring [6] and the PrePex device [7,8,9,10] offer potential advantages in reduction of procedure time which could increase throughput of clients, a lower requirement for asepsis and the procedures can be performed by less skilled providers [7,8,10] which could facilitate task shifting and sharing. Both devices must be removed 5–9 days after placement. The WHO TAG provided prequalification for use of the PrePex in men aged 18 or older, but recommended that skilled surgical back up was available to manage severe complications [12]
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