The safety and acceptance of the PrePex device for non-surgical adult male circumcision in Rakai, Uganda. A non-randomized observational study.

To assess the safety and acceptance of the PrePex device for medical male circumcision (MMC) in rural Uganda.In 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.The 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).The 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

Effects of medical male circumcision (MC) on plasma HIV viral load in HIV+ HAART naïve men; Rakai, Uganda.

BACKGROUND: Medical male circumcision (MC) of HIV-infected men may increase plasma HIV viral load and place female partners at risk of infection. We assessed the effect of MC on plasma HIV viral load in HIV-infected men in Rakai, Uganda. METHODS: 195 consenting HIV-positive, HAART naïve men aged 12 and above provided blood for plasma HIV viral load testing before surgery and weekly for six weeks and at 2 and 3 months post surgery. Data were also collected on baseline social demographic characteristics and CD4 counts. Change in log10 plasma viral load between baseline and follow-up visits was estimated using paired t tests and multivariate generalized estimating equation (GEE). RESULTS: Of the 195 men, 129 had a CD4 count ≧ 350 and 66 had CD4 <350 cells/mm3. Men with CD4 counts <350 had higher baseline mean log10 plasma viral load than those with CD4 counts ≧ 350 cells/mm3 (4.715 vs 4.217 cps/mL, respectively, p = 0.0005). Compared to baseline, there was no statistically significant increase in post-MC HIV plasma viral loads irrespective of CD4. Multivariate analysis showed that higher baseline log10 plasma viral load was significantly associated with reduction in mean log10 plasma viral load following MC (coef.  = -0.134, p<0.001). CONCLUSION: We observed no increase in plasma HIV viral load following MC in HIV-infected, HAART naïve men

Number of adverse events with PrePex circumcision.

<p>Number of adverse events with PrePex circumcision.</p

Figure 1 shows the study flow chart.

<p><a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0100008#pone-0100008-g001" target="_blank">Figure 1</a> shows the study flow chart.</p

Figure 2 shows photographs of selected adverse events with the PrePex device.

<p><a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0100008#pone-0100008-g002" target="_blank">Figure 2a</a>, device self removal with edema and superficial ulceration on day 2 post placement. <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0100008#pone-0100008-g002" target="_blank">Figure 2b</a>, device self removal with edema on day 1 post placement. <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0100008#pone-0100008-g002" target="_blank">Figure 2C</a>, wound dehiscence on day 17 post device placement. <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0100008#pone-0100008-g002" target="_blank">Figure 2d</a>, self removal of the device with edema and necrosis on day 9.</p

Details of adverse events with the PrePex device during the study.

<p>Details of adverse events with the PrePex device during the study.</p

Characteristics and behaviors of men who received the PrePex or dorsal slit circumcision.

<p>Characteristics and behaviors of men who received the PrePex or dorsal slit circumcision.</p

Study Flow Chart.

<p>Study Flow Chart.</p

Number, Mean log₁₀ viral loads, mean difference (95%CI) and p values for change in viral load at follow up visits.

<p>Number, Mean log₁₀ viral loads, mean difference (95%CI) and p values for change in viral load at follow up visits.</p