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The PrePex circumcision device causes ischemic necrosis of the foreskin, raising concerns of anaerobic overgrowth. We compared the subpreputial microbiome of 2 men 7 days after PrePex device placement to that of 145 uncircumcised men in Rakai, Uganda, using 16S ribosomal (rRNA) RNA gene-based quantitative polymerase chain reaction analysis and sequencing. PrePex users had higher absolute abundance of all bacteria than uncircumcised men (P = .001), largely due to increased numbers of the following anaerobes: Porphyromonas (5.2 × 10(7) 16S rRNA gene copies/swab in the PrePex group and 1.1 × 10(6) 16S rRNA gene copies/swab in uncircumcised men; P = .002), Peptoniphilus (1.0 × 10(7) and 1.8 × 10(6) 16S rRNA gene copies/swab, respectively; P < .05), Anaerococcus (1.0 × 10(7) and 1.1 × 10(6) 16S rRNA gene copies/swab, respectively; P < .001), and Campylobacter ureolyticus (1.7 × 10(5) and 1.6 × 10(7)16S rRNA gene copies/swab, respectively; P < .001). The PrePex-associated increase in anaerobes may account for unpleasant odor and a possible heightened risk of tetanus.

Study Type – Therapy (case control) Level of Evidence 3a What's known on the subject? and What does the study add? Local anaesthetic drugs block the generation and the conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve by slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential. Lignocaine/Lidocaine has a rapid onset action and an intermediate duration of efficacy whereas Bupivacaine has a slower onset of action with a long duration of efficacy. A combination of the two drugs creates a mixture that has a short onset of action together with a long duration of action both of which are desirable qualities in provision of effective local anaesthesia. Documenting whether use of lignocaine alone predisposes men to more pain during and after surgery will inform policy makers on the type of local anaesthesia to recommend for male circumcision, especially as circumcision programs roll out. This is important since pain has been associated with reduced acceptance of the male circumcision procedure and therefore can negatively influence male circumcision roll out programs. OBJECTIVE • To assess self-reported pain control during and after surgery with a mixture of lignocaine and bupivacaine compared with lignocaine alone among male circumcision (MC) service recipients in Rakai, Uganda. PATIENTS AND METHODS • The two formulations of local anaesthesia for MC were used alternatively at weekly intervals in 360 patients; 179 received lignocaine alone and 181 received the lignocaine and bupivacaine mixture (LBmix). • The proportions of men reporting pain during or after surgery, and the need for additional anaesthesia during surgery were determined for the LBmix vs lignocaine using Poisson adjusted rate ratios (RRs). • Characteristics including age, weight, surgeon (medical officer vs clinical officer), surgical method and duration of surgery were compared between the arms using two-sample t-tests and chi-square tests. RESULTS • Patient and provider characteristics were comparable between the two anaesthetic groups. • A higher proportion of patients reported pain during surgery in the lignocaine group (adjusted RR 11.6, 95% confidence interval [CI] 3.5–37.9, P < 0.001), required additional anaesthesia (adjusted RR 4.8, 95% CI 1.4–17.1, P= 0.015), and were more likely to report pain during the immediate postoperative period (adjusted RR 3.4, 95% CI 2.3–5.0, P < 0.001). • These differences were particularly marked among patients with MC times longer than the median (adjusted RR 13.4, 95% CI 3.1–57.0, P < 0.001). CONCLUSION • The LBmix significantly reduced pain associated with MC and the need for additional anaesthesia during MC.

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 naive 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

To assess self-reported pain control during and after surgery with a mixture of lignocaine and bupivacaine compared with lignocaine alone among male circumcision (MC) service recipients in Rakai, Uganda.The two formulations of local anaesthesia for MC were used alternatively at weekly intervals in 360 patients; 179 received lignocaine alone and 181 received the lignocaine and bupivacaine mixture (LBmix). The proportions of men reporting pain during or after surgery, and the need for additional anaesthesia during surgery were determined for the LBmix vs lignocaine using Poisson adjusted rate ratios (RRs). Characteristics including age, weight, surgeon (medical officer vs clinical officer), surgical method and duration of surgery were compared between the arms using two-sample t-tests and chi-square tests.Patient and provider characteristics were comparable between the two anaesthetic groups. A higher proportion of patients reported pain during surgery in the lignocaine group (adjusted RR 11.6, 95% confidence interval [CI] 3.5-37.9, P0.001), required additional anaesthesia (adjusted RR 4.8, 95% CI 1.4-17.1, P = 0.015), and were more likely to report pain during the immediate postoperative period (adjusted RR 3.4, 95% CI 2.3-5.0, P0.001). These differences were particularly marked among patients with MC times longer than the median (adjusted RR 13.4, 95% CI 3.1-57.0, P0.001).The LBmix significantly reduced pain associated with MC and the need for additional anaesthesia during MC.

Objective To describe the designing and usage of a locally made low-cost penile model used for male medical circumcision (MMC) skills training. Material and Methods The Rakai MMC training team has experienced a number of challenges during conduct of MMC skills training, one of which was the lack of a model to use for MMC skills training. To address this challenge, the Rakai MMC skills training team has designed and developed a low-cost penile model for use in MMC skills training. Results The model has been successfully used to demonstrate external penile anatomy, to describe the biological mechanisms through which male circumcision (MC) prevents HIV acquisition, and for demonstration and practice of the MMC procedures. Conclusions With an initial cost of only $10 and a recurrent cost of $5, this is a cost-efficient and useful penile model that provides a simulation of normal penile anatomy for use in MC training in resource-limited settings. It has also been used as a visual aid in preoperative education of patients before receiving male circumcision. The model can be improved and scaled up to develop cheaper commercial penile models.

To assess the number of procedures required to achieve optimal competency (time required for surgery with minimal adverse events) in Rakai, Uganda, and thus facilitate the development of guidelines for training providers, as male circumcision reduces the acquisition of human immunodeficiency virus (HIV) in men and is recommended for HIV prevention.In a randomized trial, 3011 men were circumcised, using the sleeve method, by six physicians who had completed training, which included 15-20 supervised procedures. The duration of surgery from local anaesthesia to wound closure, moderate or severe surgery-related adverse events (AEs), and wound healing were assessed in relation to the number of procedures done by each physician.The median age of the patients was 24 years. The number of procedures per surgeon was 20-981. The mean time required to complete surgery was approximately 40 min for the first 100 procedures and declined to 25 min for the subsequent 100 circumcisions. After controlling for the number of procedures there was no significant difference in duration of the surgery by patient HIV status or age. The rate of moderate and severe AEs was 8.8% (10/114) for the first 19 unsupervised procedures after training, 4.0% for the next 20-99 (13/328) and 2.0% for the last 100 (P for trend, 0.003). All AEs resolved with management.The completion of more than 100 circumcisions was required before newly trained physicians achieved the optimum duration of surgery. AEs were higher immediately after training and additional supervision is needed for at least the first 20 procedures after completing training.

Background The objective of the study was to compare rates of adverse events (AEs) related to male circumcision (MC) in HIV-positive and HIV-negative men in order to provide guidance for MC programs that may provide services to HIV-infected and uninfected men. Methods and Findings A total of 2,326 HIV-negative and 420 HIV-positive men (World Health Organization [WHO] stage I or II and CD4 counts > 350 cells/mm3) were circumcised in two separate but procedurally identical trials of MC for HIV and/or sexually transmitted infection prevention in rural Rakai, Uganda. Participants were followed at 1–2 d and 5–9 d, and at 4–6 wk, to assess surgery-related AEs, wound healing, and resumption of intercourse. AE risks and wound healing were compared in HIV-positive and HIV-negative men. Adjusted odds ratios (AdjORs) were estimated by multiple logistic regression, adjusting for baseline characteristics and postoperative resumption of sex. At enrollment, HIV-positive men were older, more likely to be married, reported more sexual partners, less condom use, and higher rates of sexually transmitted disease symptoms than HIV-negative men. Risks of moderate or severe AEs were 3.1/100 and 3.5/100 in HIV-positive and HIV-negative participants, respectively (AdjOR 0.91, 95% confidence interval [CI] 0.47–1.74). Infections were the most common AEs (2.6/100 in HIV-positive versus 3.0/100 in HIV-negative men). Risks of other complications were similar in the two groups. The proportion with completed healing by 6 wk postsurgery was 92.7% in HIV-positive men and 95.8% in HIV-negative men (p = 0.007). AEs were more common in men who resumed intercourse before wound healing compared to those who waited (AdjOR 1.56, 95% CI 1.05–2.33). Conclusions Overall, the safety of MC was comparable in asymptomatic HIV-positive and HIV-negative men, although healing was somewhat slower among the HIV infected. All men should be strongly counseled to refrain from intercourse until full wound healing is achieved. Trial registration: http://www.ClinicalTrials.gov; for HIV-negative men, #NCT00047073 and for HIV-positive men, #NCT00047073., Ron Gray and colleagues report on complications of circumcision in HIV-infected and HIV-uninfected men from two related trials in Uganda, finding increased risk with intercourse before wound healing., Editors' Summary Background Worldwide over 33 million people are thought to be living with HIV, and in the absence of a vaccine, preventing its spread is a major health issue. The World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS (UNAIDS) estimate that 68% of 2.5 million new infections worldwide in 2007 took place in sub-Saharan Africa, where 76% of 2.1 million AIDS-related deaths also took place. One of the principal means of person-to-person transmission of HIV is through sex without the protection of a condom. In parts of Africa, male circumcision is performed in infancy or childhood for religious or cultural reasons or is a traditional rite of passage that marks the transition from child to man. Three trials, in South Africa, Kenya, and Uganda, each found that circumcised men were around half as likely as uncircumcised men to contract HIV from HIV-positive female partners. After reviewing the results, WHO and UNAIDS issued joint advice that male circumcision should be promoted for preventing HIV infection in heterosexual men. As male circumcision does not provide complete protection against HIV infection, they advised that it should be promoted in addition to existing strategies of promoting condom use, abstinence, and a reduction in the number of sexual partners. Why Was This Study Done? Although earlier studies had shown that adult male circumcision, when performed in Africa under optimal conditions, is a safe procedure for HIV-negative men, it was not known whether it would also be a safe procedure for HIV-positive men. WHO guidelines recommend that HIV-positive men who request the procedure or have a medical need and no contraindications for it should be circumcised. Also, exclusion of HIV-positive men from circumcision programs may result in stigmatization of these men, and discourage participation by men who do not wish to be tested for HIV. Therefore, it is important to know whether the procedure is safe for HIV-positive men. What Did the Researchers Do and Find? The authors compared results from two separate clinical trials carried out with identical procedures in rural Rakai, Uganda. The first, which compared the effect of circumcision with no circumcision in HIV-negative men, was one of the three trials that persuaded the WHO and UNAIDS to promote male circumcision as an HIV prevention strategy. The second Rakai trial did the same comparison but in men who were HIV positive and without symptoms. In this present study, the authors used data from both trials to compare the likelihood of surgery-related complications following circumcision for HIV-negative and HIV-positive men. The trials recruited men aged 15–49, who were randomly assigned to be circumcised either on enrollment or two years later and were followed up to monitor complications related to the procedure, such as infections, as well as wound healing and when the participant first had sex after the operation. Condom use was recorded at enrollment and six months after enrollment. The researchers found that most complications were infrequent, mild, and comparable in both groups, with moderate-to-severe complications occurring in only 3%–4% of men in each group. However, delayed wound healing was more frequent in HIV-positive men. Complications were more likely among men who had sex before healing was complete; such men were more likely to be HIV-positive and/or married. Similarly, moderate or severe complications were more likely where men had symptoms of sexually transmitted disease at enrollment, although these were treated before surgery, and these men were more likely to be HIV-positive. Six months after enrollment, similar proportions of HIV-positive and HIV-negative men used condoms consistently, but HIV-positive men were more likely to report using condoms inconsistently than HIV-negative men. However, consistent use of a condom increased among the HIV-positive men compared to when they enrolled. What Do these Findings Mean? Circumcision in HIV-positive men without symptoms of AIDS has a low rate of complications, although healing is slower than in HIV-negative men. Because of the greater risk of complications if sex is resumed before full healing, both men and their women partners should be advised to have no sex for at least six weeks after the operation. A separately reported analysis from one of these studies found that women partners are more likely to become HIV infected by HIV-positive men who resume sex prior to complete wound healing. Therefore, for protection of both men and their female partners, it is essential to refrain from intercourse after circumcision until the wound has completely healed. Because the study found no increased risk of surgical complications in HIV-positive men who undergo circumcision, it should not be necessary to screen men with no symptoms of HIV in future circumcision programs. This should reduce the complexity of implementing such programs and reduce any stigma resulting from exclusion, making it likely that more men will be willing to be circumcised. The rise in consistent condom use among HIV-positive men suggests that messages of safe sex are reaching an important target group and changing their behavior, and that circumcision does not make men less likely to use a condom. The authors also noted that the rates of complications they observed were low compared with those following traditional circumcision procedures. Others have found that circumcision carried out under unsafe conditions has a high rate of complications. The authors of this study comment that the resources and standards of surgery during the trial represented best practice and that to attain similarly low rates of complications—and the confidence of men in the safety of the procedure—there is a need to ensure sufficient resources and high standards of training. Additional Information. Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0050116. WHO and the UNAIDS issued a joint report recommending male circumcision for HIV prevention and another on the HIV epidemic worldwide in December 2007 An information pack here on male circumcision and HIV prevention has also been developed jointly by WHO/UNAIDS, the United Nations International Children's Emergency Fund (UNICEF), the United Nations Population Fund (UNFPA), and the World Bank The University of California San Francisco's HIV InSite provides information on HIV prevention, treatment, and policy AEGIS is the world's largest searchable database on HIV and AIDS The National AIDS Trust provides information on HIV prevention