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Objectives To assess the safety and acceptability of early infant circumcision (EIC) provided by trained clinical officers (COs) and registered nurse midwives (RNMWs) in rural Uganda. Subjects and Methods We conducted a randomised trial of EIC using the Mogen clamp provided by newly trained COs and RNMWs in four health centres in rural Rakai, Uganda. The trial was registered with clinicaltrials.gov # NCT02596282. In all, 501 healthy neonates aged 1–28 days with normal birth weight and gestational age were randomised to COs (n = 256) and RNMWs (n = 245) for EIC, and were followed-up at 1, 7 and 28 days. Results In all, 701 mothers were directly invited to participate in the trial, 525 consented to circumcision (74.9%) and 23 were found ineligible on screening (4.4%). The procedure took an average of 10.5 min. Adherence to follow-up was >90% at all scheduled visits. The rates of moderate/severe adverse events were 2.4% for COs and 1.6% for RNMWs (P = 0.9). All wounds were healed by 28 days after circumcision. Maternal satisfaction with the procedure was 99.6% for infants circumcised by COs and 100% among infants circumcised by RNMWs. Conclusions EIC was acceptable in this rural Ugandan population and can be safely performed by RNMWs who have direct contact with the mothers during pregnancy and delivery. EIC services should be made available to parents who are interested in the service.

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.

Background: Medical male circumcision (MMC) is a recommended strategy for HIV prevention, but attendance for scheduled MMC is often suboptimal. We assessed the impact of cell phone and in-person reminders on uptake of MMC. Methods: Between October 2010 and June 2011, men participating in the Rakai Community Cohort Study (RCCS) were educated about the risks and benefits of MMC and those who wished to receive free MMC were referred to the Rakai MMC program. Cell phone reminders (calls and/or short message service (SMS)) and in-person renotification or persons without phone contacts were used to remind clients two days before the surgical appointment date. Proportions of men coming for scheduled surgery before (control period) and after the reminders were computed and logistic regression used to estimate adjusted odds ratios (AdjOR) and 95% confidence intervals of attendance for scheduled MMC. Results: Approximately 66.7% of men had cell phone contacts. Overall, the intervention increased attendance for scheduled MMC from 20.5% to 32.4%, AdjOR 2.01 (95%CI, 1.42, 2.83), p

OBJECTIVE: To assess completed wound healing after medical male circumcision (MMC) among human immunodeficiency virus (HIV)-negative and HIV-positive men with cluster of differentiation 4 (CD4) counts of /=350 cells/mm(3) as minimal data are available on the safety of MMC among HIV-positive men with low CD4 counts. PATIENTS AND METHODS: In all 262 HIV-negative and 177 HIV-positive consenting males aged >/=12 years accepted MMC using the dorsal slit procedure and were enrolled in the study. Socio-demographic and behavioural data and blood for HIV testing and CD4 counts were collected at baseline. Participants were followed weekly to collect information on resumption of sex condom use and both self-reported and clinically assessed wound healing. The proportions healed among HIV-positive men were compared with HIV-negative men. Time to complete wound healing was assessed by Kaplan-Meier survival analysis. RESULTS: There were no statistically significant differences in the proportion of men healed by HIV status. At 4 weeks the proportions healed were 85.9% in HIV-negative men 77.4% in HIV-positive men with a CD4 count of >/=350 cells/mm(3) and 87.1% in HIV-positive men with a CD4 count of /=350 cells/mm(3) (P = 0.052) and 7.8% (P = 0.081) among HIV-negative men. CONCLUSION: Inclusion of HIV-positive men with low CD4 counts in MMC services is not deleterious to postoperative wound healing. (c) 2013 The Authors. BJU International (c) 2013 BJU International.

OBJECTIVES Medical male circumcision (MMC) is recommended for HIV prevention in men. We assessed the acceptability and safety of the Shang Ring device compared with those of the dorsal slit method. METHODS HIV-negative, uncircumcised men aged 18 years or older who requested free MMC services in rural Rakai, Uganda, were informed about the Shang Ring and dorsal slit procedures and offered a free choice of procedure. Men were followed at 7 days postoperatively to assess adverse events related to surgery and to remove the Shang Ring. Wound healing was assessed at 4 weeks postoperatively. RESULTS Six hundred twenty-one men were enrolled, of whom 508 (81.8%) chose the Shang Ring and 113 the dorsal slit. The Shang Ring was provided to 504 men, among whom there were 4 failures of Ring placement (0.8%) that required surgical hemostasis and wound closure. Five hundred men received the Shang Ring and postoperative surgery-related moderate adverse events were 1.0%, compared with 0.8% among dorsal slit recipients. Complete wound healing at 4 weeks was 84% with the Ring and 100% with the dorsal slit (P < 0001). Resumption of intercourse before 4 weeks was 7.0% with the Ring and 15.0% with the dorsal slit (P = 0.01.) The mean time for surgery was 6.1 minutes with the Ring and 17.7 minutes with the dorsal slit. The mean time for Ring removal was 2.2 minutes. CONCLUSIONS The Shang Ring is highly acceptable and safe in this setting, and could improve the efficiency of MMC services. However, back-up surgical services are needed in cases of Ring placement failures.

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.

To assess completed wound healing after medical male circumcision (MMC) among human immunodeficiency virus (HIV)-negative and HIV-positive men with cluster of differentiation 4 (CD4) counts of350 and ≥350 cells/mm(3) , as minimal data are available on the safety of MMC among HIV-positive men with low CD4 counts.In all, 262 HIV-negative and 177 HIV-positive consenting males aged ≥12 years accepted MMC using the dorsal slit procedure and were enrolled in the study. Socio-demographic and behavioural data and blood for HIV testing and CD4 counts were collected at baseline. Participants were followed weekly to collect information on resumption of sex, condom use and both self-reported and clinically assessed wound healing. The proportions healed among HIV-positive men were compared with HIV-negative men. Time to complete wound healing was assessed by Kaplan-Meier survival analysis.There were no statistically significant differences in the proportion of men healed by HIV status. At 4 weeks, the proportions healed were 85.9% in HIV-negative men, 77.4% in HIV-positive men with a CD4 count of ≥350 cells/mm(3) and 87.1% in HIV-positive men with a CD4 count of350 cells/mm(3) . The median time to healing was 4 weeks and did not vary by HIV or CD4 status. All men had certified complete wound healing at 6 weeks after MMC. In all, 1.4% of HIV-positive men with a CD4 count of350 cells/mm(3) resumed sex before healing, compared with 8.5% among HIV-positive men with a CD4 count of ≥350 cells/mm(3) (P = 0.052) and 7.8% (P = 0.081) among HIV-negative men.Inclusion of HIV-positive men with low CD4 counts in MMC services is not deleterious to postoperative wound healing.

Objective To assess the safety of medical male circumcision (MMC) among human immunodeficiency virus (HIV)–infected men with CD4 levels 3 , CD4 counts ≥350 cells/mm 3 , and HIV-negative men. Methods Two hundred forty-two HIV-infected men and a sample of 262 HIV-negative consenting men aged 12 years or older who requested free MMC were enrolled in a prospective study. Blood for HIV testing and a CD4 count were collected before surgery. During weekly follow-up over 6 weeks, data were collected on wound healing and adverse events (AEs) by examination, and resumption of sex and condom use ascertained by interview. Surgery-related AEs were characterized by type, severity, management, and resolution. Chi-square and Fisher's exact tests were used to test for differences in AE proportions. Results Overall, only 2 of the 453 men experienced moderate AEs, a rate of 0.44 per 100 surgeries. No AE occurred among HIV-negative men, whereas the AE rate among HIV-infected men with CD4 counts ≥350 cells/mm 3 was 0.79 per 100 surgeries, and among men with CD4 counts 3 the rate was 1.19 per 100 surgeries ( P = .214). AE rates were comparable for all characteristics ( P >.05). Conclusion HIV-positive men can be safely included in MMC roll out programs without necessitating presurgery CD4 counts determination.

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.