Genital Anaerobic Bacterial Overgrowth and the PrePex Male Circumcision Device, Rakai, Uganda.

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.

Comparison of ring instruments and classic circumcision methods: a systematic review and meta-analysis.

Aim: To determine the advantages and disadvantages of both methods by comparing classic circumcision methods with circumcision methods assisted by ring instruments. Material-Methods: Only studies that compared open procedures and ring devices for male circumcision were included. A total of 6226 patients were examined in 14 studies. The methodological quality of RCT was evaluated using Cochrane collaboration's tools. The Review Manager software statistical package was used to analyze the ORs for dichotomous variables and the mean differences for continuous variables. The proportion of heterogeneity across the studies was tested using the I 2 index. Potential publication bias was assessed by identifying the presence of visual asymmetry/symmetry with funnel plot studies. Results: There were 1812 patients in the open circumcision group and 4414 patients in the ring groups. In total, there was no difference identified between the groups. The open procedure had an advantage compared to the Plastibell subgroup for hemorrhage, while in the other two subgroups, the ring instrument groups had the advantage. Statistically significant in favor of ring devices was found in operating time.There was no difference between the groups for early (postoperative) pain scores. For late-period pain scores, differences with statistical significance were identified in favor of ring devices both in subgroups and in total. For satisfaction, apart from one study in the PrePex group, statistical significance was obtained in favor of ring devices for the other subgroups and in total. Conclusion: The main factors in favor of the use of ring instruments for circumcision are the short total surgical duration, not requiring advanced surgical experience, ease of learning and application, and patient relative satisfaction rates. However, it is a condition to know open circumcision methods and to have experience of this surgery for use in situations with hemorrhage complications, mainly, and without ring instruments of appropriate size.

Novel Devices for Adolescent and Adult Male Circumcision.

There is an abundance of devices for adolescent and adult male circumcision (MC). It has been shown that the safety and efficacy of device-assisted MC are equal to or better than those for MC via conventional surgery. MC devices have the potential to simplify the procedure and increase the acceptability of circumcision among patients.

Voluntary Medical Male Circumcision to Prevent HIV in Tanah Papua, Indonesia: Field Trial to Assess Acceptability and Feasibility.

BACKGROUND: Relatively little attention has been paid to the significant HIV prevention role that voluntary medical male circumcision (VMMC) can play in populations with moderate levels of HIV prevalence. One such location is Tanah Papua, Indonesia, which in 2013 had a general population having HIV prevalence of 2.3% concentrated among indigenous Papuans (2.9% prevalence), very few of whom are circumcised. This article reports the findings of an implementation research study assessing the acceptability and feasibility of introducing VMMC for HIV prevention. METHODS: Following a situational assessment and socialization of targeted groups of men and key stakeholders, a single-arm, open-label, prospective cohort trial using the non-surgical PrePex® device was undertaken in four cities. Study participants were recruited via study-associated socialization events. Data were collected from clients prior to and following device insertion, and at several "check-up" points (2-, 21- and 42-days) using standardized case report forms. A random sample of circumcision clients from one city was surveyed six months' post-removal to assess the prevalence of compensatory sexual risk behaviours. RESULTS: Demand for circumcision was weak in three of the cities, reflecting insufficient prior socialization and lingering concerns over religious appropriateness and safety issues. Despite no prior experience with PrePex ®, the pilot implementation yielded side-effect and adverse event rates that were unremarkable in comparison with sub-Saharan African countries, where PrePex ® is widely used. No evidence of increased post-procedure sexual risk-taking was found. CONCLUSION: The study findings point to both opportunity and significant challenges in introducing VMMC on a large scale in Tanah Papua, Indonesia. Although there were enough promising signs in the qualitative research and in the limited-scale implementation trial undertaken to remain optimistic as to the potential for VMMC to help contain HIV in Tanah Papua, much remains to be done to promote the benefits of VMMC and address lingering concerns as to safety and religious appropriateness. An acceleration of the pace of task-shifting from physicians to nurses will be needed in order for VMMC to be feasible for implementation on a large scale.

Long term post PrePex male circumcision outcomes in an urban population in Uganda: a cohort study.

OBJECTIVE: The objective of this study was to determine the long term adverse events profile at least a year after safe male circumcision. RESULTS: A cohort study, investigating patients who had undergone a non surgical circumcision procedure called Prepex. The study variables included scar appearance and sexual experiences. Clients were contacted for a phone interview and data were collected using a questionnaire, for some, a physical examination was done. We obtained ethical committee approval. Data from 304 out of a possible 625 men were analyzed, the rest was lost to follow up. The follow up period was 12-24 months. The mean age was 28 years. Up to 97% were satisfied with the penile scar appearance and the absence of pain. There was no keloids formation, though one developed a hypertrophic scar. Participants reported improved sexual intercourse enjoyment (post circumcision). Up to 17% resumed sexual intercourse before the 6-week long mandatory abstinence period. The average self-reported healing time was 4.7 weeks. There was a high level of scar appearance satisfaction, there was no keloids formation. There was a perceived improvement of sexual enjoyment after circumcision. Trial registration ClinicalTrials. Gov Identifier: NCT02245126 (Date of registration: September 19, 2014).

Adverse event profile of a mature voluntary medical male circumcision programme performing PrePex and surgical procedures in Zimbabwe.

INTRODUCTION: The frequency of adverse events (AEs) is a widely used indicator of voluntary medical male circumcision (VMMC) programme quality. Though over 11.7 million male circumcisions (MCs) have been performed, little published data exists on the profile of AEs from mature, large-scale programmes. No published data exists on routine implementation of PrePex, a device-based MC method. METHODS: The ZAZIC Consortium began implementing VMMC in Zimbabwe in 2013, supporting services at 36 facilities. Aggregate data on VMMC outputs are collected monthly from each facility. Detailed forms are completed describing the profile of each moderate and severe AE. Bivariate and multivariable analyses were conducted using log-binomial regression models. RESULTS: From October 2014 through September 2015, 44,868 clients were circumcised with 156 clients experiencing a moderate or severe AE. 96.2% of clients had a follow-up visit within 14 days of their procedure. AEs were uncommon, with 0.3% (116/41,416) of surgical and 1.2% (40/3,452) of PrePex clients experiencing a moderate or severe AE. After adjusting for VMMC site, we found that PrePex was associated with a 3.29-fold (95% CI: 1.78-6.06) increased risk of experiencing an AE compared to surgical procedures. Device displacements, when the PrePex device is intentionally or accidentally dislodged during the 7-day placement period, accounted for 70% of PrePex AEs. The majority of device displacements were intentional self-removals. Overall, infection was the most common AE among VMMC clients. Compared to clients aged 20 and above, clients aged 10-14 were 3.07-fold (95% CI: 1.36-6.91) more likely to experience an infection and clients aged 15-19 were 1.80-fold (95% CI: 0.82-3.92) more likely to experience an infection, adjusted for site. CONCLUSION: This exploratory analysis found that clients receiving PrePex were more likely to experience an AE than surgical circumcision clients. This is largely attributable to the occurrence of device displacements, which require prompt access to corrective surgical MC procedures as part of their clinical management. Most device displacements were self-removals which are preventable if client behaviour could be modified through counselling interventions. We also found that infection after MC is more common among younger clients, who may benefit from additional counselling or increased parental involvement.

Evaluating the cost of adult voluntary medical male circumcision in a mixed (surgical and PrePex) site compared to a hypothetical PrePex-only site in South Africa.

BACKGROUND: Several circumcision devices have been evaluated for a safe and simplified male circumcision among adults. The PrePex device was prequalified for voluntary male medical circumcision (VMMC) in May 2013 by the World Health Organization and is expected to simplify the procedure safely while reducing cost. South Africa is scaling up VMMC. OBJECTIVE: To evaluate the overall unit cost of VMMC at a mixed site vs. a hypothetical PrePex-only site in South Africa. DESIGN: We evaluated the overall unit cost of VMMC at a mixed site where PrePex VMMC procedure was added to routine forceps-guided scalpel-based VMMC in Soweto, South Africa. We abstracted costs and then modeled these costs for a hypothetical PrePex-only site, at which 9,600 PrePex circumcisions per year could be done. We examined cost drivers and modeled costs, varying the price of the PrePex device. The healthcare system perspective was used. RESULTS: In both sites, the main contributors of cost were personnel and consumables. If 10% of all VMMC were by PrePex at the mixed site, the overall costs of the surgical method and PrePex were similar - US$59.62 and $59.53, respectively. At the hypothetical PrePex-only site, the unit cost was US$51.10 with PrePex circumcisions having markedly lower personnel and biohazardous waste management costs. In sensitivity analysis with the cost of PrePex kit reduced to US$10 and $2, the cost of VMMC was further reduced. CONCLUSIONS: Adding PrePex to an existing site did not necessarily reduce the overall costs of VMMC. However, starting a new PrePex-only site is feasible and may significantly reduce the overall cost by lowering both personnel and capital costs, thus being cost-effective in the long term. Achieving a lower cost for PrePex will be an important contributor to the scale-up of VMMC.