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Objectives: To explore factors associated with healing requiring more than 6 weeks after placement of the PrePex device for adult medical male circumcision., Methods: We enrolled 427 men ages 18-49 years in an observational study of PrePex at 1 urban and 2 peripheral clinics in western Kenya. Participants were scheduled for device removal at day 7 and a follow-up visit at day 42 (allowable range, 40-44) at which the provider recorded wound status, with complete healing defined as a dry wound without any scab, later confirmed by site investigator review of digital penile photographs. We performed univariate and multivariate logistic regression to explore associations between selected demographic, surgical, and follow-up factors and delayed healing (not healed by day 42 visit)., Results: Of the 427 men, 341 completing a day 42 visit with physical examination and recorded healing status were included. Fifty-four percent of included men were healed by day 42 visit. Factors associated with delayed healing in univariate analysis and remaining significant in the multivariate analysis were as follows: age 25 years or older [odds ratio (OR): 1.8; 95% confidence interval (CI): 1.4 to 2.4], an adverse event by day 44 (OR: 1.4; 95% CI: 1.03 to 2.0), and severe pain during device removal (protective association: OR: 0.7; 95% CI: 0.5 to 0.99)., Conclusions: Older age (25+ years), occurrence of an adverse event, and lesser self-reported pain at device removal were associated with delayed wound healing. If confirmed by larger surveillance studies, these results should be incorporated into the counseling given to male circumcision clients.

Introduction: In this study, we describe and depict unexpected sequelae of adult medical male circumcision (MMC) using the PrePex device., Materials and Methods: The PrePex system is an elastic compression device for adult MMC. The device is well studied, has been pre-qualified by the World Health Organization (WHO), and its use is being scaled-up in African countries targeted by WHO. We conducted a PrePex implementation study in routine service delivery among 427 men in the age range of 18-49 in western Kenya. We captured penile photographs to create a record of adverse events (AEs) and to monitor healing. Several unexpected AEs ensued, including some that have not been reported in other PrePex studies. We describe and depict those unexpected complications and resulting treatments to alert circumcision providers in the relevant areas., Results: We observed 5 device displacements (1.2%); 3 cases of early sloughing of foreskin tissue (0.7%) among men with long foreskins; 2 cases of a long foreskin obstructing urine flow, as it became dry and necrotic (0.5%); and 2 cases of insufficient foreskin removal caused by invagination for which surgical completion was necessary (0.5%). All of the participants healed completely by day 42 post-circumcision or shortly thereafter., Conclusion: The potential for these complications should be incorporated into PrePex training programs. Integration of devices into MMC programs in medically underserved areas requires the availability of prompt surgical intervention for some sequelae, particularly displacement events., (© 2015 S. Karger AG, Basel.)

Background: More than 4.7 million voluntary medical male circumcisions (VMMCs) had been provided by HIV prevention programs in sub-Saharan Africa through 2013. All VMMC clients are recommended to return to the clinic for postoperative follow-up, although adherence is variable. The clinical status of clients who do not return is largely unknown., Methods: VMMC clients from Nyanza Province, Kenya, aged older than or equal to 13 years, were recruited immediately after surgery from April to October 2012 from high-volume sites. Medical record reviews at 13-14 days after surgery indicated which clients had been adherent with recommended follow-up (ADFU) and which were lost-to-follow-up (LTFU). Clients in the LTFU group received clinical evaluations at home approximately 2 weeks postsurgery. Adverse events (AEs) and AE rates were compared between the ADFU and LTFU groups., Results: Of 4504 males approached in 50 VMMC sites, 1699 (37.7%) were eligible and enrolled and 1600 of 1699 (94.2%) contributed to follow-up and AE data. Medical record review indicated 897 of 1600 (56.1%) were LTFU, and 762 (84.9%) of these received home-based clinical evaluations. The rate of moderate or severe AE diagnosis was 6.8% in the LTFU group vs. 3.3% in the ADFU group (relative risk = 2.1, 95% confidence interval: 1.3 to 3.4)., Conclusions: The moderate or severe AE diagnosis rate was approximately 2 times higher in the LTFU group. National programs should consider instituting surveillance systems to detect AEs that might otherwise go unnoticed. Providers should emphasize the importance of follow-up and actively contact LTFU clients to ensure care is provided throughout the entire postoperative course for all.

Background: The rapid expansion of voluntary medical male circumcision (VMMC) has raised concerns whether health systems can deliver and sustain VMMC according to minimum quality criteria., Methods and Findings: A comparative process evaluation was used to examine data from SYMMACS, the Systematic Monitoring of the Voluntary Medical Male Circumcision Scale-Up, among health facilities providing VMMC across two years of program scale-up. Site-level assessments examined the availability of guidelines, supplies and equipment, infection control, and continuity of care services. Direct observation of VMMC surgeries were used to assess care quality. Two sample tests of proportions and t-tests were used to examine differences in the percent of facilities meeting requisite preparedness standards and the mean number of directly-observed surgical tasks performed correctly. Results showed that safe, high quality VMMC can be implemented and sustained at-scale, although substantial variability was observed over time. In some settings, facility preparedness and VMMC service quality improved as the number of VMMC facilities increased. Yet, lapses in high performance and expansion of considerably deficient services were also observed. Surgical tasks had the highest quality scores, with lower performance levels in infection control, pre-operative examinations, and post-operative patient monitoring and counseling. The range of scale-up models used across countries additionally underscored the complexity of delivering high quality VMMC., Conclusions: Greater efforts are needed to integrate VMMC scale-up and quality improvement processes in sub-Saharan African settings. Monitoring of service quality, not just adverse events reporting, will be essential in realizing the full health impact of VMMC for HIV prevention.

Background: Human resource capacity is vital to the scale-up of voluntary medical male circumcision (VMMC) services. VMMC providers are at risk of "burnout" from performing a single task repeatedly in a high volume work environment that produces long work hours and intense work effort., Methods and Findings: The Systematic Monitoring of the Voluntary Medical Male Circumcision Scale-up (SYMMACS) surveyed VMMC providers in Kenya, South Africa, Tanzania, and Zimbabwe in 2011 (n = 357) and 2012 (n = 591). Providers self-reported on their training, work experience, levels of job-fulfillment and work fatigue/burnout. Data analysis included a descriptive analysis of VMMC provider characteristics, and both bivariate and multivariate analyses of factors associated with provider work fatigue/burnout. In 2012, Kenyan providers had worked in VMMC for a median of 31 months compared to South Africa (10 months), Tanzania (15 months), and Zimbabwe (11 months). More than three-quarters (78 - 99%) of providers in all countries in 2012 reported that VMMC is a personally fulfilling job. However, 67% of Kenyan providers reported starting to experience work fatigue/burnout compared to South Africa (33%), Zimbabwe (17%), and Tanzania (15%). Despite the high level of work fatigue/burnout in Kenya, none of the measured factors (i.e., gender, age, full-time versus part-time status, length of service, number of operations performed, or cadre) were significantly associated with work fatigue/burnout in 2011. In 2012, logistic regression found increases in age (p<.05) and number of months working in VMMC (p<.01) were associated with an increased likelihood of experiencing work fatigue/burnout, while higher career total VMMCs decreased the likelihood of experiencing burnout., Conclusion: Given cross-country differences, further elucidation of cultural and other contextual factors that may influence provider burnout is required. Continuing to emphasize the contribution that providers make in the fight against HIV/AIDS is important.

Background: Countries participating in voluntary medical male circumcision (VMMC) scale-up have adopted most of six elements of surgical efficiency, depending on national policy. However, effective implementation of these elements largely depends on providers' attitudes and subsequent compliance. We explored the concordance between recommended practices and providers' perceptions toward the VMMC efficiency elements, in part to inform review of national policies., Methods and Findings: As part of Systematic Monitoring of the VMMC Scale-up (SYMMACS), we conducted a survey of VMMC providers in Kenya, South Africa, Tanzania, and Zimbabwe. SYMMACS assessed providers' attitudes and perceptions toward these elements in 2011 and 2012. A restricted analysis using 2012 data to calculate unadjusted odds ratios and 95% confidence intervals for the country effect on each attitudinal outcome was done using logistic regression. As only two countries allow more than one cadre to perform the surgical procedure, odds ratios looking at country effect were adjusted for cadre effect for these two countries. Qualitative data from open-ended responses were used to triangulate with quantitative analyses. This analysis showed concordance between each country's policies and provider attitudes toward the efficiency elements. One exception was task-shifting, which is not authorized in South Africa or Zimbabwe; providers across all countries approved this practice., Conclusions: The decision to adopt efficiency elements is often based on national policies. The concordance between the policies of each country and provider attitudes bodes well for compliance and effective implementation. However, study findings suggest that there may be need to consult providers when developing national policies.

Objective: To assess the safety, effectiveness and acceptability of the PrePex device for adult medical male circumcision (MMC) in routine service delivery in Kenya., Methods: We enrolled 427 men ages 18-49 at one fixed and two outreach clinics. Procedures were performed by trained clinical officers and nurses. The first 50 enrollees were scheduled for six follow-up visits, and remaining men were followed at Days 7 and 42. We recorded adverse events (AEs) and time to complete healing, and interviewed men about acceptability and pain., Results: Placement and removal procedures each averaged between 3 and 4 minutes. Self-reported pain was minimal during placement but was fleetingly intense during removal. The rate of moderate/severe AEs was 5.9% overall (95% confidence interval [CI] 3.8%-8.5%), all of which resolved without sequelae. AEs included 5 device displacements, 2 spontaneous foreskin detachments, and 9 cases of insufficient foreskin removal. Surgical completion of MMC was required for 9 men (2.1%). Among the closely monitored first 50 participants, the probability of complete healing by Day 42 was 0.44 (95% CI 0.30-0.58), and 0.90 by Day 56. A large majority of men was favorable about their MMC procedure and would recommend PrePex to friends and family., Conclusions: The PrePex device was effective for MMC in Kenya, and well-accepted. The AE rate was higher than reported for surgical procedures there, or in previous PrePex studies. Healing time is longer than following surgical circumcision. Provider experience and clearer counseling on post-placement and post-removal care should lead to lower AE rates., Trial Registration: ClinicalTrials.gov NCT01711411.

Background: The Kenyan Ministry of Health initiated a voluntary medical male circumcision (VMMC) program in 2008. We used data from 2 nationally representative surveys to estimate trends in the number, demographic characteristics, and sexual behaviors of recently circumcised and uncircumcised HIV-uninfected men in Kenya., Methods: We compared the proportion of circumcised men between the first and second Kenya AIDS Indicator Survey (KAIS 2007 and KAIS 2012) to assess the progress of Kenya's VMMC program. We calculated the number of uncircumcised HIV-uninfected men. We conducted descriptive analyses and used multivariable methods to identify the variables independently associated with HIV-uninfected uncircumcised men aged 15-64 years in the VMMC priority region of Nyanza., Results: The proportion of men who reported being circumcised increased significantly from 85.0% in 2007 to 91.2% in 2012. The proportions of circumcised men increased in all regions, with the highest increases of 18.1 and 9.0 percentage points in the VMMC priority regions of Nyanza and Nairobi, respectively. Half (52.5%) of HIV-uninfected and uncircumcised men had never been married, and 84.6% were not using condoms at all times with their last sexual partner., Conclusions: VMMC prevalence has increased across Kenya demonstrating the success of the national program. Despite this accomplishment, the Nyanza region remains below the target to circumcise 80% of all eligible men aged 15-49 years between 2009 and 2013. As new cohorts of young men enter into adolescence, consistent focus is needed. To ensure sustainability of the VMMC program, financial resources and coordinated planning must continue.

Objective: To provide guidance for male circumcision programmes in Kenya by estimating the population of uncircumcised men and investigating the association between circumcision and infection with the human immunodeficiency virus (HIV), with particular reference to uncircumcised, HIV-uninfected men., Methods: Data on men aged 15 to 64 years were derived from the 2007 Kenya AIDS Indicator Survey, which involved interviews and blood collection to test for HIV and herpes simplex virus 2 (HSV-2). The prevalence of HIV infection and circumcision in Kenyan provinces was calculated and the demographic characteristics and sexual behaviour of circumcised and uncircumcised, HIV-infected and HIV-uninfected men were recorded., Findings: The national prevalence of HIV infection in uncircumcised men was 13.2% (95% confidence interval, CI: 10.8-15.7) compared with 3.9% (95% CI: 3.3-4.5) among circumcised men. Nyanza province had the largest estimated number of uncircumcised, HIV-uninfected men (i.e. 601 709), followed by Rift Valley, Nairobi and Western Province, respectively, and most belonged to the Luo ethnic tribe. Of these men, 77.8% did not know their HIV status and 33.2% were HSV-2-positive. In addition, 65.3% had had unprotected sex with a partner of discordant or unknown HIV status in the past 12 months and only 14.7% consistently used condoms with their most recent partner. However, only 21.8% of the uncircumcised, HIV-uninfected men aged 15 to 19 years were sexually active., Conclusion: The Kenyan male circumcision strategy should focus on the provinces with the highest number of uncircumcised, HIV-uninfected men and target young men before or shortly after sexual debut.

As the science demonstrating strong evidence for voluntary medical male circumcision (VMMC) for HIV prevention has evolved, the President's Emergency Plan for AIDS Relief (PEPFAR) has collaborated with international agencies, donors, and partner country governments supporting VMMC programming. Mathematical models forecast that quickly reaching a large number of uncircumcised men with VMMC in strategically chosen populations may dramatically reduce community-level HIV incidence and save billions of dollars in HIV care and treatment costs. Because VMMC is a 1-time procedure that confers life-long partial protection against HIV, programs for adult men are vital short-term investments with long-term benefits. VMMC also provides a unique opportunity to reach boys and men with HIV testing and counseling services and referrals for other HIV services, including treatment. After formal recommendations by WHO in 2007, priority countries have pursued expansion of VMMC. More than 1 million males have received VMMC thus far, with the most notable successes coming from Kenya's Nyanza Province. However, a myriad of necessary cultural, political, and ethical considerations have moderated the pace of overall success. Because many millions more uncircumcised men would benefit from VMMC services now, US President Barack Obama committed PEPFAR to provide 4.7 million males with VMMC by 2014. Innovative circumcision methods-such as medical devices that remove the foreskin without injected anesthesia and/or sutures-are being rigorously evaluated. Incorporation of safe innovations into surgical VMMC programs may provide the opportunity to reach more men more quickly with services and dramatically reduce HIV incidence for all.

Objectives: To assess healing with Shang Ring removal at different prespecified times; whether spontaneous detachment occurs with delayed removal; problems, complaints, and acceptability of wearing the device; satisfaction among participants; and acceptability of the procedure among providers., Methods: Fifty HIV-negative men underwent a Shang Ring circumcision in Kenya. Men were randomly assigned for device removal at 7 (15 men), 14 (15 men), or 21 days (20 men). Follow-up visits were at 7, 14, 21, 28, and 42 days after circumcision and 2 days after removal., Results: Circumcision and device removal were conducted without significant problems. Mean times for circumcision and device removal were 6.5 (SD = 2.4) and 2.5 (SD = 0.8) minutes, respectively. Complete detachment of the device occurred in 22 (66.7%) men who wore it more than 7 days. Seven men (14.0%) with partial detachments requested removal 8-14 days postcircumcision due to pain/discomfort. Healing progressed normally in all participants; cumulative probabilities of complete healing were similar across groups. No severe or serious adverse events occurred. Acceptability among participants was high. Providers reported that Shang Ring circumcision was "very easy" compared with the forceps-guided procedure., Conclusion: The Shang Ring is safe and easy to use according to label instructions (7 day removal). Detachments occurred without significant problems, although some men requested removal of partially detached rings. Removal time had little effect on healing. These data help allay concerns about men not returning for ring removal and expand the evidence base suggesting the Shang Ring could facilitate rapid male circumcision rollout in sub-Saharan Africa.

Voluntary medical male circumcision (VMMC) reduces female-to-male HIV transmission by approximately 60%; modeling suggests that scaling up VMMC to 80% of men 15- to 49-years-old within five years would avert over 3.3 million new HIV infections in 14 high priority countries/regions in southern and eastern Africa by 2025 and would require 20.33 million circumcisions. However, the shortage of health professionals in these countries must be addressed to reach these proposed coverage levels. To identify human resource approaches that are being used to improve VMMC volume and efficiency, we looked at previous literature and conducted a program review. We identified surgical efficiencies, non-surgical efficiencies, task shifting, task sharing, temporary redeployment of public sector staff during VMMC campaign periods, expansion of the health workforce through recruitment of unemployed, recently retired, newly graduating, or on-leave health care workers, and the use of volunteer medical staff from other countries as approaches that address human resource constraints. Case studies from Kenya, Tanzania, and Swaziland illustrate several innovative responses to human resource challenges. Although the shortage of skilled personnel remains a major challenge to the rapid scale-up of VMMC in the 14 African priority countries/regions, health programs throughout the region may be able to replicate or adapt these approaches to scale up VMMC for public health impact.

Since the World Health Organization and the Joint United Nations Programme on HIV/AIDS recommended implementation of medical male circumcision (MC) as part of HIV prevention in areas with low MC and high HIV prevalence rates in 2007, the government of Kenya has developed a strategy to circumcise 80% of uncircumcised men within five years. To facilitate the quick translation of research to practice, a national MC task force was formed in 2007, a medical MC policy was implemented in early 2008, and Nyanza Province, the region with the highest HIV burden and low rates of circumcision, was prioritized for services under the direction of a provincial voluntary medical male circumcision (VMMC) task force. The government's early and continuous engagement with community leaders/elders, politicians, youth, and women's groups has led to the rapid endorsement and acceptance of VMMC. In addition, several innovative approaches have helped to optimize VMMC scale-up. Since October 2008, the Kenyan VMMC program has circumcised approximately 290,000 men, mainly in Nyanza Province, an accomplishment made possible through a combination of governmental leadership, a documented implementation strategy, and the adoption of appropriate and innovative approaches. Kenya's success provides a model for others planning VMMC scale-up programs.

Background: Following confirmation of the effectiveness of voluntary medical male circumcision (VMMC) for HIV prevention, the World Health Organization and the Joint United Nations Programme on HIV/AIDS issued recommendations in 2007. Less than 5 y later, priority countries are at different stages of program scale-up. This paper analyzes the progress towards the scale-up of VMMC programs. It analyzes the adoption of VMMC as an additional HIV prevention strategy and explores the factors may have expedited or hindered the adoption of policies and initial program implementation in priority countries to date., Methods and Findings: VMMCs performed in priority countries between 2008 and 2010 were recorded and used to classify countries into five adopter categories according to the Diffusion of Innovations framework. The main predictors of VMMC program adoption were determined and factors influencing subsequent scale-up explored. By the end of 2010, over 550,000 VMMCs had been performed, representing approximately 3% of the target coverage level in priority countries. The "early adopter" countries developed national VMMC policies and initiated VMMC program implementation soon after the release of the WHO recommendations. However, based on modeling using the Decision Makers' Program Planning Tool (DMPPT), only Kenya appears to be on track towards achievement of the DMPPT-estimated 80% coverage goal by 2015, having already achieved 61.5% of the DMPPT target. None of the other countries appear to be on track to achieve their targets. Potential predicators of early adoption of male circumcision programs include having a VMMC focal person, establishing a national policy, having an operational strategy, and the establishment of a pilot program., Conclusions: Early adoption of VMMC policies did not necessarily result in rapid program scale-up. A key lesson is the importance of not only being ready to adopt a new intervention but also ensuring that factors critical to supporting and accelerating scale-up are incorporated into the program. The most successful program had country ownership and sustained leadership to translate research into a national policy and program. Please see later in the article for the Editors' Summary.

Objective: To assess safety, preliminary efficacy, and acceptability of the Shang Ring, a novel disposable device for adult male circumcision in Kenya., Methods: Forty HIV-negative men were recruited in Homa Bay, Kenya. Circumcisions were performed by a trained physician or nurse working with 1 assistant. Follow-up was conducted at 2, 7, 9, 14, 21, 28, 35, and 42 days after circumcision. Rings were removed on day 7. Pain was assessed using a visual analog scale (VAS) (0 = no pain, 10 = worst possible). Men were interviewed at enrollment and on days 7 and 42., Results: All 40 procedures were completed successfully. Mean procedure and device removal times were 4.8 (SD ± 2.0) and 3.9 (SD ± 2.6) minutes, respectively. There were 6 mild adverse events, including 3 penile skin injuries, 2 cases of edema, and 1 infection; all resolved with conservative management. In addition, there were 3 partial ring detachments between days 2-7. None required treatment or early ring removal. Erections with the ring were well tolerated, with a mean pain score of 3.5 (SD ± 2.3). By day 2, 80% of men were back to work. At 42 days, all participants were very satisfied with their circumcision and would recommend the procedure to others., Conclusions: Our results demonstrate that the Shang Ring is safe for further study in Africa. Acceptability of the Shang Ring among participants was excellent. With short procedure times, less surgical skill required, and the ease with which it can be used by nonphysicians, the Shang Ring could facilitate rapid roll-out of male circumcision in sub-Saharan Africa.