The Safety and Acceptance of the PrePex Device for Non-Surgical Adult Male Circumcision in Rakai,Uganda. A Non-Randomized Observational Study

Objectives

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

Methods

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.

Results

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).

Conclusion

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.     

Adverse Events Profile of PrePex a Non-Surgical Device for Adult Male Circumcision in a Ugandan Urban Setting

Background

Safe Male Circumcision is a proven approach for partial HIV prevention. Several sub Saharan African countries have plans to reach a prevalence of 80% of their adult males circumcised by 2015. These targets require out of ordinary organization, demand creation, timely execution and perhaps the use of SMC devices.

Objective

To profile Adverse Events rate and acceptance of PrePex, a non surgical device for adult male circumcision.

Methods

A prospective study, conducted at International Hospital Kampala, Uganda, between August and October 2012. Ethical approval was obtained from Uganda National Council of Science and Technology.

Results

Of 1,040 men received to undergo SMC, 678 opted for PrePex, 36 were excluded at an initial physical examination screening. 642 were enrolled and consented, and another 17 were excluded before device placement. 625 underwent the procedure. Average age was 24 years (±7). Twelve moderate AEs occurred among 10 participants 12/625, (1.9%). These were all reversible. Five had device displacement, one had an everted foreskin; five had bleeding after the device was removed and one had voiding difficulties. The majority (279 out of 300) of men interviewed complained of some pain within the week of placement. Mean pain score at device placement (using visual analogue scale) was 0.5, at device removal 4.5 and within 2 min of removal the pain score was 1.4. Over 70% of the devices were placed and removed by non-physician clinicians. Presented with a choice, 60% of men chose PrePex over surgical SMC. Close to 90% would recommend the device to their friends. Odour from the necrotic skin was a concern. Removals done 1–2 days earlier than day 7 were beneficial and conferred no extra risk.

Conclusion

AEs of a moderate or severe nature associated with PrePex were low and reversible. PrePex is feasible for mass safe male circumcision scaling up.     

Skills Training of Health Workers in the Use of a Non Surgical Device (PrePex) for Adult Safe Male Circumcision

Background

Safe Male Circumcision (SMC) is a proven approach for partial protection of men from acquisition of HIV infection. Several sub-Saharan African countries have a target to circumcise 80% of males aged 15 to 49. The use of devices such as PrePex would aid scaling up of SMC. Since most health workers would have no prior experience with use of devices, skills training is needed. This paper explores a skills transfer model at an urban site in Uganda.

Objective

To assess the practicability and feasibility of rapid short duration training for safe PrePex device use.

Methods

A prospective study, conducted over 8 weeks (August–October 2012) at International Hospital Kampala, an urban Kampala hospital, examining the performance of various health worker cadres after training in the use of a non-surgical device (PrePex). The prospective study obtained approval from the Makerere School of Medicine Research and Ethics Committee and the Uganda National Council of Science and Technology. If eligible, and after the subject signed the informed consent form, they were enrolled into the study.

Results

Ten health workers were successfully trained in use of PrePex during a 3 day non-residential on-the-job training course. After the first three days of training, the trained health workers performed 561 placements and 529 device removals successfully. Over all adverse events (AE) rates were below ≤2%; however, there were some differences in AE rates across the cadres trained but not significant (p>0.25 for moderate AEs).

Conclusion

Rapid training for safe use of the PrePex device is feasible for the range of health workers available for SMC in resource limited settings, but among those with past SMC experience.     

Cost Analysis of Integrating the PrePex Medical Device into a Voluntary Medical Male Circumcision Program in Zimbabwe

Background

Fourteen African countries are scaling up voluntary medical male circumcision (VMMC) for HIV prevention. Several devices that might offer alternatives to the three WHO-approved surgical VMMC procedures have been evaluated for use in adults. One such device is PrePex, which was prequalified by the WHO in May 2013. We utilized data from one of the PrePex field studies undertaken in Zimbabwe to identify cost considerations for introducing PrePex into the existing surgical circumcision program.

Methods and Findings

We evaluated the cost drivers and overall unit cost of VMMC at a site providing surgical VMMC as a routine service (“routine surgery site”) and at a site that had added PrePex VMMC procedures to routine surgical VMMC as part of a research study (“mixed study site”). We examined the main cost drivers and modeled hypothetical scenarios with varying ratios of surgical to PrePex circumcisions, different levels of site utilization, and a range of device prices. The unit costs per VMMC for the routine surgery and mixed study sites were $56 and $61, respectively. The two greatest contributors to unit price at both sites were consumables and staff. In the hypothetical scenarios, the unit cost increased as site utilization decreased, as the ratio of PrePex to surgical VMMC increased, and as device price increased.

Conclusions

VMMC unit costs for routine surgery and mixed study sites were similar. Low service utilization was projected to result in the greatest increases in unit price. Countries that wish to incorporate PrePex into their circumcision programs should plan to maximize staff utilization and ensure that sites function at maximum capacity to achieve the lowest unit cost. Further costing studies will be necessary once routine implementation of PrePex-based circumcision is established.     

Acceptability of Male Circumcision for the Prevention of HIV/AIDS in the Dominican Republic

Background

Male circumcision (MC) is an effective strategy to prevent HIV infection in heterosexual men. To our knowledge, there are no studies of the acceptability of this procedure in the Dominican Republic (DR). The main objective of this study was to assess the acceptability of MC to prevent HIV transmission among men ages 18 to 50 years in the Altagracia Province in the Dominican Republic. Because differences in culture and beliefs between Haitians and Dominicans could potentially influence their acceptability of MC, we conducted a comparative analysis based on national origin.

Methods

A survey was administered to a convenience sample of 368 men. The questionnaire was divided in 3 sections: 1) Background demographics (including national origin), 2) Male circumcision and 3) Sexual health. Stratified and logistic multivariate regression analyses were performed to identify factors associated with the acceptability of MC.

Results

The sample consisted of 238 (65%) Dominicans and 130 (35%) Haitian immigrants. Almost all participants were uncircumcised (95%) and about half (52%) were single. The overall acceptability of MC was 29%. The number of men willing to be circumcised increased to 67% after an information session explaining the benefits of the procedure. 74% of men reported that they would be willing to circumcise their sons after hearing that information. In multivariate analysis, Haitian nationality (OR = 1.86, 95% CI 1.01–3.41), knowing that circumcision improves hygiene (OR = 2.78, 95% CI 1.29–6.0) and not believing that circumcision decreases sexual pleasure (OR = 2.18, 95% CI 1.20–3.94) were associated with a higher acceptability of the procedure. Although age was not significantly associated with the willingness to be circumcised in the multivariate analysis, stratified analysis based on national origin suggested that younger Dominicans (<30 years of age) are more likely to accept the procedure when compared to their older counterparts (OR = 2.17, 95% CI 1.14–4.12).

Conclusions

An important number of sexually active men in the DR may be willing to be circumcised if educational resources detailing the benefits of the procedure are made available. These educational activities would constitute a great opportunity to teach about sexual health and reinforce safe sex practices.     

Factors Associated with Knowledge of and Willingness for Adult Male Circumcision in Changsha,China

Background

Male circumcision (MC) has been shown to reduce the risk of male genital diseases. MC is not commonly practiced among Chinese males and little is known about the factors associated with their knowledge of and willingness for MC. This study was to explore the knowledge regarding the foreskin among Chinese males and to identify factors associated with their willingness to undergo circumcision.

Methods

A total of 237 patients with redundant prepuce/phimosis were interviewed through face-to-face interviews. The items on the questionnaire included: demographics, an objective scale assessing knowledge about the foreskin, willingness to have MC, the attitudes of sexual partners and doctors toward redundant prepuce/phimosis, and the approaches that patients used to acquire knowledge regarding the prepuce. Univariate analysis and multiple logistic regression analysis were performed to identify factors that are associated with willingness to be circumcised (WTC).

Results

A total of 212 patients completed the interview. Multivariable logistic regression showed that three factors were significantly associated with WTC: being married (OR = 0.43), perceiving redundant prepuce/phimosis as a disease (OR = 1.93), and if a patient’s partner supported MC (OR = 1.39). 58% (n = 122) had received information about the foreskin from another party: 18% (n = 37) from school, 8% (n = 17) from family, 17% (n = 36) from friends, 27% (n = 57) from health care providers. About 4% (n = 8) believed that their partners disliked their redundant prepuce/phimosis. 20% (n = 42) had received doctors’ advice to undergo circumcision.

Conclusion

Knowledge about the foreskin was low among Chinese males. Our study elucidates the factors associated with WTC and suggests that more education of the population about the foreskin can help improve the recognition of a correctible abnormality and help patients assess the potential role of MC in their health.     

PrePex Male Circumcision: Follow-Up and Outcomes during the First Two Years of Implementation at the Rwanda Military Hospital

Background

PrePex Male Circumcision (MC) has been demonstrated as an effective and scalable strategy to prevent HIV infection in low- and middle-income countries. This study describes the follow-up and outcomes of clients who underwent PrePex MC between January 2011 and December 2012 with weekly follow-up at the Rwanda Military Hospital, the first national hospital in Rwanda to adopt PrePex.

Methods

Data on570 clients age 21 to 54 were extracted from patient records. We compared socio-demographic and clinical characteristics, the operator''s qualification, HIV status, pain before and after device removal, urological status, device size and follow-up time between clients who were formally discharged and those who defaulted. We reported bivariate associations between each covariate and discharge status, number of people with adverse events by discharge status, and time to formal discharge or defaulting using life table methods. Data were entered into Epidata and analyzed with Stata v13.

Results

Among study participants, 96.5% were circumcised by non-physician operators, 85.4%were under 30years, 98.9% were HIV-negative and 97.9% were without any urological problems that could delay the healing time. Most (70.7%) defaulted before formal discharge. Pain before (p<0.001) and after PrePex device removal (p = 0.001) were associated with discharge status, although very few cases were reported, and pain was more commonly missing among defaulters. Twenty-seven adverse events were reported (7 formally discharged, 20 defaulters). Median follow-up time was seven weeks among formally discharged and six weeks among defaulters (p<0.001).

Conclusion

Given that all socio-demographic and most clinical characteristics were not associated with defaulting, we hypothesize that clients stopped returning once they determined they were healed. We recommend less frequent follow-up protocols to encourage clinical visits until formal discharge. Based on these results and recommendations, we believe PrePex MC is a practical circumcision strategy in Rwanda and in sub-Saharan Africa.     

Women's Beliefs about Male Circumcision,HIV Prevention,and Sexual Behaviors in Kisumu,Kenya

It is important to understand how women''s sexual practices may be influenced by male circumcision (MC) as an HIV prevention effort. Women''s beliefs about MC and sexual behaviour will likely influence the scale-up and uptake of medical MC. We conducted qualitative interviews with 30 sexually active women in Kisumu, Kenya. Women discussed MC related to perceived health benefits, condom use, sexual behaviour, knowledge of susceptibility to HIV and sexually transmitted infections (STIs), circumcision preference, and influence on circumcision uptake. Respondents had a good understanding of the partial protection of MC for acquisition of HIV for men. Women perceived circumcised men as cleaner, carrying fewer diseases, and taking more time to reach ejaculation. Male''s circumcision status is a salient factor for women''s sexual decision making, including partner choice, and condom use. It will be important that educational information affirms that MC provides only partial protection against female to male transmission of HIV and some STIs; that other HIV and STI prevention methods such as condoms need to be used in conjunction with MC; that MC does not preclude a man from having HIV; and that couples should develop plans for not having sex while the man is healing.     

Provider Attitudes toward the Voluntary Medical Male Circumcision Scale-Up in Kenya,South Africa,Tanzania and Zimbabwe

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.     

No-Needle,Single-Visit Adult Male Circumcision with Unicirc: A Multi-Centre Field Trial

Background

Voluntary medical male circumcision (VMMC) is a priority HIV preventive intervention. Current adult circumcision methods need improvement.

Methods

Field trial in 3 primary care centres. Minimally invasive VMMC using the Unicirc instrument following topical lidocaine/prilocaine anesthetic. Men were followed up at 1 and 4 weeks.

Results

We circumcised 110 healthy volunteers. Two men complained of transient burning pain during circumcision, but none required injectable anaesthesia. Median blood loss was 1ml and median procedure time was 9.0 min. There were 7 (6.3%) moderate complications (5 (4.5%) post-operative bleeds requiring suture and 2 (1.8%) post-operative infections) affecting 7 men. No men experienced significant wound dehiscence. 90.4% of men were fully healed at 4 weeks of follow-up and all were highly satisfied.

Conclusions

Use of topical anaesthesia obviates the need for injectable anesthetic and makes the Unicirc procedure nearly painless. Unicirc is rapid, easy to learn, heals by primary intention with excellent cosmetic results, obviates the need for a return visit for device removal, and is potentially cheaper and safer than other methods. Use of this method will greatly facilitate scale-up of mass circumcision programs.

Trial Registration

ClinicalTrials.gov NCT02091726     

Assessing Odor Level when Using PrePex for HIV Prevention: A Prospective,Randomized, Open Label,Blinded Assessor Trial to Improve Uptake of Male Circumcision

The PrePex is a WHO–prequalified medical device for adult male circumcision for HIV prevention. The Government of Rwanda was the first country to implement the PrePex device and acts as the leading center of excellence providing training and formal guidelines. As part of the Government’s efforts to improve PrePex implementation, it made efforts to improve the psychological acceptability of device by men, thus increasing uptake with VMMC in sub-Saharan Africa. Some men who underwent the PrePex procedure complained of foreskin odor while wearing the PrePex 3–7 days after it was placed. This complaint was identified as potential risk for uptake of the device. Researchers from Rwanda assumed there is a possible relation between the level of foreskin odor and patient foreskin hygiene technique. The Government of Rwanda decided to investigate those assumptions in a scientific way and conduct a trial to test different hygiene-cleaning methods in order to increase the acceptability of PrePex and mitigate the odor concern. The main objective of the trial was to compare odor levels between three arms, having identical personal hygiene but different foreskin hygiene techniques using either clear water with soap during a daily shower, soapy water using a syringe, or chlorhexidine using a syringe. One hundred and one subjects were enrolled to the trial and randomly allocated into three trial arms. Using chlorhexidine solution daily almost completely eliminated odor, and was statistically significant more effective that the other two arms. The trial results suggest that odor from the foreskin, while wearing the PrePex device, could be related to the growth of anaerobic bacteria, which can be prevented by a chlorhexidine cleaning method. This finding can be used to increase acceptability by men when considering PrePex as one of the leading methods for HIV prevention in VMMC programs.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT02153658","term_id":"NCT02153658"}}NCT02153658     

Acceptability of Voluntary Medical Male Circumcision (VMMC) among Male Sexually Transmitted Diseases Patients (MSTDP) in China

Voluntary Medical Male circumcision (VMMC) is an evidence-based, yet under-utilized biomedical HIV intervention in China. No study has investigated acceptability of VMMC among male sexually transmitted diseases patients (MSTDP) who are at high risk of HIV transmission. A cross-sectional survey interviewed 350 HIV negative heterosexual MSTDP in Shenzhen, China; 12.0% (n = 42) of them were circumcised at the time of survey. When the uncircumcised participants (n = 308) were informed that VMMC could reduce the risk of HIV infection via heterosexual intercourse by 50%, the prevalence of acceptability of VMMC in the next six months was 46.1%. Adjusted for significant background variables, significant factors of acceptability of VMMC included: 1) emotional variables: the Emotional Representation Subscale (adjusted odds ratios, AOR = 1.13, 95%CI: 1.06–1.18), 2) cognitive variables derived from Health Belief Model (HBM): perceived some chance of having sex with HIV positive women in the next 12 months (AOR = 2.48, 95%CI: 1.15–5.33) (perceived susceptibility), perceived severity of STD infection (AOR = 1.06, 95%CI: 1.02–1.10), perceived benefit of VMMC in risk reduction (AOR = 1.29, 95%CI: 1.16–1.42) and sexual performance (AOR = 1.45, 95%CI: 1.26–1.71), perceived barriers against taking up VMMC (AOR = 0.88, 95%CI: 0.81–0.95), and perceived cue to action (AOR = 1.41, 95%CI: 1.23–1.61) and self-efficacy (AOR = 1.38, 95%CI: 1.26–1.35) related to taking up VMMC. The association between perceived severity of STD infection and acceptability was fully mediated by emotional representation of STD infection. The relatively low prevalence of circumcision and high acceptability suggested that the situation was favorable for implementing VMMC as a means of HIV intervention among MSTDP in China. HBM is a potential suitable framework to guide the design of future VMMC promotion. Future implementation programs should be conducted in STD clinic settings, taking the important findings of this study into account.     

Attitudes,Perceptions and Potential Uptake of Male Circumcision among Older Men in Turkana County,Kenya Using Qualitative Methods

Background

In many communities, older men (i.e., over 25 years of age) have not come forward for Voluntary Medical Male Circumcision (VMMC) services. Reasons for low demand among this group of men are not well understood, and may vary across geographic and cultural contexts. This paper examines the facilitators and barriers to VMMC demand in Turkana County, Kenya, with a focus on older men. This is one of the regions targeted by the VMMC program in Kenya because the Turkana ethnic group does not traditionally circumcise, and the rates of HIV and STD transmission are high.

Methods and Findings

Twenty focus group discussions and 69 in-depth interviews were conducted with circumcised and uncircumcised men and their partners to elicit their attitudes and perceptions toward male circumcision. The interviews were conducted in urban, peri-urban, and rural communities across Turkana. Our results show that barriers to circumcision include stigma associated with VMMC, the perception of low risk for HIV for older men and their “protection by marriage,” cultural norms, and a lack of health infrastructure. Facilitators include stigma against not being circumcised (since circumcision is associated with modernity), protection against disease including HIV, and cleanliness. It was also noted that older men should adopt the practice to serve as role models to younger men.

Conclusions

Both men and women were generally supportive of VMMC, but overcoming barriers with appropriate communication messages and high quality services will be challenging. The justification of circumcision being a biomedical procedure for protection against HIV will be the most important message for any communication strategy.     

Acceptability of Male Circumcision among College Students in Medical Universities in Western China: A Cross-Sectional Study

Background

Male circumcision (MC) has been shown to reduce the risk of female to male transmission of HIV. The goal of this survey was to explore MC’s acceptability and the factors associated with MC among college students in medical universities in western China.

Methods

A cross-sectional study was carried out in three provinces in western China (Guangxi, Chongqing and Xinjiang) to assess the acceptability of MC as well as to discover factors associated with the acceptability among college students in medical universities. A total of 1,790 uncircumcised male students from three medical universities were enrolled in this study. In addition, 150 students who had undergone MC were also enrolled in the survey, and they participated in in-depth interviews.

Results

Of all the uncircumcised participants (n = 1,790), 55.2% (n = 988) were willing to accept MC. Among those who accepted MC, 67.3% thought that MC could improve their sexual partners’ hygiene, 46.3% believed that HIV and sexually transmitted diseases (STDs) could be partially prevented by MC. The multivariable logistic regression indicates that MC’s acceptability was associated with three factors: the redundant foreskin (OR = 10.171, 95% CI = 7.629–13.559), knowing the hazard of having a redundant foreskin (OR = 1.597, 95% CI = 1.097–2.323), and enhancing sexual pleasure (OR = 1.628, 95% CI = 1.312–2.021). The in-depth interviews for subjects who had undergone MC showed that the major reason for having MC was the redundant foreskin (87.3%), followed by the benefits and the fewer complications of having MC done. In addition, most of these participants (65.3%) said that the MC could enhance sexual satisfaction.

Conclusions

MC’s acceptance among college students in medical universities is higher than it is among other populations in western China. An implementation of an MC programme among this population is feasible in the future.     

Implications of the Fast-Evolving Scale-Up of Adult Voluntary Medical Male Circumcision for Quality of Services in South Africa

Background

The scale-up of voluntary medical male circumcision (VMMC) services in South Africa has been rapid, in an attempt to achieve the national government target of 4.3 million adult male circumcisions for HIV prevention by 2016. This study assesses the effect of the scale-up on the quality of the VMMC program.

Methods and Findings

This analysis compares the quality of services at 15 sites operational in 2011 to (1) the same 15 sites in 2012 and (2) to a set of 40 sites representing the expanded program in 2012. Trained clinicians scored each site on 29 items measuring readiness to provide quality services (abbreviated version of the WHO Quality Assessment [QA] Guide) and 29 items to assess quality of surgical care provided (pre-op, surgical technique and post-op) based on the observation of VMMC procedures at each site. Declines in quality far outnumbered improvements. The negative effects in terms of readiness to provide quality services were most evident in expanded sites, whereas the declines in provision of quality services tended to affect both repeat sites and expanded sites equally. Areas of notable concern included the monitoring of adverse events, external supervision, post-operative counselling, and some infection control issues. Scores on quality of surgical technique tended to be among the highest across the 58 items observed, and the South Africa program has clearly institutionalized three “best practices” for surgical efficiency.

Conclusions

These findings demonstrate the challenges of rapidly developing large numbers of new VMMC sites with the necessary equipment, supplies, and protocols. The scale-up in South Africa has diluted human resources, with negative effects for both the original sites and the expanded program.     

Systematic Monitoring of Voluntary Medical Male Circumcision Scale-Up: Adoption of Efficiency Elements in Kenya,South Africa,Tanzania, and Zimbabwe

Background

SYMMACS, the Systematic Monitoring of the Voluntary Medical Male Circumcision Scale-up, tracked the implementation and adoption of six elements of surgical efficiency— use of multiple surgical beds, pre-bundled kits, task shifting, task sharing, forceps-guided surgical method, and electrocautery—as standards of surgical efficiency in Kenya, South Africa, Tanzania, and Zimbabwe.

Methods and Findings

This multi-country study used two-staged sampling. The first stage sampled VMMC sites: 73 in 2011, 122 in 2012. The second stage involved sampling providers (358 in 2011, 591 in 2012) and VMMC procedures for observation (594 in 2011, 1034 in 2012). The number of VMMC sites increased significantly between 2011 and 2012; marked seasonal variation occurred in peak periods for VMMC. Countries adopted between three and five of the six elements; forceps-guided surgery was the only element adopted by all countries. Kenya and Tanzania routinely practiced task-shifting. South Africa and Zimbabwe used pre-bundled kits with disposable instruments and electrocautery. South Africa, Tanzania, and Zimbabwe routinely employed multiple surgical bays.

Conclusions

SYMMACS is the first study to provide data on the implementation of VMMC programs and adoption of elements of surgical efficiency. Findings have contributed to policy change on task-shifting in Zimbabwe, a review of the monitoring system for adverse events in South Africa, an increased use of commercially bundled VMMC kits in Tanzania, and policy dialogue on improving VMMC service delivery in Kenya. This article serves as an overview for five other articles following this supplement.     

Surgical Efficiencies and Quality in the Performance of Voluntary Medical Male Circumcision (VMMC) Procedures in Kenya,South Africa,Tanzania, and Zimbabwe

Introduction

This analysis explores the association between elements of surgical efficiency in voluntary medical male circumcision (VMMC), quality of surgical technique, and the amount of time required to conduct VMMC procedures in actual field settings. Efficiency outcomes are defined in terms of the primary provider’s time with the client (PPTC) and total elapsed operating time (TEOT).

Methods

Two serial cross-sectional surveys of VMMC sites were conducted in Kenya, Republic of South Africa, Tanzania and Zimbabwe in 2011 and 2012. Trained clinicians observed quality of surgical technique and timed 9 steps in the VMMC procedure. Four elements of efficiency (task-shifting, task-sharing [of suturing], rotation among multiple surgical beds, and use of electrocautery) and quality of surgical technique were assessed as explanatory variables. Mann Whitney and Kruskal Wallis tests were used in the bivariate analysis and linear regression models for the multivariate analyses to test the relationship between these five explanatory variables and two outcomes: PPTC and TEOT. The VMMC procedure TEOT and PPTC averaged 23–25 minutes and 6–15 minutes, respectively, across the four countries and two years. The data showed time savings from task-sharing in suturing and use of electrocautery in South Africa and Zimbabwe (where task-shifting is not authorized). After adjusting for confounders, results demonstrated that having a secondary provider complete suturing and use of electrocautery reduced PPTC. Factors related to TEOT varied by country and year, but task-sharing of suturing and/or electrocautery were significant in two countries. Quality of surgical technique was not significantly related to PPTC or TEOT, except for South Africa in 2012 where higher quality was associated with lower TEOT.

Conclusions

SYMMACS data confirm the efficiency benefits of task-sharing of suturing and use of electrocautery for decreasing TEOT. Reduced TEOT and PPTC in high volume setting did not result in decreased quality of surgical care.     

Systematic Monitoring of Male Circumcision Scale-Up in Nyanza,Kenya: Exploratory Factor Analysis of Service Quality Instrument and Performance Ranking

Background

Considerable conceptual and operational complexities related to service quality measurements and variability in delivery contexts of scaled-up medical male circumcision, pose real challenges to monitoring implementation of quality and safety. Clarifying latent factors of the quality instruments can enhance contextual applicability and the likelihood that observed service outcomes are appropriately assessed.

Objective

To explore factors underlying SYMMACS service quality assessment tool (adopted from the WHO VMMC quality toolkit) and; determine service quality performance using composite quality index derived from the latent factors.

Study design

Using a comparative process evaluation of Voluntary Medical Male Circumcision Scale-Up in Kenya site level data was collected among health facilities providing VMMC over two years. Systematic Monitoring of the Medical Male Circumcision Scale-Up quality instrument was used to assess availability of guidelines, supplies and equipment, infection control, and continuity of care services. Exploratory factor analysis was performed to clarify quality structure.

Results

Fifty four items and 246 responses were analyzed. Based on Eigenvalue >1.00 cut-off, factors 1, 2 & 3 were retained each respectively having eigenvalues of 5.78; 4.29; 2.99. These cumulatively accounted for 29.1% of the total variance (12.9%; 9.5%; 6.7%) with final communality estimates being 13.06. Using a cut-off factor loading value of ≥0.4, fifteen items loading on factor 1, five on factor 2 and one on factor 3 were retained. Factor 1closely relates to preparedness to deliver safe male circumcisions while factor two depicts skilled task performance and compliance with protocols. Of the 28 facilities, 32% attained between 90^th and 95^th percentile (excellent); 45% between 50^th and 75^th percentiles (average) and 14.3% below 25^th percentile (poor).

Conclusion

the service quality assessment instrument may be simplified to have nearly 20 items that relate more closely to service outcomes. Ranking of facilities and circumcision procedure using a composite index based on these items indicates that majority performed above average.     

包皮切割缝合器、商环及传统包皮环切术的临床疗效比较

目的:比较包皮切割缝合器与商环及传统包皮环切术治疗包皮过长或包茎的手术疗效及安全性。方法:将240例包皮过长或包茎患者随机分为传统包皮环切术组、商环组及包皮切割缝合器组(PCSD)。对比分析三组手术时间、出血量、术中疼痛评分、术后疼痛评分、切口愈合时间、感染、切口裂开、术后水肿、术后出血等情况。结果:在手术时间、术中疼痛评分、术后疼痛评分、切口愈合时间、感染、切口裂开、术后水肿方面,PCSD组都明显优于传统包皮环切术组及商环组(P0.05);PCSD组术中出血量明显少于传统包皮环切术组(P0.05),而与商环组比较未见明显差别;在术后出血方面,三组比较未见明显的差异。结论:PCSD可以明显缩短包皮过长或包茎的手术时间,降低术中、术后疼痛,减少术后并发症。     

Quality of Voluntary Medical Male Circumcision Services during Scale-Up: A Comparative Process Evaluation in Kenya,South Africa,Tanzania and Zimbabwe

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.