Background

Male circumcision (MC) is a proven HIV prevention intervention, reducing the risk of heterosexual acquisition of HIV in men by 57–67% in three randomized controlled trials and in long-term follow-up studies [1–6]. The World Health Organization (WHO) and UNAIDS approved scale-up of adolescent and adult voluntary medical male circumcision (VMMC) as part of comprehensive HIV prevention programs, and approximately 11.7 million circumcisions have been achieved in 14 east and Southern African countries through 2015 [7]. As a few countries, including Kenya, have achieved their original targets for total VMMCs and as others are expecting to do so in the next few years, governments and donor agencies are considering whether and how best to transition from focusing on adolescent and adult circumcision to early infant male circumcision (EIMC) [8–10].

In 2010, the WHO published the “Manual for Early Infant Male Circumcision under Local Anaesthesia [11],” which included pre-qualification of the Mogen, Gomco and Plastibell devices for EIMC. Since that time, several studies and demonstration projects have employed the Mogen clamp [9,10,12–14], and the Mogen is the device currently approved by the Kenyan Ministry of Health for EIMC [15]. However, other devices are being field tested and are under consideration for adoption in several African countries. These include the AccuCirc [16–18] and most recently the PrePex. These three devices differ in important ways and each has advantages and disadvantages. The Mogen is made of stainless steel and appropriate for repeated uses. It has two flat blades approximately 2.5mm apart through which the foreskin is placed following the angle of the corona, ensuring the glans is not trapped. The blades are clamped together, crushing the tissue and achieving hemostasis. The foreskin is excised along the distal edge of the clamp. The AccuCirc is a single use disposable device designed to protect the glans from laceration or amputation, a possible complication seen in some Mogen cases [19–22]. The device consists of a shielding ring and a single-action clamp that contains a circular blade. The clamp is applied and activated to deliver a circumferential, hemostatic crush while simultaneously incising the foreskin. The PrePex is an elastic compression device with a plastic ring that is placed around the shaft of the penis inside the foreskin proximal to the corona. An elastic compression ring is placed outside the foreskin fitting into the groove of the inner ring. The device is left in situ, the foreskin necrotizes, and is sloughed, while the device detaches spontaneously after a mean of 6 days [23].

Evaluations of specialized devices for EIMC are important to provide programs with the information required to make informed decisions about which devices fit different local needs. We here provide assessments by providers with experience employing all three of the devices most likely to be considered by various EIMC programs in east and Southern Africa. The providers compare the advantages and disadvantages of each device and give their informed opinions on which device would be best to use in different contexts, including as part of a large scale national EIMC program.

Methods

This study was a discussion group conducted as part of a larger evaluation of the safety and acceptability of the AccuCirc device for EIMC. The participants were clinical officers, nurses, interviewers and mobilizers who had experience in provision of EIMC services with at least two of the three EIMC devices (i.e., AccuCirc, Mogen or PrePex). The two interviewers and a mobilizer were included to gain their insights regarding cultural preferences, demand creation and mothers’ opinions about the procedure. The study participants were all employees of the Nyanza Reproductive Health Society, a Kenyan NGO that has been providing VMMC services since 2007 and EIMC since 2010. The participants did not receive any direct payment for participation but were provided with dinner after the discussion. Participation was voluntary and all participants provided verbal informed consent. Signed informed consent was not required since it would unnecessarily expose the participants to risk of loss of anonymity. An information document was provided to each participant explaining the risks and benefits of study participation and including contact information for the P.I. and the two IRBs. The study was approved by the Maseno University Ethics and Research Committee and the University of Illinois at Chicago Institutional Review Board.

Results

Participant characteristics

The study included 11 participants: 6 (55%) women and 5 (45%) men (Table 1). The median age was 32 years (range 24–45). Three participants were clinical officers, five were nurses, two were interviewers, and one was a mobilizer. All eight clinicians had performed EIMC using both the Mogen clamp and the AccuCirc, while five of the clinicians also had experience with the PrePex device.

Download:

• PPT
  PowerPoint slide
• PNG
  larger image
• TIFF
  original image

Table 1. Characteristics of study participants.

https://doi.org/10.1371/journal.pone.0171445.t001

Discussion

As policymakers and donors consider whether and how to transition to sustainable models of male circumcision for HIV prevention, some programs are assessing the feasibility and safety of introducing EIMC services into health facilities as part of MNCH programs [8–10]. Knowing the attributes and challenges associated with different EIMC methods will be critical to making informed choices regarding best and safest EIMC practices. This is the only study to date that reports the opinions of healthcare providers who have experienced provision of EIMC services using three different infant circumcision devices: the Mogen Clamp, the PrePex device, and the AccuCirc device. Their informed opinions will be useful to programmers considering introduction of EIMC services in sub-Saharan African settings.

There was no one device that was seen to be clearly superior to the others. Each had its own advantages and disadvantages. Notably, provider preferences were situation-specific. Most preferred the Mogen if they themselves were performing the procedure. However, most were concerned that not everyone will have the skills necessary for optimal safety. When asked which device they would recommend if someone else were circumcising their son, most would opt for the AccuCirc because of the risk of severing the glans when using the Mogen. A minority preferred the PrePex, but only if the baby received local anesthesia, not EMLA cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%), as presently prescribed by the manufacturer. In the context of a national EIMC program, all participants agreed that AccuCirc would be the device they would recommend due to protection of the glans from laceration and to the provision of a pre-assembled sterile kit that overcomes the need for additional supplies or autoclaving. They also all agreed that scaling up EIMC, integrating it with existing MNCH services, will face many challenges, not least of which being to persuade providers to take on an additional workload when they are already overloaded and poorly compensated.

WHO has pre-qualified three devices for EIMC: the Mogen, Gomco and Plastibell devices [24]. The Gomco clamp has an excellent safety record as a stainless steel bell protects the glans from the risk of laceration or amputation. However, a limitation of this clamp is that it requires four different parts and exists in many different sizes which require the provider to use the correctly sized parts when assembling the device [11]. As far as we are aware, there have been no evaluations of the Gomco or Plastibell in Kenya. A trial comparing the Mogen clamp to the Plastibell in Botswana found that minor adverse events were more common with the Mogen compared with the Plastibell; however, there were two severe adverse events with the Plastibell. The authors expressed preference for the Mogen clamp due to the risk of migration and retention of the Plastibell, which could result in necrosis of the glans in the absence of the kind of follow-up inherent to a research study [25]. The Mogen is the device currently approved by the Kenya Ministry of Health for EIMC [8], and several studies and demonstration projects have chosen to employ the Mogen clamp [12–14, 17, 18], including two studies conducted by our group [12, 19, 26, 27]. Adverse event rates when employing the Mogen are relatively low. However, when an adverse event occurs, it can be a laceration to the glans or even an amputation. Such events are rare, but they do occur [19–22, 27], and all providers using the Mogen are very fearful that they may inadvertently cause damage no matter how much care they take. As one provider stated it, “When I close that clamp, my heart is in my throat and I am praying that I have not pinched the glans.”

The AccuCirc device avoids any risk of damage to the glans. It has undergone evaluation in a single-arm study in Botswana with no serious adverse events [16]. A randomized non-inferiority trial of the AccuCirc versus the Mogen conducted in Zimbabwe found no difference in AE rates when employing the two devices [17], and a subsequent study by the same group found that AE rates were low (1.4%) among 500 circumcisions performed by nurse-midwives using the AccuCirc, with no serious AEs (SAE). In Kenya, among 600 EIMCs performed by our group with the AccuCirc, we had an AE rate of 2.8% with no SAEs [18]. An analysis of costs of EIMC found that AccuCirc has lower unit cost ($49.53) versus the Mogen ($55.93), primarily due to lower costs of consumable supplies [28]. The AccuCirc procedure has been found to be acceptable to parents and could increase uptake of EIMC [16–18]. The drawback of the AccuCirc is the high frequency of incomplete or partial cuts [16,18] in which the blade does not cut completely through the entire circumference of foreskin, requiring completion of the incision with scissors. Some incomplete cuts can result in bleeding that requires one or a few sutures [16,18].

The participants in our study expressed concern that integrating EIMC services with ongoing reproductive, maternal, newborn and child health platforms will be challenging primarily because of human resource constraints, competing priorities and desire for compensation for additional responsibilities. Such challenges have been voiced in the context of incipient programs in other countries [9] and in our experimental programs in Kenya [28]. These, along with the need for large scale training in the face of limited initial demand for EIMC, are challenges that will require innovation and collaboration across all segments of the healthcare system to address.

The primary limitation of this study is its small sample size of just 11 EIMC providers. As more doctors, clinical officers and nurses become trained and gain EIMC experience using different devices, the views regarding methods and how to scale up EIMC services safely and efficiently may change. This may be especially true once there is more experience with the PrePex device. However, at this time, we are unaware of any other study that has included providers who have experienced the use of the three main EIMC devices likely to be considered for scale-up of national EIMC programs in east and southern Africa. Thus this report should prove very useful to many programmers, donors and practitioners as they design their EIMC programs. Also, this study is novel for asking providers their opinions about which device is preferable under varying circumstances, going beyond preference for personal use to include preference for which device would be best in a national scale-up scenario.

Conclusion

Based on the experience and preferences of the providers included in this study who have performed EIMCs using three different devices, the AccuCirc device may be the safest and most preferred device for use in a large-scale regional or national EIMC program. The process for bringing the AccuCirc device to the WHO pre-qualification stage should move forward as countries consider implementation of sustainable circumcision programs for comprehensive HIV prevention. In addition, this study highlights some of the many challenges that programmers will face as they seek to initiate EIMC in east and southern Africa. Among those mentioned in this study are: lack of familiarity with EIMC on the part of both populations and providers, cultural and religious barriers, demand creation, low initial uptake, obtaining parental consent, comprehensive screening of infants, safety of the procedure itself, emergency response capability, training of providers, ensuring maintenance of provider skills, and integration with maternal neonatal child health services.

Acknowledgments

We thank the health providers who participated in this study, as well as the mothers and babies who chose to be circumcised during the course of the study. We are grateful to all the Nyanza Reproductive Health Society staff who contributed to this study, especially Mildred Adhiambo, Stella Adhiambo, Everline Agutu, Teresa Akech, Mary Immaculate Auma, Kentose Gutu, Caroline Muringa, Edmon Obat, Erick Okello, Valentine Pengo, Jared Wadeya, and Simon Were. We also thank Dr. Ojwang Lusi and the Kenya Ministry of Health for their support and Drs. Rebeca Plank, Marisa Young and David Tomlinson for the key roles they played in this research.