Safety and Efficacy of the PrePex Device for Rapid Scale-Up of Male Circumcision for HIV Prevention in Resource-Limited Settings

Kanombe Military Hospital, Kigali, Rwanda.
JAIDS Journal of Acquired Immune Deficiency Syndromes (Impact Factor: 4.56). 09/2011; 58(5):e127-34. DOI: 10.1097/QAI.0b013e3182354e65
Source: PubMed


To assess the safety and efficacy of the PrePex device for nonsurgical circumcision in adult males as part of a comprehensive HIV prevention program in Rwanda.
Single-center 6-week noncontrolled study in which healthy men underwent circumcision using the PrePex device, which employs fitted rings to clamp the foreskin, leading to distal necrosis. In the first phase of the study, the feasibility of the procedure was tested on 5 subjects in a sterile environment; in the main phase, an additional 50 subjects were circumcised in a nonsterile setting by physicians or a nurse. Outcome measures included the rate of successful circumcision, time to complete healing, pain, and adverse events.
In the feasibility phase, all 5 subjects achieved complete circumcision without adverse events. In the main phase, all 50 subjects achieved circumcision with 1 case of diffuse edema after device removal, which resolved with minimal intervention. Pain was minimal except briefly during device removal (day 7 after placement in most cases). The entire procedure was bloodless, requiring no anesthesia, no suturing, and no sterile settings. Subjects had no sick/absent days associated with the procedure. Median time for complete healing was 21 days after device removal. There were no instances of erroneous placement and no mechanical problems with the device.
The PrePex device was safe and effective for nonsurgical adult male circumcision without anesthesia or sterile settings and may be useful in mass circumcision programs to reduce the risk of HIV infection, particularly in resource-limited settings.

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    • "One obstacle to MMC scale up in adolescents and adults is the time and provider skills required for conventional surgical procedures (forceps guided, dorsal slit and sleeve circumcision) all of which entail a surgical time of 15–45 minutes (depending on provider experience), aseptic conditions and skill in hemostasis and suturing for wound closure. Two devices, the Shang Ring [6] and the PrePex device [7]–[10] offer potential advantages in reduction of procedure time which could increase throughput of clients, a lower requirement for asepsis and the procedures can be performed by less skilled providers [7], [8], [10] which could facilitate task shifting and sharing. Both devices must be removed 5–9 days after placement. "
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    ABSTRACT: 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.
    PLoS ONE 08/2014; 9(8):e100008. DOI:10.1371/journal.pone.0100008 · 3.23 Impact Factor
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    • "Some of the crucial contents for messages for better acceptability in India could be the assurance to provide easier options to undergo medical circumcision in the existing health systems and better follow-up and post-surgical pain management. The program can explore the usage of devices that negate the need for anesthetic injection (perceived to be painful) and sutures [55]. Messages on other benefits of MC including improved genital hygiene, reduction in chances of urinary tract infections and other STIs and relief from phimosis should also be stressed. "
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    ABSTRACT: Although male circumcision (MC) is recommended as an HIV prevention option, the religious, cultural and biomedical dimensions of its feasibility, acceptability and practice in India have not been explored till date. This study explores beliefs, experiences and understanding of the community and healthcare providers (HCPs) about adult MC as an HIV prevention option in India. This qualitative study covered 134 in-depth interviews from Belgaum, Kolkata, Meerut and Mumbai cities of India. Of these, 62 respondents were the members of circumcising (CC)/non-circumcising communities (NCC); including medically and traditionally circumcised men, parents of circumcised children, spouses of circumcised men, and religious clerics. Additionally, 58 registered healthcare providers (RHCPs) such as general and pediatric surgeons, pediatricians, skin and venereal disease specialists, general practitioners, and operation theatre nurses were interviewed. Fourteen traditional circumcisers were also interviewed. The data were coded and analyzed in QSR NUD*IST ver. 6.0. The study has not explored the participants' views about neonatal versus adult circumcision. Members of CC/NCC, traditional circumcisers and RCHPs expressed sharp religious sensitivities around the issue of MC. Six themes emerged: Male circumcision as the religious rite; Multiple meanings of MC: MC for 'religious identity/privilege/sacrifice' or 'hygiene'; MC inflicts pain and cost; Medical indications outweigh faith; Hesitation exists in accepting 'foreign' evidence supporting MC; and communication is the key for acceptance of MCs. Medical indications could make members of NCC accept MC following appropriate counseling. Majority of the RHCPs demanded local in-country evidence. HCPs must educate high-risk groups regarding the preventive and therapeutic role of MC. Communities need to discuss and create new social norms about male circumcision for better societal acceptance especially among the NCC. Feasibility studies on MC as an individual specific option for the high risk groups in health care setting needs to be explored.
    PLoS ONE 03/2014; 9(3):e91213. DOI:10.1371/journal.pone.0091213 · 3.23 Impact Factor
    • "Efficacy, Safety and Comparative studies have been completed in Rwanda and will soon be completed in Zimbabwe. No studies have yet been concluded in Uganda [8], [9], [10], although two are under way at IHK and Rakai. "
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    ABSTRACT: Modelling, supported by the USAID Health Policy Initiative and UNAIDS, performed in 2011, indicated that Uganda would need to perform 4.2 million medical male circumcisions (MMCs) to reach 80% prevalence. Since 2010 Uganda has completed 380,000 circumcisions, and has set a national target of 1 million for 2013. To evaluate the relative reach and cost-effectiveness of PrePex compared to the current surgical SMC method and to determine the effect that this might have in helping to achieve the Uganda national SMC targets. A cross-sectional descriptive cost-analysis study conducted at International Hospital Kampala over ten weeks from August to October 2012. Data collected during the performance of 625 circumcisions using PrePex was compared to data previously collected from 10,000 circumcisions using a surgical circumcision method at the same site. Ethical approval was obtained. The moderate adverse events (AE) ratio when using the PrePex device was 2% and no severe adverse events were encountered, which is comparable to the surgical method, thus the AE rate has no effect on the reach or cost-effectiveness of PrePex. The unit cost to perform one circumcision using PrePex is $30.55, 35% ($7.90) higher than the current surgical method, but the PrePex method improves operator efficiency by 60%, meaning that a team can perform 24 completed circumcisions compared to 15 by the surgical method. The cost-effectiveness of PrePex, comparing the cost of performing circumcisions to the future cost savings of potentially averted HIV infections, is just 2% less than the current surgical method, at a device cost price of $20. PrePex is a viable SMC tool for scale-up with unrivalled potential for superior reach, however national targets can only be met with effective demand creation and availability of trained human resource.
    PLoS ONE 05/2013; 8(5):e63134. DOI:10.1371/journal.pone.0063134 · 3.23 Impact Factor
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