Abstract
BackgroundThe World Health Organization (WHO) and the Joint United Nations Program on HIV/AIDS promote MC (male circumcision) as a key HIV prevention strategy where HIV prevalence and incidence are high and MC prevalence is low. In Zimbabwe, to achieve the 1.26 million circumcisions needed to be performed by 2015 to achieve optimal MC coverage, a new approach was needed. The primary objective of the current trial was to assess the performance (safety, procedure time, and cost) of the PrePex device compared to forceps-guided surgical circumcision.Methods and FindingsThis Phase II, randomized, open-label trial in Zimbabwe involved healthy, non-circumcised adult male volunteers who were randomly assigned to the PrePex device (n = 160) or surgical arm (n = 80). Three doctors and 4 nurses, all certified on both circumcision methods, performed the procedures. The PrePex device procedure involves a plastic ring with a rubber O-ring that necrotizes the foreskin to facilitate easy and minimally invasive removal. Total procedure time was the primary endpoint. Adverse event (AE) data were also gathered for 90 days post-procedure. All 80 participants in the surgical arm and 158 participants in the PrePex arm achieved complete circumcision. The total procedure time for the PrePex device was approximately one-third of the total surgical procedure (4.8 minutes, Standard Deviation [SD]: 1.2 versus 14.6 minutes; SD: 4.2; p<0.00001). There were 2 AEs for 2 participants (rate of 1.3%, 95% Confidence Interval: 0.0025–4.53%), which were resolved with simple intervention. The AEs were device related, including 1 case of pain leading to device removal and 1 case of removal of the device.ConclusionsThe trial supports previous studies’ conclusions that the PrePex procedure is safe, quick, easy to apply, and effective in terms of procedure time as an alternative to traditional surgical circumcision. The PrePex device has great potential for use in overburdened health systems and in resource-limited settings and is recommended for use in rapid scale-up of adult MC in Zimbabwe.Trial RegistrationClinicalTrials.gov NCT01956370
Highlights
Accruing evidence of meta-analyses and 3 randomized controlled trials (RCT) support the partial protective effect of male circumcision (MC) in reducing male HIV acquisition from an HIV-infected female sex partner by 53–75% [1,2,3,4,5,6]
The PrePex device has great potential for use in overburdened health systems and in resource-limited settings and is recommended for use in rapid scale-up of adult MC in Zimbabwe
The trial included: 1) a safety phase to determine the safety and efficacy of the PrePex device; 2) a comparative phase to assess the performance of the PrePex method compared to surgical circumcision; and 3) a field study to assess the ease of use by trained nurses
Summary
Accruing evidence of meta-analyses and 3 randomized controlled trials (RCT) support the partial protective effect of male circumcision (MC) in reducing male HIV acquisition from an HIV-infected female sex partner by 53–75% [1,2,3,4,5,6]. The World Health Organization (WHO) and the Joint United Nations Program on HIV/AIDS promote MC as a key HIV prevention strategy where HIV prevalence and incidence are high and MC prevalence is low [7]. The current article presents the Phase II comparative study that assessed the PrePex device performance (safety, procedure time, and cost) compared to surgical circumcision. The World Health Organization (WHO) and the Joint United Nations Program on HIV/AIDS promote MC (male circumcision) as a key HIV prevention strategy where HIV prevalence and incidence are high and MC prevalence is low. The primary objective of the current trial was to assess the performance (safety, procedure time, and cost) of the PrePex device compared to forceps-guided surgical circumcision
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
