A Phase II Randomized Controlled Trial Comparing Safety, Procedure Time, and Cost of the PrePex™ Device to Forceps Guided Surgical Circumcision in Zimbabwe

Mufuta Tshimanga; Tonderayi Mangwiro; Owen Mugurungi; Sinokuthemba Xaba; Munyaradzi Murwira; Danuta Kasprzyk; Daniel E Montaño; Daisy Nyamukapa; Basile Tambashe; Pesanai Chatikobo; Patricia Gundidza; Gerald Gwinji

doi:10.1371/journal.pone.0156220

A Phase II Randomized Controlled Trial Comparing Safety, Procedure Time, and Cost of the PrePex™ Device to Forceps Guided Surgical Circumcision in Zimbabwe

PLoS One. 2016 May 26;11(5):e0156220. doi: 10.1371/journal.pone.0156220. eCollection 2016.

Affiliations

¹ Department of Community Medicine, College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe.
² Department of Surgery, College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe.
³ Ministry of Health and Child Care, Harare, Zimbabwe.
⁴ Zimbabwe National Family Planning Council, Harare, Zimbabwe.
⁵ Battelle Health and Analytics, Seattle, United States of America.
⁶ United Nations Population Fund, Harare, Zimbabwe.

Abstract

Background: 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. 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 findings: This 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.

Conclusions: The 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 registration: ClinicalTrials.gov NCT01956370.

Publication types

Clinical Trial, Phase II
Comparative Study
Randomized Controlled Trial

MeSH terms

Adolescent
Adult
Circumcision, Male / economics*
Circumcision, Male / instrumentation*
Cost-Benefit Analysis
HIV Infections / prevention & control
Humans
Male
Middle Aged
Safety
Surgical Instruments / economics*
Time Factors
Young Adult
Zimbabwe

Associated data

ClinicalTrials.gov/NCT01956370

Grants and funding

The United Nations Population Fund funded this study (http://www.unfpa.org/public/). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.