Safety, Feasibility, and Acceptability of the PrePex Device for Adult Male Circumcision in Malawi.

Pamela K Kohler,David Chilongozi,Frank Chimbwandira,Dorothy Namate,Jason Reed,Medson Machaya,Khuliena Kabwere,Franklin Kilembe,Sean Galagan,Mwawi Mwale,Anderson Kang'Ombe,Beth A Tippett Barr,Carola Hofstee,Wezi Msunguma

doi:10.1097/qai.0000000000000774

Abstract

Introduction:Nonsurgical adult male circumcision devices present an alternative to surgery where health resources are limited. This study aimed to assess the safety, feasibility, and acceptability of the PrePex device for adult male circumcision in Malawi.Methods:A prospective single-arm cohort study was conducted at 3 sites (1 urban static, 1 rural static, 1 rural tent) in Malawi. Adverse event (AE) outcomes were stratified to include/exclude pain, and confidence intervals (CIs) were corrected for clinic-level clustering.Results:Among 935 men screened, 131 (14.0%) were not eligible, 13 (1.4%) withdrew before placement, and 791 (84.6%) received the device. Moderate and severe AEs totaled 7.1% including pain [95% CI: 3.4–14.7] and 4.0% excluding pain (95% CI: 2.6 to 6.4). Severe AEs included pain (n = 3), insufficient skin removal (n = 4), and early removal (n = 4). Among early removals, 1 had immediate surgical circumcision, 1 had surgery after 48 hours of observation, 1 declined surgery, and 1 did not return to our site although presented at a nearby clinic. More than half of men (51.9%) reported odor; however, few (2.2%) stated they would not recommend the device to others because of odor. Median levels of reported pain (scale, 1–10) were 2 (interquartile range, 2–4) during application and removal, and 0 (interquartile range, 0–2) at all other time points.Conclusions:Severe AEs were rare and similar to other programs. Immediate provision of surgical services after displacement or early removal proved a challenge. Cases of insufficient skin removal were linked to poor technique, suggesting provider training requires reinforcement and supervision.

Highlights

Nonsurgical adult male circumcision devices present an alternative to surgery where health resources are limited
Moderate and severe adverse event (AE) totaled 7.1% including pain [95% confidence intervals (CIs): 3.4–14.7] and 4.0% excluding pain
Cases of insufficient skin removal were linked to poor technique, suggesting provider training requires reinforcement and supervision

Summary

Introduction

Nonsurgical adult male circumcision devices present an alternative to surgery where health resources are limited. This study aimed to assess the safety, feasibility, and acceptability of the PrePex device for adult male circumcision in Malawi. By 2012, Malawi had reached ,2% of this target.[6] Countries with limited health infrastructure face a number of challenges in scaling up VMMC services, including inadequate financial resources, lack of surgical infrastructure, and lack of human resource capacity.[7] Nonsurgical circumcision devices present an alternative to surgery, where health infrastructure and resources are limited.[8] PrePex (Circ MedTech), one of such devices, works by compressing the foreskin with 2 rings to block circulation distally, after which the foreskin becomes necrotic and is removed after a period of 7 days. Clinical studies indicated that the PrePex device had similar adverse event (AE) rates to surgical circumcision; a somewhat longer healing time was documented.[10,11,12] After the clinical trials, the World Health

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