Safety and Acceptability of the PrePex Device When Used in Routine Male Circumcision Service Delivery During Active Surveillance in Zimbabwe.

Webster Mavhu,Frances M Cowan,Jo Keatinge,Mufuta Tshimanga,Sinokuthemba Xaba,Christopher A Samkange,Getrude Ncube,Karin Hatzold,Emmanuel Njeuhmeli,Owen Mugurungi,Tonderayi Mangwiro,Ngonidzashe Madidi,Efison Dhodho

doi:10.1097/qai.0000000000000721

Abstract

Background:Male circumcision devices have the potential to accelerate voluntary medical male circumcision roll-out, with PrePex being one promising device. Here, we present findings on safety and acceptability from active surveillance of the implementation of PrePex among 1000 males circumcised in Zimbabwe.Methods:The first 1000 men consecutively circumcised using PrePex during routine service delivery were actively followed up. Outcome measures included PrePex uptake, attendance for postcircumcision visits, and adverse events (AEs). A survey was conducted among 500 consecutive active surveillance clients to assess acceptability and satisfaction with PrePex.Results:A total of 2156 men aged 18 years or older were circumcised across the 6 PrePex active surveillance sites. Of these, 1000 (46.4%) were circumcised using PrePex. Among them, 4 (0.4%) self-removals that required surgery (severe AEs) were observed. Six (0.6%) removals by providers (moderate AEs) did not require surgery. A further 280 (28%) AEs were mild or moderate pain during device removal. There were also 12 (1.2%) moderate AEs unrelated to pain. All AEs resolved without sequelae. There was high adherence to follow-up appointments, with 97.7% of clients attending the scheduled day 7 visit. Acceptability of PrePex was high among survey participants, 93% indicated willingness to recommend the device to peers. Of note, 95.8% of respondents reported experiencing pain when the device was being removed. Additionally, 85.2% reported experiencing odor while wearing the device or during removal.Conclusions:Active surveillance of the first 1000 men circumcised using PrePex suggests that the device is both safe and acceptable when used in routine service delivery.

Highlights

Fourteen African countries are currently accelerating voluntary medical male circumcision (VMMC) roll-out.[1,2,3,4,5] Modeling studies conducted between 2009 and 2011 suggested that circumcising males aged 15–49 years to reach 80% coverage within 5 years in these countries, and maintaining this coverage thereafter, could avert 3.4 million new HIV infections within 15 years and yield treatment and care savings of US$16.5 billion.[2,3] The modeling suggested that the faster coverage of VMMC can be achieved, the greater the number of infections averted.[3]
A total of 2156 men aged 18 years or older were circumcised across the 6 PrePex active surveillance sites
Active surveillance of the first 1000 men circumcised using PrePex suggests that the device is both safe and acceptable when used in routine service delivery

Summary

Introduction

Fourteen African countries are currently accelerating voluntary medical male circumcision (VMMC) roll-out.[1,2,3,4,5] Modeling studies conducted between 2009 and 2011 suggested that circumcising males aged 15–49 years to reach 80% coverage within 5 years in these countries, and maintaining this coverage thereafter, could avert 3.4 million new HIV infections within 15 years and yield treatment and care savings of US$16.5 billion.[2,3] The modeling suggested that the faster coverage of VMMC can be achieved, the greater the number of infections averted.[3] Male circumcision devices have the potential to accelerate VMMC roll-out by making the procedure easier, quicker, and more widely accessible.[4,6] One promising device for VMMC is PrePex, which works by compressing the foreskin between a ring and an elastic band, leading to distal tissue necrosis.[7] Following results from PrePex device studies in Rwanda,[8,9] additional research with the device was conducted in Zimbabwe to establish its safety, efficacy, and acceptability among providers and clients.[10,11,12] Data from these studies contributed to the prequalification of PrePex by the World Health Organization (WHO) for use in adults aged 18 years or older.[13] In addition to the criteria defined in the Framework for Clinical Evaluation of Devices for Male Circumcision,[14] WHO outlined an evaluation series that each country. We present findings on safety and acceptability from active surveillance of the implementation of PrePex among 1000 males circumcised in Zimbabwe

Methods

Results

Discussion

Conclusion