Is the PrePex device an alternative for surgical male circumcision in adolescents ages 13–17 years? Findings from routine service delivery during active surveillance in Zimbabwe

Abstract

BackgroundMale circumcision devices have the potential to accelerate adolescent voluntary medical male circumcision roll-out. Here, we present findings on safety, acceptability and satisfaction from active surveillance of PrePex implementation among 618 adolescent males (13–17 years) circumcised in Zimbabwe.MethodsThe first 618 adolescents consecutively circumcised from October 2015 to October 2016 using PrePex during routine service delivery were actively followed up. Outcome measures included PrePex uptake, attendance for post-circumcision visits and adverse events (AEs). A survey was conducted amongst 500 consecutive active surveillance clients to assess acceptability and satisfaction with PrePex.ResultsA total of 1,811 adolescent males were circumcised across the three PrePex active surveillance sites. Of these, 870 (48%) opted for PrePex but only 618/870 (71%) were eligible. Among the 618, two (0.3%) self-removals requiring surgery (severe AEs), were observed. Four (0.6%) removals by providers (moderate AEs) did not require surgery. Another 6 (1%) mild AEs were due to: bleeding (n = 2), swelling (n = 2), and infection (n = 2). All AEs resolved without sequelae. Adherence to follow-up appointments was high (97.7% attended 7 day visit). A high proportion (71.6%) of survey respondents said they heard about PrePex from a mobilizer; 49.8% said they chose PrePex because they wanted to avoid the pain associated with the surgical procedure/surgery on their penis. Acceptability and satisfaction with PrePex was high; 95.4% indicated willingness to recommend PrePex to peers. A majority (92%) reported experiencing pain when PrePex was being removed.ConclusionsActive surveillance of the first 618 adolescent males circumcised using PrePex suggests that the device is both safe and acceptable when used in routine service delivery among 13–17 year-olds. There is need to intensify specific demand generation activities for PrePex male circumcision among this group of males.

Rollout of ShangRing circumcision with active surveillance for adverse events and monitoring for uptake in Kenya

“…The need to continuously stock all adult and adolescent device sizes may pose a challenge for procurement because the relative consumption rate of different devices sizes depends on daily service uptake by different age bands which is unpredictable. Similar challenges of device stock outs have been reported in other ShangRing studies [12,14] and may require large stock of buffer supplies in the roll out phase. An important new development that addresses this challenge is the approach of using reduced number of ShangRing sizes which was evaluated by Feldblum et al in Zambia and found to be effective and safe [16].…”

“…Based on the WHO prequalification of ShangRing and results of pilot studies in Kenya and other African counties, which demonstrated its safety, ease of use and good cosmetic outcomes [5][6][7][8][9][10][11], the Kenya national VMMC technical working group endorsed its rollout under an active AE surveillance protocol. The surveillance activity was conducted according to the WHO framework for clinical evaluation of MC devices [3] and was consistent with similar previous initiatives, notably by Mavhu et al [12]. The goal was to assess the feasibility of ShangRing device use in Kenya's VMMC program based on better understanding of the potential clinical and operational challenges or opportunities associated with its widespread use in routine clinical settings.…”

VMMC clients’ perception of increased risk of HIV infection, circumcision preferred choice of method, providers’ socio-demographics and mode of service delivery

“…On the other hand, devices are seen to be the solution to the pain caused by the injection since they use a cream as local anesthesia. Some have even called devices bloodless since there is no visible blood during the procedure 21 . Circumcision performed using Prepex device was preferred to the conventional method because for those who believed in culture since there is no spilling of blood which they believed to be a curse if you are still alive.…”