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

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.

Guidelines for surgeons on establishing projects in low-income countries.

BACKGROUND: There is increasing interest by surgeons in high-income countries to support colleagues in low-income countries to improve the provision of surgical care, particularly in rural areas. Such interest may be demonstrated by single individuals, short-term surgical missions, or establishment of partnerships. Such altruistic efforts may cause problems unless properly planned and carried out. METHODS: We reviewed the available literature and consulted widely to establish consensus guidelines for any surgeon considering participating in an initiative to improve surgical care in low-income countries. RESULTS: A series of recommendations is presented. These include ensuring that projects are appropriate, that there is an emphasis on training local healthcare providers in all aspects of perioperative care, that outcomes are monitored, and that initiatives work with local and regional training programs. CONCLUSIONS: With adherence to these recommendations, we hope that future partnerships and missions can maximize their effectiveness and minimize the risks of potential harm done.