Safety and Efficacy of the PrePex Male Circumcision Device: Results From Pilot Implementation Studies in Mozambique, South Africa, and Zambia.

BACKGROUND: Fourteen countries in East and Southern Africa have engaged in national programs to accelerate the provision of voluntary medical male circumcision (VMMC) since 2007. Devices have the potential to accelerate VMMC programs by making the procedure easier, quicker, more efficient, and widely accessible. METHODS: Pilot Implementation studies were conducted in Mozambique, South Africa, and Zambia. The primary objective of the studies was to assess the safety of PrePex device procedures when conducted by nurses and clinical officers in adults and adolescent males (13-17 years, South Africa only) with the following end points: number and grade of adverse events (AEs); pain-related AEs measured using visual analog score; device displacements/self-removals; time to complete wound healing; and procedure times for device placement and removal. RESULTS: A total of 1401 participants (1318 adult and 83 adolescent males) were circumcised using the PrePex device across the 3 studies. Rates of moderate/severe AEs were low (1.0%; 2.0%; and 2.8%) in the studies in Mozambique, Zambia, and South Africa, respectively. Eight early self-removals of 1401 (0.6%) were observed, all required corrective surgery. High rates of moderate/severe pain-related AEs were recorded especially at device removal in South Africa (34.9%) and Mozambique (59.5%). Ninety percent of participants were healed at day 56 postplacement. DISCUSSION: The study results from the 3 countries suggest that the implementation of the PrePex device using nonphysician health care workers is both safe and feasible, but better pain control at device removal needs to be put in place to increase the comfort of VMMC clients using the PrePex device.

Acceptability and Satisfaction Associated With the Introduction of the PrePex Circumcision Device in Maputo, Mozambique.

BACKGROUND: Adult device circumcision may potentially reach more men in Sub-Saharan Africa, with fewer human resource and capacity needs than surgical procedures. Despite these advantages, little is known about device acceptability, including pain and maintaining the device in situ. METHODS: Healthy, HIV-negative men, between 18 and 49 years, in a Maputo clinic, were consecutively asked to participate in a circumcision device study that included assessing acceptability. Clinical forms and self-administered surveys were used to collect data at various times during the circumcision process for consenting men. Data were entered into a central database and analyzed using statistical software. RESULTS: Between May and July, 2013, 504 men received device circumcision. Placement was painless for 98.2% of the male population, but the pain was more common during removal with 38.3% reporting severe or unbearable and 21.5% moderate pain. Satisfaction was high at both time points with 88.8% and 92.6% of men being very or somewhat satisfied at placement and removal, respectively. Half of the male population (50.2%) was very or somewhat comfortable with the device in situ; whereas, 36.8% were somewhat or very uncomfortable. Common device difficulties experienced were painful erections (38.5%) and difficult urination (21.8%) and hygiene (21.4%). By the final clinic visit at day 49, 90.4% of them were very or somewhat satisfied with the procedure. DISCUSSION: High levels of satisfaction were reported for device circumcision, despite the pain noted during removal and some challenges with the device in situ. Given the advantages and acceptability among Mozambican men in this study, device circumcision could be offered, when clinically appropriate, as an alternative to surgery.

Comparative Cost Analysis of Surgical and PrePex Device Male Circumcision in Zimbabwe and Mozambique.

BACKGROUND: The PrePex device has proven to be safe for voluntary medical male circumcision (VMMC) in adults in several African countries. Costing studies were conducted as part of a PrePex/Surgery comparison study in Zimbabwe and a pilot implementation study in Mozambique. METHODS: The studies calculated per male circumcision unit costs using a cost-analysis approach. Both direct costs (consumable and nonconsumable supplies, device, personnel, associated staff training) and selected indirect costs (capital and support personnel costs) were calculated. RESULTS: The cost comparison in Zimbabwe showed a unit cost per VMMC of $45.50 for PrePex and $53.08 for surgery. The unit cost difference was based on higher personnel and consumable supplies costs for the surgical procedure, which used disposable instrument kits. In Mozambique, the costing analysis estimated a higher unit cost for PrePex circumcision ($40.66) than for surgery ($20.85) because of higher consumable costs, particularly the PrePex device and lower consumable supplies costs for the surgical procedure using reusable instruments. Supplies and direct staff costs contributed 87.2% for PrePex and 65.8% for surgical unit costs in Mozambique. DISCUSSION: PrePex device male circumcision could potentially be cheaper than surgery in Zimbabwe, especially in settings that lack the infrastructure and personnel required for surgical VMMC, and this might result in programmatic cost savings. In Mozambique, the surgical procedure seems to be less costly compared with PrePex mainly because of higher consumable supplies costs. With reduced device unit costs, PrePex VMMC could become more cost-efficient and considered as complementary for Mozambique's VMMC scale-up program.