Background: The Voluntary Medical Male Circumcision (VMMC) program in Tanzania started in 2009, and is being implemented in 12 priority regions, with a goal of circumcising 2.1million adolescents and men by 2017. Up to December 2013 more than 780,000 VMMCs had been conducted with support from PEPFAR. Achieving this target needs innovative ways such as introduction of circumcision devices to accelerate scale up. Jhpiego, supported by USAID, therefore implemented the first safety and acceptability study for the PrePexTM device in the country. Safety of the procedure will take precedence as the new method is being introduced.
Methods: A single-arm, open-label, prospective, cohort study was conducted from June-October 2014 across 9 sites in three regions of Iringa, Njombe and Tabora, Tanzania. The study received IRB approval from JHU and the local IRB authority. Clients were aged 18-49 and fulfilled all study inclusion criteria. Analysis on adverse events was performed and adverse event (AE) rates calculated using clients returning for follow-up as a denominator. Mild adverse events were excluded from this analysis.
Results: 869 clients were eligible for circumcision using the PrePex device during the study period. Of these, placement was successful in 862 clients. All clients returned for follow-up (100% return rate). There were a total of 22 moderate and severe adverse events reported (AE rate 2.5% %). Of these, 13 (59%) were moderate and 9 (41%) severe. Ten commonest adverse events (in descending order of frequency) related to device circumcision included: pain, hematoma, swelling, early removal, bleeding, infection, difficulty removal, delayed healing, device displacement and wound dehiscence. Most AEs (61.5%) occurred with the device in situ followed by 32.1% during removal, 3.9% during follow-up and 2.5% during placement.
Conclusions: The AE rate in this study was low and similar to other safety and acceptability studies in sub -Saharan Africa. Pain was found to be the commonest adverse event highlighting the need to explore pain management alternatives. Clients need to be appropriately and adequately educated on signs and symptoms of common AEs after placement of the device since majority of AEs occur while the client is wearing the device.

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