Evaluation of the safety of the Taraklamp male circumcision device in Zambia

Abstract

Background: Male circumcision has been proved to be an effective additional means of preventing transmission of the HIV virus from females to males in heterosexual relationships with efficacy of up to 60%. Many methods and devices for adult male circumcision have now been developed. However, there are still concerns on safety, duration of procedure, and public acceptability of these devices.

Objectives: to assess safety, duration of procedure, complications, pain and public acceptability of the Taraklamp, male circumcision device, in adolescents and adult male circumcision in Zambia.

Materials and Methods: we conducted a field study with 1,046 male adolescents and adults recruited from five district clinics. Prior to circumcision, participants were educated on benefits of circumcision while undergoing HIV counseling and screening. Duration of procedure was recorded, intra and postoperative pain was assessed and adverse events were documented for each participant. Levels of satisfaction with the procedure both from doctors' and participants' perspectives were also documented.

Results: A total of 794 participants were circumcised using the TARAKLAMP device. The median time for circumcision was 4 minutes (IQR: 3-6 minutes; range: 1- 24 minutes). Approximately 5 (0.6%) of the participants experienced postoperative pain and 12 (1.5%) experienced adverse events following the procedure. Despite this all participants found the procedure safe and acceptable, as did the doctors who carried out the procedure.

Conclusions: the results from this study showed that the TARAKLAMP device is safe for medical male circumcision. Acceptability of the circumcision using the device was exceptional and it is possible to use the TARAKLAMP to roll out medical male circumcision in Zambia.