Accepted Abstract presented in CROI 2013 Conference; Atlanta, USA
HIV Prevention: Male Circumcision with a Nonsurgical Device – Evaluation of Training Efficacy and Usage of Lidocaine 5% Dermal Cream (Rwanda)
Previous clinical trials with the PrePex showed that subjects complain of mild pain in the first 4 hours after device placement due to the necrotize initiation process. The primary objective was to find a pharmaceutical method to reduce the pain post device application. The study was conducted in 2 stages assessing subjects’ pain at key time points. Stage I enrolled 100 participants and stage II enrolled 47 participants.
Data was analyzed during stage I and conclusions were implemented in stage II. In Phase I, petroleum jelly was used as a lubricant to facilitate the PrePex application. Due to reported mild pain in the first 4 hours, in Phase II, generic dermal anesthetic cream (5% Lidocaine), was used as an optional pain relief. The average VAS pain score at the first 4 hours post-placement significantly fell from 2.4 in Phase I when using petroleum jelly to 0.3 in Phase II when using the Lidocaine cream. According to the results, the Ministry of Health of Rwanda has changed its PrePex MC guidelines for HIV prevention and added the use of Lidocaine 5% cream to the MC procedure to lower the pain and increase acceptability of the procedure.