Prospective Observational Study of the Shang Ring Device for Adult Medical Male Circumcision in a Routine Clinical Setting in Malawi

We evaluated the safety and acceptability of the ShangRing device for male circumcision during routine clinical service delivery in Namitete, Malawi.  We conducted a prospective observational study enrolling 500 HIV-negative men ages 18 to 49 years at St. Gabriel’s Hospital.  Participants returned for two follow-up visits: the removal visit (day 7 after placement) and the healing check visit (day 42 after placement).  We assessed pain, adverse events (AEs), acceptability, and healing.  500 men were screened; 498 were circumcised using the ShangRing and comprised the analysis population.  Seven participants (1.4%) experienced moderate AEs related to circumcision.  93% were judged to be completely healed at or before the day 42 visit; 6% were judged to be healed later than the day 42 visit; 5 participants (1.0%) were lost to follow-up.  98% of men stated they were very satisfied with the appearance of their circumcised penis, and 99.6% would recommend ShangRing circumcision to family/friends.  Adult male circumcision using the ShangRing was safe with a low AE rate at this service delivery site.  Acceptability factors were also favorable.  Addition of the ShangRing device could be beneficial to achieving the goals of the circumcision program in Malawi. (Afr J Reprod Health 2016; 20[4]: 60-66). Resume Nous avons evalue la securite et l'acceptabilite du dispositif ShangRing pour la circoncision masculine lors de la prestation de services cliniques de routine a Namitete au Malawi. Nous avons mene une etude d'observation prospective portant sur 500 hommes seronegatifs âges de 18 a 49 ans a l'Hopital St. Gabriel. Les participants sont retournes pour deux visites de suivi: la visite de retrait (le 7ieme jour apres le placement) et la visite de guerison (le 42ieme jour apres le placement). Nous avons evalue la douleur, les effets indesirables (EI), l'acceptabilite et la guerison. On a fait passer un test de depistage a 500 hommes; 498 ont ete circoncis en utilisant le ShangRing y compris la population d'analyse. Sept participants (1,4%) ont presente des effets indesirables moderes lies a la circoncision. 93% d'entre eux ont ete juges gueris completement avant la visite du jour 42; 6% ont ete juges gueris plus tard que la visite du jour 42; 5 participants (1,0%) ont ete perdus lors du suivi. 98% des hommes ont declare etre tres satisfaits de l'apparence de leur penis circoncis, et 99,6% recommanderaient la circoncision ShangRing a la famille ou aux amis. La circoncision chez l'adulte utilisant le ShangRing etait sans danger avec un faible taux d'EI a cet endroit de prestation de services. Les facteurs d'acceptabilite etaient egalement favorables. L'ajout du dispositif ShangRing pourrait etre benefique pour atteindre les objectifs du programme de la circoncision au Malawi. (Afr J Reprod Health 2016; 20[4]: 60-66).