Safety, effectiveness and acceptability of the PrePex device for adult male circumcision in Kenya.
OBJECTIVE
To assess the safety, effectiveness and acceptability of the PrePex device for adult medical male circumcision (MMC) in routine service delivery in Kenya.


METHODS
We enrolled 427 men ages 18-49 at one fixed and two outreach clinics. Procedures were performed by trained clinical officers and nurses. The first 50 enrollees were scheduled for six follow-up visits, and remaining men were followed at Days 7 and 42. We recorded adverse events (AEs) and time to complete healing, and interviewed men about acceptability and pain.


RESULTS
Placement and removal procedures each averaged between 3 and 4 minutes. Self-reported pain was minimal during placement but was fleetingly intense during removal. The rate of moderate/severe AEs was 5.9% overall (95% confidence interval [CI] 3.8%-8.5%), all of which resolved without sequelae. AEs included 5 device displacements, 2 spontaneous foreskin detachments, and 9 cases of insufficient foreskin removal. Surgical completion of MMC was required for 9 men (2.1%). Among the closely monitored first 50 participants, the probability of complete healing by Day 42 was 0.44 (95% CI 0.30-0.58), and 0.90 by Day 56. A large majority of men was favorable about their MMC procedure and would recommend PrePex to friends and family.


CONCLUSIONS
The PrePex device was effective for MMC in Kenya, and well-accepted. The AE rate was higher than reported for surgical procedures there, or in previous PrePex studies. Healing time is longer than following surgical circumcision. Provider experience and clearer counseling on post-placement and post-removal care should lead to lower AE rates.


BACKGROUND
ClinicalTrials.gov NCT01711411.
Clinical Sciences Unit, FHI 360, Durham, North Carolina, United States of America.
Paul J
PJ
Feldblum
Nyanza Reproductive Health Society, Kisumu, Kenya; Centers for Disease Control and Prevention/Kenya, Nairobi, Kenya.
Elijah
E
Odoyo-June
Nyanza Reproductive Health Society, Kisumu, Kenya; University of Illinois at Chicago, Chicago, Illinois, United States of America.
Walter
W
Obiero
University of Illinois at Chicago, Chicago, Illinois, United States of America.
Robert C
RC
Bailey
Clinical Sciences Unit, FHI 360, Durham, North Carolina, United States of America.
Stephanie
S
Combes
Clinical Sciences Unit, FHI 360, Durham, North Carolina, United States of America.
Catherine
C
Hart
Quantitative Sciences Department, FHI 360, Durham, North Carolina, United States of America.
Jaim
J
Jou Lai
Clinical Sciences Unit, FHI 360, Durham, North Carolina, United States of America.
Shelly
S
Fischer
National AIDS & STI Control Programme, Nairobi, Kenya.
Peter
P
Cherutich
D000293:Adolescent; D000328:Adult; D002944:Circumcision, Male / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods*; D006801:Humans; D007630:Kenya; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010342:Patient Acceptance of Health Care; D057566:Self Report; D016896:Treatment Outcome; D014945:Wound Healing; D055815:Young Adult