NCT02596282

Enhanced Provision of Male Circumcision (MC) for HIV Prevention, Rakai, Uganda

A Randomized Trial of the Acceptability and Safety of Early Infant Male Circumcision (EIMC) Conducted by Nurse Midwives and Clinical Offices Using the Mogen Clamp

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 501 (actual)
• Sponsor: Johns Hopkins Bloomberg School of Public Health · Academic / Other
• Sex: Male
• Age: 1 Day – 28 Days
• Healthy volunteers: Accepted

Summary

Background: Medical male circumcision (MMC) for HIV prevention is a priority in 14 East and Southern African countries, and the long-term sustainability of MMC programs could best be achieved by early infant male circumcision (EIMC.) However, the acceptability and safety of EIMC provided by non-physicians is unknown. Methods: We conducted a trial of EIMC using the Mogen clamp provided by newly trained clinical officers (CO) and nurse midwives (NMWs) in 4 health centers in rural Rakai, Uganda. 501 healthy neonates aged 1-28 days with normal birth weight and gestational age were randomized to CO (n=256) and NMWs (n=245), and were followed up at 24 hours, 7 and 28 days. Combined analgesia was provided by paracetamol suppository, Eutectic Mixture of Local Anesthetics (EMLA) cream and a 24% sucrose solution.

Detailed description

The objective was to assess the acceptability and safety of neonatal male circumcision performed by clinical officers (equivalent to US physician assistants) and nurse midwives, using the Mogen clamp. This was a randomized, blinded trial of circumcision using the Mogen clamp under topical anesthesia in healthy male infants aged 1-28 days, with normal birth weight and gestational age, performed by trained clinical officers or nurse midwives, randomized 1:1 in Rakai District, Uganda. Mothers of male infants born in 4 health centers were invited to participate and signed an informed consent for screening and enrollment. Infants were screened on enrollment prior to randomization (1;1) to clinical officer and nurse midwife circumcision providers. Follow up was via a phone call at 24 hours, 7 days and 4 weeks post-circumcision.

Conditions

• Neonatal Male Circumcision

Interventions

Type	Name	Description
PROCEDURE	Neonatal circumcision under topical anesthesia	The standard procedure for neonatal circumcision is as follows: combined analgesia was topical 2.5% lidocaine and 2.5% prilocaine \<1 gm applied 60 minutes and 40mg acetaminophen suppository 30 minutes prior to surgery. Infants were given a 24% sucrose solution pacifier if needed. Infants under 2 weeks of age received subcutaneous Vitamin K 1 mg. The perineum cleaned, and the penis swabbed with povidone iodine. Hemostats were applied at 3 and 9 o'clock positions and the glans pushed down. Traction was applied before placing the Mogen clamp, the clamp was closed for 5 minutes and the foreskin removed with a scalpel. Petroleum jelly (e.g., Vaseline) was applied to the glans and the wound covered with sterile gauze. Infants were observed for one hour. Mothers were instructed in wound care.

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2015-11-04
• Last updated: 2015-11-04