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

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.

Study Overview

• Status: Completed
• Conditions: Neonatal Male Circumcision
• Intervention / Treatment: Procedure: Neonatal circumcision under topical anesthesia

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.

• Study Type: Interventional
• Enrollment (Actual): 501
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• age 1-28 days
• birth weight >= 2,500 gm
• gestational age >=37 weeks
• no illness. normal temperature
• no genital anatomic abnormality

Exclusion Criteria:

• age >28 days
• birth weight <2,500 gm
• gestational age <37 weeks
• Ill health
• genital abnormality

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Clinical Officer (CO),; COs were trained and provided neonatal male circumcision under topical anesthesia using the Mogen clamp	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.; Other Names: Mogen clamp; Pre-operative analgesia
Experimental: Nurse Midwife (NMW); NMWs were trained and provided neonatal male circumcision under topical anesthesia using the Mogen clamp	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.; Other Names: Mogen clamp; Pre-operative analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events related to circumcision	Adverse events graded as mild, moderate and severe	4 weeks
Acceptability as measured by the proportion of mothers directly informed about the study who consented to enroll in the trial	Proportion of registered mother-child pairs in which the male infant was circumcised	through study completion, an of 1 year
Wound healing	Completed wound healing (clean intact scar without a scab or stitch sinus)	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure time	Length of time from preoperative prep to completion	Less than 15 minutes
Parental satisfaction	Mother's report of satisfaction with the procedure	4 weeks
Neonatal pain scale (NIPS)	based of facial expression, crying, breathing patterns, movement of arms and legs, and state of arousal. NIPS scores 0 were classified as no pain, scores 1-2 mild, scores 3-4 as moderate and >4 as severe pain.	During surgery

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: MRC/UVRI and LSHTM Uganda Research Unit; Rakai Health Sciences Program
• Investigators: Principal Investigator: Ronald H Gray, MD MSc, Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

General Publications

• Kankaka EN, Murungi T, Kigozi G, Makumbi F, Nabukalu D, Watya S, Kighoma N, Nampijja R, Kayiwa D, Nalugoda F, Serwadda D, Wawer M, Gray RH. Randomised trial of early infant circumcision performed by clinical officers and registered nurse midwives using the Mogen clamp in Rakai, Uganda. BJU Int. 2017 Jan;119(1):164-170. doi: 10.1111/bju.13589. Epub 2016 Sep 6.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: October 23, 2015
• First Submitted That Met QC Criteria: November 2, 2015
• First Posted (Estimate): November 4, 2015

Study Record Updates

• Last Update Posted (Estimate): November 4, 2015
• Last Update Submitted That Met QC Criteria: November 2, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: neonatal male circumcision; Clinical officers vs Nurse midwives; Rakai, Uganda; acceptability and safety of neonatal male circumcision
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 00004524