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

NCT02596282 | Completed Phase 2 DMC

• 1 other identifier: 00004524
• Study Type: interventional
• Target: 501
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Neonatal Male Circumcision

Keywords

neonatal male circumcision; Clinical officers vs Nurse midwives; Rakai, Uganda; acceptability and safety of neonatal male circumcision

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Procedure time

  Less than 15 minutes

• Parental satisfaction

  4 weeks

• Neonatal pain scale (NIPS)

  During surgery

Study Arms (2)

Clinical Officer (CO),

ACTIVE COMPARATOR

COs were trained and provided neonatal male circumcision under topical anesthesia using the Mogen clamp

Procedure: Neonatal circumcision under topical anesthesia

Nurse Midwife (NMW)

EXPERIMENTAL

NMWs were trained and provided neonatal male circumcision under topical anesthesia using the Mogen clamp

Procedure: Neonatal circumcision under topical anesthesia

Interventions

Neonatal circumcision under topical anesthesia PROCEDURE

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.

Also known as: Mogen clamp, Pre-operative analgesia

Clinical Officer (CO),; Nurse Midwife (NMW)

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Rakai Health Sciences Program: collaborator
• MRC/UVRI and LSHTM Uganda Research Unit: collaborator

Related Publications (1)

• 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.

  PMID: 27597563 DERIVED

Study Officials

• Ronald H Gray, MD MSc

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: November 4, 2015
• Study Start: October 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: November 4, 2015

Record last verified: 2015-11