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

Neonatal Male Circumcision Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02596282
• Other study ID #: 00004524
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 23, 2015
• Last updated: November 2, 2015
• Start date: October 2014
• Est. completion date: July 2015

Study information

• Verified date: November 2015
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: Research Ethics CommitteeUganda: National Council for Science and Technology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A to 28 Days

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Neonatal Male Circumcision

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	MRC/UVRI Uganda Research Unit on Aids, Rakai Health Sciences Program

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events related to circumcision	Adverse events graded as mild, moderate and severe	4 weeks	Yes
Primary	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	No
Primary	Wound healing	Completed wound healing (clean intact scar without a scab or stitch sinus)	4 weeks	Yes
Secondary	Procedure time	Length of time from preoperative prep to completion	Less than 15 minutes	No
Secondary	Parental satisfaction	Mother's report of satisfaction with the procedure	4 weeks	No
Secondary	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	Yes