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Completed

NCT Number: NCT02596282

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

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.

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Key information

Conditions

Neonatal Male Circumcision

Age range

1 day–28 day

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Mogen clamp, Pre-operative analgesia

Primary outcomes

  1. Adverse events related to circumcision

    Time frame: 4 weeks

    Adverse events graded as mild, moderate and severe

  2. Acceptability as measured by the proportion of mothers directly informed about the study who consented to enroll in the trial

    Time frame: through study completion, an of 1 year

    Proportion of registered mother-child pairs in which the male infant was circumcised

  3. Wound healing

    Time frame: 4 weeks

    Completed wound healing (clean intact scar without a scab or stitch sinus)

Secondary outcomes

  1. Procedure time

    Time frame: Less than 15 minutes

    Length of time from preoperative prep to completion

  2. Parental satisfaction

    Time frame: 4 weeks

    Mother's report of satisfaction with the procedure

  3. Neonatal pain scale (NIPS)

    Time frame: During surgery

    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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • MRC/UVRI and LSHTM Uganda Research Unit
  • Rakai Health Sciences Program

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 4, 2015
Registry last updated
Nov 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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