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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
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02596282
Enrollment
501
Registered
2015-11-04
Start date
2014-10-31
Completion date
2015-07-31
Last updated
2015-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Male Circumcision

Keywords

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

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.

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.

Interventions

PROCEDURENeonatal 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.

Sponsors

Rakai Health Sciences Program
CollaboratorOTHER
MRC/UVRI and LSHTM Uganda Research Unit
CollaboratorOTHER
Johns Hopkins Bloomberg School of Public Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
1 Days to 28 Days
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Adverse events related to circumcision4 weeksAdverse events graded as mild, moderate and severe
Acceptability as measured by the proportion of mothers directly informed about the study who consented to enroll in the trialthrough study completion, an of 1 yearProportion of registered mother-child pairs in which the male infant was circumcised
Wound healing4 weeksCompleted wound healing (clean intact scar without a scab or stitch sinus)

Secondary

MeasureTime frameDescription
Procedure timeLess than 15 minutesLength of time from preoperative prep to completion
Parental satisfaction4 weeksMother's report of satisfaction with the procedure
Neonatal pain scale (NIPS)During surgerybased 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026