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

Study Overview
=================
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.

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

Conditions
-----------------
Neonatal Male Circumcision

Intervention / Treatment
-----------------
* Procedure: Neonatal circumcision under topical anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 28 Days

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neonatal male circumcision, Clinical officers vs Nurse midwives, Rakai, Uganda, acceptability and safety of neonatal male circumcision