Enhanced Provision of Male Circumcision (MC) for HIV Prevention, Rakai, Uganda
- Conditions
- Neonatal Male Circumcision
- Interventions
- Procedure: Neonatal circumcision under topical anesthesia
- Registration Number
- NCT02596282
- Lead Sponsor
- Johns Hopkins Bloomberg School of Public Health
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 501
- age 1-28 days
- birth weight >= 2,500 gm
- gestational age >=37 weeks
- no illness. normal temperature
- no genital anatomic abnormality
- age >28 days
- birth weight <2,500 gm
- gestational age <37 weeks
- Ill health
- genital abnormality
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Clinical Officer (CO), Neonatal circumcision under topical anesthesia COs were trained and provided neonatal male circumcision under topical anesthesia using the Mogen clamp Nurse Midwife (NMW) Neonatal circumcision under topical anesthesia NMWs were trained and provided neonatal male circumcision under topical anesthesia using the Mogen clamp
- Primary Outcome Measures
Name Time Method Adverse events related to circumcision 4 weeks Adverse 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 trial through study completion, an of 1 year Proportion of registered mother-child pairs in which the male infant was circumcised
Wound healing 4 weeks Completed wound healing (clean intact scar without a scab or stitch sinus)
- Secondary Outcome Measures
Name Time Method Procedure time Less than 15 minutes Length of time from preoperative prep to completion
Parental satisfaction 4 weeks Mother's report of satisfaction with the procedure
Neonatal pain scale (NIPS) 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.