Clinical trial NCT02596282: Enhanced Provision of Male Circumcision (MC) for HIV Prevention, Rakai, Uganda
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Neonatal Male Circumcision
Keywords: neonatal male circumcision
Clinical officers vs Nurse midwives
Rakai, Uganda
acceptability and safety of neonatal male circumcision
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Rakai Health Sciences Program
name: MRC/UVRI and LSHTM Uganda Research Unit
First posted: 2015-11-04
Enrollment: 501
Sex: MALE
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Adverse events related to circumcision
timeFrame: 4 weeks
measure: Acceptability as measured by the proportion of mothers directly informed about the study who consented to enroll in the trial
timeFrame: through study completion, an of 1 year
measure: Wound healing
timeFrame: 4 weeks
Secondary outcomes:
measure: Procedure time
timeFrame: Less than 15 minutes
measure: Parental satisfaction
timeFrame: 4 weeks
measure: Neonatal pain scale (NIPS)
timeFrame: During surgery
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Ronald H Gray, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kankaka EN, Murungi T, Kigozi G, Makumbi F, Nabukalu D, Watya S, Kighoma N, Nampijja R, Kayiwa D, Nalugoda F, Serwadda D, Wawer M, Gray RH. Randomised trial of early infant circumcision performed by clinical officers and registered nurse midwives using the Mogen clamp in Rakai, Uganda. BJU Int. 2017 Jan;119(1):164-170. doi: 10.1111/bju.13589. Epub 2016 Sep 6.