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

Johns Hopkins Bloomberg School of Public Health

Status and phase: Completed; Phase 3; Phase 2

Conditions: Neonatal Male Circumcision

Treatments: Procedure: Neonatal circumcision under topical anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT02596282

00004524

Details and patient eligibility

About

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.

Full 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.

Enrollment: 501 patients

Sex: Male

Ages: 1 to 28 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

501 participants in 2 patient groups

Clinical Officer (CO),

Active Comparator group

Description:

COs were trained and provided neonatal male circumcision under topical anesthesia using the Mogen clamp

Treatment:

Procedure: Neonatal circumcision under topical anesthesia

Nurse Midwife (NMW)

Experimental group

Description:

NMWs were trained and provided neonatal male circumcision under topical anesthesia using the Mogen clamp

Treatment:

Procedure: Neonatal circumcision under topical anesthesia