Status:
COMPLETED
Evaluation of the AccuCirc for Early Infant Male Circumcision in Nyanza, Kenya
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
University of Illinois at Chicago
Nyanza Reproductive Health Society
Conditions:
Male Circumcision
Eligibility:
MALE
1-60 years
Phase:
NA
Brief Summary
Male circumcision (MC) is an effective, research-tested, evidence-based HIV prevention strategy that is cost-saving. Randomized trials provide compelling evidence that MC reduces men's risk of heteros...
Detailed Description
Male circumcision (MC) is a research-tested, evidence-based HIV prevention strategy that has been shown to be cost-saving. Randomized trials have provided compelling evidence that MC reduces men's ris...
Eligibility Criteria
Inclusion
- Live-born male infants within the study catchment area (two facilities and their surrounding communities, respectively, served by Domiciliary Midwives (DMs))
- Ability to follow up three or four days after the procedure (and for the first 50 infants, ability to follow-up 24 hours, 3 days, 1 week, and 4 weeks after the procedure)
- Provision of written informed consent by at least one parent or guardian
Exclusion
- Neonatal sepsis or signs of potential illness (e.g., hyperthermia or hypothermia)
- Penile abnormality that might require reconstructive surgery in the future
- Family history of bleeding disorder
- Estimated infant gestational age \< 37 weeks
- Infant delivery weight \< 2,500 grams
- Growth less than 5th percentile for age
- Infant \> 60 days of age
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
704 Patients enrolled
Trial Details
Trial ID
NCT02277795
Start Date
February 1 2015
End Date
August 1 2016
Last Update
June 6 2018
Active Locations (1)
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1
Nyanza Reproductive Health Society
Kisumu, Kenya