Status:
COMPLETED
Evaluation of the ShangRing vs. Mogen Clamp for Early Infant Male Circumcision (EIMC) in Sub-Saharan Africa
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Population Council
Johns Hopkins University
Conditions:
Circumcision
Eligibility:
MALE
24-60 years
Phase:
NA
Brief Summary
The study will evaluate the safety and acceptability of the topical anesthesia-based, no-flip ShangRing technique vs. Mogen clamp for Early Infant Male Circumcision (EIMC) in neonates and infants up t...
Detailed Description
Male circumcision (MC) has been shown to reduce HIV incidence in men by 50-60% in three randomized trials, and observational studies of men circumcised in infancy or childhood have shown long-term pro...
Eligibility Criteria
Inclusion
- Male infants from 24 hours up to 60 days of life
- Gestational age ≥37 weeks
- Normal birth weight (≥2.5 Kg)
- No illness requiring medical treatment
- No penile abnormality requiring surgical repair (e.g. hypospadias, chordee)
- No family history of bleeding disorders
- Consent provided by at least one parent/legally acceptable representative (LAR) of the infant
- Parent or LAR must be able to understand study procedures and requirements of study participation;
- Parent or LAR must agree to return the client to the study site for the full schedule of follow-up visits after his circumcision;
- Parent or LAR must have a cell phone or access to a cell phone
Exclusion
- Not meeting one or more of the inclusion criteria
- Consent not provided by parents/legally acceptable representatives of the infant
- If parent(s)/legally acceptable representative(s) decline(s) the procedure or is/are uncomfortable with the procedure
- Babies \<6 weeks of age to mother without previous T.T. vaccination during ANC visits for that pregnancy
- Babies \>6 weeks of age without DPT vaccination
- Any other valid health-related issues as judged by the health workers
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2020
Estimated Enrollment :
1380 Patients enrolled
Trial Details
Trial ID
NCT03338699
Start Date
October 1 2018
End Date
December 18 2020
Last Update
March 4 2021
Active Locations (3)
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1
Homa Bay County Teaching and Referral Hospital
Homa Bay, Kenya
2
Iringa Regional Referral Hospital
Iringa, Tanzania
3
Rakai Health Sciences Program
Kalisizo, Rakai, Uganda