Status:
COMPLETED
Infant Male Circumcision in Gaborone, Botswana, and Surrounding Areas: Feasibility, Safety and Acceptability
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
HIV Infections
Circumcision
Eligibility:
MALE
Up to 28 years
Phase:
NA
Brief Summary
Background: Novel HIV prevention approaches are urgently needed in Botswana and elsewhere in sub-Saharan Africa. Although adult male circumcision (MC) has been shown to reduce the heterosexual acquisi...
Eligibility Criteria
Inclusion
- Mothers (and fathers) of liveborn male infants at one of the four study sites who are \> 21 years of age (mothers less than 21 years of age, age of majority in Botswana, will provide assent, and will need consent from a guardian to allow participation of mother and infant in this study).
- Fathers of liveborn male infants at one of the four study sites who are \> 21 years of age
- Ability to follow up regularly at study clinic until 4 months postpartum
- Provision of written informed consent
Exclusion
- Neonatal sepsis or other severe illness requiring infant hospitalization
- Penile abnormality that might require reconstructive surgery in the future (penile torsion / median raphe not midline, hypospadias / blind urethral pit, buried penis, penile-scrotal web, hydrocoele, dorsal hood / ventral foreskin missing, lack of scrotal ruggae suggesting lack of testicles bilaterally as could be karyotypic XX, megameatus or any other abnormality that may require consultation with urologist)
- Family history of bleeding disorder
- Estimated infant gestational age \< 37 weeks
- Infant delivery weight \< 2,500 grams
- Infant \> 4 weeks of age
- Infant receipt of methaemoglobin-inducing agents
- Current involuntary incarceration of mother
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
1235 Patients enrolled
Trial Details
Trial ID
NCT00971958
Start Date
May 1 2009
End Date
November 1 2012
Last Update
August 21 2013
Active Locations (1)
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1
Botswana-Harvard Partnership
Gaborone, Mochudi, Molepolole and Lobatse, Botswana