HIV/AIDS Surgery Urological and Genital Diseases Paediatrics Early infant circumcision ultimately for HIV prevention
Conditions
Interventions
Circumcision using AccuCirc
Circumcision using Mogen clamp
Sponsors
Bill and Melinda Gates Foundation
Population Services International
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Live born male infants at study sites aged 7-10 days. Ability to follow-up regularly at study clinic until 2 weeks postpartum Mother prepared to provide locator information and to be visited home between delivery and circumcision Mother prepared to provide verifiable cell phone (mobile) number Provision of written informed consent Baby should have received vitamin K (routine or offered by study staff)
Exclusion criteria
Exclusion criteria: Neonatal sepsis or other severe illness requiring infant hospitalization Penile abnormality that might require reconstructive surgery in the future Family history of bleeding disorder Estimated infant gestational age 10 days of age Infant receipt of methaemoglobin-inducing agents Current involuntary incarceration of mother
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ¿Safety - Number of AEs (minor, moderate and severe) related to each EIMC technique;¿Acceptability - The proportion of parents who report being satisfied with the procedure by EIMC technique ;¿Cost - Monetary cost of equipment usage for each technique plus training costs and labour cost associated with EIMC under each technique and the cost of AE under each technique | — |
Secondary
| Measure | Time frame |
|---|---|
| ¿ Proportion with complete wound healing at 7 and 14 days post circumcision for each EIMC technique;¿ Time required for each EIMC technique;¿ Proportion of babies excluded due to unsuitability for circumcision;¿ Safety stratified by infant HIV exposure status;¿ Assessment of competency of EIMC using each device;Provider opinions of each device | — |
Countries
Zimbabwe
Contacts
Public ContactWebster Mavhu
Coordinator
Outcome results
None listed