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Background: Novel HIV prevention approaches are urgently needed in Botswana and elsewhere in sub-Saharan Africa. Although adult male circumcision has been shown to reduce the acquisition of HIV by more than 50%, circumcision in infancy is optimal for its relative ease, lower cost and low rate of complications. We have conducted focus groups and semi-structured interviews that suggest infant male circumcision would be an acceptable public HIV prevention strategy in Botswana. The government of Botswana is committed to scaling up male circumcision services in the immediate future. Understanding decision-making around infant male circumcision will be essential to maximize the effectiveness of this HIV prevention strategy.
Specific Aims: The investigators propose to: 1) determine the acceptability and actual uptake of infant male circumcision in southeastern Botswana and identify barriers to uptake; 2) ascertain the feasibility and safety of infant male circumcision in Botswana; 3) Estimate what, if any, advantages would exist for scale up of Mogen Clamp versus Plastibell with regard to human resources, equipment needs, adverse events and acceptability to health-care providers and families in Botswana.
Study Design and Schema: The investigators will conduct structured interviews with early postpartum mothers and fathers to determine correlates of infant male circumcision acceptability and uptake, defined by infant male circumcision following informed consent. Male infants will be circumcised by a trained doctor in a hospital / clinic setting by one of two commonly used procedures: either Mogen clamp or Plastibell circumcision to occur between 1 day and 4 weeks of age. The investigators will also administer questionnaires to the parents at the regular 6-week pediatric visit and at the regularly scheduled 4-month vaccination visit to assess impressions of / satisfaction with the infant procedure outcome over time. Provider impressions of the two methods will also be evaluated. Sample size will be 150 infants per arm for a total of 300 infants males circumcised (and an estimated 700 parental questionnaires).
Public Health Significance: The World Health Organization (WHO) and UNAIDS state that countries with severe, generalized HIV epidemics but low rates of male circumcision should offer this surgery as an important, evidence-based HIV prevention intervention, including among neonates. These two agencies also recommended that additional research on the most feasible, safe, and sustainable ways of scaling up male circumcision intervention should be performed. This study will be in keeping with these recommendations.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Circumcision, Mogen Clamp, Plastibell
Brigham and Women's Hospital
Published on BioPortfolio: 2014-07-24T14:11:37-0400
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