Infant Male Circumcision in Gaborone, Botswana, and Surrounding Areas: Feasibility, Safety and Acceptability
Infant Male Circumcision in Gaborone, Botswana, and Surrounding Areas: Feasibility, Safety and Acceptability
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 acquisition of HIV by men by about 60%, MC 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 neonatal MC (< 28 days of life) would be an
 acceptable public HIV prevention strategy in Botswana. The government of Botswana is
 committed to scaling up MC services in the immediate future and they plan to include
 neonates. Understanding decision-making around infant MC 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 neonatal MC in southeastern Botswana and identify barriers to uptake; 2) ascertain the
 feasibility and safety of neonatal MC in Botswana; 3) Estimate what, if any, advantages would
 exist for scale up of Mogen Clamp, Plastibell or AccuCirc 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 neonatal MC acceptability and
 uptake, defined as neonatal MC following informed consent. Male infants will be circumcised
 by a trained doctor in a hospital / clinic setting by one of three FDA-approved devices that
 are currently in use in US hospitals: Mogen clamp, Plastibell or AccuCirc. Circumcision with
 Mogen Clamp or Plastibell will be done before 29 days of life. Circumcision with AccuCirc
 will be done before 11 days of life (FDA approval limit for device). The investigators will
 also administer questionnaires to the parents at the regular pediatric follow-up visit(s) to
 assess impressions of / satisfaction with the infant's procedure outcome over time. Provider
 impressions of the three methods will also be evaluated. Sample size will be 150 infants per
 arm for a total of 450 infants males circumcised (and an estimated 800 parental
 questionnaires).

 Public Health Significance: The World Health Organization (WHO) and UNAIDS state that
 countries with severe, generalized HIV epidemics but low rates of MC 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 MC intervention should be performed. This study will
 be in keeping with these recommendations.

 Please note the Mogen clamp and Plastibell study arms began as a randomized trial before the
 initiation of the AccuCirc single-arm portion. Although the settings in which the three
 devices were studied were similar, the AccuCirc trial enrollment began at two sites (Gaborone
 and Molepolole) only after completion of the Mogen clamp and Plastibell arms, which was
 conducted in three sites (Gaborone, Molepolole and Mochudi). Although Lobatse was a site for
 the first acceptability study with mothers, no procedures were performed there.

 Regarding the reported sample size: the total, final sample size includes both parents of
 newborn boys (because enrolled consenting parents completed questionnaires as part of this
 study), and boys whose parents consented to circumcision. We anticipated that not all parents
 who completed the questionnaire would consent to circumcising their baby; therefore, when
 planning the study it was necessary to estimate the number of parents who would participate
 in the survey (700), to achieve an enrollment of 300 neonates (therefore the initial estimate
 of 1000). The original study in fact enrolled 302 infants, 600 mothers and 19 fathers (total
 study population 921). The addition of the AccuCirc arm led to a revised estimate of total
 number of neonates and their parents (total=1250). The final enrollment was of 1,235
 participants, that includes all the participating neonates and parents.
Inclusion Criteria:

 -  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 Criteria:

 -  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