Infant Male Circumcision in Gaborone, Botswana, and Surrounding Areas: Feasibility, Safety and Acceptability
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Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infections Circumcision |
Procedure: Circumcision Device: Mogen Clamp Device: Plastibell Device: AccuCirc |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Infant Male Circumcision in Gaborone, Botswana, and Surrounding Areas: Feasibility, Safety and Acceptability |
- Bleeding [ Time Frame: Within 6 weeks ] [ Designated as safety issue: Yes ]
- Infection [ Time Frame: Within 6 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 1020 |
| Study Start Date: | May 2009 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Mogen Clamp |
Procedure: Circumcision
Neonatal circumcision using one of two non-experimental, widely available devices.
Device: Mogen Clamp
Mogen clamp is a reusable, one-size stainless steel clamp use for neonatal circumcision.
Device: Plastibell
The plastibell is a one-time use device for the circumcision of male neonates, infants and children.
Device: AccuCirc
AccuCirc is a device used for the circumcision of male infants approved for use by the FDA up to 10 days of life.
|
| Active Comparator: Plastibell |
Procedure: Circumcision
Neonatal circumcision using one of two non-experimental, widely available devices.
Device: Plastibell
The plastibell is a one-time use device for the circumcision of male neonates, infants and children.
Device: AccuCirc
AccuCirc is a device used for the circumcision of male infants approved for use by the FDA up to 10 days of life.
|
|
Active Comparator: AccuCirc
AccuCirc is a device approved by the FDA for circumcision of male infants up to ten days of life.
|
Device: Plastibell
The plastibell is a one-time use device for the circumcision of male neonates, infants and children.
Device: AccuCirc
AccuCirc is a device used for the circumcision of male infants approved for use by the FDA up to 10 days of life.
|
Eligibility| Ages Eligible for Study: | up to 28 Days |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Rebeca Milanesi Plank, MD, Physician, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT00971958 History of Changes |
| Other Study ID Numbers: | 2007p-002142 |
| Study First Received: | September 3, 2009 |
| Last Updated: | February 14, 2013 |
| Health Authority: | United States: Institutional Review Board Botswana: Health Research and Development Committee |
Keywords provided by Brigham and Women's Hospital:
|
HIV prevention Infant male circumcision |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 22, 2013