HIV InfectionsNCT00971958
Infant Male Circumcision in Gaborone, Botswana, and Surrounding Areas: Feasibility, Safety and Acceptability
A study testing Circumcision, Mogen Clamp and Plastibell in people with HIV Infections and Circumcision, run by Brigham and Women's Hospital at 1 site in Botswana.
Trial 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 acquisition of HIV by men by about 60%, MC in infancy is optimal for its relative ease, lower cost and low rate of… Read more about this study
- Who is it for?
- Ages Up to 28 days, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Circumcision
- What is being tested?
- Circumcision, Mogen Clamp and Plastibell
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,235 participants
- Where
- 1 siteBotswana
- Study dates
- May 2009to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 28 days
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Botswana1 site
Botswana-Harvard Partnership
Gaborone, Mochudi, Molepolole and Lobatse
About this study
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.
Read more
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.
- Conditions
- HIV Infections, Circumcision
- Being tested
- Circumcision, Mogen Clamp, Plastibell, AccuCirc
- Keywords
- HIV prevention, infant, neonatal, male circumcision
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CircumcisionProcedure or surgery
Neonatal circumcision using one of three non-experimental, widely available devices.
Mogen ClampDevice
Mogen clamp is a reusable, one-size stainless steel clamp use for neonatal circumcision.
PlastibellDevice
The plastibell is a one-time use device for the circumcision of male neonates, infants and children.
AccuCircDevice
AccuCirc is a device used for the circumcision of male infants approved for use by the FDA up to 10 days of life.
| Study group | Role | What they receive |
|---|---|---|
| Mogen Clamp | Active comparator | Not described Receives: Procedure: Circumcision; Device: Mogen Clamp; Device: Plastibell; Device: AccuCirc |
| Plastibell | Active comparator | Not described Receives: Procedure: Circumcision; Device: Plastibell; Device: AccuCirc |
| AccuCirc | Active comparator | AccuCirc is a device approved by the FDA for circumcision of male infants up to ten days of life. Receives: Device: Plastibell; Device: AccuCirc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events that were potentially related to neonatal MC were defined prior to study initiation and categorized as bleeding, infection, structural and other.
Bleeding requiring only the application of pressure beyond the immediate post-procedure period was defined as a minor adverse event. Intervention other than pressure (e.g. suturing) was defined as a moderate adverse event. A separate clinic visit or hospitalization for bleeding from the circumcision site or need for IV fluids or blood products were categorized as major adverse events. Infection limited to the circumcision site was defined as a minor adverse event. Soft-tissue infection spreading beyond the penis (lower abdominal wall, upper legs) was defined as a moderate adverse event. Systemic infection / sepsis was defined as a major adverse event. Removal of too much or incorrect tissue; removal of too little tissue requiring repeat procedure; or structural injury to glans, urethra or shaft were defined as major adverse events, as were subsequent problems with urination or proximal migration / retention of a Plastibell ring requiring intervention for removal.
Measured: Within 6 weeks
Parental Satisfaction
As to parental satisfaction, we asked parents to complete a structured questionnaire about their experiences with the procedure at the follow-up visits (including potential problems, and satisfaction measured by a visual analogue scale from 0 - 100%). We defined highly or completely satisfied as a score of 90% or greater. We asked whether parents would be likely to choose NMC for a future son and how likely parents would be to recommend the procedure to a relative or a friend who had a baby boy.
Measured: At 6 weeks and 4 months
Secondary outcomes (1)
Staff impressions of the comparative safety, tolerability, and ease of use of the techniques (Mogen Clamp and Plastibell only).
After all participant follow-up visits were completed, study staff were asked to fill-out a short semi-structured questionnaire of their subjective impressions of the two devices (Mogen Clamp and Plastibell only).
Measured: After 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startMay 2009
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebeca Milanesi Plank, MD, Brigham and Women's Hospital
- Investigators
- Rebecca M. Plank, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971958
- Sponsor's protocol ID
- 2007p-002142
- Status last verified
- Aug 2013
- First submitted
- 3 Sep 2009
- Last updated
- 21 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infant Male Circumcision in Gaborone, Botswana, and Surrounding Areas: Feasibility, Safety and Acceptability
- ClinicalTrials.gov ID
- NCT00971958
- Acronym / sponsor ID
- 2007p-002142
- Conditions
- HIV Infections, Circumcision
- Keywords
- HIV prevention, infant, neonatal, male circumcision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,235 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 4 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mogen Clamp | Active comparator | Procedure: Circumcision, Device: Mogen Clamp, Device: Plastibell, Device: AccuCirc |
| Plastibell | Active comparator | Procedure: Circumcision, Device: Plastibell, Device: AccuCirc |
| AccuCirc | Active comparator | Device: Plastibell, Device: AccuCircAccuCirc is a device approved by the FDA for circumcision of male infants up to ten days of life. |
Who may qualify
- Ages
- Up to 28 days
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CircumcisionNeonatal circumcision using one of three non-experimental, widely available devices. | Procedure or surgery | Mogen Clamp, Plastibell |
| Mogen ClampMogen clamp is a reusable, one-size stainless steel clamp use for neonatal circumcision. | Device | Mogen Clamp |
| PlastibellThe plastibell is a one-time use device for the circumcision of male neonates, infants and children. | Device | AccuCirc, Mogen Clamp, Plastibell |
| AccuCircAccuCirc is a device used for the circumcision of male infants approved for use by the FDA up to 10 days of life. | Device | AccuCirc, Mogen Clamp, Plastibell |
Primary outcome
Adverse events that were potentially related to neonatal MC were defined prior to study initiation and categorized as bleeding, infection, structural and other.
Time frame: Within 6 weeks
Bleeding requiring only the application of pressure beyond the immediate post-procedure period was defined as a minor adverse event. Intervention other than pressure (e.g. suturing) was defined as a moderate adverse event. A separate clinic visit or hospitalization for bleeding from the circumcision site or need for IV fluids or blood products were categorized as major adverse events. Infection limited to the circumcision site was defined as a minor adverse event. Soft-tissue infection spreading beyond the penis (lower abdominal wall, upper legs) was defined as a moderate adverse event. Systemic infection / sepsis was defined as a major adverse event. Removal of too much or incorrect tissue; removal of too little tissue requiring repeat procedure; or structural injury to glans, urethra or shaft were defined as major adverse events, as were subsequent problems with urination or proximal migration / retention of a Plastibell ring requiring intervention for removal.
Parental Satisfaction
Time frame: At 6 weeks and 4 months
As to parental satisfaction, we asked parents to complete a structured questionnaire about their experiences with the procedure at the follow-up visits (including potential problems, and satisfaction measured by a visual analogue scale from 0 - 100%). We defined highly or completely satisfied as a score of 90% or greater. We asked whether parents would be likely to choose NMC for a future son and how likely parents would be to recommend the procedure to a relative or a friend who had a baby boy.
1 secondary outcome
Staff impressions of the comparative safety, tolerability, and ease of use of the techniques (Mogen Clamp and Plastibell only).
Time frame: After 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2013.
- The Clearinghouse exists to expand global access to information and resources on male circumcision for HIV prevention.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca M. Plank, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circumcision, Mogen Clamp and Plastibell in people with HIV Infections and Circumcision, run by Brigham and Women's Hospital at 1 site in Botswana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Botswana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events that were potentially related to neonatal MC were defined prior to study initiation and categorized as bleeding, infection, structural and other. (time frame: Within 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2013.