Neonatal Male CircumcisionPhase 4NCT01115335
Feasibility, Acceptability, and Safety of Neonatal Male Circumcision in Lusaka, Zambia
A Phase 4 study testing Neonatal male circumcision in people with Neonatal Male Circumcision, run by University of Alabama at Birmingham at 1 site in Zambia.
Trial summary
In this study of neonatal male circumcision (NMC), the investigators will examine acceptability of among parents, feasibility of training providers and implementing services in various clinical settings, and the safety of service provision comparing three different surgical methods: the Gomco; the Plastibell; and the… 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
- Neonatal Male Circumcision
- What is being tested?
- Neonatal male circumcision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 661 participants
- Where
- 1 siteZambia
- Study dates
- Oct 2009to Jan 2012
- Phase
- Phase 4
- 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
- Male infants who are in the first day of life (including infants < 24 hours old) and up to 4 weeks of age will be considered for circumcision
- Gestational age >37 weeks at birth
Who cannot join
- Any current illness
- Bleeding diathesis or family history of bleeding disorder
- Abnormality of urethra or penile shaft such as hypospadias
- Local infection defined as redness, swelling, or a purulent discharge from the infant penis
- Greater than four weeks of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility, Acceptability, and Safety of Neonatal Male Circumcision at the University Teaching Hospital in Lusaka, Zambia and in the Lusaka District in Zambia Using Gomco; Plastibell; and Mogen Methods
In this study of neonatal male circumcision (NMC), the investigators will examine acceptability of among parents, feasibility of training providers and implementing services in various clinical settings, and the safety of service provision comparing three different surgical methods: the Gomco; the Plastibell; and the Mogen clamp. This operational study is being conducted to inform the scale up of neonatal male circumcision in Zambia.
Read the detailed description
As male circumcision becomes one component of Zambia's plan to prevent the spread of HIV, it is important to understand the acceptability, feasibility, and safety of implementing NMC services in various clinical settings.
In this study, we will examine the acceptability of neonatal male circumcision among parents in several ways. First, we will administer a structured questionnaire on NMC to 1000 consenting parents of newborn boys at a tertiary care institution and 1-2 primary care clinics in Lusaka. All parents approached, regardless of whether or not they complete the survey, will also be offered an opportunity to have their sons circumcised. Uptake will be calculated as the percent of parents approached who consent for their sons to be circumcised. Finally, we will assess parental satisfaction with results of the procedure.
To examine the feasibility of training providers and implementing neonatal male circumcision services in various clinical settings, we will train a group of 15-20 health care providers in three different circumcision methods (Gomco clamp, Mogen clamp, and Plastibell) at 2-3 study sites. We will recruit 600 infants to be circumcised during the training. We will use structured questionnaires and skill assessments to evaluate provider competence after completing the training curriculum, provider preferences among the three circumcision methods, and opinion about how NMC should be scaled up within the existing health care system. We will also document logistical difficulties of scaling up NMC services at the study sites.
Finally, we will examine the safety of implementing NMC by collecting and analyzing data on complications resulting from the different circumcision methods.
- Conditions
- Neonatal Male Circumcision
- Being tested
- Neonatal male circumcision
- Keywords
- neonatal male circumcision, Gomco, Plastibell, Mogen, Safety, Uptake, Acceptability, Feasibility, Zambia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neonatal male circumcisionProcedure or surgery
Circumcision performed on a male infant within the first month of life, using one of 3 devices
| Study group | Role | What they receive |
|---|---|---|
| Gomco | Active comparator | NMC performed using a Gomco clamp Receives: Procedure: Neonatal male circumcision |
| Mogen clamp | Active comparator | NMC performed using a Mogen clamp Receives: Procedure: Neonatal male circumcision |
| Plastibell | Active comparator | NMC performed using a Plastibell device Receives: Procedure: Neonatal male circumcision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication Rate
Includes intra-operative and post-operative complications such as bleeding, infection, and cosmetic problems
Measured: 0-6 weeks after the circumcision procedure
Secondary outcomes (3)
Uptake of NMC
Defined as % of parents of newborn boys approached during recruitment who consent to having their sons cirucumcised
Measured: Ongoing, over the course of the study (1.5 years)
Provider Preferences
Measure of provider preferences among 3 circumcision devices being compared
Measured: Upon completion of training in NMC
Parent Satisfaction
Score, between 0 and 100, of each parent's satisfaction with the outcome of the NMC procedure
Measured: 6 weeks following the circumcision procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startOct 2009
- Primary completionMar 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Male CircumcisionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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 4
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 661 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University Teaching Hospital, Lusaka, Zambia
- Responsible party
- Sponsor
- Investigators
- Elizabeth M Stringer, MD, Principal investigator, University of Alabama at Birmingham and Centre for Infectious Disease Research of ZambiaKasonde Bowa, MD, Principal investigator, University Teaching Hospital, Lusaka, ZambiaJohn Kachimba, MD, Principal investigator, University Teaching Hospital, Lusaka, Zambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115335
- Sponsor's protocol ID
- PS123541-06
- Status last verified
- Apr 2010
- First submitted
- 30 Apr 2010
- Last updated
- 13 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, and Safety of Neonatal Male Circumcision at the University Teaching Hospital in Lusaka, Zambia and in the Lusaka District in Zambia Using Gomco; Plastibell; and Mogen Methods
- ClinicalTrials.gov ID
- NCT01115335
- Acronym / sponsor ID
- PS123541-06
- Conditions
- Neonatal Male Circumcision
- Keywords
- neonatal male circumcision, Gomco, Plastibell, Mogen, Safety, Uptake, Acceptability, Feasibility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 661 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- University Teaching Hospital, Lusaka, Zambia
- Study start
- Oct 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 4 May 2010 (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.
In this study of neonatal male circumcision (NMC), the investigators will examine acceptability of among parents, feasibility of training providers and implementing services in various clinical settings, and the safety of service provision comparing three different surgical methods: the Gomco; the Plastibell; and the Mogen clamp. This operational study is being conducted to inform the scale up of neonatal male circumcision in Zambia.
Detailed description
As male circumcision becomes one component of Zambia's plan to prevent the spread of HIV, it is important to understand the acceptability, feasibility, and safety of implementing NMC services in various clinical settings.
In this study, we will examine the acceptability of neonatal male circumcision among parents in several ways. First, we will administer a structured questionnaire on NMC to 1000 consenting parents of newborn boys at a tertiary care institution and 1-2 primary care clinics in Lusaka. All parents approached, regardless of whether or not they complete the survey, will also be offered an opportunity to have their sons circumcised. Uptake will be calculated as the percent of parents approached who consent for their sons to be circumcised. Finally, we will assess parental satisfaction with results of the procedure.
To examine the feasibility of training providers and implementing neonatal male circumcision services in various clinical settings, we will train a group of 15-20 health care providers in three different circumcision methods (Gomco clamp, Mogen clamp, and Plastibell) at 2-3 study sites. We will recruit 600 infants to be circumcised during the training. We will use structured questionnaires and skill assessments to evaluate provider competence after completing the training curriculum, provider preferences among the three circumcision methods, and opinion about how NMC should be scaled up within the existing health care system. We will also document logistical difficulties of scaling up NMC services at the study sites.
Finally, we will examine the safety of implementing NMC by collecting and analyzing data on complications resulting from the different circumcision methods.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gomco | Active comparator | Procedure: Neonatal male circumcisionNMC performed using a Gomco clamp |
| Mogen clamp | Active comparator | Procedure: Neonatal male circumcisionNMC performed using a Mogen clamp |
| Plastibell | Active comparator | Procedure: Neonatal male circumcisionNMC performed using a Plastibell device |
Who may qualify
- Ages
- Up to 28 days
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Male infants who are in the first day of life (including infants < 24 hours old) and up to 4 weeks of age will be considered for circumcision
- Gestational age >37 weeks at birth
Key exclusion criteria (5 listed)
- Any current illness
- Bleeding diathesis or family history of bleeding disorder
- Abnormality of urethra or penile shaft such as hypospadias
- Local infection defined as redness, swelling, or a purulent discharge from the infant penis
- Greater than four weeks of age
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 |
|---|---|---|
| Neonatal male circumcisionCircumcision performed on a male infant within the first month of life, using one of 3 devices | Procedure or surgery | Gomco, Mogen clamp, Plastibell |
Primary outcome
Complication Rate
Time frame: 0-6 weeks after the circumcision procedure
Includes intra-operative and post-operative complications such as bleeding, infection, and cosmetic problems
3 secondary outcomes
Uptake of NMC
Time frame: Ongoing, over the course of the study (1.5 years)
Provider Preferences
Time frame: Upon completion of training in NMC
Parent Satisfaction
Time frame: 6 weeks following the circumcision procedure
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 13 Jul 2012.
- Local NGO in Zambia overseeing study conductLink 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.
Elizabeth M Stringer, MD principal investigator
University of Alabama at Birmingham and Centre for Infectious Disease Research of Zambia
Kasonde Bowa, MD principal investigator
University Teaching Hospital, Lusaka, Zambia
John Kachimba, MD principal investigator
University Teaching Hospital, Lusaka, Zambia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Neonatal male circumcision in people with Neonatal Male Circumcision, run by University of Alabama at Birmingham at 1 site in Zambia.
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 2 inclusion and 5 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 13 Jul 2012. 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 Zambia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Complication Rate (time frame: 0-6 weeks after the circumcision procedure). 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 13 Jul 2012.