Male CircumcisionNCT02277795
Evaluation of the AccuCirc for Early Infant Male Circumcision in Nyanza, Kenya
A study testing AccuCirc in people with Male Circumcision, run by Brigham and Women's Hospital at 1 site in Kenya.
Trial summary
Male circumcision (MC) is an effective, research-tested, evidence-based HIV prevention strategy that is cost-saving. Randomized trials provide compelling evidence that MC reduces men's risk of heterosexually-acquired HIV-1 infection by about 60%. Read more about this study
- Who is it for?
- Ages 1 day to 60 days, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Circumcision
- What is being tested?
- AccuCirc
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 704 participants
- Where
- 1 siteKenya
- Study dates
- Feb 2015to Aug 2016
- 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 1 day to 60 days
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Live-born male infants within the study catchment area (two facilities and their surrounding communities, respectively, served by Domiciliary Midwives (DMs))
- Ability to follow up three or four days after the procedure (and for the first 50 infants, ability to follow-up 24 hours, 3 days, 1 week, and 4 weeks after the procedure)
- Provision of written informed consent by at least one parent or guardian
Who cannot join
- Neonatal sepsis or signs of potential illness (e.g., hyperthermia or hypothermia)
- Penile abnormality that might require reconstructive surgery in the future
- Family history of bleeding disorder
- Estimated infant gestational age < 37 weeks
- Infant delivery weight < 2,500 grams
- Growth less than 5th percentile for age
- Infant > 60 days of age
Trial locations and contacts
1 site in 1 country.
About this study
Male circumcision (MC) is an effective, research-tested, evidence-based HIV prevention strategy that is cost-saving. Randomized trials provide compelling evidence that MC reduces men's risk of heterosexually-acquired HIV-1 infection by about 60%. Early infant male circumcision (EIMC) confers the same benefits of MC in older ages for prevention of HIV and other sexually transmitted infections, and is less expensive and safer. To provide the evidence-based guidance for implementation of EIMC services, the investigators propose an implementation study to address several salient operations-research questions. Members of the research team have conducted a pilot study of the promising, but relatively new AccuCirc device for EIMC in Botswana and found it to be very safe. The AccuCirc device has the potential to simplify supply chain management in addition to eliminating the rare but serious potential complications associated with other EIMC devices. The investigators propose to enroll 600 infants in a safety and feasibility study of the AccuCirc device. Furthermore, it is imperative to identify, understand and overcome barriers to the adoption and integration of EIMC from the perspective of providers, about which virtually nothing is known. The investigators will explore, through qualitative methods, the perspective of providers with regard to offering and providing EIMC services. Equally important is having a thorough understanding of decision-making among parents with regard to opting for EIMC. The research team proposes to study this through collection of qualitative data among fathers and mothers. Lastly, the investigators will gather observational survey data from mothers in the catchment area and data from mothers who opted for EIMC will be compared with those from mothers who did not opt for EIMC to identify factors associated with uptake, including if, when, where and by whom EIMC services were offered. Among providers and parents the researchers will specifically explore what role, if any, the EIMC device plays in decision-making. The findings from this study will provide evidence necessary to refine implementation strategies for EIMC into public health and clinical practice settings and to assist the Kenyan Ministry of Health, other African governments and PEPFAR in the scale-up of EIMC service delivery for long-term HIV prevention.
Read the detailed description
Male circumcision (MC) is a research-tested, evidence-based HIV prevention strategy that has been shown to be cost-saving. Randomized trials have provided compelling evidence that MC reduces men's risk of heterosexually-acquired HIV-1 infection by about 60%. The World Health Organization (WHO) recommends MC as part of comprehensive HIV prevention strategies and says, "Since neonatal circumcision is a less complicated and risky procedure than circumcision performed in young boys, adolescents or adults … countries should consider how to promote neonatal circumcision in a safe, culturally acceptable and sustainable manner."
In 2010, the WHO published the "Manual for early infant male circumcision under local anaesthesia, [6]", which included the Mogen, Gomco and Plastibell devices. At the time of publication, the AccuCirc was relatively new (approved by the United States Food and Drug Administration in 2007) but has promise as a device that will facilitate scale-up of early infant male circumcision (EIMC). It must, however, undergo field evaluation before it can be included in the WHO's list of prequalified EIMC devices so that it can be accessible for programmatic adoption. The investigators propose an implementation study to address several salient operations research questions that remain with regard to the role of devices in scale-up of EIMC programs in sub-Saharan Africa.
This study will include a field evaluation of the AccuCirc device with the aim of providing data that would allow evaluation of the device for WHO prequalification. Other aspects of the current study aim to understand how EIMC can be optimized and successfully implemented in routine public health settings.
The investigators therefore propose the following specific aims:
Aim 1: Complete a field evaluation of the AccuCirc device for EIMC in Nyanza Province, Kenya, with a target enrollment of 600 infants, including intensive follow-up of the first 50 infants undergoing EIMC with the AccuCirc device.
Aim 2: Qualitatively assess provider experiences and preferences with regard to EIMC devices and the relationship to future routine provision of EIMC. Research staff will train providers in both Mogen clamp and AccuCirc devices and ask them to compare the benefits and drawbacks they perceive for each device, and possible implications for scale-up.
Aim 3: Assess parental decision-making about EIMC using qualitative methods, including whether the device for EIMC would influence parental decision-making about circumcision for a son. Parents will be informed about the risks and benefits of EIMC in general, and the Mogen clamp and AccuCirc specifically, before qualitative data about decision-making is gathered.
Aim 4: Identify factors associated with having a male infant circumcised, including if, when, where and by whom EIMC services were offered to mothers, and the role of devices for EIMC in decision-making, if any. Mothers whose infants were circumcised and a comparison group of mothers of uncircumcised infants will be administered a questionnaire that will identify factors associated with uptake of EIMC and whether the device affected the circumcision decision.
- Conditions
- Male Circumcision
- Being tested
- AccuCirc
- Keywords
- Early infant male circumcision, HIV, Prevention, AccuCirc, Kenya, Providers, Parents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccuCircDevice
Also called Early Infant Male Circumcision
Circumcision with the use of the AccuCirc device.
| Study group | Role | What they receive |
|---|---|---|
| AccuCirc | Experimental | The AccuCirc procedure is performed according to manufacturer instructions: http://www.clinicalinnovations.com/site_files/files/AccuCirc_IFUs.pdf
Before the surgery, the mother (and father, if available) will be counseled on benefits and risks of EIMC in their language of choice (English, Kiswahili, DhoLuo). At least one parent/guardian will provide documented informed consent using IRB-approved Consent Form. Providers will record demographic and locator information and EIMC eligibility criteria. If the infant is eligible for EIMC, the provider will perform the procedure and document the outcome of the surgery on a post-operative form. Information recorded will include: amount and type of anesthesia provided, intra-operative adverse event and outcome, and procedure start and end time. Receives: Device: AccuCirc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events as a Measure of Safety
Adverse events have been defined in four categories. 1) Bleeding: a) requires anything beyond initial post-procedure local pressure (Minor); b) Suture (Moderate); c) Separate clinic visit or infant hospitalization for bleeding at the circumcision site (Major); d) Surgical intervention (Major); or, e) Transfusion (Major). 2) Infection (believed to be definitely or probably related to the EIMC procedure as evaluated by study staff): a) Local (Minor); or, b) Systemic (Major). 3) Structural: Removal of too much or incorrect tissue; or removal of too little tissue necessitating repeat procedure (Major). 4) Other: major directly-related adverse events (e.g. penile torsion, problem with urination requiring medical attention, other).
Measured: Up to 4 weeks following circumcision
Secondary outcomes (1)
Parental Satisfaction
Parents will be asked a few questions from a standardized questionnaire about their satisfaction with the procedure and with the written care instructions.
Measured: Approximately three days following the procedure (at the follow-up visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startFeb 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Male CircumcisionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 704 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois Chicago, Nyanza Reproductive Health Society
- Responsible party
- Principal investigator, Rebeca Milanesi Plank, MD, Brigham and Women's Hospital
- Investigators
- Fredrick Otieno, MD, Study director, Nyanza Reproductive Health Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277795
- Sponsor's protocol ID
- 2014P000774/BWH
- Status last verified
- Jun 2018
- First submitted
- 24 Oct 2014
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Plank RM, Wirth KE, Ndubuka NO, Abdullahi R, Nkgau M, Lesetedi C, Powis KM, Mmalane M, Makhema J, Shapiro R, Lockman S. Single-arm evaluation of the AccuCirc device for early infant male circumcision in Botswana. J Acquir Immune Defic Syndr. 2014 May 1;66(1):1-6. doi: 10.1097/QAI.0000000000000136.
PubMed 24594500Bailey RC, Moses S, Parker CB, Agot K, Maclean I, Krieger JN, Williams CF, Campbell RT, Ndinya-Achola JO. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. Lancet. 2007 Feb 24;369(9562):643-56. doi: 10.1016/S0140-6736(07)60312-2.
PubMed 17321310Gray RH, Kigozi G, Serwadda D, Makumbi F, Watya S, Nalugoda F, Kiwanuka N, Moulton LH, Chaudhary MA, Chen MZ, Sewankambo NK, Wabwire-Mangen F, Bacon MC, Williams CF, Opendi P, Reynolds SJ, Laeyendecker O, Quinn TC, Wawer MJ. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet. 2007 Feb 24;369(9562):657-66. doi: 10.1016/S0140-6736(07)60313-4.
PubMed 17321311Auvert B, Taljaard D, Lagarde E, Sobngwi-Tambekou J, Sitta R, Puren A. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial. PLoS Med. 2005 Nov;2(11):e298. doi: 10.1371/journal.pmed.0020298. Epub 2005 Oct 25.
PubMed 16231970
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the AccuCirc for Early Infant Male Circumcision in Nyanza, Kenya
- ClinicalTrials.gov ID
- NCT02277795
- Acronym / sponsor ID
- 2014P000774/BWH
- Conditions
- Male Circumcision
- Keywords
- Early infant male circumcision, HIV, Prevention, AccuCirc, Kenya, Providers, Parents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 704 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- University of Illinois Chicago, Nyanza Reproductive Health Society
- Study start
- Feb 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 29 Oct 2014 (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.
Male circumcision (MC) is an effective, research-tested, evidence-based HIV prevention strategy that is cost-saving. Randomized trials provide compelling evidence that MC reduces men's risk of heterosexually-acquired HIV-1 infection by about 60%. Early infant male circumcision (EIMC) confers the same benefits of MC in older ages for prevention of HIV and other sexually transmitted infections, and is less expensive and safer. To provide the evidence-based guidance for implementation of EIMC services, the investigators propose an implementation study to address several salient operations-research questions. Members of the research team have conducted a pilot study of the promising, but relatively new AccuCirc device for EIMC in Botswana and found it to be very safe. The AccuCirc device has the potential to simplify supply chain management in addition to eliminating the rare but serious potential complications associated with other EIMC devices. The investigators propose to enroll 600 infants in a safety and feasibility study of the AccuCirc device. Furthermore, it is imperative to identify, understand and overcome barriers to the adoption and integration of EIMC from the perspective of providers, about which virtually nothing is known. The investigators will explore, through qualitative methods, the perspective of providers with regard to offering and providing EIMC services. Equally important is having a thorough understanding of decision-making among parents with regard to opting for EIMC. The research team proposes to study this through collection of qualitative data among fathers and mothers. Lastly, the investigators will gather observational survey data from mothers in the catchment area and data from mothers who opted for EIMC will be compared with those from mothers who did not opt for EIMC to identify factors associated with uptake, including if, when, where and by whom EIMC services were offered. Among providers and parents the researchers will specifically explore what role, if any, the EIMC device plays in decision-making. The findings from this study will provide evidence necessary to refine implementation strategies for EIMC into public health and clinical practice settings and to assist the Kenyan Ministry of Health, other African governments and PEPFAR in the scale-up of EIMC service delivery for long-term HIV prevention.
Detailed description
Male circumcision (MC) is a research-tested, evidence-based HIV prevention strategy that has been shown to be cost-saving. Randomized trials have provided compelling evidence that MC reduces men's risk of heterosexually-acquired HIV-1 infection by about 60%. The World Health Organization (WHO) recommends MC as part of comprehensive HIV prevention strategies and says, "Since neonatal circumcision is a less complicated and risky procedure than circumcision performed in young boys, adolescents or adults … countries should consider how to promote neonatal circumcision in a safe, culturally acceptable and sustainable manner."
In 2010, the WHO published the "Manual for early infant male circumcision under local anaesthesia, [6]", which included the Mogen, Gomco and Plastibell devices. At the time of publication, the AccuCirc was relatively new (approved by the United States Food and Drug Administration in 2007) but has promise as a device that will facilitate scale-up of early infant male circumcision (EIMC). It must, however, undergo field evaluation before it can be included in the WHO's list of prequalified EIMC devices so that it can be accessible for programmatic adoption. The investigators propose an implementation study to address several salient operations research questions that remain with regard to the role of devices in scale-up of EIMC programs in sub-Saharan Africa.
This study will include a field evaluation of the AccuCirc device with the aim of providing data that would allow evaluation of the device for WHO prequalification. Other aspects of the current study aim to understand how EIMC can be optimized and successfully implemented in routine public health settings.
The investigators therefore propose the following specific aims:
Aim 1: Complete a field evaluation of the AccuCirc device for EIMC in Nyanza Province, Kenya, with a target enrollment of 600 infants, including intensive follow-up of the first 50 infants undergoing EIMC with the AccuCirc device.
Aim 2: Qualitatively assess provider experiences and preferences with regard to EIMC devices and the relationship to future routine provision of EIMC. Research staff will train providers in both Mogen clamp and AccuCirc devices and ask them to compare the benefits and drawbacks they perceive for each device, and possible implications for scale-up.
Aim 3: Assess parental decision-making about EIMC using qualitative methods, including whether the device for EIMC would influence parental decision-making about circumcision for a son. Parents will be informed about the risks and benefits of EIMC in general, and the Mogen clamp and AccuCirc specifically, before qualitative data about decision-making is gathered.
Aim 4: Identify factors associated with having a male infant circumcised, including if, when, where and by whom EIMC services were offered to mothers, and the role of devices for EIMC in decision-making, if any. Mothers whose infants were circumcised and a comparison group of mothers of uncircumcised infants will be administered a questionnaire that will identify factors associated with uptake of EIMC and whether the device affected the circumcision decision.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AccuCirc | Experimental | Device: AccuCircThe AccuCirc procedure is performed according to manufacturer instructions: http://www.clinicalinnovations.com/site_files/files/AccuCirc_IFUs.pdf Before the surgery, the mother (and father, if available) will be counseled on benefits and risks of EIMC in their language of choice (English, Kiswahili, DhoLuo). At least one parent/guardian will provide documented informed consent using IRB-approved Consent Form. Providers will record demographic and locator information and EIMC eligibility criteria. If the infant is eligible for EIMC, the provider will perform the procedure and document the outcome of the surgery on a post-operative form. Information recorded will include: amount and type of anesthesia provided, intra-operative adverse event and outcome, and procedure start and end time. |
Who may qualify
- Ages
- 1 day to 60 days
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Live-born male infants within the study catchment area (two facilities and their surrounding communities, respectively, served by Domiciliary Midwives (DMs))
- Ability to follow up three or four days after the procedure (and for the first 50 infants, ability to follow-up 24 hours, 3 days, 1 week, and 4 weeks after the procedure)
- Provision of written informed consent by at least one parent or guardian
Key exclusion criteria (7 listed)
- Neonatal sepsis or signs of potential illness (e.g., hyperthermia or hypothermia)
- Penile abnormality that might require reconstructive surgery in the future
- 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 |
|---|---|---|
| AccuCircAlso: Early Infant Male CircumcisionCircumcision with the use of the AccuCirc device. | Device | AccuCirc |
Primary outcome
Number of participants with Adverse Events as a Measure of Safety
Time frame: Up to 4 weeks following circumcision
Adverse events have been defined in four categories. 1) Bleeding: a) requires anything beyond initial post-procedure local pressure (Minor); b) Suture (Moderate); c) Separate clinic visit or infant hospitalization for bleeding at the circumcision site (Major); d) Surgical intervention (Major); or, e) Transfusion (Major). 2) Infection (believed to be definitely or probably related to the EIMC procedure as evaluated by study staff): a) Local (Minor); or, b) Systemic (Major). 3) Structural: Removal of too much or incorrect tissue; or removal of too little tissue necessitating repeat procedure (Major). 4) Other: major directly-related adverse events (e.g. penile torsion, problem with urination requiring medical attention, other).
1 secondary outcome
Parental Satisfaction
Time frame: Approximately three days following the procedure (at the follow-up visit)
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 6 Jun 2018.
- Background: PubMed 24594500Plank RM, Wirth KE, Ndubuka NO, Abdullahi R, Nkgau M, Lesetedi C, Powis KM, Mmalane M, Makhema J, Shapiro R, Lockman S. Single-arm evaluation of the AccuCirc device for early infant male circumcision in Botswana. J Acquir Immune Defic Syndr. 2014 May 1;66(1):1-6. doi: 10.1097/QAI.0000000000000136.
- Background: PubMed 17321310Bailey RC, Moses S, Parker CB, Agot K, Maclean I, Krieger JN, Williams CF, Campbell RT, Ndinya-Achola JO. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. Lancet. 2007 Feb 24;369(9562):643-56. doi: 10.1016/S0140-6736(07)60312-2.
- Background: PubMed 17321311Gray RH, Kigozi G, Serwadda D, Makumbi F, Watya S, Nalugoda F, Kiwanuka N, Moulton LH, Chaudhary MA, Chen MZ, Sewankambo NK, Wabwire-Mangen F, Bacon MC, Williams CF, Opendi P, Reynolds SJ, Laeyendecker O, Quinn TC, Wawer MJ. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet. 2007 Feb 24;369(9562):657-66. doi: 10.1016/S0140-6736(07)60313-4.
- Background: PubMed 16231970Auvert B, Taljaard D, Lagarde E, Sobngwi-Tambekou J, Sitta R, Puren A. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial. PLoS Med. 2005 Nov;2(11):e298. doi: 10.1371/journal.pmed.0020298. Epub 2005 Oct 25.
- Clearing House on Male Circumcision for HIV PreventionLink provided by the sponsor.
- Manufacturer Information About the AccuCirc DeviceLink 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.
Fredrick Otieno, MD study director
Nyanza Reproductive Health Society
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AccuCirc in people with Male Circumcision, run by Brigham and Women's Hospital at 1 site in Kenya.
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 3 inclusion and 7 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 6 Jun 2018. 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 Kenya. 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?
Number of participants with Adverse Events as a Measure of Safety (time frame: Up to 4 weeks following circumcision). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02277795, which also lists 4 linked publications.
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 6 Jun 2018.