Evaluation of the AccuCirc for Early Infant Male Circumcision in Nyanza, Kenya

NCT02277795 | Completed DMC

• 1 other identifier: 2014P000774/BWH
• Study Type: interventional
• Target: 704
• Locations: 1 country
• Sites: 1

Brief 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%. 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.

Conditions

Male Circumcision

Keywords

Early infant male circumcision; HIV; Prevention; AccuCirc; Kenya; Providers; Parents

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to 4 weeks following circumcision

Secondary Outcomes (1)

• Parental Satisfaction

  Approximately three days following the procedure (at the follow-up visit)

Study Arms (1)

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.

Device: AccuCirc

Interventions

AccuCirc DEVICE

Circumcision with the use of the AccuCirc device.

Also known as: Early Infant Male Circumcision

AccuCirc

Eligibility Criteria

• Age: 1 Day - 60 Days
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• University of Illinois at Chicago: collaborator
• Nyanza Reproductive Health Society: collaborator

Study Sites (1)

Nyanza Reproductive Health Society

Kisumu, Kenya

Location

Related Publications (4)

• 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.

  PMID: 24594500 BACKGROUND

• Bailey 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.

  PMID: 17321310 BACKGROUND

• Gray 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.

  PMID: 17321311 BACKGROUND

• Auvert 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.

  PMID: 16231970 BACKGROUND

Related Links

• Clearing House on Male Circumcision for HIV Prevention
• Manufacturer Information About the AccuCirc Device

Study Officials

• Fredrick Otieno, MD

  Nyanza Reproductive Health Society

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician

Study Record Dates

• First Submitted: October 24, 2014
• First Posted: October 29, 2014
• Study Start: February 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: June 6, 2018

Record last verified: 2018-06

Locations

KE (1)