Use of the Shang Ring Circumcision Device in Boys Below 18 Years Old in Kenya

Use of the Shang Ring Device in All Four Childhood Age Groups in the African Population

A proof of concept study to evaluate the feasibility of using the Shang Ring, a novel male circumcision device across all childhood age groups namely infants (under 1), 1-5 age group, 6-12 age group and the 13-17 age group. The study will evaluate the safety, efficacy and course of wound healing when using the Shang Ring technique across the four childhood age groups.

Study Overview

• Status: Completed
• Conditions: Human Immunodeficiency Virus
• Intervention / Treatment: Device: Male circumcision using the Shang Ring device

Detailed Description

A proof of concept study to evaluate the feasibility of using the Shang Ring, a novel male circumcision device across all childhood age groups namely infants (under 1), 1-5 age group, 6-12 age group and the 13-17 age group. The study will evaluate efficacy, procedure time, difficulties during surgery and post-operative events shall be assessed. To evaluate safety, the investigators will clinically observe for adverse events during the course of healing. The investigators will also evaluate to length of time taken for complete healing to be achieved.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Homa Bay, Kenya
    • Homa Bay District Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Must be accompanied by the parent or legally acceptable representative (LAR), who freely consents for participation of the child into the study;
• Assent from participant 7 years of age and above who understand study procedure;
• Aged between 1 month and 17 years(inclusive);
• Body weight of more than 2.5 kgs and penile shaft more than 1 cm in length.
• Must be in good general health;
• Must be free of genital ulcerations or other visible signs of STI (on examination);
• Parent or LAR and if possible the client must be able to understand study procedures and requirements of study participation;
• Parent or LAR must agree to return the client to the study site for the full schedule of follow-up visits after his circumcision;
• Parent or LAR must have a cell phone or access to a cell phone; and,
• Parent or LAR must agree to provide the study staff with an address, phone number, or other locator information while participating in the research study.

Exclusion Criteria:

• Has a known allergy or sensitivity to lidocaine or other local anesthesia;
• Takes a medication that would be a contraindication for elective surgery, such as an anticoagulant or steroid;
• Has known bleeding/clotting disorder (e.g. hemophilia);
• Has any congenital genitourinary abnormality;
• Has an active genital infection, anatomic abnormality or other condition (e.g. severe obesity, diabetes or sickle cell anemia), which in the opinion of the surgeon, prevents the man from undergoing a circumcision as part of this study; or
• Is currently participating in another biomedical research study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single arm; Single arm study study for use of Shang Ring device for male circumcision in children	Device: Male circumcision using the Shang Ring device; Other Names: Shang ring male circumcision device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate safety when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents.	Documentation of adverse events based on clinical exam findings	42 days after circumcision

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate efficacy when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents.	To evaluate efficacy, procedure time, peri- and postoperative surgical complications, and problems with use of the device will be assessed.	42 days after circumcision
To evaluate the course of wound healing when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents.	Evaluation of the course of healing and length of time required for complete healing will be based on clinical exam findings.	42 days after circumcision
To determine the acceptability of the Shang Ring device by the participants (or their parents)	Clients and/or parents shall be interviewed on their experience with the Shang Ring during their participation in the study.	42 days after circumcison
To evaluate the ease of use of the Shang Ring technique across the 4 age groups ranging from infants to adolescents	To evaluate the ease of use of the Shang Ring device, clinicians shall be interviewed on the difficulties they faced with using the device and their perception about use of the device relative to conventional surgical approaches	42 days after circumcision

Collaborators and Investigators

• Sponsor: EngenderHealth
• Collaborators: Weill Medical College of Cornell University; Kenya Ministry of Health; Kenya National AIDS & STI Control Programme
• Investigators: Principal Investigator: Quentin Awori, MBChB, CPI, EngenderHealth

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: June 25, 2013
• First Submitted That Met QC Criteria: June 28, 2013
• First Posted (Estimate): July 3, 2013

Study Record Updates

• Last Update Posted (Estimate): January 19, 2015
• Last Update Submitted That Met QC Criteria: January 15, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Children; HIV prevention; Childhood; Male Circumcision; Shang Ring
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: GCC-0139-01; GCC-0139 (Other Grant/Funding Number: Grand Challenges Canada)