Use of Male Circumcision Device in All Four Childhood Groups in the African Population

This study has been completed.
Sponsor:
Collaborators:
Weill Medical College of Cornell University
Kenya National AIDS & STI Control Programme
Kenya Ministry of Health
Information provided by (Responsible Party):
EngenderHealth
ClinicalTrials.gov Identifier:
NCT01891409
First received: June 25, 2013
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Human Immunodeficiency Virus
Device: Male circumcision using the Shang Ring device

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Use of Male Circumcision Device in All Four Childhood Groups in the African Population

Resource links provided by NLM:


Further study details as provided by EngenderHealth:

Primary Outcome Measures:
  • To evaluate safety when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents. [ Time Frame: 42 days after circumcision ] [ Designated as safety issue: Yes ]
    Documentation of adverse events based on clinical exam findings


Secondary Outcome Measures:
  • To evaluate efficacy when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents. [ Time Frame: 42 days after circumcision ] [ Designated as safety issue: Yes ]
    To evaluate efficacy, procedure time, peri- and postoperative surgical complications, and problems with use of the device will be assessed.

  • To evaluate the course of wound healing when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents. [ Time Frame: 42 days after circumcision ] [ Designated as safety issue: Yes ]
    Evaluation of the course of healing and length of time required for complete healing will be based on clinical exam findings.

  • To determine the acceptability of the Shang Ring device by the participants (or their parents) [ Time Frame: 42 days after circumcison ] [ Designated as safety issue: No ]
    Clients and/or parents shall be interviewed on their experience with the Shang Ring during their participation in the study.

  • To evaluate the ease of use of the Shang Ring technique across the 4 age groups ranging from infants to adolescents [ Time Frame: 42 days after circumcision ] [ Designated as safety issue: No ]
    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


Enrollment: 80
Study Start Date: July 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Shang ring male circumcision 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.

  Eligibility

Ages Eligible for Study:   1 Month to 17 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01891409

Locations
Kenya
Homa Bay District Hospital
Homa Bay, Kenya
Sponsors and Collaborators
EngenderHealth
Weill Medical College of Cornell University
Kenya National AIDS & STI Control Programme
Kenya Ministry of Health
Investigators
Principal Investigator: Quentin Awori, MBChB, CPI EngenderHealth
  More Information

No publications provided

Responsible Party: EngenderHealth
ClinicalTrials.gov Identifier: NCT01891409     History of Changes
Other Study ID Numbers: GCC-0139-01, GCC-0139
Study First Received: June 25, 2013
Last Updated: February 11, 2014
Health Authority: Kenya: Ethical Review Committee
Kenya: Ministry of Health

Keywords provided by EngenderHealth:
HIV prevention
Male Circumcision
Children
Childhood
Shang Ring

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 20, 2014