Clinical trial NCT01891409: Use of the Shang Ring Circumcision Device in Boys Below 18 Years Old in Kenya
Official title: Use of the Shang Ring Device in All Four Childhood Age Groups in the African Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Keywords: HIV prevention
Male Circumcision
Children
Childhood
Shang Ring
Lead sponsor: EngenderHealth
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
name: Kenya National AIDS & STI Control Programme
name: Kenya Ministry of Health
First posted: 2013-07-03
Enrollment: 80
Sex: MALE
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

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 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.

Primary outcomes:
measure: To evaluate safety when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents.
timeFrame: 42 days after circumcision
Secondary outcomes:
measure: To evaluate efficacy when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents.
timeFrame: 42 days after circumcision
measure: To evaluate the course of wound healing when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents.
timeFrame: 42 days after circumcision
measure: To determine the acceptability of the Shang Ring device by the participants (or their parents)
timeFrame: 42 days after circumcison
measure: To evaluate the ease of use of the Shang Ring technique across the 4 age groups ranging from infants to adolescents
timeFrame: 42 days after circumcision
Other outcomes:
Locations:
city: Homa Bay
country: Kenya
facility: Homa Bay District Hospital
Study officials:
affiliation: EngenderHealth
name: Quentin Awori, MBChB, CPI
role: PRINCIPAL_INVESTIGATOR
References: