A Prospective Field Study: Introducing the Shang Ring in Routine Clinical Settings

Male Circumcision Clinical Trial

Official title:

A Prospective Study of Male Circumcision Using the Shang Ring in Routine Clinical Settings in Kenya & Zambia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01567436
• Other study ID #: 10728
• Status: Completed
• Phase: Phase 4
• First received: February 28, 2012
• Last updated: September 26, 2012
• Start date: February 2012
• Est. completion date: August 2012

Study information

• Verified date: September 2012
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardKenya: Institutional Review BoardKenya: Pharmacy and Poisons BoardZambia:Institutional Review Board (UNZA REC)Zambia: Pharmaceutical Regulatory Authority
• Study type: Interventional

Clinical Trial Summary

Male Circumcision (MC) is the only new biomedical method to demonstrate consistent efficacy as an HIV prevention intervention in randomized controlled trials (WHO and UNAIDS, 2007), based on three randomized controlled trials in Kenya, Uganda, and South Africa, that reported a protective effect of about 60%

Description:

The World Health Organization, the Joint United Nations Programme on HIV/AIDS (UNAIDS), and other global reproductive health organizations have recognized the highly protective effect of male circumcision to prevent HIV infection in men. Male Circumcision (MC) is the only new biomedical method to demonstrate consistent efficacy as an HIV prevention intervention in randomized controlled trials, based on three randomized controlled trials in Kenya, Uganda, and South Africa, that reported a protective effect of about 60%. Subsequent studies have confirmed the value and persistence of MC's protection against HIV infection, and have demonstrated that MC also reduces the transmission of human papillomavirus.

A wide variety of instruments, devices, and techniques are used around the world for male circumcision. The WHO, UNAIDS and JHPIEGO document entitled Manual for Male Circumcision under Local Anesthesia, includes step-by-step instructions for performing adult male circumcision using three different surgical procedures: the forceps-guided, dorsal slit, and sleeve resection methods. Procedure times for these techniques are approximately 20-30 minutes excluding anesthesia and involve control of unavoidable bleeding and a significant amount of suturing, and can be associated with complications that include hematoma formation, infection, unsatisfactory cosmetic result, lacerations of the penile or scrotal skin and injury to the glans, particularly among inexperienced surgeons. Although training is necessary regardless of method, devices for MC have the potential to reduce both training time and surgical duration because neither hemostasis nor suturing is needed for most devices.

The Shang Ring is an innovative device for adult male circumcision that has been on the Chinese market since 2005. The Shang Ring is manufactured by Wuhu SNNDA Medical Treatment Appliance Technology Co., Ltd (SNNDA).

In the current African setting, only surgical circumcision is available for adults. Devices such as the Shang Ring have the potential to simplify and shorten surgery by eliminating the need for suturing and hemostasis. Data from two small studies in Kenya suggest that the Shang Ring has an acceptable safety profile. A randomized controlled trial was conducted in Kenya and Zambia to provide further data.

Circumcision using the Shang Ring involves a few simple steps. First, a special measuring strip is used to determine which Shang Ring size to use. Following administration of local anesthesia, the inner ring is fitted at the base of the glans penis. Next, the foreskin is everted over the inner ring and the outer ring is secured (locked) over the inner ring, thus encasing the foreskin. The sterile device forms a tight seal. The foreskin is excised and several nicks are made in the foreskin on the underside of the device to prevent formation of a stiff, circumferential scab. Bleeding is minimal and no suturing or hemostasis is required. Finally, the participant returns in seven days for removal of the Shang Ring device. After removal, a bandage is applied to the wound. Men may be given a supply of bandages and told to change the bandaging daily or as needed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 54 Years

Eligibility

Inclusion Criteria:

All men enrolled in this research study must meet the following inclusion criteria:

• Must be aged 18 and 54 years;

• Must be uncircumcised (on examination);

• Must be in good general health;

• Must agree to HIV counseling and testing no more than one week before the procedure;

• Must be free of genital ulcerations or other visible signs of STI (on examination);

• Must be able to understand study procedures and requirements of study participation;

• Must agree to return to the healthcare facility for the full schedule of follow-up visits after his circumcision;

• Must freely consent to participate in the study and sign a written informed consent form;

• Must have a cell phone or access to a cell phone; and,

• Must agree to provide the study staff with an address, phone number, or other locator information while participating in the research study.

Exclusion Criteria:

• A man will be excluded from participation in this research study if he has any of the following 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); or

• 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;

• Is currently participating in another biomedical study.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Male Circumcision

Intervention

Device:
• Shang Ring
The Shang Ring is a sterile device consisting of two concentric medical grade plastic rings: an inner ring with a silicone band and an outer, hinged ring. The inner ring fits inside the outer ring which will lock when snapped together. The Shang Ring comes in multiple sizes. The appropriate size is determined through use of a measuring strip. To ensure that men cannot remove the device prematurely, the locking mechanism must be broken open using a tool that is similar to a scalpel handle. Then, a pair of scissors is used to remove the inner ring, and a bandage or gauze dressing is applied.

Locations

Country	Name	City	State
Kenya	Homa Bay District Hospital male circumcision clinic	Homa Bay	Nyanza
Zambia	Society for Family Planning Clinic	Lusaka

Sponsors (7)

Lead Sponsor	Collaborator
FHI 360	Bill and Melinda Gates Foundation, EngenderHealth, Kenya National AIDS & STI Control Programme, Ministry of Medical Services, Kenya, University Teaching Hospital, Lusaka, Zambia, Weill Medical College of Cornell University

Countries where clinical trial is conducted

Kenya,  Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		42 days	Yes
Secondary	Acceptability of the Shang Ring Procedure		42 days	No
Secondary	Percentage of men completely healed at 42 days		42 Days	Yes