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

This study has been completed.
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
EngenderHealth
Weill Medical College of Cornell University
National AIDS/STD Control Programme: Kenya
Ministry of Medical Services: Kenya
University Teaching Hospital at the University of Zambia
Information provided by (Responsible Party):
FHI 360
ClinicalTrials.gov Identifier:
NCT01567436
First received: February 28, 2012
Last updated: September 26, 2012
Last verified: September 2012
  Purpose

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%


Condition Intervention Phase
Male Circumcision
Device: Shang Ring
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Prospective Study of Male Circumcision Using the Shang Ring in Routine Clinical Settings in Kenya & Zambia

Resource links provided by NLM:


Further study details as provided by FHI 360:

Primary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Acceptability of the Shang Ring Procedure [ Time Frame: 42 days ] [ Designated as safety issue: No ]
  • Percentage of men completely healed at 42 days [ Time Frame: 42 Days ] [ Designated as safety issue: Yes ]

Enrollment: 1200
Study Start Date: February 2012
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 54 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01567436

Locations
Kenya
Homa Bay District Hospital male circumcision clinic
Homa Bay, Nyanza, Kenya, 40300
Zambia
Society for Family Planning Clinic
Lusaka, Zambia
Sponsors and Collaborators
FHI 360
Bill and Melinda Gates Foundation
EngenderHealth
Weill Medical College of Cornell University
National AIDS/STD Control Programme: Kenya
Ministry of Medical Services: Kenya
University Teaching Hospital at the University of Zambia
Investigators
Study Chair: Marc Goldstein, M.D. Weill Cornell Medical College, NY, USA
Study Chair: Mark A Barone, DVM, MS EngenderHealth, NY, USA
Principal Investigator: Philip S Li, MD Weill Cornell Medical College, NY, USA
Principal Investigator: Richard Lee, MD Weill Cornell Medical College, NY, USA
Principal Investigator: Paul Perchal, MA EngenderHealth, NY, USA
Principal Investigator: Jared Mogouche, MD ChB EngenderHealth, Kisumu, Kenya
Principal Investigator: Quentin Awori, MB ChB EngenderHealth, Homa Bay, Kenya
Principal Investigator: Raymond Simba, MB ChB MPH Homa Bay District Hospital, Ministry of Health, Homa Bay, Kenya
Principal Investigator: Nicholas Muraguri, MB ChB MPH National AIDS/STD Control Programme, Nairobi, Kenya
Principal Investigator: John M Wekesa, MB ChB MMed Ministry of Medical Services, Nairobi, Kenya
Principal Investigator: Kasonde Bowa, MSc M. Med FRCS FACS FCS University of Zambia, Lusaka, Zambia
Principal Investigator: Robert Zulu, MD University Teaching Hospital, Lusaka, Zambia
  More Information

No publications provided

Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT01567436     History of Changes
Other Study ID Numbers: 10728
Study First Received: February 28, 2012
Last Updated: September 26, 2012
Health Authority: United States: Institutional Review Board
Kenya: Institutional Review Board
Kenya: Pharmacy and Poisons Board
Zambia:Institutional Review Board (UNZA REC)
Zambia: Pharmaceutical Regulatory Authority

ClinicalTrials.gov processed this record on April 17, 2014