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

NCT01567436 | Completed Phase 4

• 1 other identifier: 10728
• Study Type: interventional
• Target: 1,200
• Locations: 2 countries
• Sites: 2

Brief 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%

Conditions

Male Circumcision

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  42 days

Secondary Outcomes (2)

• Acceptability of the Shang Ring Procedure

  42 days

• Percentage of men completely healed at 42 days

  42 Days

Interventions

Shang Ring DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

Homa Bay District Hospital male circumcision clinic

Homa Bay, Nyanza, 40300, Kenya

Location

Society for Family Planning Clinic

Lusaka, Lusaka Province, Zambia

Location

Related Publications (2)

• Barone MA, Li PS, Zulu R, Awori QD, Agot K, Combes S, Simba RO, Lee RK, Hart C, Lai JJ, Zyambo Z, Goldstein M, Feldblum PJ, Sokal DC. Men's Understanding of and Experiences During the Postcircumcision Abstinence Period: Results From a Field Study of ShangRing Circumcision During Routine Clinical Services in Kenya and Zambia. J Acquir Immune Defic Syndr. 2016 Jun 1;72 Suppl 1(Suppl 1):S18-23. doi: 10.1097/QAI.0000000000000704.

  PMID: 27331585 DERIVED

• Feldblum PJ, Okech J, Ochieng R, Hart C, Kiyuka G, Lai JJ, Veena V. Longer-Term Follow-Up of Kenyan Men Circumcised Using the ShangRing Device. PLoS One. 2015 Sep 14;10(9):e0137510. doi: 10.1371/journal.pone.0137510. eCollection 2015.

  PMID: 26367141 DERIVED

Study Officials

• Marc Goldstein, M.D.

  Weill Cornell Medical College, NY, USA

  STUDY CHAIR

• Mark A Barone, DVM, MS

  EngenderHealth, NY, USA

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

• Robert Zulu, MD

  University Teaching Hospital, Lusaka, Zambia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2012
• First Posted: March 30, 2012
• Study Start: February 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 27, 2012

Record last verified: 2012-09

Locations

ZA (1); KE (1)