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

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

Interventions

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.

Sponsors & Collaborators

• Bill and Melinda Gates Foundation

  collaborator OTHER

• EngenderHealth

  collaborator OTHER

• Weill Medical College of Cornell University

  collaborator OTHER

• Kenya National AIDS & STI Control Programme

  collaborator OTHER

• Ministry of Medical Services, Kenya

  collaborator OTHER

• University Teaching Hospital, Lusaka, Zambia

  collaborator OTHER

• FHI 360

  lead OTHER

Principal Investigators

• Marc Goldstein, M.D. · Weill Cornell Medical College, NY, USA

• Mark A Barone, DVM, MS · EngenderHealth, NY, USA

• Philip S Li, MD · Weill Cornell Medical College, NY, USA

• Richard Lee, MD · Weill Cornell Medical College, NY, USA

• Paul Perchal, MA · EngenderHealth, NY, USA

• Jared Mogouche, MD ChB · EngenderHealth, Kisumu, Kenya

• Quentin Awori, MB ChB · EngenderHealth, Homa Bay, Kenya

• Raymond Simba, MB ChB MPH · Homa Bay District Hospital, Ministry of Health, Homa Bay, Kenya

• Nicholas Muraguri, MB ChB MPH · National AIDS/STD Control Programme, Nairobi, Kenya

• John M Wekesa, MB ChB MMed · Ministry of Medical Services, Nairobi, Kenya

• Kasonde Bowa, MSc M. Med FRCS FACS FCS · University of Zambia

• Robert Zulu, MD · University Teaching Hospital, Lusaka, Zambia

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

54 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-02-29

Primary Completion

2012-07-31

Completion

2012-08-31

Countries

• Kenya
• Zambia

Study Locations