The Shang Ring: A Novel Male Circumcision Device for HIV Prevention - Full Text View

The Shang Ring: A Novel Male Circumcision Device for HIV Prevention (ShangRing)

This study is currently recruiting participants.

Verified by Weill Medical College of Cornell University, October 2009

First Received: October 9, 2009 Last Updated: November 6, 2009 History of Changes

Sponsor:	Weill Medical College of Cornell University
Collaborator:	Engenderhealth
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00993811

Purpose

The purpose of this study is to evaluate the Shang Ring, a novel Chinese device for voluntary medical male circumcision, in order to improve the provision of male circumcision services for HIV prevention in Africa.

Condition	Intervention	Phase
Male Circumcision HIV Prevention HIV Infections	Device: Shang Ring circumcision	Phase I

Study Type:	Interventional
Study Design:	Prevention, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	The Shang Ring: A Novel Male Circumcision Device for HIV Prevention

Resource links provided by NLM:

MedlinePlus related topics: AIDS Circumcision

U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:

The efficacy and safety of the ShangRIng device for adult male circumcision in an HIV endemic region in Africa. [ Time Frame: Six week post-operative follow up appointment and examination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Behavior outcomes (surgical acceptability, satisfaction, problems encountered with the device, compliance with post-surgical instructions, and correct knowledge about the extent of the protective effect of circumcision and safe sex). [ Time Frame: Six week post-operative follow up appointment and examination ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	October 2009
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Circumcision: Experimental Males undergoing circumcision	Device: Shang Ring circumcision novel device for adult male circumcision

Show Detailed Description

Eligibility

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

Criteria

Inclusion Criteria:

Freely consents to participate in the study and signs an informed consent form
Ages 18 - 54 years
Uncircumcised
Good general health
HIV sero-negative
Able to understand the study procedures and requirements
Agrees to return to the health care facility for the full schedule of follow-up visits after his circumcision

Exclusion Criteria:

Previous circumcision on examination
Age < 18 years or > 54 years
Active genital infection, anatomic abnormality or other condition, which in the opinion of the surgeon prevents the man from undergoing a circumcision
HIV sero-positive
A condition, which in the opinion of the surgeon contradicts participation in the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00993811

Contacts

Contact: Fredrick Ndede, M.D.

(+254-20) 444-4922

fndede@engenderhealth.org

Locations

Kenya
Homa Bay District Hospital	Recruiting
Homa Bay, Kenya
Contact: Quentin Awori, M.D. qawori@gmail.com

Sponsors and Collaborators

Weill Medical College of Cornell University

Engenderhealth

Investigators

Study Director:	Mark Barone, DMD	Engenderhealth
Principal Investigator:	Marc Goldstein, M.D.	Weill Medical College of Cornell University

More Information

No publications provided

Responsible Party:	Weill Medical College of Cornell University ( Marc Goldstein, M.D. )
Study ID Numbers:	0902010241
Study First Received:	October 9, 2009
Last Updated:	November 6, 2009
ClinicalTrials.gov Identifier:	NCT00993811 History of Changes
Health Authority:	Kenya: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:

male circumcision
HIV
Africa
HIV Seronegativity

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on February 08, 2010