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

This study has been completed.

Sponsor:

Collaborator:

EngenderHealth

Information provided by:

Weill Medical College of Cornell University

ClinicalTrials.gov Identifier:

NCT00993811

First received: October 9, 2009

Last updated: December 3, 2010

Last verified: October 2009

History of Changes

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 1


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	The Shang Ring: A Novel Male Circumcision Device for HIV Prevention

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

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
Study Completion Date:	March 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

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

Show Detailed Description

Eligibility


Ages Eligible for Study:	18 Years to 54 Years (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


Kenya
Homa Bay District Hospital
Homa Bay, Kenya

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


Responsible Party:	Marc Goldstein, M.D., Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00993811 History of Changes
Other Study ID Numbers:	0902010241
Study First Received:	October 9, 2009
Last Updated:	December 3, 2010
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:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2016

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