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

NCT00993811 | Completed Phase 1

• 1 other identifier: 0902010241
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Male Circumcision; HIV Prevention; HIV Infections

Keywords

male circumcision; HIV; Africa; HIV Seronegativity

Outcome Measures

Primary Outcomes (1)

• The efficacy and safety of the ShangRIng device for adult male circumcision in an HIV endemic region in Africa.

  Six week post-operative follow up appointment and examination

Secondary Outcomes (1)

• 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).

  Six week post-operative follow up appointment and examination

Study Arms (1)

Circumcision

EXPERIMENTAL

Males undergoing circumcision

Device: Shang Ring circumcision

Interventions

Shang Ring circumcision DEVICE

novel device for adult male circumcision

Also known as: adult male circumcision

Circumcision

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• EngenderHealth: collaborator

Study Sites (1)

Homa Bay District Hospital

Homa Bay, Kenya

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Mark Barone, DMD

  EngenderHealth

  STUDY DIRECTOR

• Marc Goldstein, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 9, 2009
• First Posted: October 14, 2009
• Study Start: October 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: March 1, 2010
• Last Updated: December 6, 2010

Record last verified: 2009-10

Locations

KE (1)