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The Shang Ring: A Novel Male Circumcision Device for HIV Prevention (ShangRing)
This study has been completed.
Sponsor:
Weill Medical College of Cornell University
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
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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: | 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:
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 ]
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 ]
| 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) |
| Sexes 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
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 |
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 June 28, 2017