Evaluation of the Extension at Community Level of Safe Male Circumcision (ANRS 12126 ORANGE FARM 2)

NCT00623051 | Completed

• 1 other identifier: ANRS 12126 ORANGE FARM 2
• Study Type: interventional
• Target: 27,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study is aimed at demonstrating whether or not Male Circumcision can be used as an effective public health prevention tool that will have an impact on HIV prevalence in the South African population.

Conditions

HIV Infections

Keywords

male circumcision; HIV; sexual behavior; HIV prevention; HIV Seronegativity

Outcome Measures

Primary Outcomes (1)

• HIV prevalence in population

  at the end of the study

Secondary Outcomes (1)

• Sexual behavior, HSV-2 prevalence, circumcision prevalence, knowledge regarding HIV, AIDS and male circumcision

  at the end of the study

Study Arms (1)

1

EXPERIMENTAL

Male circumcision by experimented doctor or nurse

Procedure: Male Circumcision

Interventions

Male Circumcision PROCEDURE

1

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• being uncircumcised
• living in Orange Farm (South Africa) for more than 3 months
• agreeing to follow the instructions given by doctors, nurses and/or staff, and in particular to abstain from sex for 6-weeks after being circumcised
• having understood and sign a consent form written in their own language
• for those younger than 18 years of age having a written authorization from one parent or guardian and having signed an assent form.

You may not qualify if:

• subjects with contraindications for male circumcision
• allergy to anesthesia
• hemophilia or bleeding disorders
• genital ulceration or other symptoms of sexually transmitted infections
• signs of infections or AIDS
• abnormal genital anatomy
• history of diabetes

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead

Study Sites (1)

Male Circumcision Centre

Orange Farm, Johannesburg, South Africa

Location

Related Links

• Related Info

MeSH Terms

Conditions

HIV Infections; Sexual Behavior

Interventions

Circumcision, Male

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; Behavior

Intervention Hierarchy (Ancestors)

Body Modification, Non-Therapeutic; Cosmetic Techniques; Therapeutics; Surgical Procedures, Operative; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Bertran Auvert, MD, PhD

  University of Versailles, INSERM U687, France

  PRINCIPAL INVESTIGATOR

• David Lewis, MD

  NICD, Johannesburg

  PRINCIPAL INVESTIGATOR

• Mohamed Haffejee, MD

  Wits Medical School, Urology Department, Johannesburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2008
• First Posted: February 25, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 17, 2013

Record last verified: 2013-07

Locations

ZA (1)