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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )
ClinicalTrials.gov Identifier:
NCT00623051
First received: February 11, 2008
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
HIV Infections
Procedure: Male Circumcision

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of the Extension at Community Level of Safe Male Circumcision (ANRS 12126 ORANGE FARM 2)

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • HIV prevalence in population [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sexual behavior, HSV-2 prevalence, circumcision prevalence, knowledge regarding HIV, AIDS and male circumcision [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]

Enrollment: 27000
Study Start Date: January 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Male circumcision by experimented doctor or nurse
Procedure: Male Circumcision

Detailed Description:

A randomized, controlled trial (ANRS 1265) conducted in Orange Farm (South Africa) has demonstrated that male circumcision (MC) can reduce the risk of HIV acquisition by more than 50% among young men. This result has been confirmed by two similar studies conducted in Uganda and in Kenya.

Giving these findings, the next logical step is to demonstrate whether or not MC can be used as an effective public health prevention tool that will have an impact on HIV in populations as well as among individuals.

This research study aims to establish a MC intervention in the community where the first randomized controlled trial of the impact of MC on men's risk of acquiring HIV infection was carried out in order to evaluate its impact on:

  1. knowledge, attitudes and practice regarding MC
  2. existing means of prevention (sexual behavior change, condom use, STI treatment-seeking behavior and VCT (voluntary counseling and testing) attendance)
  3. the spread of HIV and HSV-2

This research will be carried out over a period of 60 months and will have three major components: (1) the delivery of the intervention, (2) quantitative studies (cross-sectional surveys), and (3) qualitative studies.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  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: NCT00623051

Locations
South Africa
Male Circumcision Centre
Orange Farm, Johannesburg, South Africa
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Investigators
Principal Investigator: 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
  More Information

Additional Information:
No publications provided

Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )
ClinicalTrials.gov Identifier: NCT00623051     History of Changes
Other Study ID Numbers: ANRS 12126 ORANGE FARM 2
Study First Received: February 11, 2008
Last Updated: July 16, 2013
Health Authority: South Africa: Department of Health, Gauteng

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
male circumcision
HIV
sexual behavior
HIV prevention
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 25, 2014