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

February 11, 2008
July 16, 2013
January 2008
December 2012   (final data collection date for primary outcome measure)
HIV prevalence in population [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00623051 on ClinicalTrials.gov Archive Site
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 ]
Sexual behavior, HSV-2 prevalence, circumcision prevalence, knowledge regarding HIV, AIDS and male circumcision [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Evaluation of the Extension at Community Level of Safe Male Circumcision (ANRS 12126 ORANGE FARM 2)
Evaluation of the Extension at Community Level of Safe Male Circumcision (ANRS 12126 ORANGE FARM 2)

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
Procedure: Male Circumcision
Experimental: 1
Male circumcision by experimented doctor or nurse
Intervention: Procedure: Male Circumcision
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27000
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Male
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT00623051
ANRS 12126 ORANGE FARM 2
No
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 )
French National Agency for Research on AIDS and Viral Hepatitis
Not Provided
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
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP