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

History of Changes

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:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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) ( French National Agency for Research on AIDS and Viral Hepatitis ):

Primary Outcome Measures:

HIV prevalence in population [ Time Frame: at the end of the study ]

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 ]


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:

knowledge, attitudes and practice regarding MC
existing means of prevention (sexual behavior change, condom use, STI treatment-seeking behavior and VCT (voluntary counseling and testing) attendance)
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


Ages Eligible for Study:	Child, Adult, Senior
Sexes 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:

Related Info This link exits the ClinicalTrials.gov site


Responsible Party:	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

Keywords provided by 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 ):


male circumcision HIV sexual behavior HIV prevention 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 July 26, 2017

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