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

Sponsored by:	French National Agency for Research on AIDS and Viral Hepatitis
Information provided by:	French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:	NCT00623051

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:	Prevention, Open Label, Single Group Assignment
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: AIDS Circumcision

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sexual behavior, HSV-2 prevalence, circumcision prevalence, knowledge regarding HIV, AIDS and male circumcision [ Designated as safety issue: No ]

Estimated Enrollment:	27300
Study Start Date:	January 2008
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623051

Contacts

Contact: Dirk Taljaard

27 11 782 56 87

dirk@progressus.co.za

Locations

South Africa, Johannesburg
Male Circumcision Centre	Recruiting
Orange Farm, Johannesburg, South Africa
Contact: Dirk Taljaard 27 11 782 56 87 dirk@progressus.co.za

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

No publications provided

Responsible Party:	ANRS ( Director )
Study ID Numbers:	ANRS 12126 ORANGE FARM 2
Study First Received:	February 11, 2008
Last Updated:	April 29, 2009
ClinicalTrials.gov Identifier:	NCT00623051 History of Changes
Health Authority:	South Africa: Department of Health, Gauteng

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:

male circumcision
HIV
sexual behavior
HIV prevention
HIV Seronegativity

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Orange
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on September 03, 2009