Clinical Trials For Genital Herpes 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 currently recruiting participants.

Verified by French National Agency for Research on AIDS and Viral Hepatitis, April 2009

First Received: February 11, 2008   Last Updated: April 29, 2009   History of Changes

Sponsor:

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:

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: 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


No publications provided


Responsible Party:

ANRS ( Director )

ClinicalTrials.gov Identifier:

NCT00623051 History of Changes

Other Study ID Numbers:

ANRS 12126 ORANGE FARM 2

Study First Received:

February 11, 2008

Last Updated:

April 29, 2009

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


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

Retroviridae Infections

Immunologic Deficiency Syndromes


ClinicalTrials.gov processed this record on June 15, 2010 Evaluation of the Extension at Community Level of Safe Male Circumcision (ANRS 12126 ORANGE FARM 2)

This study is currently recruiting participants.

Verified by French National Agency for Research on AIDS and Viral Hepatitis, April 2009

First Received: February 11, 2008   Last Updated: April 29, 2009   History of Changes

Sponsor:

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:

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: 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


No publications provided


Responsible Party:

ANRS ( Director )

ClinicalTrials.gov Identifier:

NCT00623051 History of Changes

Other Study ID Numbers:

ANRS 12126 ORANGE FARM 2

Study First Received:

February 11, 2008

Last Updated:

April 29, 2009

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


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

Retroviridae Infections

Immunologic Deficiency Syndromes


ClinicalTrials.gov processed this record on June 15, 2010