Evaluation of the Extension at Community Level of Safe Male Circumcision (ANRS 12126 ORANGE FARM 2) (ORANGE FARM 2)
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ClinicalTrials.gov Identifier: NCT00623051 |
Recruitment Status
:
Completed
First Posted
: February 25, 2008
Last Update Posted
: July 17, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Procedure: Male Circumcision | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 27000 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Evaluation of the Extension at Community Level of Safe Male Circumcision (ANRS 12126 ORANGE FARM 2) |
Study Start Date : | January 2008 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | December 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Male circumcision by experimented doctor or nurse
|
Procedure: Male Circumcision |
- HIV prevalence in population [ Time Frame: at the end of the study ]
- Sexual behavior, HSV-2 prevalence, circumcision prevalence, knowledge regarding HIV, AIDS and male circumcision [ Time Frame: at the end of the study ]

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00623051
South Africa | |
Male Circumcision Centre | |
Orange Farm, Johannesburg, South Africa |
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 |
Additional Information:
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 |
First Posted: | February 25, 2008 Key Record Dates |
Last Update Posted: | July 17, 2013 |
Last Verified: | July 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 |