Evaluation of the Extension at Community Level of Safe Male Circumcision (ANRS 12126 ORANGE FARM 2)
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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) |
- HIV prevalence in population [ 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 ]
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 |
---|---|
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.
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Genders 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
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Contact: Dirk Taljaard | 27 11 782 56 87 | dirk@progressus.co.za |
South Africa | |
Male Circumcision Centre | Recruiting |
Orange Farm, Johannesburg, South Africa | |
Contact: Dirk Taljaard 27 11 782 56 87 dirk@progressus.co.za |
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 |
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Additional Information:
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No publications provided
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: | March 13, 2012 |
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:
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on March 14, 2013