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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Male Circumcision
Sponsored by
French National Agency for Research on AIDS and Viral Hepatitis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring male circumcision, HIV, sexual behavior, HIV prevention, HIV Seronegativity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Male Circumcision Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Male circumcision by experimented doctor or nurse

Outcomes

Primary Outcome Measures

HIV prevalence in population

Secondary Outcome Measures

Sexual behavior, HSV-2 prevalence, circumcision prevalence, knowledge regarding HIV, AIDS and male circumcision

Full Information

First Posted
February 11, 2008
Last Updated
July 16, 2013
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
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1. Study Identification

Unique Protocol Identification Number
NCT00623051
Brief Title
Evaluation of the Extension at Community Level of Safe Male Circumcision (ANRS 12126 ORANGE FARM 2)
Acronym
ORANGE FARM 2
Official Title
Evaluation of the Extension at Community Level of Safe Male Circumcision (ANRS 12126 ORANGE FARM 2)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French National Agency for Research on AIDS and Viral Hepatitis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
male circumcision, HIV, sexual behavior, HIV prevention, HIV Seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Male circumcision by experimented doctor or nurse
Intervention Type
Procedure
Intervention Name(s)
Male Circumcision
Primary Outcome Measure Information:
Title
HIV prevalence in population
Time Frame
at the end of the study
Secondary Outcome Measure Information:
Title
Sexual behavior, HSV-2 prevalence, circumcision prevalence, knowledge regarding HIV, AIDS and male circumcision
Time Frame
at the end of the study

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertran Auvert, MD, PhD
Organizational Affiliation
University of Versailles, INSERM U687, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Lewis, MD
Organizational Affiliation
NICD, Johannesburg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed Haffejee, MD
Organizational Affiliation
Wits Medical School, Urology Department, Johannesburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Male Circumcision Centre
City
Orange Farm
State/Province
Johannesburg
Country
South Africa

12. IPD Sharing Statement

Links:
URL
http://www.anrs.fr
Description
Related Info

Learn more about this trial

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

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