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

HIV Infections Clinical Trial

— ORANGE FARM 2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00623051
• Other study ID #: ANRS 12126 ORANGE FARM 2
• Status: Completed
• Phase: N/A
• First received: February 11, 2008
• Last updated: July 16, 2013
• Start date: January 2008
• Est. completion date: December 2012

Study information

• Verified date: July 2013
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Department of Health, Gauteng
• Study type: Interventional

Clinical Trial 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.

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:

1. knowledge, attitudes and practice regarding MC

2. existing means of prevention (sexual behavior change, condom use, STI treatment-seeking behavior and VCT (voluntary counseling and testing) attendance)

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27000
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Procedure:
• Male Circumcision

Locations

Country	Name	City	State
South Africa	Male Circumcision Centre	Orange Farm	Johannesburg

Sponsors (1)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV prevalence in population		at the end of the study	No
Secondary	Sexual behavior, HSV-2 prevalence, circumcision prevalence, knowledge regarding HIV, AIDS and male circumcision		at the end of the study	No

External Links

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