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

French National Agency for Research on AIDS and Viral Hepatitis

Status: Completed

Conditions: HIV Infections

Treatments: Procedure: Male Circumcision

Study type: Interventional

Funder types: Other

Identifiers

NCT00623051

ANRS 12126 ORANGE FARM 2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27,000 patients

Sex: Male

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27,000 participants in 1 patient group

1

Experimental group

Description:

Male circumcision by experimented doctor or nurse

Treatment:

Procedure: Male Circumcision