Clinical trial NCT00623051: Evaluation of the Extension at Community Level of Safe Male Circumcision (ANRS 12126 ORANGE FARM 2)
Official title: Evaluation of the Extension at Community Level of Safe Male Circumcision (ANRS 12126 ORANGE FARM 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: male circumcision
HIV
sexual behavior
HIV prevention
HIV Seronegativity
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2008-02-25
Enrollment: 27000
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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:

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.

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

Primary outcomes:
measure: HIV prevalence in population
timeFrame: at the end of the study
Secondary outcomes:
measure: Sexual behavior, HSV-2 prevalence, circumcision prevalence, knowledge regarding HIV, AIDS and male circumcision
timeFrame: at the end of the study
Other outcomes:
Locations:
city: Orange Farm
country: South Africa
facility: Male Circumcision Centre
state: Johannesburg
Study officials:
affiliation: University of Versailles, INSERM U687, France
name: Bertran Auvert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: NICD, Johannesburg
name: David Lewis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wits Medical School, Urology Department, Johannesburg
name: Mohamed Haffejee, MD
role: PRINCIPAL_INVESTIGATOR
References: