ClinicalTrials.gg
Sign In
CompletedNCT00623051ORANGE FARM 2Updated Jul 17, 2013

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

An interventional study of Male Circumcision in HIV Infections, sponsored by French National Agency for Research on AIDS and Viral Hepatitis. Completed at 1 site in South Africa. Open to male participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-07-17.

Sponsored by French National Agency for Research on AIDS and Viral Hepatitis · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
27,000
Allocation
Not applicable
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • HIV Infections

Keywords

  • male circumcision
  • HIV
  • sexual behavior
  • HIV prevention
  • HIV Seronegativity
03

In context

HIV Infections

4,342 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 27,000 is above the median of 83 across 3,312 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

French National Agency for Research on AIDS and Viral Hepatitis is the lead sponsor of 86 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
27,000 participants (actual)

Study arms

  • Experimental
    1

    Male circumcision by experimented doctor or nurse

    Procedure: Male Circumcision

Interventions

  • ProcedureMale Circumcision
06

What researchers measure

Primary outcomes

  1. HIV prevalence in population

    Time frame: at the end of the study

Secondary outcomes

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

    Time frame: at the end of the study

07

Study locations

1 site
  • Male Circumcision Centre
    Orange Farm, Johannesburg, South Africa
08

References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00623051
Lead sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Responsible party
Sponsor
First posted
Feb 25, 2008
Start date
Jan 2008
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Jul 17, 2013

Study contacts

Bertran Auvert, MD, PhD
principal investigator · University of Versailles, INSERM U687, France
David Lewis, MD
principal investigator · NICD, Johannesburg
Mohamed Haffejee, MD
principal investigator · Wits Medical School, Urology Department, Johannesburg

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

HIV Infections →

Other studies from this sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Start the discussion