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Completed

NCT Number: NCT00623051

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Male circumcision

Procedure

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

Sponsors and collaborators

Lead sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Other Gov

Registry information

Acronym: ORANGE FARM 2

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Feb 25, 2008
Registry last updated
Jul 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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