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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00623051
Acronym
ORANGE FARM 2
Enrollment
27000
Registered
2008-02-25
Start date
2008-01-31
Completion date
2012-12-31
Last updated
2013-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

male circumcision, HIV, sexual behavior, HIV prevention, HIV Seronegativity

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.

Interventions

PROCEDUREMale Circumcision

Sponsors

French National Agency for Research on AIDS and Viral Hepatitis
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
HIV prevalence in populationat the end of the study

Secondary

MeasureTime frame
Sexual behavior, HSV-2 prevalence, circumcision prevalence, knowledge regarding HIV, AIDS and male circumcisionat the end of the study

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026