HIV InfectionsORANGE FARM 2NCT00623051
Evaluation of the Extension at Community Level of Safe Male Circumcision (ANRS 12126 ORANGE FARM 2)
A study testing Male Circumcision in people with HIV Infections, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in South Africa.
Trial 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 more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Male Circumcision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27,000 participants
- Where
- 1 siteSouth Africa
- Study dates
- Jan 2008to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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:
- 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.
- Conditions
- HIV Infections
- Being tested
- Male Circumcision
- Keywords
- male circumcision, HIV, sexual behavior, HIV prevention, HIV Seronegativity
- Medical subject headings
- HIV Infections, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Male CircumcisionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Male circumcision by experimented doctor or nurse Receives: Procedure: Male Circumcision |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV prevalence in population
Measured: at the end of the study
Secondary outcomes (1)
Sexual behavior, HSV-2 prevalence, circumcision prevalence, knowledge regarding HIV, AIDS and male circumcision
Measured: at the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Bertran Auvert, MD, PhD, Principal investigator, University of Versailles, INSERM U687, FranceDavid Lewis, MD, Principal investigator, NICD, JohannesburgMohamed Haffejee, MD, Principal investigator, Wits Medical School, Urology Department, Johannesburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623051
- Sponsor's protocol ID
- ANRS 12126 ORANGE FARM 2
- Acronym
- ORANGE FARM 2
- Status last verified
- Jul 2013
- First submitted
- 11 Feb 2008
- Last updated
- 17 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Extension at Community Level of Safe Male Circumcision (ANRS 12126 ORANGE FARM 2)
- ClinicalTrials.gov ID
- NCT00623051
- Acronym / sponsor ID
- ORANGE FARM 2 / ANRS 12126 ORANGE FARM 2
- Conditions
- HIV Infections
- Keywords
- male circumcision, HIV, sexual behavior, HIV prevention, HIV Seronegativity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27,000 participants (actual)
- Lead sponsor
- French National Agency for Research on AIDS and Viral HepatitisOther government
- Study start
- Jan 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 25 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Male CircumcisionMale circumcision by experimented doctor or nurse |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Male Circumcision | Procedure or surgery | 1 |
Primary outcome
HIV prevalence in population
Time frame: at the end of the study
1 secondary outcome
Sexual behavior, HSV-2 prevalence, circumcision prevalence, knowledge regarding HIV, AIDS and male circumcision
Time frame: at the end of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2013.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Male Circumcision in people with HIV Infections, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV prevalence in population (time frame: at the end of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2013.