TerminatedPhase 3

Effect of Male Circumcision on HIV Incidence (ANRS 1265)

Stopped: following DSMB recommandation.

South Africa3,274 participantsStarted 2002-07

Plain-language summary

Observational studies suggest that male circumcision may provide protection against HIV-1 infection. A randomized, controlled, intervention trial was conducted in a general population of South Africa to test this hypothesis.

Who can participate

Age range

18 Years – 24 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Uncircumcised men aged 18-24 years * Be in good general condition with normal physical and genital examinations * Consenting to participate in the trial and to sign an informed consent * Consenting to randomization of the medicalized circumcision schedule (performed at the beginning of study for the treated group, optional at the end of study for the control group) * Consenting to avoid sexual contact (except with condom protection) during the 6 weeks following the medicalized circumcision * Consenting to blood tests at M.0, M.3, M.12 and M.21 tested for HIV, HSV-2 and syphilis. Exclusion Criteria: * Men with AIDS * Men with contraindication for circumcision * Men thinking of moving away from the trial sites within the 21 months following inclusion * Men with clinical sexually transmitted diseases (STDs) (those men could be included after treatment)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Measure the protective effect of medicalized male circumcision on HIV infection

Timeframe: M3, M12 and M21

Trial details

NCT IDNCT00122525

SponsorFrench National Agency for Research on AIDS and Viral Hepatitis

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More HIV Infections trials