Effect of Male Circumcision on HIV Incidence (ANRS 1265)

Study Overview
=================
Brief 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.

Detailed Description
-----------------
This study is a randomized controlled intervention trial. This multi-centre study will take place in 3 centers located around Johannesburg, in the areas of Orange Farm, Sebokeng and Evaton. The intervention group patients (circumcised at the beginning of the trial) and the control group (uncircumcised men) will be followed during 21 months (from M.0 to M. 21). Randomization and medicalized circumcision will be performed at M.0 in the intervention group and might be optional in the control group at end of study. The medicalized circumcision effectiveness will be evaluated on and after M.3 (3 months after medicalized circumcision). Incidences (of HIV, HSV-2 infections and genital ulcer disease) will be compared from M.3 to M.21 between the intervention group and the control group. An intermediate analysis will take place at M. 12.

Official Title
-----------------
Effect of Safe Male Circumcision on Incidence of Infection by HIV, HSV-2 and of Genital Ulceration

Conditions
-----------------
HIV Infections, Herpes Genitalis, Venereal Diseases

Intervention / Treatment
-----------------
* Procedure: Male Circumcision


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Male Circumcision|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the protective effect of medicalized male circumcision on HIV infection |  | M3, M12 and M21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the protective effect on infections by the genital herpes agent Herpes simplex virus type 2 (HSV-2) |  | M3, M12 and M21 | 
| Measure the protective effect on the incidence of genital ulcer disease |  | M3, M12 and M21 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Male circumcision, Prevention, HSV-2, Africa, Sexual behavior