Effect of Safe Male Circumcision on Incidence of Infection by HIV, HSV-2 and of Genital Ulceration
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Enrollment
- 3,274
- Locations
- 1
- Primary Endpoint
- Measure the protective effect of medicalized male circumcision on HIV infection
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 24 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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)
Outcomes
Primary Outcomes
Measure the protective effect of medicalized male circumcision on HIV infection
Time Frame: M3, M12 and M21
Secondary Outcomes
- 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)