Trial of Male Circumcision: HIV, Sexually Transmitted Disease (STD) and Behavioral Effects in Men, Women and the Community

Summary

This randomized controlled trial conducted in Rakai District, Uganda, has enrolled 997 HIV positive men and 500 men who declined to learn HIV results (regardless of HIV status). The hypotheses are that male circumcision will be acceptable to and safe in both groups and will reduce the rates of STD acquisition in both groups and of HIV acquisition in HIV-negative men.

Enrollment was ended on Dec 12, 2006, following an interim Data Monitoring and Safety Board (DSMB) review of a closed report. At that time the DSMB determined that futility with respect to the female HIV outcome. There was an non-significantly higher rate of HIV acquisition in women partners of HIV+ men in couples who had resumed sex prior to certified post-surgical wound healing. The data indicated significant reductions (\~50%) in GUD symptoms among circumcised HIV+ men. The DSMB recommended: 1) that men and women should continue to be followed in complete two year follow up on all, 2) that circumcision for remaining HIV+ intervention arm men and for control arm men who had completed their 2 year follow should continue, contingent on a) revision of the study protocol to add additional post-surgical visits to assess wound healing, b) protocol revision to further strengthen education for both male and female partners on the need to postpone sex until certified wound healing, and c) approval of the revised protocol by the IRBs in both the US and Uganda. 3) An additional follow up visit for women be instituted at 18 months after enrollment. Protocol revision and IRB approvals have been finalized in June, 2007.

The study has also enrolled and is following 3,700 women sexual partners of men enrolled in this study and in a complementary National Institutes of Health (NIH) funded study (U1 AI51171 which is separately registered). The hypotheses are that male circumcision will be acceptable to and safe in women partners, and will reduce the women's acquisition of HIV and STDs such as herpes simplex virus-2 (HSV-2) and human papillomavirus (HPV).

Conditions

• HIV Infections
• Sexually Transmitted Diseases
• Papillomavirus Infections
• Genital Herpes
• Gonorrhea
• Chlamydia Infections
• Syphilis
• Bacterial Vaginosis

Interventions

PROCEDURE

Male circumcision

Sleeve circumcision

Sponsors & Collaborators

• MRC/UVRI and LSHTM Uganda Research Unit

  collaborator OTHER

• Rakai Health Sciences Program

  collaborator OTHER

• Johns Hopkins Bloomberg School of Public Health

  collaborator OTHER

• Wawer, Maria J., M.D.

  lead INDIV

Principal Investigators

• David Serwadda, MBChB,MPH · Makerere University Institute of Public Health, Kampala

• Godfrey Kigozi, MBChB, MPH · Rakai Health Sciences Program

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

15 Years

Max Age

49 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2003-08-31

Completion

2009-09-30

Countries

• Uganda

Study Locations