Trial of Male Circumcision: HIV, Sexually Transmitted Disease (STD) and Behavioral Effects in Men, Women and the Community
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|ClinicalTrials.gov Identifier: NCT00124878|
Recruitment Status : Unknown
Verified July 2005 by Wawer, Maria J., M.D..
Recruitment status was: Active, not recruiting
First Posted : July 28, 2005
Last Update Posted : August 10, 2007
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).
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections Sexually Transmitted Diseases Papillomavirus Infections Genital Herpes Gonorrhea Chlamydia Infections Syphilis Bacterial Vaginosis||Procedure: Male circumcision||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Trial of Male Circumcision: HIV, STD and Behavioral Effects in Men, Women and the Community|
|Study Start Date :||August 2003|
|Estimated Study Completion Date :||September 2009|
Active Comparator: Arm 1 Male circumcision
Men receive circumcision after randomization; procedure is generally provided within two weeks. A man randomized to the intervention arm who then declines circumcision for 6 or more months is considered a cross over.
Procedure: Male circumcision
No Intervention: Arm 2
Men wait for two years of follow up before being offered male circumcision
Procedure: Male circumcision
- Rates of HIV acquisition in HIV-negative (neg) males and HIV-neg female partners
- Rates of STD acquisition in HIV-neg and HIV positive (+) males and HIV-neg and HIV+ female partners
- Circumcision safety in HIV+ and HIV-neg males
- Behaviors among males and females in couples where the male is randomized to immediate versus delayed circumcision
- Behaviors among men and women in the general community
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00124878
|Rakai Health Sciences Program|
|Kalisizo, Rakai District, Uganda|
|Principal Investigator:||David Serwadda, MBChB,MPH||Makerere University Institute of Public Health, Kampala|
|Study Director:||Godfrey Kigozi, MBChB, MPH||Rakai Health Sciences Program|