Trial of Male Circumcision: HIV, Sexually Transmitted Disease (STD) and Behavioral Effects in Men, Women and the Community
Recruitment status was Active, not recruiting
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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 | Intervention | Phase |
---|---|---|
HIV Infections Sexually Transmitted Diseases Papillomavirus Infections Genital Herpes Gonorrhea Chlamydia Infections Syphilis Bacterial Vaginosis |
Procedure: Male circumcision |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
Official Title: | Trial of Male Circumcision: HIV, STD and Behavioral Effects in Men, Women and the Community |
- 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
Enrollment: | 5200 |
Study Start Date: | August 2003 |
Estimated Study Completion Date: | September 2009 |
Arms | Assigned Interventions |
---|---|
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
Sleeve circumcision
|
No Intervention: Arm 2
Men wait for two years of follow up before being offered male circumcision
|
Procedure: Male circumcision
Sleeve circumcision
|
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Ages Eligible for Study: | 15 Years to 49 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
MALES randomized to circumcision:
- Age 15-49
- Able and willing to provide written informed consent
- Have no medical contraindications to male circumcision
FEMALE partners:
- Able and willing to provide written informed consent
- No age limit
Exclusion Criteria:
- Medical contraindications, including penile pathology or anemia (males). Unable or unwilling to provide informed consent.
Please note: for participants under age 18, the study follows informed consent/assent procedures as required under US Federal Regulations. The latter are also consistent with Ugandan policy.
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Uganda | |
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 | Johns Hopkins University |
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No publications provided by Wawer, Maria J., M.D.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00124878 History of Changes |
Other Study ID Numbers: | 22006 |
Study First Received: | July 25, 2005 |
Last Updated: | August 9, 2007 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by Wawer, Maria J., M.D.:
HIV STDs Male circumcision HIV+ males HIV-negative males |
Female partners STDs such as the following: HPV HSV-2 HIV Seronegativity |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Chlamydia Infections Gonorrhea Herpes Genitalis Sexually Transmitted Diseases Syphilis Vaginosis, Bacterial Papillomavirus Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Immunologic Deficiency Syndromes |
Immune System Diseases Slow Virus Diseases Chlamydiaceae Infections Gram-Negative Bacterial Infections Bacterial Infections Sexually Transmitted Diseases, Bacterial Infection Genital Diseases, Male Genital Diseases, Female Neisseriaceae Infections Herpes Simplex Herpesviridae Infections DNA Virus Infections Treponemal Infections Spirochaetales Infections |
ClinicalTrials.gov processed this record on February 26, 2013