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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
Information provided by:

Study Description
Brief 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).

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

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Rates of HIV acquisition in HIV-negative (neg) males and HIV-neg female partners
  2. Rates of STD acquisition in HIV-neg and HIV positive (+) males and HIV-neg and HIV+ female partners

Secondary Outcome Measures :
  1. Circumcision safety in HIV+ and HIV-neg males
  2. Behaviors among males and females in couples where the male is randomized to immediate versus delayed circumcision
  3. Behaviors among men and women in the general community

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Contacts and Locations

Information from the National Library of Medicine

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
Sponsors and Collaborators
Wawer, Maria J., M.D.
MRC/UVRI Uganda Research Unit on Aids
Rakai Health Sciences Program
Johns Hopkins Bloomberg School of Public Health
Principal Investigator: David Serwadda, MBChB,MPH Makerere University Institute of Public Health, Kampala
Study Director: Godfrey Kigozi, MBChB, MPH Rakai Health Sciences Program
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00124878     History of Changes
Other Study ID Numbers: 22006
First Posted: July 28, 2005    Key Record Dates
Last Update Posted: August 10, 2007
Last Verified: July 2005

Keywords provided by Wawer, Maria J., M.D.:
Male circumcision
HIV+ males
HIV-negative males
Female partners
STDs such as the following:
HIV Seronegativity

Additional relevant MeSH terms:
Communicable Diseases
HIV Infections
Vaginosis, Bacterial
Sexually Transmitted Diseases
Papillomavirus Infections
Herpes Genitalis
Chlamydia Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Bacterial Infections
Vaginal Diseases
Genital Diseases, Female
Genital Diseases, Male
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Sexually Transmitted Diseases, Bacterial
DNA Virus Infections
Tumor Virus Infections
Treponemal Infections
Spirochaetales Infections
Herpes Simplex