Trial record 14 of 1143 for:    acquired immunodeficiency syndrome AND (woman OR women OR female)

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2005 by Wawer, Maria J., M.D..
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
MRC/UVRI Uganda Research Unit on Aids
Rakai Health Sciences Program
Johns Hopkins Bloomberg School of Public Health
Information provided by:
Wawer, Maria J., M.D.
ClinicalTrials.gov Identifier:
NCT00124878
First received: July 25, 2005
Last updated: August 9, 2007
Last verified: July 2005
  Purpose

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

Resource links provided by NLM:


Further study details as provided by Wawer, Maria J., M.D.:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124878

Locations
Uganda
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
Investigators
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

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
Immunologic Deficiency Syndromes
Genital Diseases, Female
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
Immune System Diseases
Slow Virus Diseases
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Infection
Genital Diseases, Male
Neisseriaceae Infections
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Treponemal Infections
Spirochaetales Infections

ClinicalTrials.gov processed this record on August 28, 2014