Male Circumcision and HIV Rates in Kenya

May 28, 2008 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Trial of Male Circumcision to Reduce HIV Incidence

The Luo tribe of Kisumu, Kenya, does not traditionally practice male circumcision (MC). This study will work with the Luo tribe to test the effectiveness of MC on reducing the risk of HIV infections in young men.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Since 1989, numerous epidemiological studies have reported a significant association between lack of male circumcision (MC) and risk for HIV infection through heterosexual intercourse. These results have led to calls for male circumcision to be considered as an additional HIV prevention strategy. However, there is a consensus among the international health community that a randomized controlled trial of MC is needed to control for possible confounding factors. Additionally, known risks associated with MC need further investigation. This study will assess the effectiveness of male circumcision in reducing HIV incidence and will evaluate complications of the MC procedure, changes in sexual behavior following circumcision, and the biological mechanisms by which the foreskin may increase HIV susceptibility. The study will be conducted in Kisumu, Kenya, where the Luo tribe is the main ethnic group and less than 10% of adult men are circumcised.

Uncircumcised men aged 18 to 24 years old will be offered voluntary HIV counseling and testing. HIV negative men will be asked to enroll in the study. All study participants will be interviewed to obtain socio-demographic information and assess behavioral risk factors. Participants will be examined for significant medical conditions. All men will be counseled in strategies to reduce their risk for HIV infection. Consenting men will be randomly assigned to either the treatment (circumcised) arm or the control (uncircumcised) arm of the study. After circumcision, men will be monitored for complications. They will be counseled to abstain from sex until healing is complete. Follow-up visits will occur every 6 months for 2 years. Uncircumcised men will be offered circumcision at the end of follow-up.

The primary study endpoints will be HIV incidence and surgical complications. Additional outcomes will be the incidence of other sexually transmitted diseases and behavioral risks. Additional laboratory studies of foreskin tissue will evaluate the number and density of specialized cells rich in HIV receptors in order to illuminate the biological mechanisms by which presence of foreskin may increase HIV susceptibility.

Study Type

Interventional

Enrollment (Actual)

2887

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Kisumu, Kenya
        • UNIM Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 24 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria

  • HIV uninfected and willing to be tested
  • Live in Kisumu District, Kenya
  • Uncircumcised but willing to be circumcised
  • At least one sexual partner in the 12 months prior to study entry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Circumcised immediately
Procedure: male circumcision
Placebo Comparator: Delayed Circumcision
Men who were randomized to delayed circumcision were scheduled to be offered male circumcision 2 years after their randomization.
Procedure: male circumcision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HIV incidence
Time Frame: 2 years
2 years
surgical complications
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
incidence of other sexually transmitted diseases
Time Frame: 2 years
2 years
behavioral risks
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Robert C. Bailey, PhD, MPH, University of Illinois at Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

April 23, 2003

First Submitted That Met QC Criteria

April 23, 2003

First Posted (Estimate)

April 24, 2003

Study Record Updates

Last Update Posted (Estimate)

May 30, 2008

Last Update Submitted That Met QC Criteria

May 28, 2008

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5U01AI050440-02 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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