NCT00059371

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,887

participants targeted

Target at P75+ for phase_3 hiv-infections

Timeline
Completed

Started Feb 2002

Typical duration for phase_3 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2003

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

May 30, 2008

Status Verified

September 1, 2007

Enrollment Period

4.7 years

First QC Date

April 23, 2003

Last Update Submit

May 28, 2008

Conditions

HIV Infections

Keywords

Male circumcisionHIV acquisitionSexually transmitted infectionHIV Seronegativity

Outcome Measures

Primary Outcomes (2)

  • HIV incidence

    2 years

  • surgical complications

    2 years

Secondary Outcomes (2)

  • incidence of other sexually transmitted diseases

    2 years

  • behavioral risks

    2 years

Study Arms (2)

Circumcised immediately

ACTIVE COMPARATOR
Procedure: male circumcision

Delayed Circumcision

PLACEBO COMPARATOR

Men who were randomized to delayed circumcision were scheduled to be offered male circumcision 2 years after their randomization.

Procedure: male circumcision

Interventions

male circumcisionPROCEDURE
Circumcised immediatelyDelayed Circumcision

Eligibility Criteria

Age18 Years - 24 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNIM Clinic

Kisumu, Kisumu County, Kenya

Location

Related Publications (5)

  • Davis SM, Pals S, Yang C, Odoyo-June E, Chang J, Walters MS, Jaoko W, Bock N, Westerman L, Toledo C, Bailey RC. Circumcision status at HIV infection is not associated with plasma viral load in men: analysis of specimens from a randomized controlled trial. BMC Infect Dis. 2018 Jul 28;18(1):350. doi: 10.1186/s12879-018-3257-8.

    PMID: 30055581DERIVED

  • Mehta SD, Gaydos C, Maclean I, Odoyo-June E, Moses S, Agunda L, Quinn N, Bailey RC. The effect of medical male circumcision on urogenital Mycoplasma genitalium among men in Kisumu, Kenya. Sex Transm Dis. 2012 Apr;39(4):276-80. doi: 10.1097/OLQ.0b013e318240189c.

    PMID: 22421693DERIVED

  • Mehta SD, Maclean I, Ndinya-Achola JO, Moses S, Martin I, Ronald A, Agunda L, Murugu R, Bailey RC, Melendez J, Zenilman JM. Emergence of quinolone resistance and cephalosporin MIC creep in Neisseria gonorrhoeae isolates from a cohort of young men in Kisumu, Kenya, 2002 to 2009. Antimicrob Agents Chemother. 2011 Aug;55(8):3882-8. doi: 10.1128/AAC.00155-11. Epub 2011 May 23.

    PMID: 21606224DERIVED

  • Mehta SD, Gray RH, Auvert B, Moses S, Kigozi G, Taljaard D, Puren A, Agot K, Serwadda D, Parker CB, Wawer MJ, Bailey RC. Does sex in the early period after circumcision increase HIV-seroconversion risk? Pooled analysis of adult male circumcision clinical trials. AIDS. 2009 Jul 31;23(12):1557-64. doi: 10.1097/QAD.0b013e32832afe95.

    PMID: 19571722DERIVED

  • Bailey RC, Moses S, Parker CB, Agot K, Maclean I, Krieger JN, Williams CF, Campbell RT, Ndinya-Achola JO. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. Lancet. 2007 Feb 24;369(9562):643-56. doi: 10.1016/S0140-6736(07)60312-2.

    PMID: 17321310DERIVED

MeSH Terms

Conditions

HIV InfectionsSexually Transmitted Diseases

Interventions

Circumcision, Male

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Body Modification, Non-TherapeuticCosmetic TechniquesTherapeuticsSurgical Procedures, OperativeUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Robert C. Bailey, PhD, MPH

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

April 23, 2003

First Posted

April 24, 2003

Study Start

February 1, 2002

Primary Completion

October 1, 2006

Study Completion

December 1, 2006

Last Updated

May 30, 2008

Record last verified: 2007-09

Locations

KE(1)