Condition category
Infections and Infestations
Date applied
01/09/2005
Date assigned
01/09/2005
Last edited
26/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

https://unim.rti.org/

Contact information

Type

Scientific

Primary contact

Dr Stephen Moses

ORCID ID

Contact details

University of Manitoba
Department of Medical Microbiology
Room 503
Basic Medical Sciences Bldg.
730 William Avenue
Winnipeg
Manitoba
R3E 0W3
Canada
+1 204 789 3357
smoses@cc.umanitoba.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00059371

Protocol/serial number

MCT-44180

Study information

Scientific title

A randomised, controlled trial of male circumcision to reduce human immunodeficiency virus (HIV) incidence in Kisumu, Kenya

Acronym

UNIM

Study hypothesis

1. To assess the effectiveness of male circumcision in reducing human immunodeficiency virus (HIV) incidence among young men in Kisumu, Kenya
2. To evaluate any adverse clinical effects of the circumcision procedure
3. To evaluate differences in sexual behaviour, perceptions of sexual function and sexual pleasure between men who are uncircumcised and circumcised
4. To evaluate the biological mechanisms by which presence of the foreskin increases HIV susceptibility

Ethics approval

Research Ethics Boards of:
1. Biomedical Research Ethics Board, University of Manitoba approved on the 20th March 2001
2. Kenyatta National Hospital approved on the 26th March 2001

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Human immunodeficiency virus (HIV)

Intervention

Male circumcision (surgical removal of prepuce) versus no circumcision.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

HIV seroconversion

Secondary outcome measures

1. Incidence of sexually transmitted infections
2. Sexual behaviour change
3. Complications of the circumcision procedure

Overall trial start date

01/02/2002

Overall trial end date

31/10/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Participating men must be:
1. Uncircumcised
2. Sexually active
3. Aged 18 - 24 years inclusive
4. Resident in Kisumu district with no plans to move away for the duration of follow-up
5. Agreeable to returning for follow-up as required by the study protocol, including periodic HIV testing

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

2776

Participant exclusion criteria

Men are excluded if they are:
1. Circumcised
2. Sexually active
3. Outside the indicated age range
4. Not resident in Kisumu or surroundings, or unlikely to remain there for the follow-up period
5. Unwilling to conform to the follow-up protocol
6. Having haemophilia or other bleeding disorders, or other medical conditions for which a surgical procedure is contra-indicated

Recruitment start date

01/02/2002

Recruitment end date

31/10/2007

Locations

Countries of recruitment

Kenya

Trial participating centre

University of Manitoba
Winnipeg, Manitoba
R3E 0W3
Canada

Sponsor information

Organisation

University of Manitoba (Canada) - Department of Medical Microbiology

Sponsor details

730 William Avenue
Winnipeg
Manitoba
R3E 0W3
Canada
+1 204 789 3357
smoses@cc.umanitoba.ca

Sponsor type

University/education

Website

http://www.umanitoba.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-44180)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Institutes of Health (USA)

Alternative name(s)

NIH

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed17321310

Publication citations

Additional files

Editorial Notes