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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed17321310