Male circumcision to reduce human immunodeficiency virus (HIV) incidence in Kenya

ISRCTN	ISRCTN47258104
DOI	https://doi.org/10.1186/ISRCTN47258104
ClinicalTrials.gov number	NCT00059371
Secondary identifying numbers	MCT-44180

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Stephen Moses
Scientific

University of Manitoba
Department of Medical Microbiology
Room 503, Basic Medical Sciences Bldg.
730 William Avenue
Winnipeg, Manitoba
R3E 0W3
Canada

Phone	+1 204 789 3357
Email	smoses@cc.umanitoba.ca

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
Scientific title	A randomised, controlled trial of male circumcision to reduce human immunodeficiency virus (HIV) incidence in Kisumu, Kenya
Study acronym	UNIM
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	Human immunodeficiency virus (HIV)
Intervention	Male circumcision (surgical removal of prepuce) versus no circumcision.
Intervention type	Other
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 study start date	01/02/2002
Completion date	31/10/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target number of participants	2776
Key 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
Key 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
Date of first enrolment	01/02/2002
Date of final enrolment	31/10/2007

University of Manitoba

Winnipeg, Manitoba
R3E 0W3
Canada

University of Manitoba (Canada) - Department of Medical Microbiology
University/education

730 William Avenue
Winnipeg, Manitoba
R3E 0W3
Canada

Research organisation

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

No information available

National Institutes of Health (USA)
Government organisation / National government

Alternative name(s): Institutos Nacionales de la Salud, US National Institutes of Health, NIH
Location: United States of America

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	24/02/2007		Yes	No