A Randomized Controlled Trial of Male Circumcision to Reduce HIV Incidence in Kisumu, Kenya

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A Randomized Controlled Trial of Male
Circumcision to Reduce HIV Incidence in Kisumu,
Kenya

• Robert C. Bailey J.O. Ndinya-Achola
• Univ. of Illinois at Chicago Univ. of Nairobi
• Stephen Moses Kawango Agot
• University of Manitoba UNIM Project/ IMPACT
• Ian Maclean John Krieger
• University of Manitoba University of
  Washington
• Corette Parker
• RTI International
• Supported by Division of AIDS, NIAID, NIH and the
  Canadian Institute for Health Research

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Hypotheses

• Circumcision will reduce HIV incidence among men
  aged 18-24 years by 50.
• Circumcision will result in less than a 2 rate
  of significant post-surgical complications
  requiring follow-up care.
• There will be no difference between circumcised
  men and controls in reported sexual behaviour
  following the circumcision procedure.

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Study Population

• Approximately 2,600,000 Luo live in Nyanza
  Province, western Kenya.
• Luo do not practice traditional circumcision.
• 9.9 of Luo men are circumcised.
• Kisumu District has approximately 39,000 men aged
  18-24 years.
• 86 live within 30 minutes of central Kisumu
  City.

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Clients of STD clinics Clients of VCT
centres Organizations (boda boda, jua kali, car
washers) Peer recruiters Fliers, radio,
shows Beaches, discos, rural communities
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Inclusion and Exclusion Criteria

• Inclusion Criteria
• Uncircumcised
• HIV negative
• Sexually active
• Aged 18-24 years
• Resident of Kisumu District
• No plans to move for at least the next 2 years.
• Consent to participate
• Hemoglobin over 9.0 grams per 100 ml

• Exclusion Criteria
• Foreskin covers less than half of glans
• Hemophiliac or other bleeding disorder
• High Prothrombin Time Index.
• Other medical condition contra-indicating surgery
• Absolute indication for circumcision

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INITIAL SCREENING TO RANDOMIZATION
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Baseline Characteristics
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Baseline Characteristics (cont)
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HIV Prevalence by Age N 4,643
Percent HIV
Age in Years
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STUDY VISITS
Check Wound
HIV Test Behavioral Questionnaire Collect urine,
blood, swabs
HIV Test
Surgery
3-Day
8-Day
30-Day
3 Month
6 Month
12 Month
18 Month
24 Month
Randomization
1 Month
3 Month
6 Month
12 Month
18 Month
24 Month
HIV Test Behavioral Questionnaire Collect urine,
blood, swabs
HIV Test
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Proportion of Visits Missed by Month of Scheduled
Visit
Percent
Month of Scheduled Visit
12
Percent
13
Percent
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Progress to July 17, 2006

• Recruitment was completed Sept 6, 2005
• 50 of men are in 18-20 year age group.
• 3.6 of 18-20 year-olds are HIV-infected
• 11.3 of 21-24 year-olds are HIV-infected
• 1,334 circumcision procedures completed (95.9)
• 69 in the treatment arm were not circumcised
  within six weeks (representing 5.0 crossover).
• 13 men have crossed over from control to
  circumcision arm (0.9).

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Adverse Events

• 27 AEs (1.7) definitely, probably or possibly
  related to the procedure
• 10 delayed healing or partially disrupted wounds
  (0.7)
• 6 post-operative wound infections (0.4)
• 4 bleeding episodes (0.3)
• 7 (0.5) other events (2 excessive swelling 1
  anesthetic reaction 1 excessive pain 1 pubic
  abscess related to surgical tape 1 case of
  folliculitis and 1 participant who reported
  erectile dysfunction).

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Other Surgical Outcomes

• Level of satisfaction
• 99 of clients very satisfied
• 0.5 somewhat satisfied
• 1 client somewhat dissatisfied
• 0 clients very dissatisfied
• At 30 days post-op
• 10 of participants reported having had sex since
  their circumcisions.
• 99 of men had resumed work 83 within 3 days
• At 90 days post-op visit
• 65 reported having resumed sexual intercourse
• 92 of female partners were very satisfied with
  the outcome, 5 were somewhat satisfied.

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Expected and Actual Outcomes to July 17, 2006
91 of expected person-yrs
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KEY EVENTS

• June 29, 2005 First Interim Analysis presented
  to DSMB. Instructed by DSMB to continue.
• September, 2005 Target enrollment of 2784
  completed.
• June 27, 2006 Second interim analysis presented
  to DSMB. Instructed to continue.
• September, 2007 Completion of trial

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