Male Circumcision And HIV Prevention: A Cutting Edge Intervention

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Male Circumcision And HIV Prevention A Cutting
Edge Intervention
David Stanton USAID Mini University Friday,
October 14, 2005
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Ecological data
Caldwell, 1996
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Systematic review (Weiss 2000)

• African studies only - 19 cross sectional, 5
  case control, 3 cohort, one partner study
• Substantial protective effect of MC on risk of
  HIV
• Also reduced risk of GUD
• Strongest association among high-risk men
• Adjustment for confounding strengthened the
  association in all population-based studies
• Crude RR 0.93, adjusted RR0.56, CI 0.44-0.70
• but made little difference in high risk studies
• Crude RR0.27, adjusted RR0.29, CI 0.20-0.41
• Conclusions "The data from observational
  studies provide compelling evidence of a
  substantial protective effect of male
  circumcision against HIV infection in sub-Saharan
  Africa, especially in populations at high risk of
  HIV."

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• UNAIDS multi-centre study showed male
  circumcision major predictor of regional HIV
  variation
• In study of male partners of HIV women in Rakai,
  40-137 uncircumcised and 0-50 circumcised men
  became infected

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HIV PREVALENCE AND MALE CIRCUMCISION IN KENYA
Sources ORC/MACRO, Kenya CBS, 2004
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• HIV prevalence in Nyanza Province (mainly Luo
  area) over twice as high as elsewhere in Kenya
• In Nyanza, 21 of uncircumcised and 2 of
  circumcised men had HIV
• This association has not been seen in other
  surveys

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Biologic plausibility

• In non-circumcised men
• More HIV target cells (Langerhans and other
  receptor cells) in the foreskin than elsewhere in
  the body
• Greater susceptibility to traumatic epithelial
  disruptions during intercourse
• Micro-environment more conducive to viral
  survival
• In circumcised men
• Higher keratinisation of the exposed glans
• Lower risk of GUD, a co-factor for HIV
  transmission

In vitro data shows that the foreskin absorbs HIV
nine times more easily than other genital mucosa
(Patterson, 2002)
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Randomized controlled trials

• Orange Farm, South Africa
• Design
• Screening
• Randomization
• Immediate circumcision for intervention group
• Follow-up at 3, 12, 21 months
• Circumcision of control group at end
• 3035 participants 80 power to detect 50
  reduction with 2 annual incidence
• Interim efficacy analysis after 12m follow-up

Trial was stopped early by the DSMB after interim
analysis
Bertran Auvert IAS 2005 27 July- Orange Farm
Intervention Trial (ANRS 1265)
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Male circumcision
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Results from Orange Farm MC trial
Incidence rate Intervention 0.77 (0.49
-1.23)/100 p-y Control 2.2 (1.7 -2.9)/100
p-y Total 1.5 (1.2 1.9) /100 p-y Unadjusted
RR 0.35 (0.20 0.60) p0.00013 Apparent
protective effect (1-RR) 65 (40 -80) Per
protocol unadjusted RR (no dilution effect due
to cross-over) RR 0.25 (0.14-0.46)
Protection 75 (64-86)
Adverse events were reported among 3.8 of trial
participants 48 of these were pain, swelling,
or hematoma
Bertran Auvert IAS 2005 27 July- Orange Farm
Intervention Trial (ANRS 1265)
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Acceptability

• Orange Farm
• 70 of uncircumcised males would accept
  circumcision if it reduces the risk of getting
  HIV
• Studies in Kenya, Uganda, Haiti, Tanzania,
  Botswana, Zambia, and Zimbabwe
• 45-85 of uncircumcised men expressed interest in
  getting circumcised if safe and affordable
• Interest commonly related to improved hygiene
  (independent of possible HIV benefits)

Acceptability often may be related to the
perception even where MC is no longer prevalent
that MC is a part of traditional cultural
practice
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Safety
Data from studies in East and Southern Africa

• One study in Nigerian hospital
• Complication rate of 2.8
• One study in Nigerian and Kenyan Hospitals
• Complication rate about 12
• One study in Tanzania on infants using Plastibell
• Complication rate of 2.0
• Study in Kenya
• medical circumcision 17.7 adverse events
• traditional 35.2 adverse events
• Many anecdotal reports of bleeding, infection,
  mutilation and even death

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Programming considerations

• Many different models and contexts for service
  delivery
• Neonatal (infant circumcision)
• Clinical
• Traditional (circumcision schools)
• We should proactively address disinhibition
• Men in the MC group did have more sexual partners
  than those in the control group during follow-up
  though benefits were still great
• Must provide strong behavior change programming
  to prevent disinhibition as services expand

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Programming considerations

• Men may start to vote with their feet and seek
  circumcision whether or not we get involved in
  implementation
• Expanding access to safe, clinical MC may be key
• Linking behavior change programming to MC
  services may be a strategic way to improve
  prevention coverage among men
• We should build on programmatic lessons learned
  from work USAID has supported in Zambia, Haiti
  and elsewhere...
• Role of the international/donor community
• Establishing standards and guidelines
• Training and education (public, private,
  clinical, traditional)
• Supporting integration of behavior change and MC

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Next Steps

• Results of the two ongoing randomized trials will
  be of utmost importance
• If one or both show a protective effect, the
  interest in implementing MC services will grow
  requiring donors and the international public
  health leadership to come to consensus
• It remains to be seen how well MC can be scaled
  up given the pre-existing constraints on the
  health care infrastructure in developing
  countries.

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Conclusion

• MC has been controversial but persistently
  compelling
• It has been elevated from a curious finding to a
  potentially high impact intervention
• The next 12 to 18 months will be exciting

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Thank You