Infant Male Circumcision Infant Male Circumcision in Botswana as Part of Public in Botswana as Part of Public

HIV-Prevention EffortsHIV-Prevention Efforts

Rebeca M Plank, MDRebeca M Plank, MDBotswana-Harvard PartnershipBotswana-Harvard Partnership

10 June 201010 June 2010

World Health Organization

• WHO recommends neonatal circumcision should be a component of prevention campaigns since “neonatal circumcision is a less complicated and risky procedure than circumcision performed in young boys, adolescents or adults [and] countries should consider how to promote neonatal circumcision in a safe, culturally acceptable and sustainable manner (WHO / UNAIDS, 2007).”

Neonatal Circumcision: Safety

• 100,157 circumcised– 62 local infection

– 8 bacteremias

– 83 bleeding (3 transfusions)

– 20 surgical trauma

– 20 UTIs

– No deaths

• 35,929 uncircumcised– 88 UTIs

– 32 bacteremia

– 3 meningitis

– 2 renal failure

– 2 deaths

Wiswell et al. Pediatrics 1989;83(6):1011-5

Neonatal Circumcision: Safety and Sustainability

• Virtually bloodless• No sutures• Fast healing ~ 7-10

days• Low complication rate• No risk of sex before

healing• By the time an adult

decides, he may be infected

• No loss of time from school or work

• Infant circumcision about 1/10th cost and time– Cost versus discounted

savings:

Binagwaho PLoS Med 2010 19;7:e1000211

Cultural Acceptability: Botswana• Traditional until ~ 1900

in Mochudi, others

• Revived in 1975-1982

• Circumcisions done in hospital but expensive

• July 2009: 1300 initiates circumcised medically in 10 days– MOH helped with costs

• Will be repeated this year

Table 1

Married 10 (17%)

Single 50 (83%)

Religious Affiliation -

Christian 49 (82%)

None 11 (18%)

Highest Educational Level -

No education 3 (5%)

At least some primary education 6 (10%)

At least some secondary schooling 44 (73%)

At least some tertiary education 6 (10%)

Results• Fifty-seven (95%) women reported being tested for

HIV within the last year• Twenty-one (35%) reported being HIV+• Forty-six (77%) had previously heard that male

circumcision could affect a man’s chances of becoming infected with HIV

• Thirty-one (52%) said they thought male circumcision partially protected a man from being heterosexually infected with HIV

• Twenty-six (43%) thought male circumcision completely protected a man from being heterosexually infected with HIV

If it were available, would you be interested in having your new son circumcised at this

hospital by a trained doctor?1.7%

6.7%

91.7%

1

2

3

Yes (91.7%)

No (6.7%)

“Unsure” (1.7%)

Top 3 Reasons for Circ0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

1

2

3

4

5

1

2

3

4

5

Protect him from future infections such as HIV (98%)

Protect him from bladder infections as an infant (82%)

Hygiene (71%)

Cultural, traditional or religious reasons (36%)

Personal preference (9%)

Conclusions / Discussion• Male infant circumcision appears to be highly

acceptable in Botswana• Protection from HIV / other infections appears

to be a major motivation• The exaggerated perception of the protective

benefit of MC and concerns about comfort and safety must be carefully addressed

• Assessment of the actual uptake, safety and sustainability of expanded infant MC services deserves urgent attention

Aims of Current Study1.Determine the acceptability by actual uptake of

infant male circumcision and identify barriers2.Estimate the feasibility and safety

– Primary outcomes will be rate of significant complications such as bleeding, infection or need for repeat procedure

3.Estimate what, if any, advantages would exist for sustainable scale up of Mogen Clamp versus Plastibell– Human resources, equipment needs, adverse

events and acceptability to parents and providers in Botswana

Gomco Clamp

Plastibell

Plastibell• Standard surgical

instruments• Visualize the glans

prior to procedure• Little risk of bleeding

• Retained ring– Infection (tissue)– Infection (bladder)

• Supply chain must be reliable

Mogen Clamp• No retained ring

• Higher theoretical risk of bleeding

• Could amputate part of glans

• Need sterilization or high level disinfection including water and limited by number of clamps

Aim 1: Actual Acceptability• 191/300 babies randomized• In Mochudi 100 mothers brought baby for

circumcision (85% of those interviewed and 71% of ALL mothers approached)

• In Gaborone 70 have brought baby for circumcision (42% of those interviewed and 19% of ALL mothers approached)

• 100% follow-up

Aim 2: Safety (100)

• Three cases of minor bleeding immediately following the procedure, all controlled with local pressure

• No local infections• No case of damage to urethra or glans• Study physician subjectively dissatisfied with 19

cases– All photos to be reviewed by two pediatric urologists

• One case of retained Plastibell removed at day 17 without sequelae

Aim 3: Sustainability• One infant death day of life 3

– Reviewed by 5 regulatory bodies – Thought due to neonatal sepsis NOT related to

circumcision

• Infant health and implications for scale-up– < 28 days risk neonatal death– > 28 days risk bleeding– > day 1 risk of not returning– < 4 weeks exclude those observing

confinement– < day ? exclude out of hospital births

Future Directions: Arm 3

• Like the Plastibell, there is a “bell” that protects the glans. – There is also an

adjustable foreskin holder that allows positioning and repositioning PRN

• The device acts as the clamp and blade– The blade is retained

within the device (self-destructs) and prevents reuse

Future Directions: Arm 3 +• The AccuCirc comes in a self-contained kit

– Simplifies supply chain

• No parts are retained

• All items are one-time use (no sterilizing)

+ These design advantages make it an excellent candidate for task shifting as midwives, nurses and clinical officers could easily learn to perform the procedure safely

Take Home Points• Neonatal circumcision is acceptable

– Acceptability can increase with education– Begin active process in ANC

• Neonatal circumcision is safe– Plastibell will require active follow-up and well

prepared primary providers

• Sustainability will depend on timing of procedure with regard to local infant mortality and increased likelihood of follow-up

• UNAIDS / WHO Review completed

The best time to plant a tree is 20 years ago. The next best time is now.

Thank you

Thank you• Shahin Lockman• Nnamdi Ndubuka• Joseph Makhema• Janet Mwambona• Fatima Hussein• Ali Ali• Poloko Kebaabetswe• Chiapo Lesetedi• Mompati Mmalane

• HUPA• CFAR• PEPFAR / BOTUSA / CDC• NIH K23-AI-084579• ASTMH / Burroughs Wellcome

• Jane Magetse• Magdeline Mabuse• Maggie Ngkau • Max Essex• Roger Shapiro• David Bangsberg• Ron Bosch• Daniel Halperin• Barbara Bassil