Rebeca M Plank, MD Botswana-Harvard Partnership 10 June 2010 Infant Male Circumcision in Botswana as Part of Public HIV-Prevention Efforts Rebeca M Plank, MD Botswana-Harvard Partnership 10 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

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? Yes (91.7%) No (6.7%) “Unsure” (1.7%)

Top 3 Reasons for Circ 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 Study Determine the acceptability by actual uptake of infant male circumcision and identify barriers Estimate the feasibility and safety Primary outcomes will be rate of significant complications such as bleeding, infection or need for repeat procedure 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

A view of the glans penis after the excess foreskin and clamp have been removed. The whitish color is from a thin layer of cells adherent from the inner prepuce,which will disintegrate within a day. the true color of the infant glans is more reddish-purple.

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

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