Bophelo Pele Male Circumcision Project: Orange FarmBophelo Pele Male Circumcision Project: Orange FarmDr. Dirk Taljaard, Project managerDr. Dirk Taljaard, Project managerProf. Bertran Auvert, Principal investigatorProf. Bertran Auvert, Principal investigatorDr. Dino Rech, Clinical managerDr. Dino Rech, Clinical manager

Randomised controlled trials of male

circumcision to reduce HIV infection

Source: 2006 Report on the global AIDS epidemic

(UNAIDS, May 2006)

Rakai, UgandaGray et. al. (2007) Lancet; 369: 657 – 66

Kisumu, KenyaBailey et. al. (2007)Lancet; 369: 643 – 56

Orange Farm, South AfricaAuvert et. al. (2005) PLoS Med; 2 (11): e298

B o ts w a n a

Z a m b ia

S w a z ila n d

Z im b a b w e

M a la w i

U g a n d a

S o u th A f r ic a

L e s o th o

M o z a m b iq u e

T a n z a n iaK e n y a

M a d a g s c a r

A n g o la

B e n in

C a m e ro o n

G h a n a

010

2030

40

HIV

pre

vale

nce

in a

dults

(%

), 2

005

2 0 4 0 6 0 8 0 1 0 0M a le c irc u m c is io n p re v a le n c e (% )

S u b -S a h a ra n A f r ic a

C o r re la t io n o f m a le c irc u m c is io n a n d H IV p re v a le n c e

B o ts w a n a

Z a m b ia

S w a z ila n d

Z im b a b w e

M a la w i

U g a n d a

S o u th A f r ic a

L e s o th o

M o z a m b iq u e

T a n z a n iaK e n y a

M a d a g s c a r

A n g o la

B e n in

C a m e ro o n

G h a n a

010

2030

40

HIV

pre

vale

nce

in a

dults

(%

), 2

005

2 0 4 0 6 0 8 0 1 0 0M a le c irc u m c is io n p re v a le n c e (% )

S u b -S a h a ra n A f r ic a

C o r re la t io n o f m a le c irc u m c is io n a n d H IV p re v a le n c e

HIV prevalence (%)

Male Circumcision (%)Source: Helen Weiss, LSHTM

Observational Studies of male

circumcision and HIV in Africa

Where in sub-Saharan Africa?

0

20

40

60

80

100

MC

pre

vale

nce

05

1015202530354045

HIV

pre

vale

nce

(adu

lts)

42 countries in AfricaAdult population = 331 millionUncircumcised adult men= 54 million (33% of adult men)

To prioritize and calculate the economic and human resources required for this roll-out :

Countries with “high” HIV prevalence (CEA criterion): > 5%AndCountries with “low” MC prevalence < 80%

Where in sub-Saharan Africa?

HIV(%)

MC(%)

Uncirc(million)

% totaluncirc

South Africa 25 35 8.0 32%

Zimbabwe 25 10 2.8 11%

Tanzania 9 70 2.7 11%

Malawi 14 17 2.3 9%

Zambia 17 12 2.2 9%

Mozambique 12 56 2.0 8%

Rwanda 5 10 1.8 7%

Burundi 6 2 1.7 7%

Lesotho 29 0 0.4 2%

Namibia 21 15 0.4 2%

Botswana 37 25 0.3 1%

CAR* 14 67 0.3 1%

Liberia 6 70 0.2 1%

Swaziland 39 50 0.1 1%

Total 25.2 100%

Countries: 42 countries � 14 countries (33%)Uncircumcised men: 54 million � 25 million (46%) HIV positive: 24 million � 14 million (58%)

* Central African Republic

14 countries

UgandaKenya (Nyanza province)

Programmes established

• Swaziland: • Family Life Association of Swaziland (FLAS)• PSI Swaziland

• Botswana• Public Health Facilities offer MC• PSI providing counselling services

• Zimbabwe• PSI Providing MC services

• Zambia• PSI Providing services

• Kenya• Robert Bailey’s trial group providing services• 20,000 MC done between January and June ‘09

• Uganda• Ron Gray’s trial group providing services

• Rwanda• Scale up have started in the Military

• Other countries have committed to scale up but have not implemented yet

Potential Impact of MC on HIV in sub-Saharan

Africa

� Modeling study: Over the next ten years in sub-Saharan Africa,

� MC could avert :

� 2.0 (1.1−3.8) million new HIV infections (men and women)

� 0.3 (0.2−0.5) million deaths (men and women)

� In the ten years after, a further :

� 3.7 (1.9−7.5) million new HIV infections (men and women)

� 2.7 (1.5−5.3) million deaths (men and women)

Williams et al. PLoS Med 2006 3(7): e262.

Programming benefits of MC

• Entry point to reach men, including adolescents

• Opportunity to offer VCT

• Opportunity for behavioral change counseling: partner reduction and condom use

• Roll out must include community mobilisation and involve women in decision making

• Opportunity for STI treatment and advice …

Evidence for other benefits of male

circumcision

Urinary tract infections in infants o 12X risk in uncircumcised boys than circumcised

Syphiliso 1.5-3.0 fold higher risk in uncircumcised men

Chancroido 2.5 fold higher risk in uncircumcised men

Human Papilloma Virus (HPV)o 63% reduction in circumcised men

Invasive penile cancer in meno 22 times more frequent in uncircumcised men

Cervical cancer in female partnerso 2.0 – 5.8 times more frequent in women with uncircumcised

partners (link with HPV)

Net cost

* in million US$

Private Public

Cumulative net cost* at 10 years + 538 (296 – 846) - 111 (-282 – 90)

Cumulative net cost* at 20 years - 3 494 (-4 698 – -2 180) - 4 358 (-5 665 – -3 246)

After adjustment for averted HIV medical costs>0 � expenses<0 � saving

� saving!

Number of circumcisions to avoid one HIV

infection

Number of MAMC to avert 1 HIV infection

(in 10 years)7.2 (6.5 - 7.9)

Number of MAMC to avert 1 HIV infection

(in 20 years)2.3 (2.0 - 2.5)

� 2 – 7 circumcisions to avoid 1 HIV infection in the first 10-20 years

Risk factors for MC roll out

� Unsafe surgery leading to

complications/ adverse events

� Acceptability

� Cost

� Feasibility

� Possible unintended promotion of female genital mutilation or cutting FGM/C

� Behavioural risk compensation - MESSAGING

2006: review of 13 acceptability studies in 9 sub-Saharan countries:

Uncircumcised men for themselves: 65% (29-87%) Women (for their partners): 69% (47-79%) Men for their son: 71% (50-90%)Women for their son: 81% (70-90%)

Acceptable in sub-Saharan Africa ?

Westercamp et al. AIDS Behav. 2006 Oct 20.Not surprising: Zulus, Twanas …

In South Africa?

� Policy and National Guidelines are in process –

� SANAC

� Technical Task Team, Mr. Dayanund Loykissoonlal, Acting Director, Prevention Strategies, NDOH

Objectives:

� To fulfil an ethical obligation from the 1265 Male Circumcision Trial – by offering free and safe MC to the community (Orange Farm, South Africa) where the trial was done

� To establish a MC program in a community

� To evaluate the impact of such program on: � Knowledge, attitudes and practices towards MC

� Existing prevention strategies like sexual behaviour change, condom use, STI treatment seeking behaviour and VCT attendance

� The spread of HIV and HSV-2

General information to the community

Community advisory boardCAB: Local NGO’s, Political structures, local leaders, scientists,

interested parties

Community meetings

RecruitmentOutreach activities

• Schools, churches, community leaders • Local radio station: Thetha FM• Community outreach activities: all households

“What women should know about MC”“What men should know about MC”

• Community stakeholder workshops i.e.loveLife

• Local GPs• In the clinics (STI patients)

Door-to-door outreach

Local radio

Outreach activities

In partnership with Society for Family Health

Door-to-door outreachLocal radio station:

Thetha FM

• Schools, churches, Shopping malls• Community

stakeholder workshops i.e.loveLife

• Train Station• Taxi ranks

Outreach activities

In partnership with SFH

• We working together with local GPs• We have started communication in the

clinics, especially among STI patients

A Mobile speaker system is usedPamphlets are distributed

Inclusion activities at Outreach centres

• Information session, anyone can attend, parents, spouses, partners� Safe sex messaging� Section on MC

Partial protection for men only6-week period of abstinence

� Individual counselling• VCT is recommended and offered• CD4 count test (on site) � ARVs• Paper work (minimum) for Inclusion,

including Informed consent

Wait 3 days before surgery!(7 days for smokers!)

SurgeryWITS Urology Department Study Site

• Started with 2 surgery rooms• Need for High Volume high

quality models• Dr. Dino Rech and Dr. Sean

Doyle developed• 7 beds, in one room divided

by curtains• 1 doctor, 4 aux nurses, 1

suture nurse = 10 MC per hour• Maximum capacity with 3

doctors = 150+ per day

SurgeryWITS Urology Department Study Site

• HIV+ participants are alsoCircumcised

• Cost: ZAR 300 approximately• Surgical kits developed and used• Monopolar electrocautery used• Assisted in the development of

MC MOVE • There is a follow-up visit 2-3

days after surgery• Emergency response

for participant after surgery• The rate of AE is 2.0% (187/9290). Ten participants (0.1%) were hospitalized.

What can the research community do at this time?Basic research (biological receptors etc)Phase-4 studiesOperational researchMeetings, country consultations, toolkits…

With the aimTo improve our knowledge in MC, MC-HIV, MC-STIsTo contribute to guide implementation

Scientific evidence1986-2007

Implementation(regional, national, locallevel)

Recommendations2007

2009

Where are

we?

Some research findings

What are the characteristics of the men

being circumcised within the project?

Age (y) MC Pop

Mean 21.8 24.5

Median 20 22

0%

10%

20%

30%

40%

50%

60%

15-19 20-24 25-29 30-34 35-39 40-44

Population

Intervention

Age group OF Male pop MC cards

15-19 35.7 % 50.1 %

20-24 30.2 % 27.9 %

25-29 14.4 % 9.7 %

30-34 8.0 % 6.4 %

35-39 5.2 % 3.3 %

40-44 3.3 % 1.7 %

Age distribution

Self reported MC status

� In a survey men were asked “Are you circumcised?”

� After the interview a physical examination was done to which they consented at the beginning of the interview

� Physical examination was done by a male nurse

� 45% of men who said they were circumcised had intact foreskin

� Possible reasons: � Confusion between MC and Initiation

� Confusion with words used, vernacular

� Lack of knowledge on what MC is

� How does HIV compare in these groups?

HIV (%) and circumcision status

0

5

10

15

20

25

‘’Circumcised’’with foreskin

Uncircumcised

PRR=0.93p=0.73

18.8%20.2%

HIV (%) and circumcision status

‘’Circumcised’’with foreskin

Uncircumcised

0

5

10

15

20

25

PRR=0.48 p=0.002

18.8%20.2%

9.5%

‘’Circumcised’’without foreskin

Thus, self reported MC status is a VERY unreliable indicator

Findings

Not surprising: Zulus, Twanas …

Preferred circumcision status of partners, for sexually active women

Findings

Not surprising: Zulus, Twanas …

89% of women who were included were sexually active. 35% of the 15 year olds were sexually active and of 17 year olds almost 70% were already sexually active. The mean age for sexual debut was 15.7 year of age.

The percentage of men and women who agreed with the following statements:

Kim Dickson UNIADS Brian Pazvakavambwa WHOGeorge Schmidt, WHORichard Hayes, LSHTMCate Hankins, UNAIDSDaniel Halperin, HarvardDavid Wilson, WBHelen Weiss, LSHTMHelen Jackson, UNFPA CST, Harare

Acknowledgements

David LewisAdrian PurenScott BillyCynthia NhlapoGoliath GumedeVeerle Dermaux-MsimangVenessa MasekoFrans RadebeBongiwe Klaas Tsietsi MbusoGaph Phatedi Bongani MazibukuAgenda GumbuDr. ShilalukeDr. ZuluDr. GwalaDaniel ShabanguAudrey MakwanasiMale ChakelaPamela Maseko

Thank you!