Male circumcision: promise for prevention. Limakatso Lebina Neil Martinson Perinatal HIV Research Unit July 2011

Transcription

1 Male circumcision: promise for prevention Limakatso Lebina Neil Martinson Perinatal HIV Research Unit July 2011

2 WHY ANOTHER C?

3 Circumcision oldest and most common surgery performed % of men circumcised. Religious, culural A relief on the tomb of Ankh-Mahor

4 Biological Rationale Biological plausibility Inner mucosa of foreskin is rich in HIV target cells (9x) External foreskin/ shaft keratinized and not vulnerable After circumcision, only vulnerable mucosa is meatus Foreskin is retracted over shaft during intercourse Large surface area - inner mucosal surface exposure Micro-tears, especially of frenulum Intact foreskin associated with infections GUD Balanitis/phimosis Possible increase HIV entry or shedding

5 Keratinised outer surface of Human Foreskin External Surface Patterson et al. Am J Pathol 2002 Mucosal Surface

6 % HIV linked with % Circumcised Males Bongaarts AIDS 1989

7 Male Circumcision And HIV In Asia Bangladesh 0 Pakistan 0 Philippines Indonesia High (>80%) male circumcision Fiji China Vietnam PNG Low (<20%) male circumcision India Burma Thailand Cambodia Sources: UNAIDS, 2004

8 Acquisition/100py Protecting men Circumcised Uncircumcised <10,000 10,000-49,999 >50,000 Female viral load 40/137 uncircumcised men (16.7/100 py) vs. 0/50 of circumcised men became infected after two+ years (p = 0.004). Quinn et al NEJM 2000

9 Transmission/100py Protecting Women Circumcised Uncircumcised <10,000 10,000-49,999 >50,000 Male Viral load Of 47 couples in which circumcised male partner was HIV+ AND whose viral load was <50,000 particles, 0 of female partners were infected after two years, vs. 26 of 143 female partners of uncircumcised HIV+ men (9.6/100 py) (p = 0.02). Quinn et al NEJM 2000

10 HIV Prevalence by age in circumcised and uncircumcised men. Rakai, Uganda Kelly et al AIDS 1999, Current Male age Circumcised HIV (%) Uncircumcised HIV (%) PRR (CI) ( ) ( ) ( ) Effects of MC appear to be long lasting

11 Impact of Circumcision on other STI s Moses et al Sex Transm Infect 1998 STI No. studies reporting protective effect No. studies reporting increased risk Chancroid/ syphilis HSV Gonorrhoea NGU Genital warts No. studies reporting no association

12 Potential Biases Internal validity Ascertainment of circumcision status Ascertainment of HIV status Completeness of follow up External validity Representivity of population Participation rate Potential confounding factors Age Location Religion SES Marital status Sexual behaviour History of STI Condom use Travel Other exposures

13 The Circumcision Trials Kenya South Africa Uganda

14 Orange Farm RCT Design HIV Screening Randomisation of HIV- HIV+ Circumcision Month 0-3 Month 0-3 Month 4-12 Month 4-12 Month Month Circumcision

15 South Africa, Orange Farm Months Total Circumcision (1 432) No circumcision (1 398) Unadjusted RR: % reduction in HIV in circ ed men

16 Kisumu, Kenya Months Total Circumcision (1 367) No circumcision (1 393) Relative risk % reduction in HIV risk in circ d men

17 Rakai, Uganda Months Total Circumcision (2 263) No circumcision (2 319) Unadjusted RR: % reduction in HIV risk in circ ed men

18 Modelling cost effectiveness in South Africa 1000 circumcisions avert 308 infections over 20 years; two-thirds in men and one-third in women. Cost: $181 per HIV infection averted Net savings: $2.4 million. Kahn et al Plos Med 2006

19 What is it? What about Behavioural Disinhibition? Increase sexual risk behavior from a perceived protective effect Trials: little evidence (SA, Kenya, Uganda) BUT Depending on incidence rates may/may not overcome protective effect of circumcision. COMMUNICATION STRATEGIES Partial Protection v Maintain condom use

20 Modelling benefits 100% condom use 50% condom use (baseline) 10% 20% DECREASED INFECTIONS MC protective effect 30% 40% 50% 60% No condom use INCREASED INFECTIONS Mesesan K AIDS Conf Toronto 06 61% protection 3% condom use 63% protection, 0% condom use

21 Policy issues A surgical procedure to prevent public health disease (biomedical approach) Coverage required? Duties of Gov: Prevent epidemics Access to care Children s act (2005): circ needs special consent in kids<16 Age of consent 12, 14, 16?

22 Are we missing something in SA? Circumcision fever begins to sweep Swaziland Fran Blandy Mbabane, Swaziland Mail and Guardian online 02 February 2007 significant step forward in HIV prevention. Countries with high rates of heterosexual HIV infection and low rates of male circumcision now have an additional intervention which can reduce the risk of HIV infection in heterosexual men. Kevin De Cock, Director of WHO s HIV/AIDS Department. countries.. urgently scaling up access to the procedure. WHO STATEMENT

23 Gadgets, Gizmos and Gomkos

24 Ring block or Nerve block or Both Local aneasthetic

25 Nurses doing Circ s? S.A Nursing Council Not in Scope of Practice Medical superintendent authorises 1.Trained and competent 2.Controlled situation Women nurses agree! 74% of 50 nurses at PHRU said would do circs if trained Rural provincial hospital Nurses train com service docs 3-5 circs/day

26 Resources required for mass scale-up Theatres 6 room (recovery, 2 theatre, reception) Resus, sterilisation equipment R1.5m capital cost Operator + Assistant Not a difficult procedure On the job training and certification (weeks) Referral mechanism

27 GPs in Orange Farm Dr George Shilaluka No operating theatres No gowns No sterilisation units No scrubbing facilities No gadgets FORCEPS GUIDED METHOD Very few adverse events

28 Demand for circ Seasonal Peaks: Chris Hani Bara To circ 60% of all 14yr old Boys in Soweto would need per annum (De Bruyn et al 2007)

29 Westonaria, South Africa Rain-Taljaard et al AIDS care 2003

30 Botswana Kebaabetswe Sex Transm Inf 2003

31 Carletonville, South Africa Lagaarde et al AIDS 2003

32 Hlabisa and Mtubatuba, South Africa A cross-sectional convenience sample of 100 men and 44 women was surveyed, and two male focus groups held, to ascertain circumcision preferences within the population. Four in-depth interviews with service providers assessed the feasibility of promoting male circumcision. Fifty-one per cent of uncircumcised men and 68% of women favoured male circumcision of themselves or their partners; while 50% of men and 73% of women would circumcise their sons. For men, the main predictors of circumcision preference pertained to beliefs surrounding sexual pain and pleasure; for women, knowledge about the relationship between male circumcision status and STI acquisition was the key indicator for circumcision preference. Among both sexes the main barrier to circumcision was fear of pain and death. The greatest logistical barrier was that circumcision can presently only be carried out by trained hospital doctors. Scott, Weiss, Viljoen AIDS Care 2005

33 What about traditional circumcision? More Acceptable (male operators, culturally appropriate) Accessible Social Marketing BUT Complications: >10% Hemorrhage, infection/septicemia/gangrene, amputation of penis or permanent damage (Mogoha E Afr Med J 1999, Ahmed Ann Trop Ped 1999) Assault Fluid restriction Renal failure Infections

34 REMEMBER THESE NUMBERS! 65% reduction in HIV in circ ed men

35 Circumcise young men in South Africa? Shisana et al Nelson Mandela/HSRC Study of HIV/AIDS

36 Apart from circ, what else is there? Diaphragms? Treating HSV? Vaccines? VCT ARVs?

37 A B C

38 REMEMBER THESE NUMBERS: South Africa! 65% reduction in HIV in circ ed men

39 Dr Tom Quinn Ms Nkeko Tshabangu Prof Veller Prof Mzwai Prof Smith Prof Puren Dr Shilaluke Acknowledgments President s Emergency Plan for AIDS Relief through USAID South Africa