Male Circumcision: The Road from Evidence to Practice

Male Circumcision: The Road from Evidence to Practice
IDPH Conference, Springfield - Nov 1, 2006 Male Circumcision: The Road from Evidence to Practice Prof. Robert C. Bailey Division of Epidemiology School of Public Health University of Illinois at Chicago 4000 men get infected with HIV in sub-Saharan Africa every day. Probably 3000 of those men are uncircumcised. How many female partners of those 3000 newly infected men will become infected is beyond my abilities to estimate. But certainly, it is now a largely preventable number. Male circumcision has been likened to a vaccine. Not a perfect vaccine, but an effective one – about 60% effective in preventing new HIV infections in adult heterosexual men. I am going to very briefly review the evidence for the efficacy of male circumcision in reducing HIV acquisition, and discuss some guidelines for the way forward – the road from evidence to practice.

Current Prevention Tools Against Heterosexual HIV Transmission
IDPH Conference, Springfield - Nov 1, 2006 Current Prevention Tools Against Heterosexual HIV Transmission Risk Reduction Abstinence Faithfulness Condoms STI Treatment Voluntary Counseling and Testing PrEP? Anti-retroviral therapy? Microbicides? Diaphragm HSV-2 suppressive therapy? Vaccines? As we are all aware, our present weapons against heterosexual transmission of HIV are severely limited. Here in white font are the tools that are currently widely accepted, although the evidence supporting their effectiveness is sometimes questioned. They include the A B and Cs – abstinence, be faithful and use condoms – for risk reduction, early diagnosis and treatment of STIs, and Voluntary Counseling and HIV testing. We are all hopeful that additional weapons will be developed and will be proven effective. Unfortunately, we’ve had a few setbacks recently in microbicides and the diaphragm, and just yesterday a disappointing report from Mwanza on HSV-2 suppressive therapy, but we have learned a lot that we can put to good use we must remain hopeful.

IDPH Conference, Springfield - Nov 1, 2006
Male circumcision is probably the oldest and most common surgery performed in humans Male circumcision is not a new health related intervention. The ancient Egyptians over 4300 years ago performed the procedure, and it has developed independently in several disparate cultures around the world.

Male Circumcision Background Information
IDPH Conference, Springfield - Nov 1, 2006 Male Circumcision Background Information Globally, approximately 30% of men are circumcised. In Africa, approximately 68%. It is a practice observed mostly for cultural and religious reasons, less often for health reasons. It is a simple procedure that may confer health benefits, but being a surgical procedure it entails risks. The benefits of MC must be weighed against the potential harm. Now approximately 30 to 35% of adult men are circumcised worldwide. In Africa, about two-thirds of men. It is practiced mainly for religious reasons, as seen here in this photograph where a traditional mohel is circumcising a jewish child eight days after birth, and for cultural reasons, as with these adolescent boys who were circumcised at ages 10 – 18 as a rite of passage in Bungoma, Kenya. Circumcision is a simple surgical procedure, very safe when done by a trained practitioner under anasceptic conditions, but like any surgical procedure it entails risks, and any benefits of circumcision have to be weighed against the potential harm.

Protective Effect of MC against Other Conditions
IDPH Conference, Springfield - Nov 1, 2006 Protective Effect of MC against Other Conditions Outcome RR (95% CI) Urinary tract infection 0.13 (0.08,0.20) Chlamydia 0.18 (0.06,0.58) Chancroid 0.40 (0.24,0.66) Invasive penile cancer 0.43 (0.24,0.77) Cervical cancer 0.54 (0.39,0.74) Syphilis 0.67 (0.54,0.83) Aside from HIV infection, male circumcision has been found to be protective against many other conditions. In this slide, put together by Helen Weiss, I believe, you can see that neonatal circumcision has a strong protective effect against urinary tract infections in infants. The female partners of circumcised men have been found to be at less risk for chlamydia. Men who are circumcised have about 60% less likelihood of contracting chancroid, and invasive penile cancer is very rarely seen in circumcised men, unlike in some regions where it is seen all too often clinically in uncircumcised men. A multi-site cross-sectional study found that most strains of HPV are less prevalent in circumcised men, and the partners of circumcised men experience less cervical cancer. The evidence for a protective effect against syphilis and HSV-2 infection is less clear. HPV 0.80 (0.61,1.05) HSV-2 0.88 (0.77,1.01) .1 .5 .75 1 2 3 Risk ratio

Observational Studies of the Association Between Circumcision and HIV Infection 4 ecological studies 37 cross-sectional studies 15 prospective studies The adjusted relative risk of HIV infection for circumcised men found in the prospective studies is 0.52 – 0.14 Turning now to male circumcision and HIV infection, prior to the three RCTs, there was ample evidence of the association of HIV infection and lack of circumcision. There are four ecological studies, at least 37 cross-sectional studies, and 15 prospective studies that have found a significant association between HIV acquisition and lack of circumcision. In those prospective studies that controlled for confounders, such as differences in sexual behavior, religion, age, alcohol consumption, etc., the relative risk of HIV infection ranged from 0.52 to 0.18, or a two to eight-fold increased risk of infection for uncircumcised men.

Meta-analysis (Weiss et al., AIDS 2000; 14:2261-70)
IDPH Conference, Springfield - Nov 1, 2006 Meta-analysis (Weiss et al., AIDS 2000; 14: ) This is a graph from a paper published in AIDS in 2000 by Weiss, Quiggley and Hayes. They found 15 observational studies published at that time in which at least some confounders were included and they could calculate an adjusted odds of infection for circumcised men. As shown here, all 15 studies had an adjusted odds of less than 1, and in 10 of the 15, the confidence intervals did not cross one. The overall adjusted odds of HIV infection for the circumcised men was Remember that figure. This means that an uncircumcised man, according to these observational studies, was about 2 and a half times more likely to be HIV infected than an uncircumcised man.

Schema of Uncircumcised Penis Flaccid (A) and Erect with Foreskin Retracted (B) A B For those of you who are not familiar with the uncircumcised penis, in the schematic above is shown the flaccid uncircumcised penis and below the erect uncircumcised penis. Notice that the foreskin, shown here, covers all or most the glans penis. The red area is the inner mucosal surface of the foreskin which, when the penis becomes erect, becomes exposed. Studies by McCoombe and Short have shown that there is a substantial layer of squamous epithelial cells on the surface of the glans and the outer surface of the foreskin. McCoombe & Short, AIDS :

Outer surface of foreskin Inner surface of foreskin This is a section of foreskin tissue from a young man from Chicago. On you left is the outer surface of the foreskin, showing the thick layer of keratin serving as a genital epithelial barrier for access to the underlying immunocometent target cells. In contrast, look at the section on the right hand side, which is from the inner, mucosal surface of the foreskin. The layer of keratin is very thin, if present at all, allowing HIV and other pathogens access to the HIV target cells lying near the surface. Patterson et al., 2002

Outer surface of foreskin Inner surface of foreskin This is further shown in these beautiful slides provided by Scott McCoombe shere, on the left, the langerhans cells appearing in green are beneath the epitheliail barrier; whereas on the right, they are close to the surface with extensions reaching right to the edge of the mucosa, easily accessible to HIV if it should happen to be in the neighborhood. McCoombe and Short, 2006

Inner (A) and Outer (B) Surfaces of Foreskin Infected by HIVBal in Explant Culture B A Back to the foreskin of the young man in Chicago. On the left side, is tissue from the outer surface of the foreskin. Upon introduction of HIV to the tissue in explant culture, no HIV was present after 12 hours in the cells of the outer surface. HIV was seen to penetrate the epithelial barrier. In sharp contrast, a great many of the langerhans cells, shown in yellow and the CD4+ T cells, shown in green, were found to take up HIV. When we compared cervical tissue and the inner surface of the foreskin, six times more of the cells in the foreskin tissue were infected compared to the cervical tissue. Red = uninfected cells Yellow = infected Langerhans’ cells (Patterson et al., 2002) Green = infected CD4+ T cells

Need for Clinical Trials
IDPH Conference, Springfield - Nov 1, 2006 Need for Clinical Trials “Randomized clinical trials are needed to determine the utility of circumcision as an HIV preventive measure.” Reasons: All epidemiological studies had been observational. Confounding could exist. Risk of too early resumption of sexual activity after circumcision or subsequent behavioural disinhibition (risk compensation) could counteract any protective effect. Risk of post-surgical complications must be balanced against any protective effect. Most of the evidence I have shown you so far, and actually much more, including studies of discordant couples in Rakai with no infections in circumcised men compared to high incidence in uncircumcised men, was available in At that time, over 35 observational studies, the ecological relationships with high HIV prevalence in non-circumcising communities, the compelling biological findings as well as clear plausibility – all this was available, but only a handful of scientists and no policy makers were persuaded that circumcision should be considered as a possible new HIV prevention strategy. It became clear that randomized controlled trials were going to have to be done before the international health community could be persuaded to move. This was because all the studies to that time were observational. There could be factors other than circumcision itself like religion, hygiene, sexual behaviors that could account for the differences that were being found in so many studies in many different populations. Also, if circumcision were actively promoted as preventing HIV acquisition, men may get circumcised and feel protected, as one man put it, “ah, I have a natural condom,” and circumcision could actually increase, rather than decrease HIV incidence. And of course, there were concerns about safety. Could circumcision be done on adult men without causing undue harm?

Randomised controlled trials of male circumcision to reduce HIV infections Source: 2006 Report on the global AIDS Epidemic (UNAIDS, May 2006) Rakai, Uganda Gray et. al. (2007) Lancet; 369: 657 – 66 Kisumu, Kenya Bailey et. al. (2007) Lancet; 369: 643 – 56 Orange Farm, South Africa Auvert et. al. (2005) PLoS Med; 2 (11): e298 So the results from three RCTs are now available. All three were stopped before they went to full completion, because the protective effect of circumcision was found to be so strong that there was miniscule statistical doubt that it was effective, and it would not have been ethical to continue to withhold an effective prevention method from those in the control or uncircumcied group.

Effect of MC on HIV Incidence: Observational Studies and 3 RCTs Risk ratio .15 .2 .3 .4 .5 1 1.5 (95% CI) 0.42 (0.34,0.52) Observational 0.40 (0.24,0.68) South Africa 0.41 (0.24,0.70) Kenya 0.49 (0.28,0 , 0.84) Uganda 0.43 (0.32,0.58) Summary RCTs (95% CI) Here are shown below the top horizontal line, the results of the three trials. You can see that the results are remarkably strong and remarkably similar. The South Africa trial, which was stopped nearly two years ago, had a result very similar to the summary odds ratio of the 15 observational studies, a relative risk of 0.40, or a 60% protective effect. The trials in Kisumu, Kenya and Rakaio, Uganda were stopped by their DSMBs on December 12 of last year and the results were very consistent with the South Africa trial. Overall, the trials showed a RR of 0.43, a reduction in HIV incidence in circumcised men of 57%. One would be challenged to find any public health intervention with such a strong and consistent efficacy. Certainly, we have nothing else like this in the field of HIV prevention. So six years, over 20 million dollars, and probably 1 million new preventable infections later we arrive at the same conclusion that was staring us in the face in I’m not sure what could have been done differently, but it does raise the question whether we have raised the bar too high for converting evidence to action in the face of a crippling pandemic. Perhaps for the next intervention, the threshhold of proof will not be quite so high and we can start acting sooner. For circumcision, the time for action is now.

Based on the results that became available last December, the WHO and UN agencies convened a consultation of international experts in Montreux, Switzerland on March 6 to review the evidence. WHO/UNAIDS Consultation Montreux, Switzerland March 6, 2007

WHO/UNAIDS Statement March 28, 2007
IDPH Conference, Springfield - Nov 1, 2006 WHO/UNAIDS Statement March 28, 2007 “The efficacy of male circumcision in reducing female to male HIV transmission has now been proven beyond reasonable doubt. This is an important landmark in the history of HIV prevention.” “Scaling up male circumcision in (certain) countries will result in immediate benefits to individuals.” “Male circumcision should be considered as part of a comprehensive HIV prevention package.” This statement, which in total is fairly detailed and comprehensive, provides the imprimatur of the international normative agency for national governments, their agencies and donors to formulate country and region-specific policy toward provision of male circumcision services.

What is the Impact of Circumcision on Incidence of other STI? Circumcision One interesting and important question is does circumcision work only directly to reduce HIV, or is some of the protective effect of circumcision attributable to a reduction in other STIs, which then translates into a reduction in HIV? STI HIV

MC Impact on STIs: Results from RCTs
IDPH Conference, Springfield - Nov 1, 2006 MC Impact on STIs: Results from RCTs Outcome Orange Farm S Africa Kisumu, Kenya HSV-2 incidence 0.84 ( ) 0.99 ( ) Gonnorhea 0.68 ( ) 0.97 ( ) Chlamydia 1.10 ( ) 0.93 ( ) Syphilis 1.02 ( ) 1.68 ( ) Trichomonas - 0.78 ( ) We have results from two of the three RCTs. Shown here are the relative risks for incident infections of HSV-2, gonorrhea, chlamydia, syphilis and trichomonas. All of the RRs are near one, or the confidence intervals are very wide and cross one. Remarkably, circumcision had no efficacy against any of the STIs measured. We are still awaiting results of our HPV studies.

Incidence of Signs and Symptoms of Selected STI: Kisumu Trial
IDPH Conference, Springfield - Nov 1, 2006 Incidence of Signs and Symptoms of Selected STI: Kisumu Trial In contrast, circumcised men were about half as likely to experience clinical signs of genital ulcer disease. So despite there being no difference in the two groups in HSV-2 incidence, the clinical manifestations of herpes were nearly twice as frequent in the uncircumcised controls. This might lead us to suspect that HSV-2 suppressive therapy may have greater efficacy in reducing HIV acquisition in uncircumcised men and in the partners of uncircumcised men, and this should be looked for. Remarkably, as we would expect, circumcision did not reduce incidence of genital discharge, but did reduce incidence of genital warts by nearly sevenfold.

Will Sexual Disinhibition erode the efficacy of MC?

Behavioural Disinhibition/Risk Compensation
IDPH Conference, Springfield - Nov 1, 2006 Behavioural Disinhibition/Risk Compensation Agot et al., 2007 prospective study: no difference in risk behaviours 3 RCTs Orange Farm, South African 5 of 5 risk behaviors ⁭were greater in the circumcision group Mean # sexual encounters increased (p<0.05) Adjusting for differences in sexual behaviour had no effect on the RR of HIV infection Rakai, Uganda Difference in inconsistent condom use at 6 months (p<0.05) Control group more likely to drink alcohol Kisumu, Kenya Risk behaviours were reduced significantly in both groups Circumcised men had more unprotected sex (p<0.03) and less consistent condom use at 24 months (p<0.03) There is actually quite a bit of information now available addressing this question. Kawango Agot conducted a very nice case-control study comparing the sexual behaviors of men after circumcision to the behaviors of uncircumcised controls and found no differences. The data from the three trials suggest that, atleast in those settings, sexual disinhibition did not occur. In South Africa, the circumcised men did exhibit riskier behaviors, but only # of sexual encounters was significantly greater in the circumcision group, and when the differences were controlled for in analyses, there was no change in the protective effect of circumcision. In Rakai, circumcised men used condoms less consistently during one study interval, but men in the control group drank significantly more alcohol. It would be entertaining to speculate why uncircumcised men might drink more, but we will move on. To Kisumu, where sexual risk behaviors in both groups were reduced significantly. At 24 months there was a difference between the two groups, with circumcised men having more unprotected sex and less consistent condom use than their uncircumcised counterparts, but still less risky behavior than when they started the trial.

Sexual Risk Scores Baseline, 6 Months and 12 Months: Kisumu Trial
IDPH Conference, Springfield - Nov 1, 2006 Sexual Risk Scores Baseline, 6 Months and 12 Months: Kisumu Trial We did an intensive study of risk behaviors in a sub-sample of our trial cohort, and my student, Christine Mattson, developed an elegant method for creating a risk index. Looking at the risk scores of the two groups, risk behavior declined significantly in both the circumcised and the uncircumcised men, with greater decline in the first six months in the control group, but equal risk scores in the two groups at 12 months. Mattson et al., submitted

Results III Gonorrhea, Chlamydia, or Trichomonas Infections We used non-ulcerative STIs as biological markers for risk, and these were quite consistent with our behavioral results. The circumcised men started with greater prevalence of these STIs at baseline, they had greater incidence up to the 6 month visit, but the incidence of STI in both groups were equal by the 12 month study visit. In summary, then, in the context of the RCTs with repeated study visits and intensive behavioral counseling, we see no evidence of behavioral disnhibition. In fact, we see a reduction in risk behaviors and their biological markers during participation in the studies. *Prevalent infections included since circumcised men had more infections at baseline

What will be the Impact of Circumcision Interventions? What is the potential impact of circumcision interventions on HIV incidence and prevalence in varying populations? There have been several modeling appraoches to this question. But in the absence of current interventions, we actually already have a very good idea of what the impact is likely to be.

Botswana Zambia Swaziland Zimbabwe Malawi Uganda South Africa Lesotho Mozambique Tanzania Kenya Madagscar Angola Benin Cameroon Ghana 10 20 30 40 HIV prevalence in adults (%), 2005 60 80 100 Male circumcision prevalence (%) Sub-Saharan Africa Correlation of male circumcision and HIV prevalence IDPH Conference, Springfield - Nov 1, 2006 That is from the ecological evidence. There is a strong inverse correlation between the prevalence of circumcision in countries and the prevalence of HIV. All the highest HIV prevalence countries are those where circumcision is little practiced. In fact, no country with nearly universal circumcision coverage has ever had an adult HIV prevalence higher than 8%, including countries such as Cameroon where a 1997 survey found sexual behaviour to be higher risk than that in countries with prevalence of around 25%.

Correlation of male circumcision and HIV prevalence Asia 2 Papua New Guinea Cambodia 1.5 Thailand HIV prevalence in adults (%), 2005 1 India A similar picture is seen in south and southeast Asia, where overall HIV prevalence is much lower, but the countries with highest HIV prevalence have little male circumcision (Papua New Guinea, Cambodia, Thailand). Conversely, HIV prevalence is extremely low in those countries where most men are circumcised (Pakistan, Bangladesh, Indonesia, Philippines). .5 Indonesia Republic of Korea Pakistan China Japan Philippines 20 40 60 80 100 Male circumcision prevalence (%)

Modeling the Impact of MC on HIV Prevalence/Incidence
IDPH Conference, Springfield - Nov 1, 2006 Modeling the Impact of MC on HIV Prevalence/Incidence Williams et al., 2006 100% uptake of MC could avert 2.0 million new infections and 0.3 million deaths over ten years in sub-Saharan Africa Could avert 5.7 million new infections over 20 years Mesesan et al., 2006 50% uptake of MC could avert 32,000 – 53,000 new infections in Soweto, SA over 20 yrs. Prevalence would decline from 23% to 14%. Nagelkerke et al., 2007 Prevalence in Nyanza Province, Kenya would decline from 18% to 8% with 50% uptake of circumcision over 10 years. Gray et al., 2007 Assuming 50% uptake in Rakai, incidence would decline from 1.4% to .81%, and Ro would decline to 0.89. There have been several different modeling approaches to predict what will happen once we are able to roll out circumcision. Williams et al, assuming 100% uptake of circumcision, estimate that circumcision could avert 2 million new infections and 300,000 deaths over ten years. Over 20 years, 5.7 million new infections could be averted. 100% uptake is probably not realistic. Mesesan et al reported in Toronto that with 50% uptake in Soweto, South Africa, between 32 and 53 thousand new infections could be averted over 20 years abd HIV prevalence would be reduced from 23% to 14%. Nico Nagelkerke, based on data from our Kisumu trial, estimated that prevalence in Nyanza Province would decline from 18% in men to 8% over 10 years. Ron Gray and collaborators in Rakai, where HIV incidence is lower, reckoned that with 50% uptake over ten years, incidence would decline to below 1% and Ro, the reproductive rate of the epidemic, could decline to below 1 ot 0.89%. In other words, circumcision could drive the epidemic to a declining state.

Cost-effectiveness Models
IDPH Conference, Springfield - Nov 1, 2006 Cost-effectiveness Models Kahn et al., 2006 Cost is $181 per HIV infection averted over 20 years in Guateng, SA. With 25.6% prevalence. Cost-effectiveness is sensitive to HIV prevalence, cost of MC. If HIV prevalence is 8%, cost per infection averted is $550. Well, what about cost effectiveness? How will circumcision interventions compare to other prevention modalities? Is it worth doing? Jim Kahn and colleagues at UCSF estimate that the cost per HIV infection averted over 20 years in an area of South Africa where the HIV prevalence is 25.6% would be just $181. Of course, cost effectiveness is most sensitive to the HIV prevalence in the population and the cost of the procedure. In a population where the prevalence is 8%, cost per infection averted goes up to $550. In areas of Asia where prevalence of HIV tends to be 1% or less and many transmissions are not due to sexual contact, widespread circumcision programs are not likely to prevent a great many HIV infections and are unlikely to be cost-effective. Gray et al. estimated cost-effectiveness of circumcision in Rakai and came up with much higher estimates. Namely $2631 per infection averted. Two reasons for their higher estimates are that HIV incidence is lower in Rakai, and they were looking at effectiveness over ten years, instead of 20 years. Obviously, the longer circumcision is in place, the greater the number of infections averted, increasing the cost-effectiveness.

What is the impact of the pace of scale-up?
IDPH Conference, Springfield - Nov 1, 2006 What is the impact of the pace of scale-up? This speaks to the pace at which circumcision is scaled up. This modeling by Gayle Martin, John Stover and others looks at rolling out circumcision in a steady, linear manner – the red line – versus scaling up gradually – the lower line in blue – or scaling up early and rapidly, all ending up after 8 years at the same level of uptake.

The Impact of the Pace of Scale up
IDPH Conference, Springfield - Nov 1, 2006 The Impact of the Pace of Scale up Linear scale-up Slower scale-up Faster scale-up % difference with linear scale-up Avg annual # MCs 27,473 -1.6% +1.5% Avg annual # IAs 4,533 -16.4% +15.9% Cost per IA $292 +14% -10% Comparing the linear form of scale up to the slower and faster forms, it is clear that, if we delay, by the end of eight years, we will have averted 16.4% fewer HIV infections and the cost per infection averted will be greater. On the other hand, the faster we scale up, the more infections we can prevent – about 16% more - and each infection averted costs us 10% less. Not delaying and putting our best effort into providing services now will save lives and save money.

Cost per HIV Infection Averted Across Prevention Interventions
IDPH Conference, Springfield - Nov 1, 2006 Cost per HIV Infection Averted Across Prevention Interventions Adult MC $ $2,631 PMTCT $ 20 – 21,000 Condoms $ 11 – 2,198 Treatment of STI $ $514 School-based $ 7,288 - $13,326 The cost-effectiveness of male circumcision, even using the most conservative estimates, compares very favorably to other HIV prevention interventions, some of which actually have limited evidence supporting their efficacy.

Location of Studies of Acceptability
IDPH Conference, Springfield - Nov 1, 2006 Location of Studies of Acceptability Thirteen studies from nine sub-Saharan African countries were identified through a comprehensive search of electronic databases (MEDLINE) and contact with authors. Will circumcision be acceptable to people in communities where it is currently little practiced. If we provide the services, will they come? All indications are that they will come and they will come in large numbers, as they did to participate in the trials. We have reviewed 13 studies of acceptability conducted in nine different countries in sub-Saharan Africa.

Main Barriers and Facilitators for Acceptability of MC
IDPH Conference, Springfield - Nov 1, 2006 Main Barriers and Facilitators for Acceptability of MC Barriers: Cost Fear of pain Concern for safety Facilitators: Hygiene Reduced STIs Attractiveness All of these studies were conducted before the results of the RCTs were available, in the absence of any concerted communication or education efforts. A median of 65% of uncircumcised men said that they would prefer to be circumcised if it could be done safely and at no or minimal cost. Women were slightly more enthusiastic than men about their partners getting the procedure, and high proportions of both men and women, but especially women, were in favor of their sons getting circumcised. Women especially point to increased cleanliness and reduced chances of a man carrying an STI as reasons why males should be circumcised. As sex partners, as sisters and as mothers women are going to be instrumental in assuring rapid and broad uptake of circumcision in these communities. Any scale-up program should be sure to engage women and include them in plans for consultation and mobilization. Uncircumcised men for themselves: 65% (29-87%) Women (for their partners): 69% (47-79%) Men for their son: % (50-90%) Women for their son: % (70-90%) Westercamp and Bailey, 2006

The Road to Practice Minimum package: HIV counseling and testing STI diagnosis, treatment and partner referral Behavioral counseling, including safe sex after MC Additionally: Comprehensive RH Services As we provide safe, voluntary circumcision services, they must be integrated with our existing HIV prevention measures. At a minumum, men seeking circumcision services should be encouraged to receive HIV counseling and testing. Diagnosis and treatment of STIs should be available, and special behavioural counseling will be required to communicate the concept of partial protection and the dangers of resuming sex prior to full healing. Additionally, there will be the opportunity to include other reproductive health messages and services, including couples counseling, family planning, gender equality, and reduction of violence against women. It also offers a superb opportunity to gain access to the sex partners of the men who, because they are sexually active in high HIV prevalence communities, are vulnerable and can gain from comprehensive reproductive services. Couples counseling Family planning Gender equality Access to female partners

The Road to Practice Male circumcision services should be made available as soon as possible in regions where HIV prevalence is high and most infections occur through heterosexual transmission. MC should be integrated with other HIV/STI prevention strategies – not a stand alone procedure. Install systems for monitoring and evaluation of adverse events and behavioural risk compensation. Consider innovative means to reach the maximum number of males; e.g., mobile services; medical missions, “circumcision weekends” other? In short, Male circumcision services should be made available as soon as possible in regions where HIV prevalence is high and most infections occur through heterosexual transmission. MC should be integrated with other HIV/STI prevention strategies – not a stand alone procedure. Install systems for monitoring and evaluation of adverse events and behavioural risk compensation. Consider innovative means to reach the maximum number of males; e.g., mobile services; medical missions, “circumcision weekends” other?

Research Questions Is there a protective effect for females? Is there a protective effect for MSM? How long after the procedure does it take for full healing and keratinization to occur? How much of the protective effect of MC is attributable to its effect against GUD? What is the impact of MC programs on HIV at the population level? (Phase 4) Will behavioral disinhibition/risk compensation occur? Will risk behaviours decline? Operational research There are many research questions that still should be addressed. Just a few are: Is there a protective effect for females? Is there a protective effect for MSM? How long after the procedure does it take for full healing and keratinization to occur? How much of the protective effect of MC is attributable to its effect against GUD? What is the impact of MC programs on HIV at the population level? (Phase 4) Will behavioral disinhibition/risk compensation occur? Will risk behaviours decline? And as we design and implement the interventions, there will be many Operational research questions to address. A recent WHO/UNAIDS convened consultation spent two days discussing operational issues and didn’t exhaust the possibilities.

Summary of Advantages and Challenges
IDPH Conference, Springfield - Nov 1, 2006 Summary of Advantages and Challenges Advantages Clearly protective One-time intervention Cost-effective Opportunity to reach men Opportunity to reach sexually active women Opportunity to improve infrastructure and related services Challenges Only partially protective Safety Disinhibition Excuse not to use condoms Benefits take 5+ years Must have high coverage Potential stigma As we introduce and make male circumcision services widely available, there will be many challenges to ensure that we do it safely, affordably, without descrimination or stigmatization, minimizing disinhibition, and communicating in community specific ways the nuances of partial protection. The challenges that face the implementation of circumcision are many of the same that will face other interventions as hopefully they prove efficacious. But circumcision is unique in that it is a one-time treatment, no booster is necessary, adherence once the procedure is complete, is complete. We can focus on the hurdles before us, and we should, but we must keep our eye on the prize. Male circumcision in east and southern Africa, and perhaps in other regions for selected populations, will save millions of lives. Instead of seeing challenges, we can consider opportunities: opportunities to access vulnerable young men who seldom contact health facilities; to counsel and provide services for their sexual partners, and to provide the training and resources to build capacity of health systems in resource-challenged settings. We have a proven efficacious HIV prevention intervention. One cannot help but contemplate that if it were a drug or a compound or a shot with a fancy label, international agencies and donors would have been fighting to be the first to make it available many months, even years ago. But no one stands to profit from male circumcision – no one that is but the 4,000 men in Africa who will be newly infected tomorrow, and their partners and their children. Haven’t we delayed long enough? Let’s finally take the turn from the long road of contemplation to the highway of action. We must make safe, affordable, voluntary circumcision available NOW.

Many Thanks James Kahn Daniel Halperin Brian Williams Richard Hayes
Nico Nagelkerke Gayle Martin John Stover Scott McCoombe Roger Short Brian Morris Melanie Bacon Jeffrey Klausner Richard Campbell Cate Hankins George Schmidt Helen Weiss Bertran Auvert Stephen Moses Christine Mattson Nelli Westercamp Corette Parker Norma Pugh Jack Ndinya-Achola Kawango Agot Ian MacLean Carolyn Williams Ron Gray Maria Wawer Alan Landay Bruce Patterson Lori Bollinger

Male Circumcision: The Road from Evidence to Practice

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Male Circumcision: The Road from Evidence to Practice

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