AIDS and Circ Study

[Carlyle]

Anyone have a link to the study on circ reducing the spread of AIDS in Africa?

I have a friend on facebook who posted this link: http://www.gatesfoundation.org/hivai...cumcision.aspx and it made me really sad. I commented on it, but she has spent lots of time in Africa and is really in favor of circ as a means of stopping the spread of the disease to women in Africa.

So I'm now wanting to read the actual study (not because it will change my mind, but so that I can discuss it without sounding like an idiot). Is it available online anywhere?

[Mama Metis]

Sure, see links below! There are many many many studies on adult male circumcision for prevention of HIV transmission in Africa. The three largest and most well-known were in South Africa, Kenya, and Uganda - I'll link you to those. They all saw similar results - about a 60% decreased risk of heterosexual transmission.

Kisumu, Kenya
http://www.sciencedirect.com/science...98cdb05584824d

Rakai, Uganda
http://www.sciencedirect.com/science...721d42450e6a8d

Orange Farm, South Africa
http://www.who.int/hiv/topics/maleci...oSJuly2006.pdf

And a meta-analysis:
http://www3.interscience.wiley.com/j...TRY=1&SRETRY=0

Just to clarify, circing for HIV prevention DOES NOT prevent transmission to women directly. Rather, it reduces the liklihood of transmission from an infected female to an unifected male during vaginal sex. (It has not been shown to be effective in preventing transmission between two male partners.)

I also want to mention that circumcision in sub-Saharan Africa for prevention of HIV transmission is different from RIC in the US in a few ways: 1) It is adult men, not newborns, and they are making their own personal decision to be circumcized; 2) It is not done for traditional or cultural reasons, but rather in response to an unprecedented disease burden.

For the record, I am STRONGLY opposed to RIC!

[Fellow Traveler]

Originally Posted by Mama Metis

Sure, see links below! There are many many many studies on adult male circumcision for prevention of HIV transmission in Africa. The three largest and most well-known were in South Africa, Kenya, and Uganda - I'll link you to those. They all saw similar results - about a 60% decreased risk of heterosexual transmission.

Kisumu, Kenya
http://www.sciencedirect.com/science...98cdb05584824d

Rakai, Uganda
http://www.sciencedirect.com/science...721d42450e6a8d

Orange Farm, South Africa
http://www.who.int/hiv/topics/maleci...oSJuly2006.pdf

And a meta-analysis:
http://www3.interscience.wiley.com/j...TRY=1&SRETRY=0

Just to clarify, circing for HIV prevention DOES NOT prevent transmission to women directly. Rather, it reduces the liklihood of transmission from an infected female to an unifected male during vaginal sex. (It has not been shown to be effective in preventing transmission between two male partners.)

I also want to mention that circumcision in sub-Saharan Africa for prevention of HIV transmission is different from RIC in the US in a few ways: 1) It is adult men, not newborns, and they are making their own personal decision to be circumcized; 2) It is not done for traditional or cultural reasons, but rather in response to an unprecedented disease burden.

For the record, I am STRONGLY opposed to RIC!

I don't have time for a full reply but I would point out that it isn't just men making their own decision, they are targeting boys and infants as well. Keep in mind that whenever public health officials speak of voluntary adult circumcision for one thing or the other, they never mean voluntary and they never mean adult.

[Mama Metis]

Originally Posted by Fellow Traveler

I don't have time for a full reply but I would point out that it isn't just men making their own decision, they are targeting boys and infants as well. Keep in mind that whenever public health officials speak of voluntary adult circumcision for one thing or the other, they never mean voluntary and they never mean adult.

I'm curious to learn more about what you're saying here.

Just as a point of fact, none of these studies enrolled infants or boys. But I do know of cases of people using this data to make a case for infant circumcision, which I believe is a misuse of the data. In particular, this data cannot be applied to the US, which has very different HIV prevlence and transmission patterns. I would say, from my experience, that most proponents of adult circumcision for prevention of HIV in Africa are NOT proponents of RIC in the states.

[Fellow Traveler]

Originally Posted by Mama Metis

I'm curious to learn more about what you're saying here.

Just as a point of fact, none of these studies enrolled infants or boys. But I do know of cases of people using this data to make a case for infant circumcision, which I believe is a misuse of the data. In particular, this data cannot be applied to the US, which has very different HIV prevlence and transmission patterns. I would say, from my experience, that most proponents of adult circumcision for prevention of HIV in Africa are NOT proponents of RIC in the states.

I'd like to get into this further but I can't from my PDA I won't have good access untill Sunday evening. I understand what you're saying about relative vs absolute and contextualized risk and while those studies did only include adults, the programs in Africa that were derived from them are to be focused on children and infants too. There are also a number of researchers who were connected with the trials trying to apply them to US infants too.

[tennisdude23]

While there may be some relation between circumcision and HIV in the limited context of the three RCTs in Africa, the 60% reduction rate will most likely not materialize in Africa or anywhere else once other factors come into play, which the RCTs did not/could not control for. One of the biggest problems with the studies is that they were terminated early, showing relatively few events. For example, far more men dropped out of the trials than we infected with HIV, and many of the infections occurred through means outside of sexual contact.

In any case, I think you should check out the blog below as it has the RCTs in pdf format as well as a wealth of other high quality information on the subject: http://www.circumcisionandhiv.com/.

For a little light reading, I would suggest these posts as they explain well the pragmatic and ethical problems of introducing large scale circumcision programs in Africa: http://www.adriancolesberry.com/life/?cat=22.

And for a quick summary, here is a great fact sheet: http://www.intactamerica.org/sites/d...ousMistake.pdf

There is plenty of other great information online. My suggestion would be to avoid the "big headline news stories" as they provide almost no critical analyses other than reporting the big 60% statistic, which once scrutinized is really not that impressive.

Lastly, even if circumcision were to reduce HIV by 60% or higher, you have to ask yourself whether that is the best way to stop AIDS in sub-suharan Africa, the classic question of whether the ends justify the means. My answer is no. Condoms and education have been shown to work far better. Really, this is a great exercise of looking outside of the box. If, for example, cutting off parts of female genitalia were shown in an RCT to reduce HIV transmission would the western world all of sudden promote clinical female circumcision? The answer to that is probably not. For sure, people would be reluctant to do so, calling, at the very least, for more research. Indeed, our society has a double standard here, one that becomes ever more clear once you shift the paradigm.

[Mama Metis]

I completely agree with your concerns about this data being used to justify RIC. Nevertheless, this was a huge breakthrough for HIV prevention. As an staunch opponent of RIC, I will admit I felt very threatened by these findings at first. (And sometimes still do.) It's much nicer when things break down into black and white, i.e. circ = always bad. But circ for HIV prevention in Africa falls into one of those difficult shades of gray. It is certainly not risk-free, and by no means is it an ideal intervention, but it has already saved lives.

[Mama Metis]

Tennisdude, I agree with some of your points. The main concern about scaling up circ programs in Africa is whether or not the same degree of quality and health education that was made available in the studies can be made widely available. For example, if a man has sex before his circ wound is healed, his risk of contracting HIV is much higher. This is a real and valid concern.

I disagree that the studies showed "relatively few events." These were all very large studies with good retention rates. And the fact that several studies were done in several different contexts and yeilded very similar results is a good indication that the findings can be considered valid.

Remember that the reason that the studies were stopped early was that the results were so overwhelming that it would have been unethical to continue to study the intervention. For those unfamiliar with research protocols, the decision to stop a study is not made by the researchers, but by an Institutional Review Board (IRB) which is in charge of ensuring that research is done ethically.

[tennisdude23]

Originally Posted by Mama Metis

I completely agree with your concerns about this data being used to justify RIC. Nevertheless, this was a huge breakthrough for HIV prevention. As an staunch opponent of RIC, I will admit I felt very threatened by these findings at first. (And sometimes still do.) It's much nicer when things break down into black and white, i.e. circ = always bad. But circ for HIV prevention in Africa falls into one of those difficult shades of gray. It is certainly not risk-free, and by no means is it an ideal intervention, but it has already saved lives.

I agree that very little is ever black and white, but circumcision falls into one those categories that I think is really not all that grey. For example, has is it really saved lives, given the horrid state of African health clinics, the high complication rates, and the lack of convincing evidence of reduction? The causes of HIV in Africa are complex and difficult to understand. Nevertheless, many of them can be directly traced to poverty and the lack of access to resources, fresh water, jobs, and education as well as the after effects of rapid decolonization. If any of the above factors could be changed, HIV transmission would rapidly go down. Indeed, a lot can be done, but all of that takes large-scale financial and capital investment. I think that instead of circumcision programs, money should be pumped into schools, clinics, and other infrastructure. People should be taught that condoms and behavioral changes decrease transmission, not circumcision. Why would someone chop part of their penis off, if they can simply wear a condom? Given this, I am very curious as to what these supposedly "consenting" adults are being told when they sign up for the procedures.

[Fellow Traveler]

Originally Posted by Mama Metis

I completely agree with your concerns about this data being used to justify RIC. Nevertheless, this was a huge breakthrough for HIV prevention. As an staunch opponent of RIC, I will admit I felt very threatened by these findings at first. (And sometimes still do.) It's much nicer when things break down into black and white, i.e. circ = always bad. But circ for HIV prevention in Africa falls into one of those difficult shades of gray. It is certainly not risk-free, and by no means is it an ideal intervention, but it has already saved lives.

I agree with some of what you're saying and I don't with sime other things. If the powers that be clearly limited application to adults I'd have less of a problem with them, they aren't and that is unethical considering the nature of he intervention, its limited effectiveness, and more. 15+ years is a long time for alternatives to appear in addition to today's alternative. Make no mistake though they are targeting children and infants they are neither adults nor volunteers.

I look forward to perhaps continuing this on Sunday.

[Mama Metis]

Lastly, even if circumcision were to reduce HIV by 60% or higher, you have to ask yourself whether that is the best way to stop AIDS in sub-suharan Africa, the classic question of whether the ends justify the means. My answer is no. Condoms and education have been shown to work far better.

I thought I should also mention that I agree that condoms and education are important tools in the fight against HIV. But if you've ever lived or worked in Africa, you'll know that lack of availability and cultural acceptibility of condoms have long been a challenge in many areas. These efforts should absolutely continue, but no single approach to reducing transmission will be a solution on it's own.

Do the ends justify the means? Well, that's not really for you or me to decide. Thousands of African men are deciding that the ends do justify the means. And the penises belong to them.

[tennisdude23]

Originally Posted by Mama Metis

Tennisdude, I agree with some of your points. The main concern about scaling up circ programs in Africa is whether or not the same degree of quality and health education that was made available in the studies can be made widely available. For example, if a man has sex before his circ wound is healed, his risk of contracting HIV is much higher. This is a real and valid concern.

I disagree that the studies showed "relatively few events." These were all very large studies with good retention rates. And the fact that several studies were done in several different contexts and yeilded very similar results is a good indication that the findings can be considered valid.

Remember that the reason that the studies were stopped early was that the results were so overwhelming that it would have been unethical to continue to study the intervention. For those unfamiliar with research protocols, the decision to stop a study is not made by the researchers, but by an Institutional Review Board (IRB) which is in charge of ensuring that research is done ethically.

I am not saying the RCTs were not valid. In the limited context of the trials, they indeed showed there is a relationship between circumcision and HIV and within the 24 months of the studies, the relative risk reduction was 60%. Some of the questions that are still unanswered is how come this result occurred, what would the 60% reduction rate translate to in the real world if the absolute risk was only around 1% and other factors came into play, and would the reduction rate have increased or decreased had the studies been continued longer? From what I remember in at least one of the RCTs, the rates of circumcised and uncircumcised men acquiring HIV was becoming even in the later months. From everything that I have read about randomization both in my methodology class and background reading, RCTs that are terminated early because of high success rates are notorious for over-estimating the effects of the drug or procedure that they are testing, especially if there were few events. I believe there were 291 infections in the circumcision RCTs, some of which occurred through means outside of sexual contact. In one meta-analysis of RCTs (ones in general, not just circumcision) that I read, 500 events were said to make an RCTs less likely to over estimate a high success rate if it were terminated early. On that note, the results of the RCTs and the rate of successfully decreasing transmission in the real world should be called into question. Lastly, just because a study passes by an IRB does not mean its ethics are sound or that it does not have major flaws.

PS: I am aware of the cultural inhibitions to condom usage in Africa. Certainly, if a man wants to be circumcised because he a) does not to want to wear condoms and b) feels that it will offer him some protection because he is in a high risk category, that's great. I don't have a problem with that as everybody should have a choice as to what they do to their bodies. What concerns me in particular is the idea that circumcision is being totted as some kind of vaccine and that the results of the RCTs can be extrapolated to infants in the US and Africa. Concerning the first point, if you are in a high risk group and having unprotected sex with HIV positive individuals, you will sooner or later acquire HIV no matter how much of your genitals you cut off, which is why I question the whole notion that circumcision will save lives, assuming that the 60% reduction rate is valid. I don't think I have to explain myself on the second point.

By the way, I think all of your points are completely valid, and I agree with some of what you are saying as well. However, the thing that always bothered me was the fact that there was very real little of this type discussion about the validity of the RCTs in Africa. It seemed that they got a particular set of results and said ok, let's starts circumcising without asking further questions.

[Mama Metis]

I think that instead of circumcision programs, money should be pumped into schools, clinics, and other infrastructure.

Wouldn't this be amazing???

You are absolutely right about the social conditions that give rise to rapid HIV transmission. I really wish there were more resources to tackle root causes.

But despite all these valid concerns, we cannot ethically turn away from evidence that can save lives. 60% is not 100%, but remember that each prevented transmission saves not only that man's life, but the lives of his partners as well as the partners of his partners, and any children they conceive. When it comes to a virus, 60% is actually a big deal. Even 50%, 40% or 30% would be a big deal in this particular context.

[Mama Metis]

By the way, I think all of your points are completely valid, and I agree with some of what you are saying as well. However, the thing that always bothered me was the fact that there was very real little of this type discussion about the validity of the RCTs in Africa. It seemed that they got a particular set of results and said ok, let's starts circumcising without asking further questions.

This is interesting and true. In my experience, the validity of the studies was/is almost never questioned in the research community, as the results were considered very strong. There were other criticisms raised though, for sure. The main criticisms were twofold - 1) the scaling issues that you already identified, and 2) the what about the women? How might this disrupt the power balance between genders? Anyway, interesting stuff... thanks for the conversation!

[Pirogi]

I don't have a lot of time to post, but wanted to point out these concerns that I have seen cited regarding the African AIDS/circ trials.

Potential problems with the African HIV/circumcision studies:

1. Males in the circumcised group received repeated and extensive counseling regarding condom use and safe sex practices. The control group (intact males) did not receive this counseling. This study may have simply shown that counseling and condom use reduces the likelihood of HIV infection.

2. Circumcised males in the trials were given two years of free medical care, which could have influenced the type of person participating in the study.

3. Circumcised males were paid to participate, which could have influenced the type of person participating in the study.

4. Circumcisions during the trials were performed in highly resourced (funded) settings with stellar sanitary conditions. These conditions are unlikely to be replicated in the majority of African circumcision sites, which could have a negative impact on HIV infection rates resulting from the circumcision itself.

and most importantly ...

5. Circumcised men had to observe a period of abstinence following the circumcision, which intact men did not have. The trials were terminated early (which should have invalidated the results, IMHO), which may have resulted in artificially inflated incidence of HIV infection among intact men. If the trials had been allowed to continue to completion, it may have resulted in similar levels of HIV infection, as intercourse rates (and infection opportunities) evened out between the two groups.

Now, I don't know that any or all of these actually influenced the outcome of the trials in one direction or the other. That is the point - these concerns were not controlled for and/or could have impacted the data.

[Mama Metis]

Hi Pirogi. Most of the variables you bring up actually were controlled for. If they hadn't been, you are right that the results would be very questionable. In the studies I'm aware of, men who agreed to participate in the trial were randomized either to receive circ or not receive circ. Everything else was the same:. All the men had medical care, all the men had health education, all the men had access to as many condoms as they wanted, and all of the men were paid the same amount for their participation. As you rightly point out, you need to minimize any differences between the treatment and control groups to get good data.

As for your point #4, you are absolutely correct. This is one of the main criticisms of scaling up the intervention. It turns out many places have had sucesses in scaling, but this is definitely a concern.

As for your point #5, you're right that there is no way to control for this completely. But the risk of HIV transmission goes DOWN as the circ heals, not up. So the fact that the trial was stopped early probably underestimates the protection, if anything. Again, the trials were stopped because the results were so much more extreme than was expected, not because they were questionable.

[MCatLvrMom2A&X]

I cant help but think if circ was really helpful in preventing HIV then why didnt that make a difference back in the 80's here in the USA when thousands died from HIV. Knowing circ rates where upwards of 80% or even higher.

I am convinced the education the men received played a much larger roll than having been circed.

[tennisdude23]

Here are a few more links on circumcision and HIV. The first one is more about the new gel, but summarizes the same statistical problems that make the circumcision studies suspect (for example, the fact that the raw numbers in both studies when it came to new infections were actually very low and should not necessarily be extrapolated to the 22 million people living in southern Africa and even more so to young infants in the US).

Here is a highlight: "I came to the conclusion that much of the AIDS in Africa was due to the numerous and informal sexual affairs common in Southern African nations, found both among married and unmarried men, especially with a much smaller highly infected group of very sexually active women who trade sexual favors for material goods and money. I write about this explanation in an academic article published here."

http://www.huffingtonpost.com/john-r..._b_654904.html

I also like this youtube video as it explains the difference efficacy and effectiveness in epidemiology and the way these two terms relate to circumcision in the African context.

http://www.youtube.com/user/Bonobo3D#p/u/15/RGdAP1YWYj0

The last link is an interesting opinion piece from Zimbabwe.
http://www.newsday.co.zw/article/201...ch#makecomment

[Greg B]

Originally Posted by Mama Metis

...
But despite all these valid concerns, we cannot ethically turn away from evidence that can save lives. 60% is not 100%, but remember that each prevented transmission saves not only that man's life, but the lives of his partners as well as the partners of his partners, and any children they conceive. When it comes to a virus, 60% is actually a big deal. Even 50%, 40% or 30% would be a big deal in this particular context.

I disagree. We can ethically turn away from this. I say this because to be ethical means to look at things carefully and thoughtfully. And when I do that, I fail to see an argument that makes me believe this is a good strategy. It is only a good strategy if you only take some parts of the issue into consideration, but leave out other critical parts.

And it seems compelling when the statistics are taken out of context, of course, which is how it is typically reported and how you are doing here.

60% is incorrect. Circ did not protect 60% of the men in the study population. Instead, the numbers should be given in the context of the study population, namely circ’d men had a 1.6% chance of contracting aids, while the normal men had a 3.4% chance. Or if you were circ’d you had an incidence of 16 men out of a 1,000, while normal men had an incidence of 34 men out of 1,000.

Another key point is that circ did not and does not protect against aquiring HIV in the sense that "protect" is usually used. Instead it reduced the chances that any one encounter would result in aquiring HIV. Have enough encounters and you will still get HIV.

And even the authors themselves state that a man needs to practivce safe sex, including wearing condoms. The abslouelty do not say that all you need to do is get circ'd.

So, taking this in the proper context, a man (or his guardian) can choose to get circ'd or not. Then one should compare these two alternatives by looking at the advantages and disadvantages. If he gets circ'd, he:

Loses the function of his penis for both himself and his partner

Loses the a great deal for feelings during sex

Risks complications

Is subjected to pain

Has an odd looking penis

Gains soem resistence to aquiring HIV

Maybe less likely to use condomd, due to the great loss of feeling that Circ causes

And he still must use safe sex and condoms to avoid getting HIV, just like an intact person.

On the other hand, if he stays intact, he:

Has a fully functioning penis for both himself and his partner

Gets to enjoy the full feelings that sex should provide

Maybe more likely to wear condoms

And must use safe sex and condoms to avoid getting HIV.

Nope, as far as I am concerned, we cannot ethically promote circumcison as a way to reduce HIV. This arguement is not ethical, unless you ignore the role a foreskin plays in sex.

Regards

[jenP]

Originally Posted by tennisdude23

I also like this youtube video as it explains the difference efficacy and effectiveness in epidemiology and the way these two terms relate to circumcision in the African context.

http://www.youtube.com/user/Bonobo3D#p/u/15/RGdAP1YWYj0

Excellent video, thank you for the link.
As he point out, these RCT's were not done by HIV/AIDS researchers, but were done by long-time circumcision promoters who were able to get massive funding to push their agenda.

And, the studies are absolutely being used not to promote voluntary adult circumcision to at-risk individuals in Africa. In Africa AND IN THE USA the results are being used to push for universal infant circumcision. Has anyone done an analysis comparing the small risk reduction for HIV acquisition vs. the complication rates, including deaths, that will be seen if infant circ rates skyrocket? Will there be a net saving of lives?

Also, what of the fact that the longest study was 22 months? Surely part of the reason that the circumcised group saw fewer HIV infections was that they spent a good percentage of that time "out of commission" sexually speaking. I've read the claim that the IRB stopped the studies early because due to the "wild success" it would be "unethical" to not offer the intervention to the control group. BUT I see no reason why they could not have continued to collect data even after doing so. Let's see five or more years down the road what became of those who were originally circumcised, those who were originally in the control group but opted to get circumcised later, and those who remained intact throughout. I can think of no reason to not collect such data except the fear that it would not fit their desired results.

Another question to ask is, if it is ethical to study foreskin amputation as an HIV preventative, and if researchers are truly ONLY interested in stopping the spread of HIV and are willing to study ANY possible solution, then WHY are there no RCT's being done on female circumcision? Some may call female circumcision mutilation, but hey, the ends justify the means, right? After all, what does it matter if thousands of women (and girls!) have their genitals surgically reduced, if it may possibly prevent a certain number of HIV infections, right?

Jen