March 2007
The National Institutes of Health announced late last year that it was
halting two clinical trials in eastern Africa because an interim review
revealed that safe male circumcision significantly reduced acquisition of
HIV through heterosexual intercourse.
The trial in Kisumu, Kenya, showed a 53 percent reduction of HIV in
circumcised men participating relative to uncircumcised men, while a trial
in Rakai, Uganda, showed a reduction of 48 percent in circumcised men.
The news follows on the heels of a famous 2005 trial in South Africa that
was also stopped early in the face of evidence that men who were circumcised
were showing 60 percent fewer infections.
The findings have brought much buzz to the world of health care, which
has spent many years looking for the “silver bullet” to end the global
HIV/AIDS epidemic. But doctors are careful to warn that circumcision does
not replace the need for men to wear condoms or limit risky behavior.
BOTUSA’s Associate Director for Science Dr. Doug Fleming has answered a few
questions about the trials and their implications in places like Botswana.
What’s the real message from the preliminary results of these trials? Are
we really telling men that if they are circumcised, their chances of getting
infected by HIV are reduced by at least 50 percent?
Fleming: Yes. The results of the three trials were very clear and
consistent. But we need to emphasize that the reduction in risk from
circumcision depends on men maintaining safe sexual behaviors. HIV
prevention from circumcision and from other means such a safer sex (using
condoms, faithfulness, etc.) need to go together.
Can you explain how circumcision works? How does it help reduce chances
of contracting HIV?
Fleming: The foreskin is very vulnerable to HIV infection. The inside
of the foreskin is moist and delicate, and can experience small cuts where
HIV can enter in to the body. The skin of the foreskin is also rich in cells
that HIV can infect. So we would expect that removing the foreskin would
reduce how vulnerable a man is to HIV, and how often he might transmit HIV
to a partner. Further, once the foreskin is removed the tip of the penis
dries and it becomes more difficult for HIV to enter in.
During circumcision, the foreskin is removed. In a doctor's office or health
facility, the foreskin is carefully removed through a variety of specific
methods, all of them with analgesia (to reduce pain) and with sterile
conditions (to avoid infection). It is very important to avoid pain and
infection.
Circumcision is not a new practice. So why are we only now learning about
this tremendous benefit as a prevention tool?
Fleming: It has been suspected for a long time that circumcision
protects against HIV. One of the earliest signs was that groups of people
with high prevalence of male circumcision (like the Gikuyu in Kenya) had
much lower prevalence of HIV infection. But no one could be sure if there
might be other factors that could explain the low prevalence of HIV among
circumcised men. Only a randomized controlled trial can answer this kind of
question.
The decision to use male circumcision as a way to prevent HIV is a big one,
since circumcision has potentially large benefits, but also has potential
side effects. Only a randomized controlled trial can tell us with enough
certainty what the balance is between benefits and risk.
Why were these trials stopped early?
Fleming: Running a trial is of great benefit for the nation when the
trial can answer a question that we all need to know. Once that question is
answered with certainty, then continuing the trial is of little further
benefit. In fact, once the trial organizers in these recent trials knew that
male circumcision worked, it was clear that circumcision should be offered
to those men in the "control" group, that is, those men who had not been
circumcised. This way, the men in the "control group" could receive the same
benefit. Making sure that these men could receive circumcision was written
into the procedures of the trial from the very beginning.
Do we need to conduct a similar trial in Botswana to determine if
circumcision would have the same results here?
Fleming: No. In fact, it would likely be considered wrong and
unethical to study people who have not received a procedure that we already
know would help them.
Knowing these results, do you think the international community has a
moral obligation to support the up-scaling of circumcision in African
countries where HIV infection rate is high?
Fleming: Each country decides what is best for the health of the
nation. It is wonderful to know that male circumcision is such a powerful
resource for prevention, but the benefits and risks must be weighed
carefully. Many other means of prevention are available and are important.
I am sure that many countries around the world will be examining the
evidence for prevention with male circumcision, evaluating the side effects
that were observed in the trials, and defining where male circumcision will
fit in the nation's overall prevention program. Furthermore, they will need
to look at the feasibility for each country. What are the operational
implications, such as costs, who will do it and what policy changes will
need to take affect?
Fleming: Personally, I do hope that those countries that choose to
make male circumcision a part of their prevention program will receive
support from the international community.
Would the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR)
support efforts to upscale circumcision?
Fleming: Shortly after the trial results were announced, Ambassador
Mark Dybul issued a statement, part of which says:
"PEPFAR is awaiting normative guidance from international organizations or
other normative bodies, and thereafter will support implementation of safe
medical male circumcision for HIV/AIDS prevention based on requests from
host governments and in keeping with their national policies and guidelines.
It is important that male circumcision be safely provided and that it be
integrated into, and not substituted for, a comprehensive HIV/AIDS
prevention program."
No country has adopted a public health policy on circumcision, though
several African countries are in consultations over how to do so. What are
the risks in making circumcision part of a government’s policy?
Fleming: The risks of circumcision itself are the immediate side
effects (pain and infection). Fortunately, these seem to be relatively low
risks if the procedure is done carefully in a health facility, with proper
equipment and well trained personnel.
Perhaps the biggest risk is that circumcised men might consider themselves
to be fully protected from HIV. They might then engage in riskier
activities, which might partly cancel the benefit of male circumcision. It
is for this reason that Ambassador Dybul emphasized that "prevention efforts
must reinforce the ABC approach – abstain, be faithful and correct and
consistent use of condoms, and must be linked to voluntary counseling and
testing and screening and treatment of sexually transmitted infections." |