1. ARV-Based Prevention What it means for women Your name here
[Note to speaker: Please begin by introducing yourself and your organisation. Explain why you are making this presentation and why this issue is important to you. After introducing yourself, you might say:]
This presentation was prepared by the Global Campaign for Microbicides, a global coalition of more than 350 nonprofit organisations working to expand HIV prevention options for women and encourage ethical research that involves civil society.
The Global Campaign does not fund or conduct any clinical research or develop any products. Instead, it works to build public support and demand for new HIV prevention tools for women and to make sure that civil society groups have a voice in the scientific process.
If you have been following discussions and developments around HIV prevention in recent years, you probably have heard about a number of existing prevention options that have been proven to work—male and female condoms; needle exchanges; circumcision; treatment after exposure to HIV in medical settings; and post-exposure prophylaxis, which is also called PEP. Other prevention options are still in the research stage, including vaccines; microbicides; diaphragms; and PrEP, or pre-exposure prophylaxis.
Many people in the HIV prevention field have been talking about a group of these options—some proven, and some whose efficacy is not yet proven. They group these options under the umbrella term “antiretroviral (ARV)-based prevention”. Today, I will provide a brief overview of what is meant by ARV-based prevention, which uses antiretroviral drugs that generally are used to treat people who are already infected with HIV.
[Note to speaker: References are on the final page of the script for this presentation.]
Date of last update: January 2010.
Your name here

2. Presentation outline
Prevention methods, those based on ARVs and those not using ARVs
State of access to proven methods
State of research to develop new methods
Timelines
Questions and concerns
Advocacy messages
How to get involved
Over the course of this presentation, we will:
Discuss what we mean by HIV prevention tools that use antiretroviral drugs, or ARVs, as opposed to HIV prevention tools that do not include ARVs.
Discuss access to ARV-based prevention methods that have already proven to be effective.
Provide an overview of the state of research to develop new HIV prevention tools using ARVs, and outline when we are likely to know if they work or not.
Discuss some of the questions and concerns people have raised about some ARV-based prevention methods.
Suggest some ways you can advocate for HIV prevention, stay informed, and get involved.

3. 33 million people now live with HIV/AIDS
2.7 million new infections annually
Among newly infected people:
50% are women (higher in some areas)
95% live in developing countries
80–90% of all HIV+ people in southern Africa do not know they have HIV
Let us start by reminding ourselves why HIV prevention is so important.
You have probably seen how many people are living with HIV globally and how many new infections there are every year. You may know that half of new infections are found in women, and that number is even higher in some populations. In South Africa, for example, more than three quarters of people between 15 and 24 years old who get HIV are girls and young women.
We also need to bear in mind that 95% of people who are HIV-positive live in developing countries. Many do not have good access to either HIV testing or HIV prevention services. Stigma, denial, and other factors make people reluctant to get tested for HIV.
In the southern part of Africa, for example, it is estimated that 80 to 90% of all the people who are thought to be HIV-positive do not know that they have the virus.
[Note to speaker: You can add your own regional statistics here, as appropriate. For example: In North America, an estimated 25 to 30% of people living with HIV are unaware that they are infected. In Europe, three out of 10 people living with HIV do not know they are infected.]
This means that right now, most of the 33 million people in the world who have HIV do not know they are carrying the virus. This is an important point to keep in mind as we think about new HIV prevention options and how we might use them.

4. Percentage of at-risk people with access to HIV prevention
<20% Sex workers with access to behaviour change programmes
11% HIV+ pregnant women with access to PMTCT
10–12% Adults in Africa accessing HIV testing
9% Men who have sex with men with access to appropriate behaviour change programmes
9% Sexually active people with access to male condoms
8% Injection drug users with access to harm reduction programmes
Rose to 45% recently
Now let us look at some examples of how far we have come in making HIV prevention and testing services available to everyone. These numbers are a bit shocking, are they not?
Recently, lots of resources have been put toward preventing vertical transmission—which people also call PMTCT, or prevention of mother-to-child transmission of HIV. This is great! But even after this increased investment, these strategies are still available to less than half of all who need them. This is progress—but it is also not enough.
You can see that only one in every 10 or so African adults has access to HIV testing services. So it is not surprising that so many people do not know their HIV status!
Fewer than one in 10 people who need male condoms has regular access to them. And, since we know that less than 1% of all condoms distributed worldwide are female condoms, the number of people who have access to those is incredibly small.
So, as we think about expanding the number of available tools for preventing HIV, we also need to keep in mind that people need both new tools and better access to existing HIV prevention tools that have been proven to work.
Neither research nor increased access to existing prevention tools alone will turn the tide on this massive pandemic. We need both. 20 40 60 80
100
Global HIV Prevention Working Group 2008; WHO/UNAIDS/UNICEF 2007

5. Imagine a full spectrum of interventions
Prior to exposure
Point of transmission
After infection
Rights-focused behaviour change
Voluntary counselling & testing
Sexually transmitted infection screening and treatment
Male medical circumcision
Preventative vaccines
Pre-exposure prophylaxis (PrEP)
Male & female condoms and lubricant
Treatment to prevent vertical transmission (PMTCT)
Clean injecting equipment
Post-exposure prophylaxis (PEP)
Vaginal & rectal microbicides
Cervical barriers
Antiretroviral treatment
Treatment for opportunistic infections
Basic care/nutrition
Prevention for positives
Education and rights-focused behaviour change
Therapeutic vaccines
Here is one way to think about what an expanded toolkit of HIV prevention and treatment options would look like. A comprehensive approach to HIV prevention should have many elements.
Right now, we have many tools that people can use before exposure, right at the point of HIV transmission, and after being infected. We all agree that we need to improve people’s access to the existing tools, shown here in grey.
Advocates and researchers around the world are also working to see what new options could be added to this toolkit in the near future. These are shown here in blue.
As we will see, ARV-based prevention options could exist at all of these points.

6. ARV-based prevention options
Prior to exposure
Point of transmission
After exposure
Preventing vertical transmission (PMTCT+)
PrEP
Treatment of HIV+ partner
Vaginal microbicides (rings)
Here is a chart showing all of these interventions, and where the ARV-based prevention options could be used.
Prevention of vertical transmission of HIV has many components. Among ARV-based options alone, we know that an HIV-positive woman can receive ARVs during pregnancy and at the time of delivery to help prevent HIV transmission. The baby gets ARV syrup in the weeks following birth. So, this method spans all three time periods.
Using PrEP on a routine basis—for example, once a day—would ensure that a constant level of ARVs is present in a person’s system before possible exposure and at the point of exposure.
Using treatment of an HIV-positive partner as prevention means that the HIV-positive person takes ARVs on an ongoing basis to reduce the risk of transmission during sex. We will discuss later how this could reduce the risk of transmitting HIV.
Vaginal microbicides could be used well before exposure or immediately before exposure. ARV-based microbicides in the form of gels, films, or foaming tablets, for example, would have to be inserted vaginally shortly before sex. However, if they were formulated as rings that slowly release the active ingredient, they could remain in the vagina for weeks at a time, providing protection when a woman has sex.
Rectal microbicides will likely have to be formulated as gels, suppositories, douches, or enemas, so they would be used very close to the time of possible exposure.
Finally, PEP must be started soon after a possible exposure to HIV. People taking PEP after a potential exposure must continue a daily course of ARVs for four weeks.
Vaginal microbicides (gels)
Rectal microbicides
PEP

7. HIV prevention
A full spectrum of HIV prevention options includes some that are based on ARVs, and some that are not.
Male and female condoms, medical male circumcision, vaccines, needle exchanges, and voluntary counselling and testing are all examples of prevention interventions that do not include ARVs.
The tools that rely on ARVs to be effective include PEP, PrEP, and treatment for the HIV-positive partner.
Some vaginal and rectal microbicides might be based on ARVs, and others might work in other ways. Prevention of vertical—or mother-to-child—transmission of HIV includes some tools that are based on ARVs. On the slide, you see these methods listed where the blue and pink circles overlap, because they may or may not be based on ARVs.
Some people have started calling ARV-based microbicides “topical PrEP”. But the Global Campaign for Microbicides believes it is important to talk about microbicides as a separate concept and not to confuse it with PrEP, which is always ARV based. Calling all topically applied products “microbicides” reminds us that we need both microbicides that are based on ARVs and those that are not based on ARVs. We also need some products for vaginal use and others for rectal use.
In addition, the concept of a “microbicide” focuses on the prevention needs of women specifically in a way that broader terms cannot. The word “microbicide” was first used by women’s health advocates. They said that receptive sex partners, whether they are women or men, need more prevention options, including tools that they can initiate. PrEP can be used by anyone, but microbicides are for receptive sex partners.

8. Comparing ARV-based prevention methods
PEP
Preventing vertical transmission
(PMTCT)
Treat HIV+ partners
PrEP
Microbicides
Drugs used
Multiple ARVs
Nevirapine; combination, if possible (AZT+3tc+
nevirapine)
Tenofovir and Truvada
Tenofovir, TMC 120 (daviripine), UC781, MV-150
Delivery formats
Oral pills
Pills, dropper
Oral pills, injection
Vaginal and rectal gels with applicators, vaginal rings, film
Frequency of use
Daily for 4 weeks
Varies from ongoing treatment to doses just before, during, after delivery
At least daily
At least daily, possible
dosing related to exposure
Before and possibly after sex, possibly daily dosing
The table on this slide shows you which drugs are currently being used or tested for each approach, and how they would be used.
The columns in green are methods that already have proven effective. We know for sure that PEP and prevention of vertical transmission both work. As you can see, several different ARVs can be used for both of these approaches. For PEP, people get the drugs in pill form. To prevent vertical transmission, the mother gets ARVs in pill form, and a dropper is used to give the baby a syrup containing the ARVs.
Treatment for the HIV-positive partner is shown in yellow because no controlled study has been completed yet proving that this works. But some observational studies have shown that HIV-positive people on effective treatment are less likely to transmit the virus to their partners. The drugs used are a range of ARVs in pill form, and as I mentioned, they have to be taken at least daily. Some prescribed ARVs have to be taken more than once a day. Taking the pills on time every single day is essential for this approach.
PrEP and microbicides are in the red columns here because we still do not know if they will work or not. Clinical trials with thousands of participants are going on now to test these two approaches. We should have some answers in the next few years. But these experimental methods will not be available for use until they are proven to be both safe and effective.
Now I am going to talk about each of these methods in a little more depth.

9. PEP Post-Exposure Prophylaxis (After) (Prevention)
PEP refers to taking antiretroviral drugs to reduce the chance of infection in individuals who have likely been exposed to HIV
PEP stands for post-exposure prophylaxis. In everyday English, post means after, and prophylaxis is another word for prevention.
So, when we are talking about HIV prevention, post-exposure prophylaxis refers to taking antiretroviral drugs after you have likely been exposed to HIV to reduce your risk of becoming infected.

10. PEP access Work-related, or occupational, exposure Other exposure
Most common: medical settings, needle-sticks
Other exposure
Unprotected sex, rape, condom breaks, sharing needles
People have concerns about PEP that is not work related
Access must be very fast
PEP is mostly used after a work-related, or occupational, HIV exposure. It is most commonly given to health care workers exposed to HIV from accidentally getting stuck with a used needle.
PEP may also be considered in other situations of known exposure to HIV, such as unprotected sex and sharing needles with a partner known to be HIV-positive. But it is most commonly prescribed to someone exposed in an unexpected or involuntary situation, such as after a rape or when the condom breaks accidentally. In these cases it is known as nPEP – non-occupational Post Exposure Prophylaxis.
Many policymakers and health care providers have expressed concerns about using PEP for exposure in situations not related to work. There are several reasons for their concern:
PEP is complicated, requiring a person to take several drugs for up to 30 days.
PEP may cause unpleasant side effects.
PEP is costly.
With the exception of workplace accidents or violent attacks, people could be exposed to HIV repeatedly and it is not feasible to use PEP as the main form of protection from HIV.
PEP may encourage some people to continue unsafe behaviours. It should not be used regularly as a replacement for safer sex and drug-using practices.
Policies about access to PEP vary from place to place. The important thing to remember is that PEP should be started as soon as possible after exposure to HIV, ideally within 2 hours and up to 72 hours after potential post-exposure. Contact your doctor or health service provider immediately if you find out that you may have been exposed to HIV. If you cannot reach them within 24 hours, contact your local sexual health clinic or emergency department for advice.

11. Preventing Vertical Transmission (PMTCT)
Preventing vertical transmission – also called Prevention of Mother-to-Child Transmission (PMTCT)
Providing ARVs to pregnant women living with HIV, particularly before and during labour
Providing ARVs to the baby during the first few weeks after birth
If possible:
- Delivery by Caesarean section
- Avoidance of breastfeeding
Plus (+) = focus on mother and baby
Ideally, we should increase prevention programmes to ensure that fewer women become HIV-positive. In many parts of the world, rates of infection are highest amongst women of child-bearing age. Women often want children, and face pressures to have them from culture and family.
Women who are HIV-positive should have access to life-saving ARVs regardless of whether they plan to become pregnant. The chance that HIV will pass from an HIV-positive woman to her baby is significantly reduced if the woman stays as healthy as possible and follows a successful HIV treatment regimen.
To prevent vertical transmission, it is most important to provide ARVs to the mother during her pregnancy and labour and to the baby during the first few weeks after birth. Delivery by Caesarean section and avoiding breastfeeding also can significantly reduce the risk of transmission. If avoiding breastfeeding is not possible, breastfeeding the baby exclusively, rather than alternating between breastfeeding and using formula, is less risky.
A comprehensive approach to preventing vertical transmission places as much importance on the mother as the baby. In addition to the steps on the slide, it includes making sure that prevention services are available to women to help them stay HIV-negative. It also calls for care, treatment, and support services for all HIV-positive women, their partners, and their families. This broader approach is sometimes called PMTCT+ (plus).

12. Percentage of pregnant women with HIV receiving ARVs for PMTCT in low- and middle-income countries, 2004 and 2007
Western and central Africa
Eastern and southern Africa
East, south, and southeast Asia
Latin America and the Caribbean
Eastern Europe and central Asia
Total
2% %
11% %
9% %
26% %
72% %
10%
33%
When we compare where the burden of HIV infection is to where services to prevent vertical transmission are available, it is clear that much more needs to be done. This graph shows how many pregnant women with HIV receive ARVs for prevention of vertical transmission in different regions of the world. As you can see, in sub-Saharan Africa, where by far the greatest number of HIV-positive pregnant women live, only a small percentage have access to ARVs as part of services to prevent vertical transmission. 10 20 30 40 50 60 70 80

13. Treatment as prevention
HIV+ people taking ARVs regularly
Does it work at individual level?
Treatment = less virus = less transmission?
Can it work at population level?
Increased testing = more knowledge of status = less risk-taking
Increased testing = more HIV+ people on treatment = less virus
Less risk-taking + less virus = less transmission?
Treatment for people who are HIV-positive might prove to be an ARV-based prevention option. Scientists think it may work two ways.
First, it may work at the individual level. We know that individuals who successfully follow an ARV treatment regimen have a reduced amount of virus in their blood. This is called their viral load. Clinical trials are underway to see if the risk of HIV transmission is lower in couples in which one partner is HIV-positive and the other is HIV-negative when the HIV-positive partner is taking ARVs. 
Second, it may work at the population or community level. Some people argue that doing HIV testing on a massive scale along with providing treatment to anyone who tests HIV-positive could significantly reduce the number of new infections. The argument goes something like this: Massive testing campaigns would make more people aware of their status. Once they know their status, HIV-positive people could then reduce their risk-taking and seek treatment. Both a decrease in risk-taking and a decrease in viral load as a result of successful treatment could decrease the rate of new HIV infections. But no study has yet proven this theory.
It’s important to note that this proposed approach differs from calls for universal access to voluntary counselling and testing, followed by universal access to treatment to anyone who needs it. Treatment is proposed immediately upon testing HIV-positive, which in some cases may be earlier than what is currently recommended by most guidelines.

14. Steps needed for “Treatment as prevention”
How effective this prevention approach might be depends on having a large number of HIV-positive people know their status and making sure that all of them have access to and regularly take ARVs.
Worldwide, only a small minority of people who are HIV-positive know their status. Even people who know they are HIV-positive do not all have access to treatment. At the end of 2008, less than half of people in low- and middle-income countries who needed HIV treatment had access to it.
Even if clinical trials show that successful treatment reduces the chances of transmission, there are many stumbling blocks in the way of implementation of the approach. One is ensuring universal access to treatment. Another is that the approach depends on people knowing their HIV status promptly after infection. At that time, people can have a very high viral load, so they are more likely to transmit the virus. But it is also the time when HIV antibody tests can produce a negative result that is wrong because antibodies to the virus have not yet built up in the blood.
The only tests that show if someone is HIV-positive promptly after infection identify the virus itself—and are more expensive than antibody tests. The added cost—along with the difficulty of getting people tested frequently—may make it extremely challenging to do the widespread testing needed.
Another difficulty is that under current treatment guidelines in most countries, it is highly unlikely that people would start taking ARVs immediately after becoming HIV-positive. Some supporters of this approach recommend access to treatment earlier than most guidelines suggest. Most countries cannot afford to supply early and ongoing ARV treatment for everyone as soon as they test positive for HIV.

15. Pre-exposure prophylaxis (PrEP)
Taking medicine to prevent rather than to treat a disease or condition.
For example:
Taking pills to prevent malaria when you travel.
Using hormonal contraceptives (injections or pills) to prevent pregnancy.
Taking pills to avoid pneumonia, if you are at risk.
PrEP stands for pre-exposure prophylaxis (prō-fuh-LAX-iss). The term means using medicine to prevent a disease or condition instead of using it to treat a disease or condition once you already have it.
Here are some examples of prophylaxis that may already be familiar to you. [Note to speaker: indicate slide and pause to allow audience to read it.]
Some people take malaria medication when they travel to areas with mosquitoes that carry malaria. When the medicine already is in our systems, the chances that we will get malaria from a mosquito bite are greatly reduced.
Hormonal contraceptives are also a kind of PrEP. Women can take pills or get injections to prevent the condition of pregnancy. By tricking a woman’s body into thinking she is already pregnant, the hormones keep her from releasing an egg during her monthly cycle. No egg means there is nothing for the sperm to fertilise—so no pregnancy.
People who have weak immune systems—from AIDS or for other reasons—are more vulnerable to pneumonia and other infections. So doctors may give them medicine to help their bodies fight off infections when they are exposed. This can prevent them from getting sick.
All of these are examples of pre-exposure prophylaxis—using medicine as a shield before exposure in order to protect yourself.

16. Status of current or planned PrEP trials
Where
Who
What
When
US (CDC)*
Men who have sex with men
tenofovir
2010
Thailand (CDC)
Injection drug users
Brazil, Ecuador, Peru, US, Thailand, South Africa (iPrEX)
Truvada
Botswana (CDC)
Heterosexual men and women
2011
Uganda, Kenya (Partners PrEP)
Serodiscordant couples (men and women)
tenofovir, Truvada
2012
Kenya, Tanzania, South Africa (FEMPrEP)
Women
Southern Africa (sites TBD**) (VOICE)
tenofovir (pill & gel), Truvada
Here is an overview of the studies that are going on right now to see if PrEP is safe for people to use and whether it works or not.
As you can see, late-stage trials have sites in 10 countries. They are enrolling thousands of men and women all over the world to see whether taking PrEP every day can reduce their risk of HIV infection.
People in all these trials receive free condoms and counselling to encourage them to use condoms to protect themselves. They also receive screening and treatment for sexually transmitted infections—either from the trial clinic or from another clinic where the trial has arranged for them to get care.
The first late-stage trials are expected to produce results in These trials are amongst men who have sex with men and injection drug users. The first study listed here is being conducted in three large cities in the United States. It has enrolled 400 men who have sex with men, and these participants are taking PrEP daily for up to two years. This study is not large enough to tell us if the drug is effective. But it will provide information about the rate of side effects, how well people do with taking their pills daily, and what effect (if any) it has on their risk-taking behaviours.
The next five trials listed here are happening amongst many different populations [point out on slide]. The last trial is expected to start in 2009 and will enrol 4,200 women in southern Africa. It will compare the effectiveness of PrEP (ARVs in pill form) with an ARV formulated as a microbicide gel and inserted vaginally. Women will be divided into groups; some will get pills whilst others get the gel. All will receive condoms, risk reduction counselling, and other health care services. By 2012, we should be able to see what effect each of these interventions had.
*CDC: US Centers for Disease Control and Prevention
**TBD: To be determined

17. What is a microbicide?
A suppository or a gel applied with an applicator before sex
A vaginal ring that stays in place for up to a month
A microbicide is any substance that can substantially reduce the risk of acquiring or transmitting sexually transmitted infections, including HIV, when it is inserted in the vagina or rectum. It is important to understand that no proven microbicides are on the market yet. What we are talking about here are products that are still being researched.
Microbicides might look a lot like some of the over-the-counter medications we already know—the gel, foam, cream, and suppository-type products that have been on the shelves for years. They will not contain the same chemicals as these products, but they will come in some of the same formulations.
Scientists are also working on developing new formulations that may eventually make microbicides even more user friendly than gels or creams that are inserted with an applicator. For example, they are working to make formulations that women can leave in place for long periods of time. One possibility is a vaginal ring—a device that could slowly release the protective substance over a month and provide round-the-clock protection. Another possibility is combining a physical barrier—such as a diaphragm or cervical cap—with a microbicide. The cervix is the opening to the uterus, or womb. It is much more delicate and vulnerable to infection than the vaginal wall. So putting a microbicide into a cap or diaphragm that can protect the cervix by covering it might give highly effective protection.
Almost all microbicides in the research pipeline now are based on ARVs.

18. Comparing ARV-based and non-ARV-based microbicides
Not ARV
More potent against HIV
May be long lasting
Not contraceptive
Could work against HIV and other sexually transmitted infections
Could be contraceptive
May be more toxic
May cause resistance
Unlikely to protect against other sexually transmitted infections
May be less potent against HIV
Must be used at time of sex
Advantages
Now let us talk about the differences between ARV-based microbicides and those that are not based on ARVs.
ARV-based microbicides:
Might be more potent against HIV because they are based on drugs designed specifically to attack HIV.
Might be longer lasting—for example, if they are delivered through a vaginal ring that slowly and constantly releases the drug.
May not prevent pregnancy. Since condoms are contraceptive, a microbicide that is not a contraceptive would be the first tool to reduce HIV risk whilst allowing pregnancy.
Might cause more side effects, or be more toxic, than other products.
Might lead to resistance. We will discuss this later.
Are unlikely to protect against other sexually transmitted infections since they are based on drugs that target HIV specifically.
On the other hand, microbicides that are not based on ARVs:
Might work against HIV and other sexually transmitted infections, depending on their mechanism of action.
Possibly could be contraceptive, and provide women with another family planning option.
Probably would be less effective against HIV than ARV-based products.
May have to be used right before sex because they may be harder to put into time-released devices like vaginal rings.
Each type of product has advantages and disadvantages. The Global Campaign for Microbicides believes that both types should be developed to meet a variety of user needs.
Disadvantages

19. ARV-based prevention trials: When will we know?
2010
2011
2012+
PrEP
Men who have sex with men
Heterosexual men/women
Serodiscordant couples
Injection drug users
Treatment
Women
Microbicides
PrEP/Microbicides
Between 2010 and 2012, several late-stage clinical trials in the HIV prevention field are expected to produce results. Many of these trials are testing ARV-based prevention methods.
At least one late-stage result from PrEP trials should be available every year from 2010 to 2012 (shown in blue on the slide). So, PrEP is likely to be the HIV prevention method that will be most widely discussed during that time.
One late-stage ARV-based microbicide trial—in lavender here—is expected to show some results in And results are expected in 2012 from one trial—shown in green on the slide—that is testing whether providing treatment to an HIV-positive partner reduces the risk of transmission to an HIV-negative partner.
The box with two colours [point to the box] shows a trial that is comparing the effectiveness of PrEP with ARVs in pill form with ARVs in a microbicide gel that is inserted in the vagina.
If you would like more information, the AIDS Vaccine Advocacy Coalition keeps an updated table of expected trial results on its website at

20. If PrEP and ARV-based microbicides work
1. Only take if you KNOW you are HIV negative.
Regular testing is necessary.
2. May be available by prescription only.
Access to a qualified health care provider is necessary.
3. Only the dosing used in trials is known to work.
PrEP: only daily dosing for now.
ARV-based microbicides: for now, applied daily or shortly before sex.
If PrEP or ARV-based microbicides prove to be effective, there are some important considerations to keep in mind concerning their access and acceptability. These include how people will get them, how they will use them, and whether they could put people at risk of developing HIV that is resistant to the drugs. If an ARV-based product is shown to be effective, we will have to address these issues to make sure that women can use them safely.
First, it will be important to ensure that only people who know they are HIV-negative use these products. An HIV-positive woman may use it accidentally if she does not know her HIV status. To be safe, anyone wishing to take PrEP or an ARV-based microbicide will need to be tested for HIV regularly.
Second, PrEP and ARV-based microbicides will be available only by prescription. In part so they can be monitored for side effects, women will have to see a health care provider and get an HIV test before receiving the product. PrEP and ARV-based microbicides are unlikely to be available over the counter in shops, causing access problems for many people, including women.
Finally, at first we will only know that the dosing options tested in clinical trials work. For PrEP, this means taking a daily dose of ARVs. For ARV-based microbicides, it means either using gel applied daily or shortly before having sex. It is very possible that longer-term dosing options will work, but we will not know for sure until further research is done. For example, perhaps PrEP could be effective if people take ARVs for a day or two before having sex and continue taking them daily until a day or two after having sex. For ARV-based microbicides, trials are already being designed for a vaginal ring that would slowly release the drug into tissue over a period of several weeks. If this approach is shown to be effective, it will give women dosing options that may be more convenient.

21. Drug resistance
More likely if taking only one drug (or one type of ARV)
Can still become HIV+ using ARV-based prevention
Use by people who don’t know they are HIV+ might lead to resistance?
Options for treatment may be more limited, might pass on resistant virus
Unanswered questions at this point
Developing resistance to ARVs is more likely to occur—and to occur more rapidly—if an HIV-positive person takes only one drug or only one class of drugs. That is why standard treatment includes several drugs from more than one class of ARVs.
Remember: ARVs reduce the risk of infection. They do not eliminate it. It is possible for someone using PrEP or an ARV-based microbicide to become HIV-positive. If she continues to use the product, drug-resistant HIV could possibly develop. This is why one requirement for access to ARV-based prevention is regular HIV testing.
When drug resistant virus develops, people’s treatment options may be limited. They might have to use more expensive, second-line treatment drugs to fight their virus effectively. They might also pass on the resistant virus to other people. This concern about potential resistance is higher for PrEP since the drug is taken orally and absorbed in the bloodstream at higher doses. Researchers are testing whether ARV-based microbicides may be less likely to be absorbed in the bloodstream because they are used topically.
To be safe, most researchers believe that regular HIV testing should be part of any PrEP or ARV-based microbicide roll-out until more research can be completed to tell us:
How quickly resistance could develop using PrEP or ARV-based microbicides.
Whether it would cause enough resistant virus to affect future treatment options.
Whether that resistant virus would be likely to spread in a community.
Limiting options for future treatment is an especially big concern in developing countries. There, first-line treatment drugs are often the only available and affordable option.

22. Questions women have about ARV-based prevention
If I think my husband has HIV, will I be able to get PrEP?
If I use a microbicide, how will I make my man use a condom?
Even if the doctor gives me pills, will I be able to keep them for myself?
ARV-based prevention is a source of hope for many women—especially those at high risk of contracting HIV. Many women want to have their own HIV prevention tools. Making this possible is the goal of research to develop both PrEP and microbicides.
We have learnt from participants in microbicide studies that most probably would tell a male partner if they were using something for HIV prevention—even if the method is not as obvious to him as condoms. Some women say they would discuss it because they do not want to have secrets from the man they love. Some say they would do it out of fear that their partner would suspect unfaithfulness or punish them for disobedience if they are discovered using something secretly.
Here are some of the questions women have about ARV-based prevention options [point to the questions on the slide]:
Will I be able to get PrEP if I do not know for sure whether I am at risk of getting HIV? Women generally get HIV tests when they go to antenatal clinics. So in most countries, women are far more likely than men to be tested for HIV. But what happens if a woman’s partner refuses to be tested? Can she still get PrEP, or will it be reserved for women considered high risk, such as sex workers and those who know for sure that their partners are positive?
If my man knows I am using a microbicide, will he still use condoms? Since condoms are the safest option, his refusal to use one could raise her risk, even if she is using a microbicide.
Even if the doctor gives me pills, will I be able to keep them for myself? Many women are expected to sacrifice everything for their partners or other family members. These women say the pills likely would be taken away from them for use by another family member who is viewed as needing them more, or a woman may feel that it is her duty to give the pills to a family member who is HIV-positive for use as treatment.

23. More questions women have
How much
will it cost?
Where will I get it?
People will notice if I have to go in for testing and to get my pills. What will they say about me?
Will it make me sick?
Can I take PrEP when I am pregnant?
Will it hurt my baby?
What about breastfeeding?
Will my husband let me go to the clinic?
In most of the world, bearing and raising healthy children is seen as a woman’s number one responsibility. So it is not surprising that women have questions about how ARV-based prevention might affect pregnancy and breastfeeding. Some HIV-negative women who have HIV-positive partners may want to use PrEP or ARV-based microbicides when they are trying to become pregnant. If the methods work, they might offer a way for women in these relationships to get pregnant with less risk of becoming HIV-positive themselves. On the other hand, young women may not want to use ARV-based prevention until we know more about how or if it affects pregnancy.
For many women, using ARV-based prevention may raise issues of stigma. Since frequent HIV testing will be necessary, how we present the idea of testing and how we protect people’s privacy will be critically important.
Even if she is at high risk of getting HIV, a woman may choose not to use PrEP or ARV-based microbicides for a number of reasons:
She may be afraid that people will assume that she is HIV-positive. Or her husband may refuse to let her go for fear of what people will think.
She may worry that people will think she is promiscuous or a sex worker, especially if public messages link using PrEP or microbicides with sex workers.
She may wonder if PrEP could have serious side effects that could make her sick and unable to take care of her family.
Or the methods simply may be beyond her reach if she cannot afford them or cannot get to a clinic.

24. Advocates are calling for:
Better access to existing proven prevention options.
Research into new prevention options, both ARV based and not based on ARVs.
Research into drug resistance, alternate dosing, pregnancy and breastfeeding, and a greater variety of drugs.
Attention to access hurdles: more uptake of HIV testing, access to prescribers.
Increased community engagement.
As we wait for results on the effectiveness of new prevention options, HIV prevention advocates are calling for improved access to existing prevention options that have been proven to work. People at greatest risk of getting HIV still lack access to male and female condoms, needle exchanges, medical male circumcision, PEP, prevention of vertical transmission, and voluntary counselling and testing.
We also must advocate for research into and development of new prevention options, including both ARV-based tools and those that do not use ARVs.
Research into the risk of resistance as well as into alternative dosing schedules are crucial to ensuring the most effective, most acceptable, and safest prevention options.
And once scientists identify effective ARV-based prevention options, we will need more research to assess their effect on pregnancy or breastfeeding. We must also demand testing of a greater variety of drugs, particularly for PrEP. This would ensure that alternatives are available if the drugs currently in testing do not work. It will also help ensure a greater range of options, since no one prevention tool will work or be acceptable to everyone.
We also need to work now to address the barriers to access that we know will come. This includes the need for much wider uptake of HIV testing, and systems that will give people access to health care providers for methods that are available only by prescription. It will also require that we make sure that health services and personnel have the capacity to undertake this work.
Finally, we must ensure that well-informed advocates can engage meaningfully in discussions and research into new prevention options.

25. What you can do: Become better informed. Tell your colleagues.
Check out the resources on the next slide.
Tell your colleagues.
Send them a link or a fact sheet.
Host a discussion forum.
Use this presentation at work or in your community.
Join advocacy efforts.
Contact other HIV prevention advocates in your region.
You can take action today in several ways.
Information is power. Many resources exist that can help you better understand the issues we discussed today. To get started, take a look through some of the websites we suggest on the next slide.
There is power in numbers. Tell your friends and colleagues about what you learnt today. Send them a fact sheet or links to the websites suggested.
Consider adapting this presentation and using it yourself. Host a discussion at your workplace or in your community. This way, you can hear what others think about ARV-based prevention options, and perhaps discover other advocacy actions.
Finally, your community is probably home to other HIV prevention advocates. Join existing efforts at the local, national, or global level.

26. For more information… PEP: http://tinyurl.com/hivpep
PMTCT:
PrEP:
Microbicides
(Alliance for Microbicide Development)
Treatment of HIV+ partner
(look under HPTN052)
So if you want to do all this, how do you start? Here are some good sources of information.
The Global Campaign for Microbicides is developing a knowledge base on what new HIV prevention tools will mean to women. You can find all kinds of materials for advocates by clicking on the “What Does It Mean for Women” button on the homepage of their website, including easy-to-read fact sheets and a copy of this presentation. GCM asks only that you remember to acknowledge them when you download and use these materials.
You are welcome to download any of the Global Campaign materials to use as you talk about these issues. We encourage you to download the slides and script for this presentation. Using the script, you can give this presentation, yourself, to groups that you think might be interested!
You can also go to PrEPwatch, a project of the AIDS Vaccines Advocacy Coalition and the UCLA Program in Global Health. It is a good source of information about the science behind PrEP. The PrEPwatch website has a complete listing of all the PrEP trials, including when they are likely to be completed. It also provides links to helpful articles on PrEP research, and the latest developments.
Before we end, I’d like to share some inspiring words.

27. “Sure, you know about [all types of existing and new prevention options]...
We need you to unravel the secrets of the science, to make all of that elusive and mysterious information accessible to the untutored rest of us…
Somehow, along with the science, we need the activism. They are inseparable.”
Stephen Lewis, Co-Director, AIDS-Free World, and Former United Nations Secretary-General’s Special Envoy for HIV/AIDS in Africa (2001–2006)
July 19, 2009, International AIDS Society conference, Cape Town, South Africa
I hope this presentation has explained clearly what ARV-based prevention is and how it might help people reduce their risk of HIV infection.
Besides talking about the science, we have also explored some of the realities we face with access to existing or possibly upcoming ARV-based prevention tools.
Science alone cannot address all these challenges. Advocates, health care planners, funders and government policy makers will have to figure them out. We have to come up with good answers if we want ARV-based prevention tools to be widely accessible and effective over the long term.
If we fail, we could also end up with tools that women cannot get or cannot afford. As advocates, we have the power to shape how these questions are answered and by whom. Using that power starts with lots of us asking the important questions.
© Nick Wiebe 2006

28. Questions from the audience
This slide and the next are for the speaker’s reference only. You do not need to display them as part of the presentation. They will help you answer questions you may get from the audience.
Audiences most frequently ask, “How do you know that?” The next slide has a list of sources for the facts in this presentation. You can cite these as the sources for your information.
We have listed the questions we have heard so far below. If you get questions that you think should be included to help future speakers, please send them to Anna Forbes at
Thanks!
Here are some other possible questions, and ideas on how to answer them.
From Slide 7: What are the non-ARV-based elements of preventing vertical transmission?
Answer: As we will see on Slide 11, delivery by Caesarean section and avoiding breastfeeding can significantly reduce the risk of HIV transmission. If avoiding breastfeeding is not possible, exclusively breastfeeding the baby is less risky than alternating between breastfeeding and using formula.
From Slide 14: What about the “Swiss statement” on HIV transmission?
Answer: You may have heard of the controversy around the Swiss statement. Basically, a group of Swiss doctors said that in their opinion, individuals who meet the following three criteria cannot transmit HIV: (1) The HIV+ partner is on a successful ARV treatment regimen (meaning they are taking their medications exactly as prescribed and the medications are working very well). (2) For at least six months, they have had an undetectable viral load (meaning so little HIV is in their blood that it is practically impossible to find it in tests). (3) Neither partner has a sexually transmitted infection. Some critics have raised concerns about this statement.
From Slides 22 and 23: Where did you get the women’s questions about ARV-based prevention that you show on the slides?
Answer: The Global Campaign for Microbicides held focus group discussions and consultations with women in eastern and southern Africa to ask them what they thought about PrEP and what their concerns are. The questions on the slides were the ones women raised most frequently. We have adapted the questions to reflect ARV-based prevention.

29. “How do you know that?”
The notes for this slide list the sources for facts in this presentation. You can cite these as the sources for your information. This list includes sources for facts and statistics that are not well known. We do not list sources here for commonly known statistics.
Slide #3: 80 to 90% of people living with HIV in southern Africa have not been tested and do not know they have HIV.
The numbers for Africa are from an interview with Kevin DeCock, Director of the World Health Organisation’s HIV/AIDS Department. The interview appeared in the January 2008 issue of the Lancet Student online blog. DeCock is quoted as saying, "Knowledge of HIV serostatus is extremely low worldwide. Several studies in sub-Saharan Africa suggest that only about 12% of men and 10% of women had actually been tested for HIV and knew their HIV status". You can see this interview online at
US numbers come from the US Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report (Vol. 55, No. RR14; September 2006).
European numbers come from a November 2007 press release issued by the European Centre for Disease Prevention, called "ECDC launches European HIV/AIDS report in Tallinn and pledges support to Estonia in its fight against HIV/AIDS". 
Slide #4: Global HIV Prevention Working Group. Behavior Change and HIV Prevention: [Re] Considerations for the 21st Century. August Available online at
Slide #12: Epkini R. Prevention of mother-to-child transmission of HIV: Status of implementation and ways forward. Presentation available online at
Slide #14: At the end of 2008, less than half of people in low- and middle-income countries who needed HIV treatment had access to it.
World Health Organisation. Available online at
Slide #16: Hillier S. Pre-exposure prophylaxis: Could it work? Sixteenth Conference on Retroviruses and Opportunistic Infections, Montreal, Quebec; 2009.
Slide #19: AIDS Vaccine Advocacy Coalition. HIV prevention research: A comprehensive timeline of efficacy trial results. Available online at