1. Microbicides: New Hope for Prevention of HIV and other STIs
[Please start off by introducing yourself and your organization. Say why you are making this presentation and why this issue is important to you. You may want to say that you are doing this presentation on behalf of the Global Campaign for Microbicides which is a coalition of 285 non-profit organizations that advocate for new HIV prevention options. The Global Campaign does not sponsor trials or do the research. Then you could say something like:]
Microbicides are products that have the potential to transform the HIV prevention landscape by giving us a new method of protection that is user-initiated, instead of partner initiated.
I think it is clear to all of us that not everyone has the power in their relationships to insist on condom use during every act of intercourse. So we need to start talking about what IS possible for women and men in this situation -- what can be developed that would enable both partners to protect themselves when a condom isn’t being used and add to the effectiveness when condoms are used.
Today, I would like to talk about three things:
1) First, I will introduce you to the concept of microbicides and how they might fit into an overall program of HIV prevention;
2) Then, I will talk a little bit about how microbicides are being developed, how they would work and where the research is at right now;
Finally, I will talk about why we have to develop a vocal and active constituency for microbicides to make sure that this vital new technology reaches the market as soon as possible.
[Note to speaker: References are on the final page of the script for this presentation; You are welcome to add your group’s logo to the home page, and your website to the bottom of each slide]
Your name here

2. The Global Impact of HIV
People living with HIV in 2006
New infections in 2006
Worldwide
39.5 million
4.3 million
Sub-Saharan Africa
24.7 million
2.8 million
Asia & Eastern Europe
10.25 million
1.23 million
North America,
Western/Central Europe
2.14 million
65,000
Other
2.49 million
242,100
Even if you don’t work in HIV/AIDS or women’s health, you can tell by reading the newspaper or listening to the news how urgently we need more prevention options to fight the spread of the pandemic around the world and right here at home.
The statistics are mind-numbing.1 AIDS has killed more than 25 million people since it was first recognized in 1981, making it one of the most destructive epidemics in recorded history.2 More than 14,000 people are newly infected every day, and almost 40 million people are living with HIV today.
Sub-Saharan Africa has been the hardest hit region, with rates soaring in other parts of the world as well, particularly in China and India.
It is women who are bearing the brunt of the pandemic in Africa, especially young women. In Sub-Saharan Africa, young women are three times more likely to be infected than young men (aged 15-24).1
Women are disproportionately affected by AIDS:
In Sub-Saharan Africa, young women are 4 times more likely to be infected than young men.

3. Why We Need Female Controlled Methods
Biology
Women are 2-4 times more likely than men to get HIV from unprotected sex
Economics
Economic need or dependency
Less able to assert their rights
Social & Cultural
Gender norms about sexuality
Gender based violence
Current methods (abstinence, fidelity, and condom use) often require male consent, participation & cooperation
Women are at higher risk of HIV infection than men partly because of biology, partly because of economics, and partly because of culture.
Women are more vulnerable to HIV because they are exposed to more virus for a longer period of time during sex.3 Young girls are especially at risk because their reproductive tracts are not fully mature.
Economically, in many places, women have less access than men to education, job opportunities, property, or credit, making them financially dependent on their partners.4 As a result, women often cannot afford to leave relationships that put them at risk of HIV and other STIs.
Culture also plays a role. Here and abroad, women are expected to be faithful but men are not. A male partner’s infidelity is one of the greatest HIV risks women face. In addition, gender based violence is a big factor in women’s risk. 5
The current prevention methods (abstinence, fidelity, and condom use) often require active acceptance, participation, consent and cooperation by both partners. But women don’t always have control over when and how they have sex. Although we are making important progress on getting treatment to people, we still need to do everything we can to give people more prevention options especially those that they themselves can control.
[Note for some audiences: In this presentation, I am talking mainly in terms of the risk women experience when their male partners won’t use condoms. I realize that all people need tools to protect themselves. For the sake of simplicity, I’m going to just say “women’s risk” here – and ask you to bear in mind that both men and women need more prevention options.]

4. What is a Microbicide?
A substance that can reduce the transmission of HIV and other STI pathogens when applied vaginally and, possibly, rectally. They are not yet available.
First Generation:
Gels and creams
In the future:
Sponges, vaginal rings
Gels with barrier devices
So what is a microbicide? A microbicide is any substance that can substantially reduce the risk of acquiring or transmitting sexually transmitted infections, including HIV, when it is applied in the vagina or rectum.
It’s important to understand that no proven microbicides exist yet on the market. What we’re talking about here are products that are still being researched.
The first generation of microbicides could be available on the market in as little as five to seven years. They will probably look a lot like the over-the-counter yeast infection treatments and birth control products we already know -- the gel, foam, cream and suppository-type products that have been on the shelves for years. They won’t contain the same chemicals as these birth control products but they will come in some of the same formulations.
But scientists are also working on developing new formulations that may make the second generation of microbicides even more user-friendly than today’s spermicides.
For example, they’re working to make formulations that women can use several hours or even days before intercourse, if necessary. One possibility is a vaginal ring or sponge-- something that could slowly release the protective substance over time, providing round the clock protection. Another possibility is combining a physical barrier -- such as a diaphragm or cervical cap -- with a microbicide. Since the cervix is more vulnerable to infection than the vaginal walls, this combination might provide highly effective protection.
© Salam Dahbor, Courtesy Doubleshots Studio

5. We Need Microbicides That:
Are contraceptive and non-contraceptive
Reduce risk of other STIs
Are safe and non-irritating
Are inexpensive and available over the counter
Could be used without partner’s cooperation or even awareness
Some of the microbicides being developed will also be contraceptive. And that’s great because many women would like to have a product that can protect them from disease and pregnancy at the same time. But scientists are also working on non-contraceptive microbicides that would be helpful to women and men who want to conceive a child while still protecting themselves from possible infection --- something that is impossible with condoms.
Some microbicides are also being tested for efficacy against other sexually transmitted infections (STIs), and several of them appear to reduce risk of at least one or two other STIs. Eventually, scientists may be able to combine active ingredients so that one product can serve several purposes.
Obviously, we need products that are safe and don’t irritate any tissue or organs. Irritation, inflammation or allergic reaction to any product can actually increase HIV and STI transmission risk because it makes it easier for pathogens (germs) to enter the bloodstream. So it’s critical to have products that are safe, even when they are used several times a day.
The issue of access is one of the fundamental goals of the Global Campaign. Advocates around the world are already working to make sure that microbicides are affordable and easily accessible and made available without a prescription.
Finally, when using a microbicide, a woman wouldn’t need to gain her partner’s active cooperation at each act of intercourse – the way she has to with male or female condoms. Many women probably will choose to discuss microbicide use with their partners. But this could be a one time conversation -- and it wouldn’t have to happen right before sex. After that, the woman could manage her own protection without need to “negotiate” or interrupt sexual spontaneity every time.

6. How Could Microbicides Benefit People Living with HIV/AIDS?
Could reduce risk of co-infection with other HIV strains
May help protect both partners
Could reduce risk of other STIs, yeast and bladder infections
May allow conception while protecting partner
Microbicides are not something just for HIV negative people. A lot of HIV positive people want them, too.
Some microbicides may be able to neutralize pathogens in both semen and vaginal secretions. This could give HIV positive people a way of reducing their partners’ risk of HIV exposure during sex, as well as a way of reducing their own risk of infection with other HIV strains. This is what is known as “bi-directional” protection – when a product can reduce risk in both directions, for both partners.
Some products may also be able to reduce a woman’s risk of getting other STIs, bladder infection or yeast infections. For people with compromised immune systems, this could be an important advantage.
Using a non-contraceptive microbicide could help a positive woman to conceive without endangering her partner if he is HIV negative.
I want to be clear here, we are not yet sure what the first generation of microbicides will be able to achieve these goals. These are just some of the possibilities, and things that the research needs to consider For these reasons, it’s important that HIV positive people are advocating for microbicides that will work for them, and also making sure that any microbicide that becomes available is safe for all people, regardless of their HIV status.
[Note to speaker: Check out the Global Campaign Factsheet #7 if your audience will be particularly interested in microbicides for HIV positive people.]

7. Microbicides & Anal Sex
Many people (women and men) need microbicides for anal sex
Creating an effective rectal microbicide is scientifically more complicated
Vaginal microbicides must be accurately labeled
Formulating a microbicide for rectal use is more challenging than making one for vaginal use just because the rectum is a very different environment. First of all, it’s an open ended cavity. The vagina is a closed pouch. You can coat the inside of the vagina with about 3-5 ml of product.
Since the rectal cavity isn’t closed, it could require significantly more product to protect the rectal walls where they need protection. One of the key questions scientists are trying to answer now is exactly how much product it will take and what areas have to be covered to get a good protective effect.
Rectal tissue is also more fragile than the tissue lining most of the vagina. It is thinner and populated with cells that are especially vulnerable to HIV infection.6
Research has begun to develop rectal microbicides. They are urgently needed -- not only by gay men but also by the many women who engage in anal intercourse. The International Rectal Microbicide Working Group brings together advocates and researchers, and now has over 200 members. You can find out more through the Global Campaign website.
But until we have an effective rectal microbicide, we have to insist that all vaginal microbicides nonetheless be tested for safety in the rectum, even if not designed for that use. And products designed for vaginal use must be carefully labeled to alert users that they should not be used rectally, until proven safe and effective for rectal use.
[Note: if the audience is particularly interested in rectal microbicides, visit for a factsheet and complete presentation on rectal microbicides. Also visit
Image courtesy of

8. How Effective Will Microbicides Be?
First microbicides may be 40-60% protective
Second generation may be 60-80%
Promoted as a back-up to condoms, not as a replacement.
“Use a microbicide with your condom for added pleasure and protection.”
“Use a male or female condom every time you have sex; if you absolutely can’t use a condom, use a microbicide.”
Microbicides will help people reduce risk of infection -- but we need to be clear about the fact that they aren’t going to eliminate risk.
Microbicides will probably never be as effective as condoms.7 It’s safer to keep a virus out of your body than it is to try to kill or disable it once it’s there. That’s common sense.
But remember, we’re talking about microbicides as an option for people who can’t or don’t use condoms. The first microbicides are only likely to be 40-60% protective against HIV. The second generation microbicides may be 60-80% effective against HIV.7
A condom with 80 to 95% effectiveness8 is definitely the most effective disease prevention option, but it has ZERO effectiveness if a couple is not using it. It is our hope that although microbicides may be less effective, couples may be able to use them more consistently than they currently use condoms.
So we should talk about microbicides as part of a risk reduction approach. We need to encourage people to continue to use condoms if they possibly can. Many folks may want to use microbicides with their condoms for back-up protection and added pleasure.
Microbicides would give us something to suggest when a woman says “I just can’t make him use a condom. Isn’t there something else I can do to protect myself?” Once microbicides become available, we’ll be able to answer by explaining clearly that these new products aren’t as effective as condoms -- but they are much better than nothing. And, as we all know, a lot of women are getting infected because “nothing” is all they have.

9. Protection in Primary Partnerships: Difficult to Achieve
People generally are willing to to use condoms with new partners, or during casual or commercial sex
But once “trust” enters the equation the condom comes off
Sex with a primary partner is the biggest source of HIV infection among women globally
A little recognized truth is that more women get infected with HIV from their boyfriends and husbands, than from casual or commercial sex.
Throughout the world, once trust enters a relationship –- condoms usually exit the scene. With proper condom promotion programs, we can help people use condoms in the context of casual or commercial sex. But few people continue to use condoms once they establish a regular partnership. Even with intense condom promotion efforts, consistent condom use among regular partners is difficult to achieve, unless of course the couple knows that one is infected and one is not. 9
“In representative surveys of women in 13 African countries found that fewer than 7% report condom use in the last sex act with their regular partner.” 9,10
Microbicides could potentially help to fill the gap by offering couples a more intimate option in long-term relationships.

10. Imagine a Full Spectrum of Interventions
Prior to exposure
Point of transmission
Treatment
Rights-focused behaviour change
VCT
STI screening and treatment
Male circumcision
Preventative vaccines
PREP
Male and female condoms and lube
PMTCT
Clean injecting equipment
Vaginal and rectal microbicides
Cervical barriers
PEP
Anti-retroviral treatment
Treatment for opportunistic infections
Basic care/nutrition
Prevention for positives
Education and behavior change
Therapeutic vaccines
[Speaker should note that this list is not comprehensive.]
We need to work towards an expanded toolkit of HIV prevention and treatment to combat this epidemic.
Right now, we have many tools that people can use before exposure, right at the point of HIV transmission, and also after being infected. Admittedly we need to improve people’s access to these existing tools—we need to make sure that male and female condoms are available to those who need them at an affordable price, that women can access prevention of mother to child transmission services when they need them, and that we figure out a way to introduce male circumcision programs. [Speaker can indicate existing interventions in blue] [More information on male circumcision results at:
Advocates and researchers around the world are also working to see if there are new options that we can add to this spectrum in the near future. [Speaker can indicate new interventions in pink]
[Speaker may choose to use this slide only with audiences who are familiar with the field of HIV/AIDS.]
VCT is voluntary counseling and testing for HIV
PREP is pre-exposure prophylaxis
PMTCT is prevention of mother to child transmission
PEP is post-exposure prophylaxis

11. Comprehensive Strategies for Protection
Social Power
Protection
None of these technological interventions – vaccines, microbicides, condoms, or PREP, will be a magic bullet to combat the HIV/AIDS pandemic.
Technology is just one piece of a comprehensive response. In order for women to really be able to use these technologies, we need to address the broader structural issues that make it difficult for women to insist on condoms in the first place. We need to work to give women more economic opportunities and more social power. This means everything from:
Reducing violence against women
Protecting the property and inheritance rights of women and girls
Supporting on-going efforts toward universal education for girls
Economic Opportunities
Technology
Source: Brady, Martha. Population Council, Conceptual Framework

12. Potential Public Health Impact
If a 60% effective product
Offered to 73 lower income countries
Is used by 20% people reached by health care
during 50% of unprotected sex acts
= 2.5 million HIV infections averted
in 3 years including women, men and children
Even if we are talking about partially effective microbicides that complement other interventions, they could still have a big impact. Computer modeling conducted at the London School of Hygiene and Tropical Medicine estimates that:7
if a 60% effective microbicide
is introduced in 73 low income countries with high HIV rates
and gets used by only 20% of the people with access to existing health services
and those people use it only half of the time when they’re not using condoms
it could prevent 2.5 million new HIV infections among women, men & children over 3 years.4
I’m not saying that this impact would be immediate. But we’re still talking about millions of lives potentially saved. And, as you see, these calculations are on relatively modest estimates of effectiveness, uptake and use. A more effective microbicide, used by a larger number of people, would have an even greater effect.
Microbicides are not a panacea. But they could save a lot of lives and make an enormous difference in the spread of the pandemic.
Now before I tell you more bout how microbicides work and where we are at in the research, are there any questions before we move on?

13. 1. boosts vagina’s natural defenses 2. surfactants
So how do microbicides work?
The products now in the research pipeline fall into four basic categories -- defined by how they work. These are also known as ”mechanisms of action”. This slide is a picture of the vaginal wall and illustrates the different ways that candidate products might work to reduce infection.12
1. The first approach is to build or improve upon what the body already does to protect itself. For example a healthy vagina is normally acidic, which makes it inhospitable to invading pathogens like HIV. But semen counteracts this acidity, creating an environment where HIV can survive. Some candidate microbicides build on the simple principle of maintaining the vagina’s natural acidic even in the presence of semen.
2. Surfactants disable the virus by breaking up its surface membrane or envelope. They can also disable sperm in the same way so they are also effective contraceptives. The trick is to make sure that surfactants are strong enough to disrupt the invading pathogen, but without damaging the healthy cells that line the vagina’s walls.
3. Entry inhibitors work by interfering with the virus getting into the body’s white blood cells—the target cells of HIV. There are two categories of entry inhibitors: attachment inhibitors that prevent attachment of the virus to the white blood cell and fusion inhibitors that prevent HIV from actually entering the cell.
4. Finally, some microbicides are being created by reformulating the same anti-retroviral drugs developed to treat people with HIV. These drugs are designed to stop HIV from replicating. So what happens if you make them into products that can be applied in the vagina? Could you stop the replication of any HIV that enters a vaginal cell so that the virus does not have a chance to disseminate and enter the blood stream? That’s what some researchers are trying to find out.
The first microbicides to become available may operate with just one mechanism of action. It is very likely, however, that later generation microbicides will be combination products -- using two or more mechanisms of action to enhance their effectiveness.
4. anti-retrovirals
3. entry inhibitors
Source: Shattock, R.; Moore, J. Inhibiting Sexual Transmission of HIV-1 Infection. Nature Reviews Microbiology. Vol 1, October 2003.

14. The Product Pipeline in 2006
3 products
3 products
4 products
30+ products
Laboratory Testing
2-6 Years
Phase I
(safety)
1 to 6 Months
Phase II
(safety)
Up to 2 Years
Phase III
(efficacy)
2 to 4 Years
25 – 40 people
people
3,000-10,000 people
As you can see, drug development is a long and complicated process…taking more than a decade to develop and test a new drug for use.
Before any new drug candidate can be tested in human beings, the developers have to show that (a) it’s not likely to be harmful to humans and (b) it may be beneficial. The research is done in laboratory testing and in animals and can take anywhere from 2 to 6 years. Currently there are over 30 candidates in pre-clinical testing (i.e. that is, that have not yet entered human testing).
If a product is approved for human trials, it goes first through a series of Phase I safety trials, where small numbers of people who are at low risk of infection use the product and are carefully monitored for signs of problems. Next come one or more Phase II trials to gather extended safety data and establish safety among different groups of people–-for example, those who may already be HIV positive or have another sexually transmitted infection.
If a product is shown to be safe in these first two phases, a product can then be tested for effectiveness. The Phase III trials can take several years because they need to enroll thousands of women who use the product for many months up to several years to see if it reduces their risk of HIV infection. It may be necessary to do two Phase III trials before a product can be licensed for use.
While clinical trials are going on in women, researchers also need to undertake separate trials to look at whether the product is irritating to the penis or rectum.
[Products in Phase I/II are counted as Phase II and products from Phase II/IIB are counted as Phase III products. 13]
Simultaneous studies in some cases:
HIV+, penile & rectal safety
10 or more years
Source: Alliance Pipeline Update, first week of every month -

15. Clinical Trial Sites in 2007
EUROPE
- Belgium: Phase I/II
THE AMERICAS:
-United States: Phase I, II, IIB
-Brazil: Phase II
ASIA
-India: Phase II
-Thailand: Phase I
WEST AFRICA:
-Cameroon: Phase I, II
AUSTRALIA
- Phase I
SUB-SAHARAN AFRICA:
-Botswana:
-Kenya: planned
-Madagascar: Phase
-Malawi: Phase II, IIB
-Rwanda: Phase I/II
-South Africa: Phase I, IIB, III
-Tanzania: Phase III
-Uganda: Phase III
-Zambia: Phase IIB, III
-Zimbabwe: Phase I, II, IIB
This slide is to give you a sense of where these trials are taking place.14
As you see, Phase I and II safety trials are going on all over the world, but especially concentrated in the U.S. and Africa.
To study effectiveness, a microbicide has to be tested by large numbers of women at high risk of sexually transmitted HIV. This means that the countries in which Phase III trials are carried out must have:
·  A high incidence of HIV
· A stable population so that participants can be followed up easily
·  Almost no injecting drug use or other sources of HIV risk among women
These conditions are found across sub-Saharan Africa and in India and parts of Southeast Asia. Places where HIV is prevalent among women in the North America and Europe also tend to have high rates of injecting drug use. This factor could confuse the trial results by introducing other sources of HIV risk. In part due to this reason, the majority of effectiveness trials are taking place in Africa, as indicated here.
[Map21]
Source: Alliance for Microbicide Development

16. Experience of a Phase III Participant
Family Planning
Informed consent for screening
Informed consent to enroll.
Condoms + comparator gel
Condoms + experimental gel
Every woman who is recruited for an effectiveness trial goes through a careful informed consent process in their own language and is tested for HIV and other STIs. Women who test positive for HIV can’t enroll in these first effectiveness trials because women have to be negative at the start of the trial to see how well the product helps them to remain negative. Women who test positive are connected to local providers of HIV-related care, treatment and support.
Everyone in a Phase III trial receives state-of-the-art HIV prevention services. Right now, this means participants receive intensive risk reduction counseling, including condom counseling, large supplies of condoms and treatment for sexually transmitted infections if needed. All the women are encouraged to use condoms, whether they are given the active microbicide or not.
In order to actually find out if the experimental microbicide works, the trial participants are randomly divided into two groups:
Those who receive the condoms and prevention services plus the experimental microbicide gel.
Those who receive the condoms and preventions services plus a placebo gel that looks just like the drug being studied but does not contain the active ingredient.
An independent data safety monitoring board monitors the trials for any concerns that suggest the trial should be stopped.
At the end of the trial researchers compare the two groups to see if the HIV rate is lower among those who received the microbicide versus those who received the placebo. If it is, that difference is the measure of the microbicide’s effectiveness.
Trials can also bring increased health care, prevention services and treatment access into highly-impacted communities. How those services are provided and how well they are continued after the trial is a subject of intense ethical debate among researchers and communities. One of the Global Campaign’s functions is to help trial communities prepare to advocate effectively for their communities during this process.
Recruitment: Participant receives information about the trial in their own language
Screening Visit 1: Education about the trial, HIV and pregnancy test, STI tests and treatment, baseline data collected
Screening Visit 2: Results of tests, counseling, reinforce education about trial
Randomization: Participant assigned by chance to a group.

17. 3 Products Furthest Along
Trial sponsor
# women to be enrolled
Location
Preliminary results expected in
Buffer Gel
HPTN035-NIH
3,100 women
South Africa, Malawi, Zambia, Zimbabwe and Philadelphia
April 2009
Carraguard
Population Council
6,299 women
South Africa – 3 locations
December 2007
PRO2000 (.5%)
PRO2000
(.5 and 2%)
DFID, MRC
9,763 women
South Africa, Uganda, Zambia, Tanzania
December 2009
As you saw earlier, there are currently three products in large scale effectiveness trials around the world. This slide shows the names of these products and the group running the trial in the first column, how many people the trials aim to recruit, where they are taking place, and when we can expect results assuming everything goes according to plan.14
I like to show this slide not only so that you can become familiar with the names of the products and also to recognize the thousands of women who are involved in this endeavor. On average a woman in a current effectiveness trial will attend 29 study visits, including monthly visits for HIV and pregnancy tests, and have 11 pelvic exams and over 2 years. It is so important to recognize and honor their commitment.16 Without their participation, it would be impossible to find out which, if any of these candidate microbicides, actually works.
[Expected preliminary results.15]
[For a more technical audience, you can hand out a copy of the Global Campaign’s Factsheet #13 Clinical Trial Watch that describes these products in more detail –
[For more information on the January 2007 Cellulose Sulfate trials closure, please see:

18. When can we expect a microbicide?
Earliest results from current Phase III trials in
If shown to be effective, a microbicide may be available in a few countries via introductory studies in the next 5 years
If not, we will have to wait for results from second generation products
Results from the trials furthest along could become available in 2008, but it will take additional time for the products to be reviewed and approved for licensure – at least 1-2 years. Thus, a microbicide could be ready for introduction by 2010, but that would only happen in a few countries, and most likely through smaller scale introductory programmes.
If the current set of products in effectiveness trials does not prove effective, the time horizon will be longer. There are several second-generation leads already in human testing, so we need to ensure that the entire pipeline continues to advance.
Due to advocates work around the world and the recent attention on microbicides at the 2006 International AIDS Conference in Toronto, millions of people have heard about microbicides. The challenge that the microbicide field faces now is to find the correct balance between building enthusiasm and political support for microbicides, while avoiding raising unrealistic expectations in the media or our outreach work.

19. Public Funding is Essential
Why aren’t large pharmaceutical companies investing?
Perceived low profitability
Liability concerns
Lack of in-house expertise
Uncertain regulatory environment
Philanthropic Sector, 13%
Public Sector, 87%
New drugs are usually developed by large pharmaceutical companies with the resources to pay for large clinical trials and other costly research processes. Microbicides-- like malaria vaccines, new contraceptives, and many other products – however are called “public health goods”. They could yield huge returns to society but they hold little profit potential for private investors. Thus, no large pharmaceutical companies are putting substantial funding into microbicide research yet. Instead, small biotech companies, universities, government agencies, and non-profit entities are doing the research and are being funded by governments and private foundations.17 This means trials are not moving forward as rapidly as they could because they are delayed due to lack of money.
Some large pharmaceuticals have allowed non-profit groups to test products that they own. The pharmaceutical companies do not pay for the trials for these products, they simply lend the product to these non-profit organizations. It is still tax payers and private foundations that are footing the bill for these very expensive clinical trials – up to $50 Million for a Phase III trial18. Money remains a major limiting factor in how rapidly microbicide research can proceed.

20. Annual funding needs to double!
$3M
Annual funding needs to double!
In June 2005 several organizations, calculated how much was being spent on microbicide research, development and advocacy worldwide19. The answer was US$140 million in 2004 (all of the blue bars added up). Of that, $65 million went to research, $72 million went to product development and $3 million went to advocacy efforts.
The group then calculated what was really NEEDED annually to assure the successful development of a microbicide within the next 10 years20. The answer was $280 million (the bottom bar); with
Advocacy more than tripling
An additional $20 million invested in the development and maintenance of clinical trial sites
Clinical trials funding increasing by 60% from $72 million to $120 million. Keep in mind that each Phase III trial can cost up to $50 million18.
Basic scientific research to identify new candidate products doubling from $65 million to $130 million
This is how much is needed to keep the research pipeline moving forward efficiently and to get a safe, effective microbicide on the market as quickly as possible. Under-funding is costing us by delaying progress – and, when it comes to HIV prevention, that delay can be measured in numbers of lives.
All combined: Need $280M

21. The Global Campaign for Microbicides works to:
Ensure that as science proceeds, the public interest is protected - Accountability
Mobilize demand and investment for research and development of new prevention technologies
Conduct policy advocacy for development, introduction, access, and use
The Global Campaign for Microbicides was created to coordinate and support advocacy in the microbicide field toward three goals.
First, a cornerstone of our work is to ensure that, as the science proceeds, the public interest is protected and the rights and interests of trial participants, users, and communities are fully represented and respected. The Campaign works with partners in trial communities to make sure that they are fully informed and involved in how the trials proceed. We want to make sure that the researchers are accountable to the communities they work with.
Second, the Campaign works to mobilize resources that will accelerate the process of microbicide research and development. But people can’t demand what they have yet to envision. So we start by raising awareness so that the people see microbicides as a possible tool that they have the right to demand.
Finally, the Campaign advocates for timely and fair development, introduction, and use. We are vitally concerned about access -- making sure that the approved products will be widely available and introduced in a way that helps people understand them and use them correctly. This means we also have to focus on issues of pricing, distribution, stigma, gender bias and women’s empowerment, as well as product development and approval.

22. GCM Global Partners Europe: UK, Ireland, Netherlands,
Scandinavia, Spain, Portugal, Germany,
France, Belgium, and Russia
Canada
Asia:
Thailand
and India
Australia
The Global Campaign for Microbicides works primarily through the shared commitment and collective agenda of its 285 endorsing groups worldwide, of whom 55 serve as active Campaign partners. These partners are, or work with, key interest groups including women’s health advocates, gay men's health advocates, international development organizations, gender equality organizations, and HIV/AIDS service providers. The Campaign is coordinated by two secretariats in Washington DC and Brussels, and we also have staff based in Kenya and India.
The Global Campaign amplifies advocates’ voices by equipping them with a growing body of free resources and materials. We work with and support partners and coalitions around the world [Indicate Map].
We work with these partners not just on advancing microbicides, but also to support advocacy for increased access to existing prevention strategies, research into other prevention technologies like cervical barriers and vaccines, funding for treatment and care initiatives, and more broadly working on issues of social justice and gender equality. It is only by a comprehensive response that we will ever tackle the HIV/AIDS pandemic.
Map20
United States:
CA, CT, DC, IL, NY, MA, OH, PA, WA
African:
Kenya, Ghana,
Nigeria, Uganda, and
South Africa.

23. In the Global North public demand political support public awareness
increased resources for R&D ($$$)
Goal: All people know about & have access to affordable microbicides
safe and effective microbicides on the market
Before I finish, I want to talk a bit more specifically about how we do our work in the Global North and Global South. Based on the funding figures I showed you earlier, advocates around the world have a very clear message: “We need new HIV prevention methods. Public investment into microbicide research and development must be doubled until the first products are available.”
But how do we take this message and make it a reality? How do we generate the political pressure it will take to achieve our long term goal – getting microbicides into the hands of the women and men who most need them. (indicate largest circle on the slide) [Talk through diagram going counter-clockwise from the yellow circle]
Before we can achieve this goal, we need to first have safe and effective products on the market – microbicides that have gone through all of the laboratory and clinical testing and even made it through the necessary regulatory hoops.  
All of this testing takes money. And governments generally don’t invest in projects like this unless there’s public pressure on them to do so. Most of the time, politicians act in response to some type of public demand. The public demand for microbicides has to really grow before it generates enough heat to make the politicians increase research funding.
So the very first step, and the one we need your help with, is getting the word out about what microbicides are, why they are so critical at this moment in time and what we need to do to make them a reality.

24. U.S. Microbicide Development Act
Will authorize funding increases as needed
Will require National Institutes of Health to:
establish a branch dedicated to microbicides
expand and coordinate the research efforts of all 3 federal branches (NIH, CDC and USAID)
Take Action: Write, call, or visit your legislators to ask for their support!
Here in the US, the Microbicide Development Act is one example of a policy initiative mobilized by the Global Campaign and its allies and advanced at the grassroots level by the collective advocacy of American Global Campaign sites. This bill was introduced will be introduced with bipartisan support in both the House and Senate in March 2007.
The Global Campaign and other advocates work with supportive legislators to draft the bill and conduct meetings with key legislators to build support. The Bill is written to greatly strengthen the federal commitment to microbicide research by requiring increased funding and by requiring the US National Institutes of Health (NIH) to establish a dedicated microbicides branch. Currently the NIH is the largest government funder of microbicide research in the world, but it still spends less than 2% of its AIDS research budget on microbicides.
Legislation of this type has been introduced in the US Congress previously but it has never passed because not enough legislators have supported it. It’s not that anyone is publicly opposing funding for microbicide research. The problem is that most Congress members have never heard of microbicides. Their constituents haven’t been calling them about it.
Global Campaign advocates in the U.S. are out to change that by asking people to write, call, or even visit their Representatives and Senators and urge them to support the Microbicide Development Act. The US section of the Global Campaign’s web site, features a page where voters can their legislators.

25. In the Global South Community involvement initiative
Facilitating authentic public engagement among communities hosting trials
Providing trainings and a resource kit
Research ethics initiative
Finding a balance between urgency and ethical standards
Facilitating dialogue, ethics training course
Support national advocacy efforts
The Global Campaign’s agenda in developing countries, or, what we call the Global South, focuses on activities and partnerships in countries hosting microbicide trials. Our community involvement initiative supports researchers and communities to build effective partnerships for microbicide research. Too often, commitments to “involve” consumers or community groups in research achieve mere tokenism. To address this, we work with partners to create a framework for developing “community involvement plans” —grounded in principles of partnership, mobilization, and sustainability—that facilitate the design and conduct of clinical trials that are both scientifically rigorous and ethically sound. Together, we have created and produced skills-building programs and activities that help build civil society capacity for taking on authentic participation and ensure that their advocacy strategies are informed by an accurate understanding of the scientific issues at hand.
The Global Campaign’s work on ethics helps build capacity in the community sector for ethical deliberation and debate. Our aim is to find a balance between:
the urgency of finding a safe and effective microbicide,
the need to maintain rigorous ethical standards, and
the critical imperative protecting the rights and interests of trial participants and host communities.
The Global Campaign offers a training course in ethical reasoning that builds stakeholders’ capacity to effectively advocate on behalf of their own constituencies.
In addition Global Campaign works to support and strengthen existing advocacy efforts in key developing countries that have a high profile in global AIDS discourse and networks, like India, Nigeria, and South Africa.

26. What You Can Do Visit www.global-campaign.org…
Get in touch with local advocates
Sign up for GC News
Write to your public officials!
Endorse the Global Campaign
Educate others:
Presentations
Events
Web-links
I don’t want you to leave here today thinking that you, as an individual can’t make a difference on this issue. You can.
The first thing you can do is link up with a Global Campaign partner organization if there is one active I your area. They will welcome your involvement -- even if you just want to be on their mailing list to find out more about what’s going on locally.
At our website, you can sign up to receive our (free) monthly e-newsletter, find additional information about what’s happening in the microbicides field, and also write to your public officials.
You can urge community groups, organizations and service providers in your community to endorse the Global Campaign.
Finally, now that you have heard this presentation, you know more about microbicides than most people around the world. We hope that you will join us in spreading the word about this vital new technology. You can make a presentation like this one – the slides and accompanying script are on the Global Campaign website, you can write an article on microbicides in a newsletter, or you can distribute the Campaign’s simple factsheets, available in a variety of languages. Finally, you can order our short film, In Women’s Hands and incorporate it into an event. Please come talk to me after the presentation to talk about how you can get involved.
I want to leave you with an image that I find inspiring – it is a picture of five women who worked at a clinical trial site in Uganda. Thank you for your attention.
Newsletters
Use our film
Fact sheets

27. References: I don’t want to die before I turn 25.
Remember! Updates of this presentation are available at
Report on the Global AIDS Epidemic. UNAIDS. World Health Organization. Geneva, Switzerland. Dec 2006.
2. World Health Organization, AIDS Epidemic Update. December 2005.
3. European Study Group on Heterosexual Transmission of HIV. Comparison of female to male and male to female transmission of HIV in 563 stable couples. British Medical Journal ; 304:
4. Economic Security for Women Fights AIDS. Global Coalition on Women and AIDS Report, Issue #3. UNAIDS Initiative. Geneva, Switzerland
Kelley Hallman, “Gendered socioeconomic conditions and HIV risk behaviors among young people in South Africa,” African Journal of AIDS Research, 2005, 4(1):37-50.
Richard Strickland, “To Have and To Hold: Women’s Property and Inheritance Rights in the Context of HIV/AIDS in Sub-Saharan Africa,” ICRW Working Paper, June 2004.
5. Garcia-Moreno C and Watts C (2000) ‘Violence against women: its importance for HIV/AIDS’, in AIDS, 14, Geneva.
6. Royce, R.A.; Sena, A.; Cates, W. Sexual transmission of HIV. New England Journal of Medicine. 1997; 336:
Abreu, M.; Anton, P.; Coombs, R. Anatomy, physiology, immunology of the anorectal mucosa. From: Rectal Microbicides Workshop: Baltimore, MD, June 7-8, 2001; Rectal microbicides that protect against HIV infection:8. American Foundation for AIDS Research.
7. Foss, A.; Vickerman, P.; Heise, L. Shifts in condom use following microbicide introduction: should we be concerned? AIDS 2003, 17:
8. Studies show that consistent use of latex condoms reduces the likelihood of HIV infection by 80 to 90 percent. “USAID: HIV/STI Prevention and Condoms. May 2005”: 
Pinkerton, S.D.; Abramson, P.R. Effectiveness of condoms in preventing HIV transmission. Social Sciences & Medicine 44(9):1, From Condom Promotion for AIDS Prevention in the Developing World: Is it Working? By Norman Hearst and Sanny Chen.
Davis KR and Weller SC. The effectiveness of condoms in reducing heterosexual transmission of HIV. Fam Plann Perspect 1999;31:
Weller S, Davis K. Condom effectiveness in reducing heterosexual HIV transmission (Cochrane Review). In: The Cochrane Library, Issue 2, Chichester, UK, John Wiley & Sons, Ltd.
HIV Tools Research Group: Department of Public Health and Policy, London School of Hygiene and Tropical Medicine. Are people using condoms? Current
evidence from Sub-Saharan Africa and Asia and the implications for microbicides. November 2003.available from GCM website:
Foss, A.; Watts, C. Condoms and prevention of HIV are essential and effective, but additional methods are also needed. British Medical Journal. Vol July pp
Jenkins, R. A.; Manopaiboon, C.; Samuel, A. P. Condom use among vocational school students in Chiang Rai, Thailand. AIDS Educ Prev 2002; 14(3):
11. Brady, Martha. Population Council, Conceptual Framework
12. Shattock, R.; Moore, J. Inhibiting Sexual Transmission of HIV-1 Infection. Nature Reviews Microbiology. Vol 1, October 2003.
13. Alliance for Microbicide Development News Digest. Vol. 7, No. 33. September 2006 Pipeline Update.
14. Alliance for Microbicide Development, Microbicides Research and Development Database.
15. Ramjee, G. Microbicides and other prevention technologies. XVI International AIDS Conference, Toronto: 15 August, Plenary session: Proven approaches and new technologies.
16. Microbicide Clinical Trials: Needs and Challenges, Salim Abdool Karim, MBChB, PhD, Director, Centre for the AIDS Programme of Research in South Africa (CAPRISA), Presented at US Congressional briefing, 18 July 2006.
17. Financing the expanded response to AIDS: HIV vaccine and microbicides research and development. UNAIDS,
18. Lamphear, T. Determining the Costs: Getting to proof-of-concept. Microbicides 2004 Conference. London, UK, 30 March, 2004.
19. Harrison, P.; Lamourelle, G.; Rowley, J. Warren, M. Tracking funding for Microbicide Research and Development: Estimates of annual investments 2000 to HIV Vaccines and Microbicides Resource Tracking Working Group Report. June 2005.
20. African Microbicides Advocacy Group, Alliance for Microbicide Development, Global Campaign for Microbicides, International Partnership for Microbicides. (8 July 2005). “Global Health Leaders React to G8’s First –Ever Call for More Investment in Microbicides to Protect Women from HIV”. Press release.
21. Graphic Maps.
22. Quote from last slide: Quote found in UNICEF, Facing the Future Together: Report of the Secretary-General's Task Force on Women, Girls and HIV/AIDS in Southern Africa, July – Quote from UNICEF’s Voices of Youth,
Frank Herholdt, Courtesy of Microbicide Development Project
I don’t want to die before I turn 25.
I refuse to sit down and watch my generation fall to pieces.
I am going to make a difference…Will you?
Rumbidzai Grace Mushangi, age 15, Zimbabwe