Rationale

Most of the world's women do not control when, with whom and with what protection, if any, they have sexual relations.

This powerlessness is most acute in developing countries where HIV prevalence is highest (20-30% in women) and where the epidemic is escalating.

Women's most urgent need - and arguably the world's most urgent need in relation to HIV/AIDS - is for a prevention technology which women control themselves.

Now rather than later, lack of power and autonomy is the root cause of women's vulnerability. But empowerment will take generations!

 

Why must the technology be controlled by women?

• We know from experience with contraceptives that when women control use and when they do not need to involve their partners, the method is used more effectively.
• Condoms (male or female) offer protection but they are not used and women cannot control their use. Studies have shown very low use of male condoms even in favourable circumstances.

What is a microbicide?

A microbicide is any substance that can substantially reduce transmission of sexually transmitted infections (STIs) when applied either vaginally or rectally. While no effective microbicidal products are currently available, potential products could be in the form of:

• Gels
• Creams
• Films
• Sponge or vaginal ring
• Suppositories
• Contraceptive and non-contraceptive formulas
  A cream, gel or suppository that can be discreetly inserted into the vagina before sex. Ideally it would kill or block not only HIV but also other sexually transmitted infections. For the many women, especially in developing countries, wanting to have children, we also need a microbicide which is not a spermicide.

Who needs microbicides?

• 15 million new STI cases are reported each year in the U.S., translating into 42,000 new infections each day. Roughly one half of individuals infected with STIs contract lifelong infections.
• Two-thirds of new STI infections occur in people younger than 25 years of age. .Biologically, women are four times more vulnerable to HIV and are the fastest growing group with HIV/AIDS in the country. They accounted for 23% of new AIDS cases and 32% of new HIV cases in 2001.
• African-American women and Latina women suffer disproportionately from HIV/AIDS: though only 23% of the female population in the US, they account for 76% of AIDS cases reported among women.

Why is there a need for methods of disease prevention that women initiate?

• Many women lack the power within relationships to negotiate condom use and the social and economic resources to abandon partnerships that put them at risk. .Anatomical differences place women at a greater risk of contracting STIs than men.
• Age-related changes in the cervix make risk of infection even higher for adolescent women.
• Heterosexual sex, once the source of only a small fraction of HIV infections, now accounts for three out of four new infections in women.

Why are STIs a major health concern?

• All STIs, both those that create visible, open sores and those that are invisible and asymptomatic, increase a woman's risk of contracting HIV. .Pelvic Inflammatory Disease (PID) is a common result of undetected or untreated STIs. As many as 100,000 U.S. women may become infertile and 45,000 may experience a dangerous ectopic pregnancy as a result of PID.
• Researchers estimate that at least one in four Americans - and maybe as many as one in two - will contract an STI in their lifetime.
• The total cost on the US economy of STIs, excluding HIV infection, was approximately $10 billion in 1999 alone. That number rises to $17 billion when the economic costs associated with HIV are included.
• In parts of sub-Saharan Africa, as many as one in four people are infected with AIDS, 55% of them are women. Nearly 25% of 15- to 19-year-old girls are infected with HIV compared with 4% of their male peers.
• More than 10 million children under the age of 15 have lost one or both parents to AIDS worldwide.

What options exist for detection, treatment and prevention of STIs?

• Many women who contract STIs do not experience symptoms, making detection difficult. Screening of asymptomatic women is the only way to detect many infections. While cost-effective technologies for STI screening exist, routine screening is not common because of lack of awareness among healthcare providers and lack of resources for screening activities.
• Bacterial STIs can often be treated and cured with antibiotics, especially if diagnosed early. We have no cure for viral STIs, but symptoms associated with the infection can be remedied. Treatments for HIV/AIDS, including antiretroviral drug therapies, are often successful in reducing the amount of the virus in the body. .Adequate and appropriate treatment for STIs, especially for HIV/AIDS, is often not available to the under- and uninsured. Those most affected by and infected with HIV/AIDS often lack access to treatment options.
• Abstinence and consistent condom use are the only effective methods of STI prevention available. These are not feasible options for some women. .Aside from the female condom, no woman-initiated methods of STI prevention are currently available.

Why might women be more likely to protect themselves if microbicides were available?

• Microbicides are less intrusive than condoms, could be applied in advance of intercourse, and could be used without the partner's knowledge.
• Even if microbicides were theoretically less efficacious than condoms, they may be more effective in prevention of STIs due to greater consistency and prevalence of use. In other words, microbicides could have a greater protective effect in practice than condoms because they might be used more often and more consistently.

Do products which contain N-9 help prevent STIs?

Clinical trials have shown N-9, the active ingredient in most over-the-counter spermicides, has not been effective in preventing HIV transmission and is not recommended as a method of STI prevention.

Why so little research?

Sixty candidate microbicides are in the pipeline; but none will be available to the public very soon.

Research and Development is being done by small biotechnology companies, individual academic researchers, on shoestring budgets.

Development costs tens of millions of dollars which only the big pharmaceutical companies have.

Trials must meet high ethical standards, e.g. all women enrolled must use both condom and microbicide; huge numbers of participants required and will be very costly.

Microbicides are not seen as profitable; principle market being poor women. Advocates argue that the potential market is larger than this.

Some advocates say candidate microbicides should be distributed at low cost to women in need, before further testing. They are generally regarded as safe, we just don't know how well they work - 80% or 30% efficacy.

Sources:

1. Centers for Disease Control and Prevention. Tracking the Hidden Epidemics: Trends in STDs in the United States, 2000. Report prepared for the 2000 National STD Prevention Conference, Milwaukee, Wisconsin.

2.Emron. STD Update: Incidence Trends and New Screening Tests. The Contraception Report. 2000; 2(3); 4-10.

3.Heise, Lori. Topical Microbicides: New Hope for STI/HIV Prevention. CHANGE, 2000.

4.The Rockefeller Foundation Microbicide Initiative. Mobilization for Microbicides: The Decisive Decade. 2002

5. WHO Fact sheet 246 June 2000.