1. Improving women's reproductive health through expanding access to key health technologies

2. For maximize impact, new RH product introduction requires: Clear and understood health needs Safe and effective product/approach Demonstrated pilot project success Health systems strengthening Engagement of and support among stakeholders at various levels Global and regional advocacy

3. Introducing new interventions or products for maximum impact Advocate for evidence- based change Disseminate lessons and tools Assess needs Harmonize with communities and existing health care systems Design and implement interventions Evaluate acceptability and performance Involve stakeholders Build capacity Monitor quality Maximize impact

4. Burden of women’s RH health includes 122 million women (1/3 are women 15-24 yr old) have an unmet need for contraception 37 million HIV+ people worldwide; females make up over 60 percent of HIV+ 15-24 year olds; 75 percent in sub-Saharan Africa 500,000 maternal deaths occur each year (70,000 from unsafe abortion) Almost 500,000 new cases of cervical cancer each year, 85 percent in the developing world

5. New and/or underutilized RH technologies and interventions Microbicides Female barrier methods Emergency contraception Cervical cancer prevention strategies

6. 1. Microbicides: search for a safe & effective STI protection product S ubstances that reduce risk of transmission of HIV, STI pathogens when applied vaginally and, possibly, rectally Current research - gels or creams applied with an applicator Future formulations - sponges, time- released vaginal rings, gels combined with cervical barrier devices

7. 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 half of unprotected sex acts 2.5 million HIV infections would be averted in 3 years

8. Laboratory Testing 2 - 6 Years Phase III (effectiveness) 2 - 4 Years Simultaneous studies: HIV+, penile & rectal 10 or more years 5 products 2 products 10 products 10 - 20 products Phase I (safety) 1 - 6 Months Phase II (safety) Up to 2 Years 25 - 40 people 200 - 400 people 3,000 - 10,000 people The product pipeline

9. What do these trials cost? Laboratory Testing Phase I (safety) Phase II (safety) Up to $13 Million Phase III (efficacy) Up to $50 Million Visit www.global-campaign.org

10. 2. Female condoms: build broad stakeholder support and launch large- scale demonstration projects Only female-initiated method currently available for STI prevention, available in over 100 countries As effective as a male condom for pregnancy and STI prevention, and acceptable to many couples But…12 million FC distributed annually compared to 6 to 9 billion male condoms

11. Existing Products

12. Why not more widely used? Lack of political will and donor support Acceptability issues with first-generation product Stigma (identified with sex workers) Product cost, limited product options Social context of women's lives (gender issues, ability to negotiate use, access)

13. How to increase impact Advocacy to boost funding for introduction so women’s protection is a viable option Fund demonstration projects to answer ongoing questions about impact and acceptability Develop collaborations to share research and program tools Accelerate development and approval of next-generation female condoms

14. PATH Woman’s Condom: Performance Objectives Easy to handle and insert Easy to use (especially for new users) Stable during use Comfortable for both partners Easy to remove Less expensive than current options

15. PATH Woman’s Condom Soft-cling foam ellipses provide stability and comfort for a wide range of users Insertion “capsule” makes insertion easy

16. 3. Emergency Contraception: build awareness and systems support Emergency contraception is more effective the sooner it is taken, up to 120 hours after unprotected intercourse. 1 Progestin-only regimen reduces pregnancy risk 89% Combined estrogen/progestin regimen reduces pregnancy risk 75% 2 1. Von Hertzen, H. et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomized trial. Lancet 360(9348):1803-1810 (2002). 2. WHO Task Force on Postovulatory Methods of Fertility Regulation. Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception. Lancet 352(9126):428-433 (1998).

17. Emergency Contraceptive Pills (ECPs) ECPs can prevent unintended pregnancy, BUT Due to low awareness: ECP product availability is restricted Health providers don’t offer it to clients Women don’t know to ask for it

18. Systems support: pharmacies as alternative providers of RH needs Experience in Cambodia, Kenya, and Nicagagua: Pharmacy staff are key primary health providers 1 Clients appreciate easy access Pharmacy schools and networks support offering RH services 1 Data from Food and Drug Administration, Ministry of Public Health, Thailand says that 70% of patients receive services from drugstore. PATH Thailand.Drugstore Capacity-building Programs:A Chronicle of PATH Experiences. 2000.

19. Increase ECP access through building awareness Communicate key messages to 3 key audiences: Evidence-based safety and effectiveness information for policy and decision makers Technical information and counseling skills for health providers and program managers Where to find and how to use ECPs for women who need them. Visit www.cecinfo.org

20. Logos and posters

21. Job aids

22. Client materials

23. Cervical Cancer Prevention: a holistic approach Focus areas: Screening and treatment technologies Service delivery guidelines Community needs and involvement Advocacy * PATH, EngenderHeatlh, PAHO, IARC, JHPIEGO * Visit www.alliance-cxca.org

24. VIA-positive VILI-positive VIA-positive VILI-positive a

25. HPV Testing: a new product on the horizon: START (Screening Tests to Advance Rapid Testing) Existing testSTART test Assay time 4-7 hrs~ 2 hours Accuracy95% sens/85% specAt least comparable Plastic consumablesMultiple stepsGreatly reduced Reagent stabilityRequires refrigeration at 4°C Stability for >90 days at 40°C Instrumentation (heater/shaker) Large footprint, non- portable Portable prototype completed Results readoutLuminometerPrototype instant-film holder

26. Findings Demand for cervical cancer prevention services is strong among women and communities. Organized prevention programs are feasible and can be integrated with existing services.

27. Findings Test characteristics of HPV testing and visual-screening approaches are acceptable in a range of settings. Cryotherapy is safe and effective, and can be delivered by mid-level providers.

28. Findings The single-visit screen-and-treat approach is safe and effective in low- resource settings. This is a major paradigm shift in cervical cancer prevention.

29. HPV vaccine news headlines “Vaccine prevents most cervical cancers.” - New York Times, October 7, 2005. Vaccine proves 100 percent effective in preventing cervical cancer – Seattle Times, October 6, 2005. “Promising new vaccines could wipe out cervical cancer. But they must be administered to preteens, and some groups oppose that.” – Philadelphia Inquirer, July 4, 2005. “OK Roll up your sleeve; new vaccines are arriving but the economics are still a challenge” – Business Week, July 25, 2005.

30. The HPV-cervical cancer link Human papillomavirus (HPV) is a very common infection (more than 50% of adults get it, in most it is a transitory infection). 99.7% of cervical cancer cases are associated with HPV. Progression from HPV infection to cancer usually takes 20-30 years. Currently, there is no treatment for HPV infection.

31. Global distribution of HPV types in cervical cancer

32. HPV vaccine opportunity 2 vaccines protecting against HPV 16 and 18 are nearing licensure. Both have high efficacy in Phase II trials and appear very safe. Phase III trials will involve over 50,000 women worldwide. Both manufacturers express interest in serving developing country markets.

33. But…. Can vaccines be made broadly accessible to the young women who need them the most, given challenges around product supply, information needs, delivery system weaknesses, and community awareness?

34. PATH’s HPV vaccine focus Advance HPV vaccines and promote evidence-based cervical cancer prevention approaches: Public-private sector partnerships Country demonstration projects Forecasting and financing efforts Policy and advocacy programs

35. Introducing new interventions and/or products Advocate for evidence- based change Disseminate lessons and tools Assess needs Harmonize with communities and existing health care systems Design and implement interventions Evaluate acceptability and performance Involve stakeholders Build capacity Monitor quality Maximize impact

36. Jacqueline Sherris, PhD Strategic Program Leader, Reproductive Health sherris@path.org www.path.org