FEMALE CONDOMS OF TODAY AND TOMORROW: STRATEGY CALL ON RESEARCH AND DEVELOPMENT (R&D) AND ADVOCACY

Transcription

1 FEMALE CONDOMS OF TODAY AND TOMORROW: STRATEGY CALL ON RESEARCH AND DEVELOPMENT (R&D) AND ADVOCACY Center for Health and Gender Equity (CHANGE), AIDS Foundation of Chicago, PATH, AVAC, Conference Call Notes, September 30, 2010 I. Overview of female condoms currently available worldwide - Kimberly Whipkey, Senior Associate for Advocacy and Outreach, CHANGE Current products available through commercial or private sectors: 1. FC1 and FC2 are manufactured by the Female Health Company. FC1 and FC2 are identical in design and appearance, with a silicone lubricated sheath and flexible rings at each end to aid insertion/anchor the condom in the vagina, but FC2 is made of nitrile, a synthetic latex that decreases manufacturing costs. FC1 is no longer manufactured. WHO deemed the FC2 acceptable for bulk procurement by UN agencies in To date, FC1 and FC2 are the only female condoms approved by the U.S. Food and Drug Administration (USFDA). FC2 is available in more than 120 countries worldwide. 2. VA w.o.w (also known as Reddy, V-Amour, L amour) is manufactured by MedTech Ltd of India. It is made of latex, comes with silicone lubrication, has a V-shaped outer frame, and uses a sponge to secure the condom in the vagina.va w.o.w. is not USFDA approved and is under WHO review, pending data from a 2011 clinical trial. It carries the CE Mark and has been distributed in many countries such as India, Brazil, Portugal, South Africa, and the United Kingdom. 3. Cupid is a new design and is manufactured and available in India and some European countries. It is made of latex, comes lubricated with silicone, is available in natural and pink colors and a vanilla flavor, has an octagonal frame, and uses a sponge to secure the condom inside the vagina. Cupid does not have USFDA approval and is under review at the WHO, with further clinical trials planned. It has the CE Mark and is registered by the Indian Drug Authority Control. 4. Phoenurse is produced and distributed in China. It is made of polyurethane and comes with an insertion tool, a water-based lubricant, sanitary towel, and disposable bag. Phoenurse does not have USFDA or WHO approval, though it has approval from the Chinese State Food and Drug Administration. 5. Panty condoms are available in many designs, such as the Natural Sensation Panty Condom. The panty performs same function as the outer ring/frame in other female condoms. New sheaths must be secured in the panty and removed after each use. The Natural Sensation Panty Condom carries the CE mark and is in limited global supply. 1 P a g e

2 II. What advocates can do to accelerate female condom research and development - Mitchell Warren, Executive Director, AVAC Global Advocacy for HIV Prevention We must get smart about the state of play regarding female condoms and identify the needs and opportunities for FC R&D. Advocacy should not just focus on more money. In a time of resource constraints, how do we do better with what resources we have? FC R&D has been going on for a long time o Alterations or improvements have been made to existing products (FC1/FC2) o But different models do not work the same, which has implications for regulatory pathways o Safety, efficacy, and function of FC models that differ from FC1/FC2 must be quantified through clinical studies, and this costs money. How do we accelerate FC R&D processes? o We need to advocate for clear regulatory processes All female condom products go through a review process with regulatory agencies, like the U.S. Food and Drug Administration, WHO, UNAIDS Advocates should push for clear descriptions of what information from clinical studies is required during regulatory review vs. what is nice to have Advocates can also push for advanced market or purchase commitments. Advanced purchase agreements would send a signal to developers and donors that if you build it, we will come. o We need to do multilayer advocacy. Advocacy for products today strengthens advocacy for tomorrow s female condoms. Advocating for procurement and programming of available FCs sends signal to developers that this is a product to be taken seriously. Donors can invest in product design, clinical studies, etc. with confidence that the product will be procured and successfully programmed and distributed. o Nothing happens in vacuum FC R&D advocates need to think about the broader prevention context, especially funding. Many demands for funding of different interventions (PrEP, microbicides) Must develop a budget for FC R&D that lies within the context of other HIV prevention technologies, within the context of broader HIV/AIDS interventions 2 P a g e

3 III. Female condoms in the research and development pipeline - Patricia Coffey, Senior Program Officer and Woman s Condom Team Leader, PATH The Woman s Condom, developed by PATH, was designed to improve acceptability and ease of use What does R&D mean relative to the Woman s Condom? o PATH looks at product development within context of larger market development o Innovation realm, narrow focus o Introduction realm, how to develop markets for these products o Demonstrate usefulness in field, so can expand availability and have impact at the population level o Must ensure sustainable supply and strategic programming of FC PATH started work on the Woman s Condom in 1996, in response to the need for more woman-initiated prevention products, and also in response to some limitations of FC1 PATH talked with women and men around the world to determine whether there was a need for a new FC product design and what features would be desirable This needs assessment helped create the following specifications for the Woman s Condom: o Ease of handling and insertion o Ease to use, especially for new users o Stability during use o Comfort o Ease of removal o Less expensive important programmatic issue in today s climate Woman s Condom description: o Insertion capsule of polyvinyl alcohol aids insertion and makes the condom look smaller, more aesthetically pleasing o Once inserted, the capsule comes into contact with moisture in vagina, and starts to dissolve quickly o Condom unfurls, and four foam pads lightly adhere to walls of vagina to keep condom in place during sex o Sheath made of polyurethane film (thin, transmits heat, feels good) o Ring fits against pubic region, does not allow for significant movement o Does NOT come lubricated, users should add lube inside the pouch (and on capsule, to aid in insertion) Clinical/Regulatory Status of Woman s Condom o Manufactured by Shanghai Dahua Medical Apparatus Company in China o Submitted dossier to Chinese SFDA o Expecting product registration in China end of 2010 or beginning of 2011 o Planning product launch in China beginning of 2011 Phase II-III effectiveness trial by NIH in US 3 P a g e

4 o Will start soon, anticipate conclusion of study in 2012 o If data is favorable, PATH will compile regulatory dossier for submission to USFDA for regulatory approval in 2013 Women s Condom is also currently in study implemented by CONRAD using the presence of semen in the vagina as a biomarker to assess whether contraceptive failure occurred. The study is ongoing and should be ending in 2010, with data available in IV. Current U.S. and international female condom distribution efforts - Lucie van Mens from Universal Access to Female Condoms (UAFC) Joint Programme UAFC is a consortium of European and African organizations aimed at making FC affordable, available, and accessible UAFC invests in large scale FC programming and education about FC, with programs in Nigeria and Cameroon UAFC also involved with FC R&D through financial support Why more R&D? Variety and choice will positively affect use of FC. Market competition will have a positive impact on the procurement price, as price is a barrier for FCs relative to male condoms. UAFC also advocates for R&D through international meetings and conferences o At AIDS 2010, promoted FC2, Reddy, and Woman s Condom UAFC does manufacturing and regulatory advocacy o Ex: UAFC initiated and supports a functionality study that will start this fall in China and South Africa comparing different FCs: Reddy, PATH, Cupid against the FC2 benchmark. o This study is important because its results can be used in the WHO prequalification process. Clearance from WHO gives UN agencies authority to procure reproductive health products. UAFC participating in UNFPA/WHO meeting in Bangkok in December for FC manufacturers. Meeting will cover: design, production, quality assurance, tests and testing requirements, clinical evaluation, specification, prequalification and approval for bulk procurement. V. Jessica Terlikowski, Policy Manager, AIDS Foundation of Chicago (AFC) Chicago FC campaign launched in March 2010, messaging reaches gay men in addition to women and girls Key partners include government agencies, women s organizations, gay men s health organizations, reproductive justice, HIV/AIDS groups Wanted to introduce FC2 to a new generation of people, because it s been 17 years since FC1 was introduced, so there is a new and potentially captive audience. Campaign organizing started around approval of FC2 with CBO and government education and outreach Decided to make FC fun and developed Put a Ring on It! slogan. Wanted language, materials, and messaging that would resonate with people and connect with new communities 4 P a g e

5 Questions and discussion AFC developed comprehensive training program for service providers, prevention specialists, and educators about FC use, based off NYC s model. AFC now provides many useful resources: o Brochures, palmcards, website (ringonit.org) - all fun, flashy, colorful o Information on how agencies can access FC2 o Information on how individuals can find agencies with FC2 Successes o Integrated FC2 into HIV 101 training program at the DOH HIV/AIDS unit. o Increased FC2 profile in HIV/STI clinics around the city o Trained 200 service providers at 60 agencies across city on FC2 o 88 percent of trained service providers use the FC2 materials they were given with their staff/communities o 20 percent of those trained increased number of FC2 they are purchasing o More agencies able to distribute FC2 through pool purchasing with the Female Health Company Comment: Participant wanted to reiterate Mitchell s call to action that a clear FC R&D strategy with dollars and a plan for reaching out to larger donor community is absolutely essential. Q: How can we get more money allocated towards programming to ensure female condoms are actually being distributed on the ground? A: R&D advocacy has to be all the way through, all the way down to the programming level. This underscores why we need to have a comprehensive costing plan for FC R&D that includes programming, so we have the evidence to back up our advocacy. Q: The South African government has not been importing female condoms because of questions around government tender process. Does anyone have clarification about whether this is specific to the FC2 or female condoms in general? There s a major lack of female condoms in South Africa, especially around the time of the World Cup A: Some female condoms were available for World Cup. Issues with the tender are being challenged in country, not sure what the status is. Condom importers say that tender documents favor one female condom, the FC2, as it is the only female condom with the WHO approval required for importation. Q: For Jessica, if you had to get permission from Beyonce to use her song, how did you do it? A: Didn t need her permission b/c just using phrase and not song, and not using phrase for the same purpose as she did. Spoke with her lawyers and trademark specialists to make sure there was no conflict. 5 P a g e

6 Q: On the naming and branding of female condoms: we know gay and trans people use FC, so how did PATH decide on name of Woman s Condom? A: Patricia: PATH calls it Woman s Condom to differentiate it from FC2, but don t anticipate that it would be branded or sold as Woman s Condom. For example, in China we have a brand name that we believe will be appealing to both men and women, though the name cannot be released right now. Also, the USFDA categorizes the product as female condom. So we generically call it that, but that s not how the product has to be marketed. Lucie: Nigeria and Cameroon have re-branded the female condom ( Elegance in Nigeria, for example) in UAFC s programs. Gender-neutral naming is very important, so men will not feel threatened. Kim: Just to clarify, female condoms are often re-branded in local markets. One example is that Population Services International branded the FC1 as Feel in Myanmar, with MSM as the target population. Q: Thinking about product roll-out after approvals, what efforts will you undertake to engage women in marketing and branding? How can we ensure that FCs are not targeted only to sex workers? A: Patricia: PATH worked directly with communities of women and men in four different countries (US, South Africa, Mexico, Thailand) when developing the Woman s Condom. Prototypes used, critiqued, and refined by these groups. This process was performed several times. We did not target CSW, but rather appealed to wide range of people with unmet reproductive health needs. Lucie: We distribute female condoms in schools, hair salons, and other places where women congregate in Nigeria and Cameroon. Marriage is still a risk factor for HIV, and we emphasize that FC is dual protection method for married women who have partners resistant to condom use. We also include men in our education and outreach. Q: What is actual status of PATH s Phase II/III trial? A: Patricia: PATH is not involved with the actual trial other than supplying the condoms, though we are monitoring it. CONRAD is the regulatory sponsor for the study, with funding from the U.S. National Institute of Child Health and Human Development, which will take place in 10 U.S. cities. 6 P a g e